WHO-Technical Briefing Seminar | 03 November 2010 Gilles Forte 1 |1 | WHO Technical Briefing Seminar...

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WHO-Technical Briefing Seminar | 03 November 2010 1 | WHO Technical Briefing Seminar Geneva 01- 05 November 2010. WHO Collaