CONDOM AND LUBRICANT MANUFACTURERS SURVEY
JUNE 2018
CONDOM AND LUBRICANT MANUFACTURERS SURVEY
JUNE 2018
This publication is made possible by the generous support of the American people through the US Presidentrsquos Emergency Plan for AIDS Relief (PEPFAR) with the United States Agency for International Development (USAID) under the Cooperative Agreement Strengthening High Impact Interventions for an AIDS-free Generation number AID-OAA-A-14shy
00046 The information provided does not necessarily reflect the views of USAID PEPFAR or the US Government
AIDSFree
The Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project is a five-year cooperative agreement funded by the US Presidentrsquos Emergency Plan for AIDS Relief (PEPFAR) with the United States Agency for International Development (USAID) under Cooperative Agreement AID-OAA-A-14-00046 AIDSFree is implemented by JSI Research amp Training Institute Inc with partners Abt Associates Inc Elizabeth Glaser Pediatric AIDS Foundation EnCompass LLC IMA World Health the International HIVAIDS Alliance Jhpiego Corporation and PATH AIDSFree supports and advances implementation of the US Presidentrsquos Emergency Plan for AIDS Relief by providing capacity development and technical support to USAID missions host-country governments and HIV implementers at local regional and national levels
Recommended Citation
Thior Ibou 2018 Condom and Lubricant Manufacturers Survey Arlington VA Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project
Acknowledgments
Special appreciation to Ms Bidia Deperthes from UNFPA Frank Roijmans from i+solutions Brian McKenna from the Reproductive Health Coalition who contributed to the testing of the survey instrument and to all participating companies
Ibou Thior PATH AIDSFree Prevention Advisor conducted the survey
Contributing editors include Kuyosh Khadirov USAID Senior Market Development Adviser Ariel Berry USAID Program Analyst Chris Jones Global Insights consultant Elizabeth Connor AIDSFree Managing Editor JSI Research amp Training Institute Inc and Margot Harrington AIDSFree Digital Publications Officer John Snow Inc
JSI Research amp Training Institute Inc 1616 Fort Myer Drive 16th Floor Arlington VA 22209 USA Phone 703-528-7474 Fax 703-528-7480 Email infoaids-freeorg Web aidsfreeusaidgov
CONTENTS Executive Summary viii
Background 1
Objectives 2
Methodology 3
Results 4
Company Profile and Products 4
Biggest Barriers to Entering the African Market 4
Ways to Mitigate Manage or Share Risks of African Market Entry 9
Public-Private Partnership 11
Study Limitations 12
Conclusions 13
Recommendations to Facilitate Market Entry 13
Participating Companies 13
Appendix 1 Supplementary Figures 15
Appendix 2 Survey Instrument 17
Appendix 3 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa 25
vi
vii
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
CONDOM AND LUBRICANT MANUFACTURERS SURVEY
JUNE 2018
This publication is made possible by the generous support of the American people through the US Presidentrsquos Emergency Plan for AIDS Relief (PEPFAR) with the United States Agency for International Development (USAID) under the Cooperative Agreement Strengthening High Impact Interventions for an AIDS-free Generation number AID-OAA-A-14shy
00046 The information provided does not necessarily reflect the views of USAID PEPFAR or the US Government
AIDSFree
The Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project is a five-year cooperative agreement funded by the US Presidentrsquos Emergency Plan for AIDS Relief (PEPFAR) with the United States Agency for International Development (USAID) under Cooperative Agreement AID-OAA-A-14-00046 AIDSFree is implemented by JSI Research amp Training Institute Inc with partners Abt Associates Inc Elizabeth Glaser Pediatric AIDS Foundation EnCompass LLC IMA World Health the International HIVAIDS Alliance Jhpiego Corporation and PATH AIDSFree supports and advances implementation of the US Presidentrsquos Emergency Plan for AIDS Relief by providing capacity development and technical support to USAID missions host-country governments and HIV implementers at local regional and national levels
Recommended Citation
Thior Ibou 2018 Condom and Lubricant Manufacturers Survey Arlington VA Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project
Acknowledgments
Special appreciation to Ms Bidia Deperthes from UNFPA Frank Roijmans from i+solutions Brian McKenna from the Reproductive Health Coalition who contributed to the testing of the survey instrument and to all participating companies
Ibou Thior PATH AIDSFree Prevention Advisor conducted the survey
Contributing editors include Kuyosh Khadirov USAID Senior Market Development Adviser Ariel Berry USAID Program Analyst Chris Jones Global Insights consultant Elizabeth Connor AIDSFree Managing Editor JSI Research amp Training Institute Inc and Margot Harrington AIDSFree Digital Publications Officer John Snow Inc
JSI Research amp Training Institute Inc 1616 Fort Myer Drive 16th Floor Arlington VA 22209 USA Phone 703-528-7474 Fax 703-528-7480 Email infoaids-freeorg Web aidsfreeusaidgov
CONTENTS Executive Summary viii
Background 1
Objectives 2
Methodology 3
Results 4
Company Profile and Products 4
Biggest Barriers to Entering the African Market 4
Ways to Mitigate Manage or Share Risks of African Market Entry 9
Public-Private Partnership 11
Study Limitations 12
Conclusions 13
Recommendations to Facilitate Market Entry 13
Participating Companies 13
Appendix 1 Supplementary Figures 15
Appendix 2 Survey Instrument 17
Appendix 3 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa 25
vi
vii
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
AIDSFree
The Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project is a five-year cooperative agreement funded by the US Presidentrsquos Emergency Plan for AIDS Relief (PEPFAR) with the United States Agency for International Development (USAID) under Cooperative Agreement AID-OAA-A-14-00046 AIDSFree is implemented by JSI Research amp Training Institute Inc with partners Abt Associates Inc Elizabeth Glaser Pediatric AIDS Foundation EnCompass LLC IMA World Health the International HIVAIDS Alliance Jhpiego Corporation and PATH AIDSFree supports and advances implementation of the US Presidentrsquos Emergency Plan for AIDS Relief by providing capacity development and technical support to USAID missions host-country governments and HIV implementers at local regional and national levels
Recommended Citation
Thior Ibou 2018 Condom and Lubricant Manufacturers Survey Arlington VA Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project
Acknowledgments
Special appreciation to Ms Bidia Deperthes from UNFPA Frank Roijmans from i+solutions Brian McKenna from the Reproductive Health Coalition who contributed to the testing of the survey instrument and to all participating companies
Ibou Thior PATH AIDSFree Prevention Advisor conducted the survey
Contributing editors include Kuyosh Khadirov USAID Senior Market Development Adviser Ariel Berry USAID Program Analyst Chris Jones Global Insights consultant Elizabeth Connor AIDSFree Managing Editor JSI Research amp Training Institute Inc and Margot Harrington AIDSFree Digital Publications Officer John Snow Inc
JSI Research amp Training Institute Inc 1616 Fort Myer Drive 16th Floor Arlington VA 22209 USA Phone 703-528-7474 Fax 703-528-7480 Email infoaids-freeorg Web aidsfreeusaidgov
CONTENTS Executive Summary viii
Background 1
Objectives 2
Methodology 3
Results 4
Company Profile and Products 4
Biggest Barriers to Entering the African Market 4
Ways to Mitigate Manage or Share Risks of African Market Entry 9
Public-Private Partnership 11
Study Limitations 12
Conclusions 13
Recommendations to Facilitate Market Entry 13
Participating Companies 13
Appendix 1 Supplementary Figures 15
Appendix 2 Survey Instrument 17
Appendix 3 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa 25
vi
vii
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
CONTENTS Executive Summary viii
Background 1
Objectives 2
Methodology 3
Results 4
Company Profile and Products 4
Biggest Barriers to Entering the African Market 4
Ways to Mitigate Manage or Share Risks of African Market Entry 9
Public-Private Partnership 11
Study Limitations 12
Conclusions 13
Recommendations to Facilitate Market Entry 13
Participating Companies 13
Appendix 1 Supplementary Figures 15
Appendix 2 Survey Instrument 17
Appendix 3 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa 25
vi
vii
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
vii
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
EXECUTIVE SUMMARY
Male and female condoms are the only devices that reduce the transmission of HIV and other sexually transmitted infections and prevent unintended pregnancy Yet donor funding for condom procurement has been reduced in recent years and to date few condom manufacturers have entered the African market
In 2015 several condom manufacturers joined donor agencies to form a coalition whose main goal is to provide 20 billion condoms to low- and middle-income countries by 2020 Between August and October 2017 AIDSFree conducted research on barriers that prevent condom manufacturers from entering the African market AIDSFree used a self-administered semi-structured questionnaire and in-depth interviews to collect information
Nineteen manufacturersmdashincluding the biggest male condom manufacturer in the world and all three female condom-producing companiesmdashfrom 12 countries participated in the research They identified high-risk of insufficient return on investment inefficient distribution channels low purchasing power of targeted populations lengthy and costly registration processes free and subsidized condoms and difficulty to vet financially strong local partners as the biggest barriers to entering the African condom market Other barriers were macroeconomic and market-specific challenges related to government currency stability and trade policies
Research respondents and AIDSFree analysts had suggestions for how African governments might create an enabling environment for market entry These included harmonizing regulatory standards providing tax exemptions and incentives reducing registration processing times and fees facilitating adequate financing of local condom distributors and establishing a public-private partnership for a healthy condom market The authors recommended that donor agencies and governments limit free and subsidized condoms to intended recipients (key and poor populations) exclusively and dedicate funds for demand generation and promotion activities to expand the condom market and make it more attractive
viii
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
ix
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
BACKGROUND
In early 2015 several condom manufacturers joined the United States Agency for International Development (USAID) the United Nations Population Fund (UNFPA) the World Bank the Reproductive Health Supplies Coalition and the International Labour Organization (ILO) to form a coalition whose main goal is to increase the number of condoms in low- and middle-income countries to 20 billion by 2020 (the 20 x 20 Initiative)
The second meeting of the coalition held in October 2015 in Windhoek Namibia led to the commission of a series of studies produced by USAIDrsquos Strengthening High Impact Interventions for an AIDS-free Generation (AIDSFree) Project1 to develop a better understanding of condom markets in five selected sub-Saharan African countries Kenya Nigeria South Africa Zambia and Zimbabwe
To complement the information collected by this series of studies and to better understand barriers to entry into the African condom market AIDSFree conducted a survey among commercial condom manufacturers
1 Assessment of the Retail Environment of Male Condoms in Kenya Nigeria South Africa Zambia and Zimbabwe 2017 (available at httpsaidsfreeusaidgovsitesdefaultfiles20171025_af-retail-env-condoms-reppdf) Review of the History of Price Revisions of Social-Marketed Brands of Male Condoms in Select Countries (httpsaidsfreeusaidgovsitesdefaultfiles2017117_af-socmarket-condoms_finalpdf) An additional study on willingness to pay for condoms is underway
shy
1
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
OBJECTIVES
1 To assess barriers to entry into the African condom market from commercial condom manufacturersrsquo perspectives
2 To assess macroeconomic sector- market- and company-specific factors that commercial condom manufacturers consider when entering a condom market
3 To gather manufacturersrsquo recommendations on ways to mitigate manage or share risks associated with entering the African condom market
2
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
METHODOLOGY
AIDSFree developed a self-administered semi-structured questionnaire to collect data on company profiles International Organization for Standardization (ISO) quality certifications received and types of condoms produced including size flavor texture color and lubricant used The questionnaire also gathered data on number of condoms sold annual condom production capacity commercial brands owned market presence type of brand management brand management challenges source of market intelligence used to inform market entry macroeconomic sector-specific market-specific and company-related factors considered when entering a condom market strengths and weaknesses considered when entering a market and largest anticipated barriers to entering the African market The survey also collected suggestions on ways to mitigate risks to market entry and market conditions necessary for condom manufacturers to enter African markets as well as major opportunities and challenges associated with investing in African condom markets Finally the survey included the type of market intelligence or data that would best inform condom manufacturersrsquo entry into a market or support their brands already in the market
The full survey instrument can be found in Appendix 1 of this document Appendix 2 contains supplementary figures displaying survey results not discussed in the body of the report Appendix 3 contains the 2016ndash2020 African Medicines Regulatory Harmonisation Programme Plan for Implementation of Pharmaceutical Manufacturing Plan for Africa
AIDSFree also interviewed three manufacturers (two African-based condom manufacturers and one company that manufactured only female condoms) who agreed to be contacted to collect additional information according to answers they shared To grade the importance of barriers to entry into the African market the project asked manufacturers to rank them using a scale of 1 to 5 with 1 denoting not a barrier and 5 being a very large barrier The analysis used ranks 4 and 5 as important barriers
3
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
RESULTS
Company Profile and Products AIDSFree conducted the survey from August 2017 to October 2017 Nineteen manufacturers out of 52 from a composite list of manufacturers (derived from 20 x 20 meeting attendees USAIDUNFPA condom suppliers and internet searches) who were invited to participate in the survey completed the questionnaire Participating companies are from 12 countries most of them located in Asia All companies have received ISO quality certifications with ISO 4074 most frequently reported (15 out of 19 manufacturers or 80) The vast majority of companies surveyed (89) produce male condoms only three produce both male and female condoms Their main products are latex lubricated and flavored male condoms The most common sizes manufactured were 52plusmn2mm (84) 49plusmn2 mm (79) and 52plusmn1mm (58) The most frequently manufactured condom flavors are banana mint and vanilla (84) and cherry and chocolate (68 each) The most common textures are plain (94) ribbed (78) dotted (78) and both ribbed and dotted (67) The most common colors are natural (97) red (74) yellow (74) and green and pink (69 each) The most commonly manufactured lubricants are silicone (47) water-based (42) and hybrid (11)
During the past 12 months participating manufacturers produced between 1 million and 600 million branded units those under procurement contracts produced from 8 million to 580 million units Annual condom production capacity ranged from 70 million to 5 billion pieces
Almost all companies (90) have their own commercial brands marketed to consumers and 84 percent support their own brands General markets where their commercials brands are available are mostly located in Asia (94) Africa (63) and Europe (50) Commercial brands are managed through non-licensed sales to interested importers (63) andor licensed agreements with importers (56) Only six manufacturers have an in-country presence to manage their brands
No specific country market was reported as the most profitable but condom manufacturers seem to prefer certain markets Some respondents indicated domestic regional or international markets as the most profitable based on market share reliable distribution channels and better pricing (higher margin)
Biggest Barriers to Entering the African Market
Regulatory Requirements
About two-thirds of participants (68) viewed regulatory requirements as a large barrier to entering the African condom market Forty-seven percent considered it a very large barrier even compared to other barriers such as free subsidized condoms and lack of purchasing power in targeted marketed segments (See Figure 1) Trade policy and technical regulations which include condom registration testing taxes and tariffs represent the greatest market entry barriers for condom manufacturers They expressed
4
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
concerns about lengthy and costly registration processes or requirements One manufacturer mentioned that it took her company five years to register a particular condom brand in one African country
Lengthy regulatory processes are reportedly caused by corruption and a lack of expertise and harmonized technical regulations and standards Frequently condom manufacturers have to determine which departmentmdashthe Ministry of Trade or Ministry of Healthmdashwill handle their application Condoms are registered as a medical device and in the vast majority of African countries most condom procurements are either for donation or for the Ministry of Health Regulatory oversight with regard to donorsrsquo procurements or from pre-certified condom suppliers is reportedly less restrictive than oversight of commercial condoms Once the manufacturer has identified the correct regulatory agency the next challenge is determining the right person to handle the application In many cases that officer does not have sufficient training to handle condom registration which leads to delays in processing registration and potentially to corruption Inadequate staffing and staff turnover was another reason cited for the backlog of applications and lengthy delays In addition although condoms are part of the HIV prevention package decision-makers are not supportive of female condoms in some countries Building the capacity of regulatory officers and changing decision-makers attitudes toward female condoms could create an enabling environment for condom market entry
90
80
70
60
50
40
30
20
10
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 1 Regulatory Requirements
11 0 21 21
47
100
Percentages may not equal 100 due to rounding
Lack of Local Partners and Difficulty in Vetting Credibility of Potential Local Partners
Fifty-eight percent of manufacturers mentioned the lack of local partners as an important impediment to market entry about two-thirds said that ensuring the credibility of potential local partners is one of the major challenges for their entry into the African condom market (see figures 2 and 3) In fact a good number of them (42) reported both the lack and difficulty of vetting local partners as a very large barrier The availability of free and subsidized condoms compounds this challenge Local financial institutions are not convinced of the potential for a good return on investments in condom
5
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
manufacturing in Africa because of the presence of low- or no-cost condoms Reportedly local investment services providers are not very familiar with the condom manufacturing industry Even Africa-based condom manufacturers report major hurdles in securing financial support Financially strong potential partners would rather focus on business with bigger margins than condoms
Figure 2 No Local PresencePartner
5 0
37
16
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure 3 Difficulty of Vetting Credibility of Potential Local Partners
5 0
26 26
42
0
10
20
30
40
50
60
70
80
90
100
Not a barrier Slight barrier Neutral A barrier A very large barrier
6
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Lack of Purchasing Power of Targeted Segments
Sixty-nine percent of manufacturers reported that the lack of purchasing power within targeted market segments was an important barrier to entering the African market (rated at a difficulty of 4 and 5) In fact half of the extreme poor live in sub-Saharan Africa with 389 million people living on less than US$190 a day in 20132
However all the condom manufacturers interviewed recognized the opportunities the African market can offer including growing their market size and profits and expanding awareness of their condoms and lubricant brands
Although sub-Saharan African countries are resource-limited their economies are growing in several regions and an increasing segment of the population can afford priced condoms Nigeria South Africa and Angola the continentrsquos largest economies are reportedly experiencing a rebound from a sharp slowdown in 2016 Available data also reveal that seven countries (Cocircte drsquoIvoire Ethiopia Kenya Mali Rwanda Senegal and Tanzania) continue to exhibit economic resilience supported by domestic demand posting annual growth rates above 54 percent in 2015ndash2017 These countries house nearly 27 percent of the regionrsquos population and account for 13 percent of the regionrsquos total gross domestic product3 In addition to the growing economy in some sub-Saharan African countries unwanted pregnancies and sexually transmitted infections including HIV are highly prevalent and there is a huge gap in condom needs4 despite the distribution of free and subsidized condoms Participants also acknowledged that Africa has an untapped market potential a large population of young educated customers a flourishing online payment system and unrestricted manufacturing and sales of contraceptives
Inefficient Distribution Channels
The majority of participants (74) mentioned weak distribution channels as another important barrier to market entry (Figure 4) Distribution channels are critical in marketing since they represent channels that help consumers get their needed and wanted products Inefficient distribution channels characterized by unorganized retailers and wholesalers and poor road network represent a hurdle that can affect not only a companyrsquos market share but also its profit Many sub-Saharan African countries are landlocked commercial products must be delivered by road This can be very costly outside urban areas and in conflict zones In many African countries commercial sector condoms are distributed through wholesalers retailers pharmacies supermarkets convenience stores hotels bars and street vendors Distribution channels can be either simple or if multiple channels are needed to reach consumers complex and costly Some local condom manufacturers have partnered with companies with wide distribution networks (eg breweries) to reach their last-mile customers
2 httpwwwworldbankorgentopicpovertyoverview 3 World Bank Group 2017 Africas Pulse No 16 October 2017 World Bank Washington DC httpsopenknowledgeworldbankorghandle1098628483 4 Yolande Coombes Leigh Ann Evanson Chris Jones Yasmin Madan Chastain Mann Nora Miller and Fred Rariewa nd The Condom Program Pathway Available at httpmarketbookshelfcomwp-contentuploads201709MGH_Condom-LandscapingshyReport_Final_091117pdf
7
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Free or Subsidized Condoms Dominate the Market
Fifty-eight percent of manufacturers considered that free or subsidized condoms represent a significant barrier to entering the African condom market The availability of free and subsidized condoms creates unfair direct competition and reduces potential commercial market size
Free and subsidized condoms can lead to inefficiencies Well-off consumers who could afford commercial brands can overcrowd the market of subsidized and free condoms Public sector or free condoms very often are not adequately targeted to those in need (or key populations)
In many countries free and subsidized condoms hold the vast majority of the market share raising concerns about sustainability of national condom programs567 Several condom landscaping and case studies have suggested that better segmentation and coordination among the sectors public social marketing and commercial would ensure that appropriately priced brands are reaching the right consumers A total market approach can help governments meet the health needs of poorest and key populations while enabling the commercial sector to fulfill its role
Lack of Market Intelligence
Forty-seven percent of participants mentioned a lack of market intelligence as a significant barrier to entering the African condom market Participants reported that they access condom market intelligence using data from market research organizations (eg The Nielsen Corporation) condom distributors and retailers demographic health surveys and country economic trade and financial reports
Entering international markets can result in significant profits or losses therefore market intelligence is critical in understanding a market and determining current and future trends in the business environment
Reportedly there are four classes of information companies should gather for each global market8
1 The factors shaping the political legal and business environment Information used to assess general conditions in a market and the risks associated with them
2 The market infrastructure This information can be used to evaluate the difficulties and costs that will be associated with the physical distribution of a product or service
3 The forces affecting the market This information includes market size consumer trends and market dynamics
4 Product- or service-specific data This information informs the suitability of the companyrsquos product or service to determine whether adaptation or positioning might be required
When asked the type of market intelligence or data that would best inform market entry or support their existing brands already in the market the clear majority of manufacturers mentioned that this information would include data on market size (volume and value) processes and timelines governing policies and regulatory requirements Eighty-nine percent of participants also mentioned data on
5 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zimpdf 6 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_zambiapdf 7 httpsaidsfreeusaidgovsitesdefaultfilesmgh_condom_cs_kenyapdf 8 httpwwwtradereadyca2014fittskills-refresheruse-market-intelligence-make-better-trade-decisions
8
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
subsidies and consumer purchasing behavior Additional important data to inform market entry included analysis of market potential (83) consumer segmentation analysis (78) retail panels or surveys (67) and studies on willingness to pay (61)
Insufficient Return on Investment
As shown in Figure 4 74 percent of manufacturers reported that the risk of insufficient return on investment is an important barrier to entering the African market Forty-two percent identified it as a very large barrier The risk of insufficient return on investment is compounded by the big market share of free and subsidized condoms in many African countries target populationsrsquo low purchasing power weak distribution systems limited market intelligence lengthy and costly registration processes and potential currency instability For manufacturers of female condoms the challenge is not free or subsidized condoms but the small size of its customer base (the global female condom market is 6 million condoms per year) which requires significant marketing costs
Figure 4 RiskReward Outlay
100
90
80
70
60
50
40
30
20
10
0 0
5 21
32 42
Not a barrier Slight barrier Neutral A barrier A very large barrier
Ways to Mitigate Manage or Share Risks of African Market Entry Condom manufacturers proposed several solutions to mitigate manage or share risks when entering the African market They included the provision of easier access to information on trade policies and regulatory standardsmdasha function that could be facilitated by a coalition group such as the 20 x 20 Initiative Participants also suggested harmonizing regulatory requirements to make registration in several countries much easier It is worth mentioning that in 2009 a partnership including the New Partnership for Africarsquos Development the Pan-African Parliament the World Health Organization the Bill amp Melinda Gates Foundation the United Kingdom Department for International Development and the Clinton Health Access Initiative established the African Medicines Regulatory Harmonization (AMRH)
9
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Initiative9 Through the AMRH Initiative the East African Community (Kenya Uganda Tanzania and Burundi) launched its Medicines Regulatory Harmonization Programme which led to the approval of 12 products between 2011 and 2013 The Southern African Development Community (Angola Botswana Democratic Republic of Congo Lesotho Madagascar Malawi Mauritius Mozambique Seychelles South Africa Swaziland United Republic of Tanzania Zambia and Zimbabwe) created the Southern Africa Regional Programmes on Access to Medicines and Diagnostics Under this initiative the Zanzibona Collaborative Medicines Registration Process a collaboration between national medicines regulatory authorities (NMRAs) in Botswana Namibia Zambia and Zimbabwe program was initiated and an estimated 105 products have been reviewed with subsequent registration of 28 products The Southern African Development Community guidelines for registration of medicines and common technical document format are apparently aligned to the East African Community models It is critical to find out if these harmonization programs include or could include medical devices like condoms Involvement and support from local governments to facilitate import and export of goods reduction of regulatory fees and processing time provision of import tax exemptions and reduction or elimination of free and subsidized condoms to allow fair competition were also part of the list of solutions proposed by manufacturers to mitigate risks associated with market entry
Some manufacturers suggested a public-private partnership to create an enabling environment with attractive trade policies and regulatory standards including product registration and tax exemptions that motivate commercial condom manufacturers and local partners Manufacturers of female condoms and lubricants also recommended more demand generation and marketing support for their products from nongovernmental organizations or associations promoting their use
Other Factors Considered for Market Entry
Even if all biggest barriers to entry were resolved or eased not all condom manufacturers would enter the African condom market Participants mentioned that they also considered macroeconomic factors such as a countryrsquos gross domestic product government and currency stability inflation rate and trade policies Sector-specific factors that could inform market entry include pricing and brand positioning Market-specific factors that also inform market entry are government taxes and
Box 1 Considerations for Market Entry
bull Presence of other commercial condom manufacturers
bull Their companylsquos production capacity bull Their international and regional
marketing experience
bull Pricing bull Quality of their product compared to
existing products packaging and standards
bull Their flexibility in terms of production (ability to produce small and large quantities)
bull Market size (including the possibility of accepting a lower margin for bigger volumes)
bull Brand credibility (track record for quality UNFPA pre-certification
procurements for big donors and
social marketing organizations) bull Product differentiation bull Financial resources and support bull Potential for job creation
9 New Partnership for Africarsquos Development (NEPAD) 2016 African Medicines Regulatory Harmonisation Programme Plan for Implementation of PMPA Strategic Plan 2016ndash2020 Midrand South Africa NEPAD (see Appendix 3)
10
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
subsidies the retail environment competition and marketing cost Company-related factors play an important role for entering international trade Participants considered their regional experience financial resources product differentiation and innovation before deciding to enter a new market Box 1 contains a more detailed list of reported considerations
Manufacturers also take their own and other competitors weaknesses for market entry These weaknesses could include uncompetitive pricing inadequate distribution networks insufficient brand promotion and limited financial resources among others
Public-Private Partnership Forty-seven percent of condom manufacturers reported having participated in a public-private partnership outside of procurement Partnerships included providing donations to international and national HIV organizations and supplies to governments through nongovernmental organizations The survey participants did not provide further details about the nature of their partnerships
Public-private partnerships pool public and private resources and capitalize on the skills of the respective sectors to improve the delivery of services Both sectors can work together to support disease prevention programs (eg HIV sexually transmitted infections and reproductive health services) if they acknowledge that a partnership would be mutually beneficial If one partner is not convinced of its benefits the partnership could fail
11
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
STUDY LIMITATIONS
The study had some limitations Although AIDSFree made every effort to secure as many participants as possible the respondent pool remained small AIDSFree also found numerous original equipment manufacturers in the latex industry but was unsuccessful in getting their participation despite numerous attempts to contact them Most of them did not manufacture condoms as their main products and were not part of the list of pre-certified condom suppliers for UNFPA and USAID However participants are representative of the condom manufacturing industry in that they are from 12 countries and include the largest manufacturer in Asia (KAREX) major condom providers to USAID and UNFPA two companies from the African continent (RRT MEDCON and Gemi Rubber) and other large companies with international brands that include female condoms and lubricants
As expected participants did not give detailed answers to questions potentially related to companiesrsquo market entry strategies however they did provide a general overview of these matters Although AIDSFree had a limited number of participants available for in-depth interviews the study team was able to communicate with two Africa-based condom manufacturers to address concerns or challenges raised by those participants who have not yet entered the African condom market
12
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
CONCLUSIONS
The condom manufacturer survey identified several critical barriers to entry into the African markets
1 Lack of adequate product registration policy and regulations 2 Scarcity of financially strong local partners 3 Inefficient distribution channels 4 Availability of free and heavily subsidized condoms 5 Limited market condom data from African countries 6 Macroeconomic and market-specific challenges related to government and currency stability and
trade policies
Recommendations to Facilitate Market Entry 1 Harmonization of regulatory standards for condom registration 2 Capacity building through training or technical assistance for condom-related regulatory processes
including support to Ministries of Health for strong condom program stewardship 3 Creation of an enabling environment for market entry through easier access to policy and regulatory
information exemptions and incentives and reduced processing time and fees 4 Better allocation (to the right populations) of free and subsidized condoms by local government and
donor agencies 5 Facilitation for adequate financing of local distributors or condom manufacturers 6 Establishment of a public-private partnership for condom program to enable a healthy condom
market 7 Establishment of partnerships with local companies with wide distribution networks (eg the
beverage industry) to extend access to remote areas 8 Better collection and sharing of condom market analytics by local government and donor agencies 9 Sustained demand generation and promotion activities by local governments andor donors (socioshy
behavioral change communication) to grow the condom market
Participating Companies 1 Guangzhou Double One Latex Products Co Ltd 2 Suretex Ltd 3 Guilin Zizhu Latex Co Ltd 4 RRT Medcon 5 NRS Ulinzi Latex FZE 6 Universal Prophylactic Pvt Ltd 7 Veru Female Health Company 8 Medevice3s Joint Venture Co Ltd
13
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
9 Indus Medicare Ltd 10 KAREX Industries Sdn Bhd (KAREX Berhad) 11 Unidus Corporation 12 Twin Catalyst Sdn Bhd 13 MHL Healthcare Ltd 14 Reckitt Benckiser 15 Gemi Rubber 16 Thai Nippon Rubber industry 17 Gel Works PTY Ltd 18 Dongkuk Techco Rubber 19 Vietnam Rubber Technology
14
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
APPENDIX 1 SUPPLEMENTARY FIGURES
Figure A-1 Lack of Purchasing Power of Targeted Market Segments
100
90
80
70
60
50
40
30
20
10 11 0
0
37 32
21
Not a barrier Slight barrier Neutral A barrier A very large barrier
Figure A-2 Inefficient Distribution Channels
100
90
80
70
60
50
40
30
20 5
10
0
11 11
37 37
Not a barrier Slight barrier Neutral A barrier A very large barrier
Percentages may not equal 100 due to rounding 15
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Figure A-3 Free or Subsidized Condoms Dominate the Market
100
90
80
70
60
50
40
30
20
16 510
0
Not a barrier Slight barrier Neutral A barrier A very large barrier
21
32 26
Figure A-4 Lack of Market Intelligence
16
100
90
80
70
60
50
40
30
20
10
0
26 26 21
16 11
Not a barrier Slight barrier Neutral A barrier A very large barrier
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
APPENDIX 2 SURVEY INSTRUMENT
1 Name ___________________________________________________________________________________________________ 2 Email ____________________________________________________________________________________________________ 3 Phone Number __________________________________________________________________________________________ 4 Participants Title ________________________________________________________________________________________ 5 Could we contact you for a more in-depth telephone interview following this survey
Yes No
6 Company Name ________________________________________________________________________________________ _
7 Company Address________________________________________________________________________________________
8 Has your company received any ISO quality certifications Please check all that apply
ISO 4074 Natural rubber latex male condoms
ISO 23409 Male condoms made from synthetic materials
ISO 25841 Female condoms
Other
9 Which types of male condoms do you manufacture Please check all that apply
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
Flavored
Textured
No male condom manufactured
10 Which types of female condoms do you manufacture Please check all that apply 17
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Latex
Non-latex
Spermicidal
Lambskin
Lubricated
No female condom manufactured
11 What sizes of condoms does your company manufacture Please check all that apply
49 plusmn2 mm
52 plusmn 1 mm
52 plusmn 2 mm
Other
12 What types of flavored condoms does your company manufacture Please check all that apply
Apple
Banana
Cherry
Chocolate
Cola
Lemon
Marshmallow
Mint
Orange
18
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Vanilla
Other
13 What types of textured condoms does your company manufacture Check all that apply
Plain
Ribbed
Dotted
Ribbed and dotted
Other
14 What types of colored condoms does your company manufacture Check all that apply
Natural
Black
Blue
Brown
Green
Orange
Pink
Purple
Red
Yellow
Other
15 What types of lubricants does your company manufacture Check all that apply
19
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Water-based
Silicone
Hybrid
Oil-based
No lubricants manufactured
Other
16 How many branded condoms did you sell last year in the commercial market
_______________________________________________________________________________________________________________
17 How many condoms have you sold over the past year under procurement contracts
_______________________________________________________________________________________________________________
18 What is your annual condom production capacity
_______________________________________________________________________________________________________________
19 Does your company have a commercial brand (that is a condom brand marketed to end users)
Yes No
20 Does your company currently support commercial brands marketed to consumers (Generic condoms
supporting government donor or social marketing procurement would not be categorized as
brands) If ldquonordquo please continue to question 22
Yes No
21 Please list your commercial brands
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
20
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
22 In which general markets are your brands available Check all that apply
Africa
Asia
Central America
Europe
South America
United States and Canada
Other ____________________________________________________________________________________________________
23 Which country markets are most profitable and why
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
___________________________________________________________________________
24 How do you manage your brands in the markets you are present in Please check all that apply
Licensed agreements with importers
Non-licensed sales to interested importers
In-country presence
Other ___________________________________________________________
25 What are some of the challenges you faced with regarding how your brand is managed
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
21
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
26 What type of market intelligencedata informs your entry andor supports your brands in the condom
market
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
27 What macroeconomic factors do you consider when entering a condom market (eg country GDP
stability of currency inflation etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
28 What sector-specific issues do you consider when entering a condom market (pricing positioning
competitive opening)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
29 What market-specific issues do you consider when entering a condom market (distribution systems
local partners etc)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
30 What are the company-related factors that you consider when entering a market (eg financial
considerations product differentiation regionalinternational experience etc)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
___________________________________________________________________________________________________________
31 When entering a new market which strengthsweaknesses (your own and your potential
competitors) do you consider
Strengths
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Weaknesses
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
32 What do you see as the biggest barriers to entering the African market Please rank the following
from 1ndash5 with 1 being not a barrier and 5 being a very large barrier
22
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Lack of purchasing power of targeted market segments 1 2 3 4 5
Free or subsidized condoms dominate the market 1 2 3 4 5
Riskreward outlay--insufficient return on i nvestment to make brands work
1 2 3 4 5
Lack of market intelligence (market volume and value size competition etc)
1 2 3 4 5
Regulatory requirements 1 2 3 4 5
Inefficient distribution channels 1 2 3 4 5
No local presencepartner 1 2 3 4 5
Difficulty to vet credibility of potential local partners 1 2 3 4 5
Other (please describe below) 1 2 3 4 5
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
33 How could risks to African market entry be mitigated managed or shared to support market entry _______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
34 What market conditions are necessary for condom manufacturers to enter African markets
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
23
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
35 Can you summarize the major opportunities and challenges associated with investing in African condom markets
Opportunities
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
Challenges
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
36 Outside of procurement have you ever participated in a public-private partnership on condoms If yes please describe the partnership
Yes No
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
37 What type of market intelligencedata would best inform your entry into a market or support existing
brands already in the market Check all that apply
Consumer segmentation analysis
Consumer purchase behaviors preferences etc
Willingness to pay studies
Market size (volume value)
Role of subsidy in market (free subsidized socially marketed condoms)
Retail panelssurveys
Market potential analysis
Regulatory requirements process and timeline
Other ____________________________________________________________________________________________________
24
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
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Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
APPENDIX 3 AFRICAN MEDICINES REGULATORY HARMONISATION PROGRAMME PLAN FOR IMPLEMENTATION OF PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA This is an excerpt the full document is available here
25
ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
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Email infoaids-freeorg
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ABBREVIATIONS AMRH African Medicines Regulatory Harmonization
AMU Arab Maghreb Union
AU African Union
AUC African Union Commission
BMGF The Bill and Melinda Gates Foundation
CHAI Clinton Health Access Initiative
CENSAD Community of Sahel-Saharan States
COMESA Common Market for Eastern and Southern Africa
DFID United Kingdom Department of International Development
EAC East African Community
ECCAS Economic Community of Central African States
ECOWAS Economic Community of West African States
EDCTP European and Developing Countries Clinical Trials Partnerships
IGAD Inter-Governmental Organization for Development
OCEAC Organization for the fight Against Endemic diseases in Central Africa
MoU Memorandum of Understanding
MRH Medicines Registration Harmonization
NEPAD New Partnership for Africarsquos Development
NGO Non-Governmental Organization
NMRA National Medicines Regulatory Authority
NPCA NEPAD Planning and Coordinating Agency
PDPs Product Development Partnerships
PAP Pan African Parliament
PMPA Pharmaceutical Manufacturing Plan for Africa
RECs Regional Economic Communities
SADC Southern African Development Community
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
SARPAM Southern Africa Regional Programme on Access to Medicines
UNAIDS Joint United Nations Programme on HIVAIDS
UEMOA The West African Economic and Monetary Union
WB The Wold Bank
WHO World Health Organization
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
EXECUTIVE SUMMARY Since 2009 NEPAD Agency in collaboration with the African Medicines Regulatory (AMRH) Initiative Partners has been coordinating the programme through the African Union (AU) regional economic communities (RECs) and Member States Based on consensus reached in February 2009 among the AU RECs Member States and partners significant progress has been recorded in the development and subsequent implementation of the AMRH programme in the continent We are now witnessing implementation of harmonized guidelines for registration of generic medicines good manufacturing practice (GMP) quality management systems (QMS) and information management system (IMS) in the East African Community (EAC) and the Southern African Development Community (SADC) Replication of the East African Community Model in the Southern Western Central and North-Eastern African regions is key for cross-REC consistency and also serves as a foundation for establishment of the African Medicines Agency (AMA)
The AMRH Implementation Tool Kit and Monitoring and Evaluation Framework will assist in standardizing and shaping implementation approaches and ensure consistencies across RECs and countries The AU Model Law on Medical products Regulation will further complement and facilitate programme implementation and serve as a guide for countries to review their national laws and subsequent establishment of semi-autonomous national medicines regulatory agencies (NMRAs) to ensure effective regulation of medical products and technologies All these efforts are aimed to ensure effective efficient and transparent regulatory processes and services that will ultimately contribute to availability of quality safe and effective medical products and technologies and improve the health outcomes of the African populations
NEPAD Agency will continue to exercise its mandate by improving and strengthening coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy through a robust monitoring evaluation and knowledge management framework The coordination of partners working in the medicines regulatory space is aimed to ensure streamlined efforts reduce overlapping work programs instil accountability and sustain gains achieved thus far This includes advocacy for alignment of the African Vaccines Regulatory Forum (AVAREF) with AMRH domestication of the African Union (AU) Model Law for Medical products regulation and utilization of the Regional Centers of Regulatory Excellence as a framework for standardized regulatory sciences training in Africa The established governance structures will be transitioned into the African Medicines Agency based on the AU Executive Council Decision EXCLDec857(XXVI)
The challenges faced during the first phase of implementation of the AMRH Programme lessons learnt continental and global policy frameworks instruments and decisions will provide direction for the second phase of the programme This includes Agenda 2063 Science Technology and Innovation Strategy for Africa (STISA) 2024 Africa Health Strategy (AHS) 2016-2030 and its corresponding Africa Research for Health Strategy which set the socio-economic development vision for Africa This will be done in alignment with Sustainable Development Goals (SDGs) and other global developmental frameworks In undertaking its role the Agency will continue to work with WHO as a lead technical agency and the World Bank responsible for management of the Global Medicines Regulatory Harmonization Multi Donor Trust Fund (GMRH-MDTF)
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
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Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
1 INTRODUCTION Strengthening regulatory capacity governance and accountability in the pharmaceutical sector is in every nationrsquos interest it provides an opportunity to drive economic development
and growth in the pharmaceutical sector Even more importantly from a public health perspective a functional regulatory environment is a prerequisite to increasing access to new medicines and to improving the quality of drugs in circulation which ultimately should save lives and improve health outcomes In realization of challenges posed by lack of good quality safe and affordable medicines to the majority of African population the African Union (AU) Assembly in January 2005 through decision 55 (AssemblyAUDec55(IV)) mandated the African Union Commission (AUC) to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of New Partnership for Africarsquos Development (NEPAD) One of
the critical components to advance the PMPA agenda is the provision of an enabling environment for development of the pharmaceutical industry hence the inception of the African Medicines Regulatory Harmonization Initiative In addition the AU approved the Roadmap for Shared Responsibility and Global Solidarity on HIV TB and Malaria response in Africa which emphasizes the need for access to medicines and regulatory harmonization In 2009 a consortium of partners including the NEPAD Agency Pan African Parliament (PAP) the World Health Organization (WHO) Bill amp Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) and the Clinton Health Access Initiative (CHAI) came together to establish the African Medicines Regulatory Harmonization (AMRH) Initiative In addition the AMRH initiative received endorsement by the Pan African Parliament (PAP) committees on Health and SampT in 2007 amp 2008 the African Ministerial Conference on Science and Technology decision in 2008 the NEPAD Agency and PAP joint consensus meeting with RECs and National Medicines Regulatory Authorities (NMRAs) in February 2009 In 2011 NEPAD Agency developed a comprehensive five year strategic plan (2011-2015) that provided direction for the implementation of the AMRH Programme during this period In addition the funding from the Bill amp Melinda Gates Foundation (BMGF) in 2011 enabled the World Bank to set up a Global Medicines Regulatory Harmonization (GMRH) multi-donor trust fund to implement AMRH and scale up activities elsewhere in the world Using the NEPAD Agency model of intervention in the African continent the AMRH Programme works with Regional Economic Communities (RECs) to improve public health by increasing access to good quality safe and effective medicines through harmonizing medicines regulations and expediting registration of essential medicines The aim is to ensure that regulatory requirements and practice in Africa meet the internationally accepted standards by strengthening pharmaceutical sector governance and regulatory systems The East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania while the Economic Community of West African StatesWest African Economic and Monetary Union (ECOWASUEMOA) and the Southern Africa Development Community (SADC) launched their reginal MRH Projects in 2015 The Economic Community for Central African States (ECCAS) in collaboration with the Organization for Coordination of the Fight Against Endemic Diseases in Central Africa (OCEAC) and the Intergovernmental Authority on Development (IGAD) are at different levels of implementation
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
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Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Considering that the regulatory landscape in Africa is dynamic and has undergone considerable changes since the launch of implementation of the AMRH Strategic Plan 2011-2015 and its expiry in 2015 the need arises to develop a new AMRH Strategic Plan (2016-2020) The AMRH Strategic Plan (2016-2010) defines the key strategic directions for the harmonization agenda in Africa building on the achievements of the last five years and taking into account the prevailing global and continental regulatory environment opportunities challenges and lessons learned A key development is the African Union (AU) decision to establish the African Medicines Agency (AMA) through its Executive Council Decision EXCLDec857(XXVI) that recognized the need to strengthen the capacity for regulation of medical products in Africa and the harmonization of medicines regulatory systems as a foundation for the establishment of regional and continental medicines agencies This is within the context of the AMRH and as part of the PMPA FrameworkThe AU Executive Council further endorsed the milestones for AMArsquos creation and tasked NEPAD Agency AUC and
WHO with defining the scope of the medical products to be covered Looking forward implementation of the AMRH Initiative and its expanded scope in alignment to the PMPA Framework needs to take into account the AU decision policy instruments and declarations and also various developments at continental and global levels These include the ongoing review of the Africa Health Strategy and Research for Health Strategy African Sustainable Development Goals and AU Agenda 2063 which set the socio-economic development vision for Africa This Strategic Plan apart from providing direction for the overall implementation of the AMRH Programme it will also provide guidance on expansion of scope of regulatory functions and products to be covered in the REC harmonization schemes In addition the Strategic Plan 2016-2020 will provide a framework for facilitating operationalization of the PMPA Business Plan The present document aims to detail the rationale and content of the AMRH Strategic Plan 2016-2020 It consists of several parts and sections the first addressing achievements challenges and lessons learned in the implementation of the AMRH Strategic Plan 2011-2015 The second part covers strategic issues themes directions and objectives as well as the strategic framework The third part outlines the results framework as well as monitoring evaluation and impact assessment And the last part covers the AMRH Strategic Plan 2016-2020 Budget
2 ACHIEVEMENTS The NEPAD Agency and African Union Commission (AUC) have continued to coordinate and harmonise follow-up actions on the PMPA including the preparation of concrete plan of actions in collaboration with regional economic communities (RECs) the World Health organization (WHO) and other partners Some of the progress made include the ldquoStrengthening
pharmaceutical innovation in Africardquo report produced by COHRED and NEPAD with the
George Institute and the tools designed to support countries in moving forward on Pharmaceutical Innovation
Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
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Email infoaids-freeorg
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Furthermore the NEPAD Agency undertook to compose a Consortium1 which has been spearheading the African Medicines Regulatory Harmonization initiative since 2009 as part of implementation of PMPA To date the AMRH Programme has made significant progress in its engagements with the AU RECs and countries Some of these achievements include
Launch and subsequent implementation of RECs Medicines Regulatory Harmonization
(MRH) Programmes Through the AMRH Initiative the East African Community (EAC) successfully launched the Medicines Regulatory Harmonization (MRH) Programme in March 2012 in Arusha Tanzania Notable achievements include the development of harmonized technical guidelines with subsequent adoption by the EAC Council of Ministers in September 20 2014 and publication of compendia for use by all the EAC Partner States In addition two pilot projects between WHO Medicines Prequalification Program (WHO-PQP) and EAC on joint assessments and inspections in 2011 and 2013 have led to subsequent approval of 5 and 7 products respectively The EAC now has expanded the scope of the programme to add drug safety (pharmacovigilance) strengthening clinical trials oversight regulation and quality assurance of medical devices including diagnostics and harmonization of regulation of vaccines with other partners joining in to provide both technical and financial support As the EAC MRH Programme enters its second phase the question on most minds is the sustainability after external funding declines or phases out In this regard the EAC Secretariat in collaboration with NMRAs has instituted the Regulators Forum as a platform for coordinating MRH activities after end of project In addition the framework for Mutual Recognition is being worked out to serve as a legal instrument for acceptance of decisions among the NMRAs in the region
Following the development of the medicines regulatory harmonization (MRH) project proposal for the Southern African Development Community (SADC) in 2011 breakthrough activities were agreed and supported under the DFID Funded Project the Southern Africa Regional Programme on Access to Medicines and Diagnostics (SARPAM) Among other things with technical support from WHO the ZAZIBONA Scheme was initiated in 2013 as a collaboration framework for registration of medicines between the four SADC countries namely Zambia Zimbabwe Botswana and Namibia The ZAZIBONA Scheme was officially integrated as part of the broader SADC Framework for Regulatory Harmonization since 2014 The SADC Regulators Forum further endorsed the implementation of MRH Programme using the ZAZIBONA approach To date 105 products have been reviewed under ZAZIBONA Scheme with subsequent registration of a total of 28 products in Botswana (25) Namibia (13) Zambia (11) and Zimbabwe (20) While fourteen (14) products were recommended for non-registration sixty one (61) are pending responses from manufacturers The SADC guidelines for registration of medicines and the common technical document format are aligned to the EAC Model while efforts are being made to adapt the GMP QMS and IMS standards This has been achieved through a collaborative framework between SADC Secretariat NEPAD World Bank and WHO
1The AMRH consortium consists of the African Unionrsquos New Partnership for Africarsquos Development (NEPAD Agency) the Pan African
Parliament (PAP) the World Health Organization (WHO) the Bill amp Melinda Gates Foundation the UK Department for International
Development (DFID) the Clinton Health Access Initiative (CHAI)
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Together with AMRH Partners2 NEPAD Agency facilitated the launch of the West Africa MRH Project in February 2015 which included the establishment of a joint MRH Programme Steering Committee and formation of seven Technical Working Groups (TWGs) Additionally a framework of collaboration between WAHO and WAEMU and a joint three years plan of action (2014-2016) was agreed Harmonization of WAHO and WAEMU CTDs has beed carried out with technical support from WHO The region will now be moving into developing technical guidelines through its TWGs A series of twinning activities between regional agencies have also been undertaken as part of capacity and confidence building among NMRAs In order to initiate activities in the Central Africa region NEPAD Agency in collaboration with ECCAS OCEAC and WHO developed a collaborative framework to spell out activities with clear roles and responsibilities for partners involved in the implementation of the MRH Programme A mapping exercise will be carried uot in Q2 2016 to establish the status or regulatory systems in Member States that will inform the MRH Project development process
The 1st IGAD Member States NMRAs meeting held in August 2015 in Addis Ababa Ethiopia agreed and signed the Call for Action to initiate implementation of a regional MRH Programme The 2nd meeting convened from 26-26 April 2016 and agreed on the establishment of the IGAD MRH Steering Committee the TWGs and a Coordinating Unit as part of IGAD Health and Social Development Department In addition the NMRAs agreed to i) establish a sustainable financing mechanism for the IGAD Regional program ii) build the capacity of IGAD secretariat and its member states to ensure effective coordination and implementation of the program iii) establish an integrated information management system that links all authorities and enables joint activities and develop a website for information sharing and exchange iv) initiate a phased approach for harmonization of medicines regulation based on the priorities identified in the IGAD member states and v) support the development of an overarching regional pharmaceutical policy and the adoption of modern legislative frameworks based on the AU Model Law Furthermore it was agreed that the IGAD regional Medicines Regulatory Collaboration and Harmonization Program be hosted by the Government of the Sudan
Initiation and implementation of continental Programmes At the continental level NEPAD Agency has facilitated the development of the AU Model Law on Medical products regulation with the view to address the prevailing legislative gaps at national level In addition in order to streamline the ad-hoc regulatory training programmes and address the human resource gap inherent in most African countries the Agency has spearheaded the designation of eleven (11) Regional Centers of Regulatory Excellence (RCoREs) since 2014 using the existing academic research and regulatory institutions The RCOREs serve as a framework for standardized training on regulatory sciences and systematic regulatory capacity development platform for Africa which will ensure sustainability Furthermore a database of regulatory experts has been developed with the view to provide resource to RCoREs In addition The Agency facilitated the convening of the 1st Scientific Conference on Medicines Regulation in Africa from 1-2 December 2013 followed by the 3rd African Medicines Regulators Conference (AMRC) from 3-5 December 2013
2 NEPAD Agency African Union Commission (AUC) Pan African Parliament (PAP) World Health Organization (WHO) World Bank (WB) Bill and Melinda Gates Foundation (BMGF) UK Department for International Development (DFID) US Government (PEPFAR) and GAVI
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Furthermore the Agency facilitated the review and expansion of scope of terms of reference for the PMPA Technical Committee with subsequent endorsement by the African Union Conference of Ministers of Health (CAMH-5) convened from 17-19 April 2011 in Windhoek Namibia This has culminated in galvanizing the work of the PMPA Technical Committee with subsequent development of the PMPA Business Plan with support from United National Industrial Development Organization (UNIDO) Furthermore the Specialised Technical Committee on Health Population and Drug Control (STC-HPDC) in its meeting held from 13-17 April 2015 in Addis Ababa Ethiopia approved 2015 approved the implementation of GMP roadmap through national and regional certification schemes The STC-HPDC further recommended that the biennial African Medicines Regulators Conference (AMRC) be institutionalised within the AU institutional framework to be coordinated by NEPA Agency and AUC in collaboration with WHO
3 CHALLENGES AND LESSONS LEARNED Some of the important lessons coming out of the AMRH Programme implementation that are useful for increasing development impact and effectiveness include the need to allocate resources to institutionalize capacity in addition to building technical skills The most important message emerging from the regional harmonization process is the value of capacity-building both human and institutional to ensure sustainability In addition commitment to strategic sharing of information to improve effectiveness requires clarifying the roles of development partners in the medicines regulatory space This is critical to avoid duplication of work programs Furthermore the regional harmonization process is shedding light on the uniqueness of each region in regards to medicines regulatory harmonization and convergence Some of the challenges encountered in the implementation of the AMRH Programme include i) differences in the economic status of participating countries and the corresponding wide variation in regulatory capacity ii) ownership and buy-in from national and regional key stakeholders requires more consultation and additional time to materialize than anticipated when a project is planned and iii) donor partners working in the medicines regulatory space have overlapping work programs which require better coordination One of the key success factors of the AMRH Initiative is clarity in roles and responsibilities among the implementing partners Under this partnership NEPAD Agency is responsible for coordination of regional programmes partners and stakeholders while facilitating policy and political advocacy in Africa The World Health Organization (WHO) on the other hand is responsible for providing technical guidance and the requisite international expertise to boost regional capacities The World Bank is responsible for overall coordination and fiduciary oversight of the initiative
4 PURPOSE OF THE STRATEGIC PLAN The 2nd AMRH Strategic Plan covering the period 2016-2020 is aimed at taking stock of lessons learnt and challenges faced during the implementation of the 1st Strategic plan (2011-2015) This plan provides strategic direction in advancing pharmaceutical sector development programmes It will further provide guidance in monitoring evaluation and impact assessment for the next five years (2016-2020) The results framework has been elaborated which
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
provides the necessary input outputs and expected outcomes at the end of the planning period A budget estimate has been provided as a vehicle for mobilising the needed resources Oversight of this plan will be done through the established governance and management structures namely the AMRH Advisory Committee the Technical Working Groups and the NEPAD Agency AMRH Secretariat While the AMRH Advisory Committee shall be responsible for providing strategic and policy guidance on medicines regulatory issues in Africa the technical work shall continue to be delegated to the established Technical Working Groups (TWGs) on Regulatory capacity Development and on Medicines Policy and Regulatory Reforms Other TWG will be constituted based on identified needs The governance and management action plans shall be formulated in line with the strategic themes based on NPCA mandate namely coordination of implementation of continental and
regional priority programmes and projects mobilization of resources and partners conducting
and coordinating research and knowledge management monitoring and evaluation of
implementation of programmes and advocacy on the AU and NEPAD vision mission and
core values These strategic themes will enable the AMRH programme to focus resources and efforts towards driving the NEPAD Agency vision and delivering on its mandate during the implementation period
5 HIGH LEVEL STATEMENTS The high level statements for the AMRH Programme are derived from and support the NEPAD Mission and Vision Statements New Partnership for Africarsquos Development
(NEPAD) is an African Union strategic framework for Pan-African socio-economic development adopted by African Heads of State and Government of the Organization of the African Union (OAU) in 2001 The NEPAD Framework was ratified by the African Union (AU) in 2002 to address Africas development problems within a new paradigm with a view to reduce poverty put Africa on a sustainable development path halt the marginalization of Africa and empower women The NEPAD Secretariat was transformed and integrated into the structures and processes of the AU in 2010 as NEPAD Planning and Coordinating Agency (NEPAD
Agency)
NEPAD Vision
NEPAD Mission
To Work with African countries both individually and collectively towards sustainable
growth and development
To build an integrated prosperous and peaceful Africa driven by its own citizens and
representing a dynamic force in the global arena
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Core Values of NEPAD The NEPAD core principles and values are based on four key elements ndash the facilitator
mobiliser agent of change and learning organisation as indicated in Table 1 below
Value Statement Focus Description
Pan-Africanism
Participatory Commitment to actively take part in meetings conferences workshops and other fora convened to achieve the NEPAD vision
Consultative Commitment to promote the participation of all stakeholders including the AU member states the AU Commission civil society RECs development partners and the private sector
Partnership Commitment to working in partnership with RECs AU member countries civil society the private sector development partners as well as other stakeholders
Integration Commitment to align the NEPAD Agency with AU structures and processes
Inclusive Commitment to involve all relevant major groups
Accountability amp Transparency
Accountability Commitment to be accountable and accessible to African leaders AU member states all major groups and staff commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Responsibility Commitment to taking responsibility for all actions in carrying out the mandate of the NEPAD Agency
Transparency Commitment to operate in an open manner Democracy Commitment to operating the NEPAD Agency within a
consultative and democratic framework Fairness Commitment to treat all staff members justly and fairly
irrespective of their race origin gender age religion language culture or ethnicity
Professionalism
Ethical Commitment to observe the legal systems and ethical norms Honesty Commitment to be honest with all stakeholders Ingenuity Commitment to keep abreast of new developments in relevant
fields of expertise and to be innovative in carrying out the mandate of the NEPAD Agency
Integrity Commitment to consistently observe the core values Mutual Respect
To value each otherrsquos contribution to the vision and goals of the NEPAD and the strategic plan
Peaceful Commitment to adhere to peaceful settlement of all disputes as well as promote a peaceful environment
Effective Delivery amp Results Orientated
The NEPAD Agency is committed to effectively facilitate the implementation of all NEPAD decisions within the AU member countries and other structures of the AU It will focus on obtaining results
The NEPAD Planning and Coordinating Agency (NPCA) Core Functions
The core functions of NPCA are derived from its mandate and aims to a Facilitate and coordinate the implementation of continental and regional programmes
and projects b Mobilize resources and partners in support of the implementation of Africarsquos priority
programmes and projects c Conduct and coordinate research and knowledge management d Monitor and evaluate the implementation of programmes and projects and e Advocate on the AU and NEPAD vision mission core principles and values
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
6 STRATEGIC ISSUES THEMES DIRECTIONS AND OBJECTIVES Strategic themes are broad service areas in which AMRH needs to deliver in order to drive
the NPCA vision and mission They are priority or focus areas that cluster related strategic
objectives based on NEPAD Agency mandate Strategic issues are challenges faced by the
NPCA in managing the AMRH Programme resulting from its internal and external environment
as listed here below
Table 2 Strategic Themes and Issues
STRATEGIC THEMES STRATEGIC ISSUES
Facilitate and coordinate implementation of continental and regional programmes and projects
Weak governance and management structures Inadequate coordination of programme and partners at
national regional and continental levels Weak medicines regulatory capacity
Research and Knowledge Management
Language barriers due to historical heritage Inadequate knowledge and skills for medicines regulation
and pharmaceutical production Partnership with
stakeholders amp resource mobilization
Weak partnerships Poor stakeholder relations Inadequate operational budget Dependence on donor funding Duplication of efforts by partners
Monitoring evaluation amp impact assessment
Low implementation rate of AU decisions Accountability for results Evidence-based decision making
Policy amp Advocacy Incoherent policies public health industrial development trade and STI
Inadequate medicines legislations Conflicting regulatory requirements Multi membership to RECs Lackinadequate access to quality safe efficacious and
affordable essential medicines by African patients
Strategic themes of AMRH are the key focus areas that drive its mission as derived from the
NEPAD Agency core functions as provided in Table 3 while strategic objectives are aligned
to themes as summarised in Table 4 below
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Table 3 Strategic Themes in Context
STRATEGIC THEME AIM Facilitate and coordinate implementation of continental and regional programmes and projects
To improve coordination of programmes and partners
Research and Knowledge Management
To provide a platform for knowledge generation peer learning research and information gathering and sharing create knowledge and learning arenas that form the basis for long-term planning development and implementation of programmes and project amongst member states partners and other stakeholders
Partnership with Stakeholders and resource mobilisation
To establish maintain and enhance stakeholder relations and mobilise resources
Monitoring evaluation amp impact assessment
To institute performance measurement tools based on NPCA indicators
Policy amp Advocacy To influence public-policy and resource allocation decisions within political economic and social systems and institutions
Table 4 Strategic objectives linked to themes
STRATEGIC THEME STRATEGIC DIRECTION
STRATEGIC OBJECTIVES
1 Facilitate and coordinate implementation of continental and regional programmes and projects
2 Research amp Knowledge Management
3 Partnership with Stakeholders amp Resource Mobilisation
4 Monitoring evaluation amp impact assessment
5 Policy amp Advocacy
1 Policy alignment 2 Regional
integration and harmonization
3 Human and institutional capacity development
1 Enhanced policy coherence in RECs and Member States for public health and pharmaceutical industry development
2 Increased use of harmonized policies and regulatory frameworks for faster quality predictable and transparent approval of medical products and technologies
3 Increased human and institutional capacity for regulation of medical products and technologies
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
6 STRATEGIC FRAMEWORK
Objective
Enhanced policy coherence in RECs and member
states for public health and pharmaceutical industry
development
Objective
Increased use of harmonized policies and regulatory
frameworks by member states for faster quality
predictable and transparent approval of medical
products
Objective
Increased human and institutional capacity for
regulation of medical products and technologies
Targets
15 regional centres of regulatory excellence operational by 2020
Curricula on Regulatory Science in alignment with WHO Global Curricula Framework by 2018
10 increase in the number of regulatory experts in Africa by 2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
African Regulatory Professional Fellowship Programme developed and administered by 2020
Align regulatory systems strengthening programmes with AMRH and AMA
Targets
At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines and standards by 2020
AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
AMRH MampE framework implemented in 3 regions by 2020
Targets
At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Policy legal and institutional framework for the establishment of African Medicine Agency (AMA) endorsed by AU by 2016
Vision
African people have access to essential medical products and technologies
AMRH Strategic Framework 2016 - 2020
Mission
Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa
Direction 1
Policy alignment and Regulatory Reforms
Direction 2
Regional integration and harmonization
Direction 3
Human and institutional capacity development
Coordination partnership and resource mobilization
Objective Effective coordination and alignment of regulatory interventions with AMRH Framework amp AMA Targets
50 of NMRA resources mobilized locally or through broadened bilateral and multilateral sponsors by 2019
50 of NEPAD Agency funding for AMRH initiative mobilized from other sources by 2020
Partnership Platform Accountability Framework developed and implemented by 2020
Scientific and regulators conferences convened bi-ennially
AMRH Secretariat capacity strengthened by 2017
AMRH Advocacy and Communication strategy implemented from 2016
AMRH Advisory committee and at least 4 Technical Working Groups operational by 2018
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
7 RESULTS FRAMEWORK
Objective Target Initiative Activities Timelines Budget Results
Direction 1 Policy Alignment amp Regulatory Reforms $1 386 526
Enhanced policy coherence in RECs and member states for public health and pharmaceutical industry development
111 At least 3 regions have adopted regional policies and legal frameworks for regulation of medicines by 2020
112 At least 25 countries have domesticated the Model Law on Medical Products regulation by 2020
Adoption and domestication of AU Model Law on medical products regulation
Adoption of the Model Law by the African Union
2016 50 of African countries with comprehensive pharmaceutical policies and legal frameworks aligned to AU Model law
3 RECs implementing pharmaceutical policies and legal frameworks aligned to the AU Model
Mutual recognition procedures implemented in 3 RECs and Member States
Conduct a rapid assessment on the current status of National Medicines Laws and pharmaceutical policies in Member State to update the existing date
2016
Implement a Model Law adoption and advocacy strategy in support of Member States domestication in collaboration with AUC and PAP
2016-2020
Develop required Model Regulations in support of implementation of the AU Model Law on Medical Products Regulation
Ongoing
Develop a Continental Pharmaceutical Policy
2016
Support the REC TWGs on Policy and Legal Frameworks to align the regional policy and legal frameworks with AU Frameworks
Ongoing
113 At least 10 countries implementing pharmaceutical innovation framework and PMPA by 2020
Alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national
Develop criteria for selection of RECS and countries to engage in PMPA activities and identify 2 RECs and 10 AU Member States as pilots for implementation based on expression of interest
2016 20 of the AU countries implementing comprehensive pharmaceutical production strategies in alignment with the PMPA
Engage with high level policy makers in the identified Member States to create ownership
2016
Assess national pharmaceutical innovation systems
2016
Collect data using the identified tool 2016
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
regional and continental levels
Map regional and national pharmaceutical production capacities and possible collaborations for industrial clusters produce and validate reports identify follow up steps based on the findings
2017
Support the alignment of public health pharmaceutical STI and industrial development policies with pharmaceutical manufacturing plans at national regional and continental levels and development of national strategies in 10 countries
2016 ndash 2018
Develop a monitoring and evaluation system including a database for continuous monitoring of the national innovation systems
2016
Leverage governmentsrsquo commitment to build conducive policy and regulatory systems for successful and sustainable pharmaceutical industry
Ongoing
114 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017 80 of pharmaceutical manufacturers complying with regional and continental GMP certification schemes
Mobilize resources (technical and financial) for strengthening the capacity of local manufacturers in complying to GMP requirement
Ongoing
Conduct advocacy for the regional certification schemes for GMP and compliance by manufactures
Ongoing
115 Policy legal and institutional framework for the establishment of AMA endorsed by
Development of policy legal and institutional framework for the establishment of AMA
Develop a draft policy legal and institutional framework for AMA
2015 AMA Legal amp Institutional Framework endorsed by AU Policy Organs Present the draft policy legal and
institutional framework for AMA to the Technical team
2015
Present the draft policy legal and institutional framework for AMA to Ministers of Health
2016
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
AU Policy Organs by 2018
Present the draft policy legal and institutional framework for AMA to Ministers of Justice
2016
Submit the policy legal and institutional framework for AMA to AU organs for adoption
2016
Direction 2 Regional integration and harmonization $838 677
22 Increased use of harmonized policies and regulatory frameworks by member states for faster quality predictable and transparent approval of medical products
221 MRH projects developed for 5 RECs by 2020
222 AMRH project scope expanded to cover clinical trials oversight post-marketing surveillance and pharmacovigilance medical devices and diagnostics in 5 regions by 2020
Development and institutionalization of REC MRH Projects
Finalise and facilitate utilization of the AMRH Implementation Tookit
2016 of RECs implementing AMRH framework
and types of regional harmonized guidelines endorsed by the REC Policy Organs
of countries implementing regional harmonized guidelines
of countries participating in joint reviews and GMP inspections
of products registered using regional harmonized guidelines
Agreed framework for benchmarking NMRAs in Africa
African NMRAs meeting internationally acceptable standards of Good Regulatory Practice
Develop and finalize project dossiers for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
Develop programme for post marketing surveillance pharmacovigilance clinical trials medical devices and diagnostics for the EAC region in the 5 RECs in collaboration with WHO
2016
Facilitate the expansion of project scope for SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in the 5 RECs in collaboration with WHO
2016-2017
223 At least 5 regions and 25 countries have adopted regionally agreed regulatory technical guidelines
Development and adoption of regionally agreed regulatory technical guidelines and standards
Support regional Expert Working Groups (EWG) Technical Working Groups (TWGs) Steering Committees and Regulators Forum in the 5 RECs in collaboration with WHO
2016-2020
Support implementation of regionally agreed regulatory technical guidelines and standards in the 5 RECs in collaboration with WHO
2016-2020
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
and standards by 2020
Facilitate adoption and implementation of regionally agreed regulatory technical guidelines and standards by the industry in the 5 RECs
2016-2020
224 At least 3 regions have implemented Innovative GMP Certification Schemes by 2020
Implementation of Innovative GMP Certification Schemes at regional and national level
Support two RECs to design a regional GMP roadmap and certification scheme
2016 -2017
225 AMRH MampE framework implemented in 3 regions by 2020
Conduct MampE of RECs MRH projects
Pilot the AMRH indicators tracking and data collection tool in the EAC region
2016
Develop an electronic data management system for AMRH indicators
2016
Collect data on AMRH indicators and assess the status of implementation of agreed harmonised guidelines in the SADC ECOWASUEMOA ECCASOCEAC IGAD and AMU in collaboration with WHO
2017 ndash 2020
Produce annual performance reports and policy documents
2016-2020
Direction 3 Human and institutional capacity development $1 250 673
Increased human and institutional capacity for regulation of medical products and technologies
Curricula on Regulatory Science in alignment with Global Curricula Framework by 2018
Streamlining Curricula on Regulatory Science in alignment with Global Competency and Curricula Framework
Review the Body of Knowledge for RCOREs in alignment with the Global Regulatory Competency and Curricula
Harmonized curricula in regulatory science approved by appropriate competent authorities
RCOREs adopted harmonized regulatory science curricula
Conduct annual review of performance of
designated RCOREs 2016-2020 Regulatory training
programmes
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
15 regional centres of regulatory excellence operational by 2020
Coordination of Regional Centres of Regulatory Excellence (RCOREs)
Develop and publish Expression of interest to designate the planned 5 additional RCOREs in identified regulatory functions and review applications
2018 institutionalized in the RCOREs
Support RCOREs and Regulatory Professionals Fellowship Programmes
2016-2020
50 of experts in the ldquoPool of Regulatory Expertsrdquo utilized by 2020
Coordination of a pool of regulatory experts
Redesign a user friendly Pool of Regulatory Experts portal and interface
2016 Regulatory pool of Experts providing training in RCOREs Re-launch the Pool of Regulatory Experts
portal 2017
Review applications received for entry into the pool of regulatory experts database and maintain a register
2016-2020
10 increase in the number of regulatory experts in Africa by 2020
Facilitate the establishment of African Regulatory Professional Fellowship Programme (ARPFP)
Conduct and assessment to determine the existing regulatory workforce in Africa
2016 increase of number of regulatory workforce in Africa
Commission consultancy to carry out feasibility studyoptions analysis for establishment of the Governing Body for the African Regulatory Fellowship Programme
2016
Review the Consultants Options Analysis Report and elaborate the governance structures and anchorage of the ARPFP within AU structures
2016 ndash 2017
Develop a Resource Mobilizationviabilitysustainability strategy for the ARPFP governing bodycollegesocietyassociation
2017
Establish the Governing bodycollegesocietyassociation to administer the African Regulatory Professional Fellowship Programme
2017-2018
Develop and publish guide for administering African Regulatory
2017
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
Professional Fellowship Programme(ARPFP)
Launch programmes administered by African Regulatory Professional Fellowship Programme (ARPFP)
2018
Align regulatory systems strengthening programmes with AMRH and AMA by 2018
Scale up successful national amp regional regulatory interventions
Coordinate scale-up of regulatory interventions in alignment with AMRH and AMA
2016-2020 Regulatory systems strengthening programmes aligned with AMRH and AMA
Direction 4 Enabling Environment Coordination partnership and resource mobilization $5 114 013
Effective coordination and alignment of regulatory interventions with AMRH Framework and AMA
At least 4 functional Technical working Groups (TWGs) by 2018
African Medicines Conference aligned with the AMRH governance structure and AU Institutional Framework by 2016
Scientific Conference convened bi-ennially
Strengthen AMRH governance structures
Convene meetings for TWGs on Policy and Regulatory Reforms Regulatory Capacity Development and Specialised Regulatory Expert Committees
2016 ndash 2020
AMRH transitioned into AMA
Convene the Advisory Committee meetings to deliberate on recommendations from the TWGs
2016 - 2020
Integrate the AMRC into the AU Institutional Framework and convene bi-ennially Scientific and AMRC conferences in collaboration with the AUC and WHO
2017 2019
Draft and publish Scientific and AMRC conference reports
2016-2020
Partnership Platform Accountability
Development and implementation
Conduct mapping of partners engaged in regulatory interventions in Africa identify those with interest and agree on areas of collaboration on AMRH
2016
Streamlined medicines regulatory interventions and partners in Africa
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
Objective Target Initiative Activities Timelines Budget Results
Framework developed and implemented by 2020
of the AMRH Partnership Accountability Framework
Develop AMRH Partnership Accountability Framework
2016
Convene a Partnership platform meeting on regulation of medical products and technologies alongside the Scientific and AMRC conferences
2016-2020
AMRHAMA Secretariat capacity strengthened by 2016
Support human resource development for the coordination of AMRH
Recruit an intern for data collection 2016 AMRH transitioned into AMA
Support a Senior Programme Officer to Support PMPA implementation
Support personnel for the AMRH programme at the NEPAD Agency
Identify training needs and facilitate AMRH Staff development programmes
AMRHAMA advocacy strategy implemented from 2016
Advocate for AMRH as a foundation for AMA
Develop the AMA Advocacy strategy Design branding concept and produce
advocacy and communication materials Support design and hosting of the AMA
website Produce and disseminate a brochure on
the role of AMRH in the establishment of AMA
Advocate for AMA at national regional continental and partners meetings
NMRA Financing Models advocated by 2018
Advocate for sustainable financing of NMRAs
Scale-up NMRA financing studies to West Southern Central and NorthNorth-Eastern African regions in collaboration with AMRH Partners
Ongoing NMRA Financing Models adopted at national and regional levels
Convene high level policy dialogues on sustainable financing for NMRAs in collaboration with AMRH Partners
Ongoing
TOTAL $9 792 472
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
8 STRATEGIC PLAN BUDGET
The five years strategic plan budget is US$9 792 472 The resource requirement contained in
this plan requires concerted effort by all stakeholders The AMRH Programme strives to focus
on strengthening partnerships diversification of revenue and employing innovative
approaches to create new projects and programmes
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
AIDSFree 1616 Fort Myer Drive 16th Floor
Arlington VA 22209
Phone 703-528-7474
Fax 703-528-7480
Email infoaids-freeorg
Web aidsfreeusaidgov
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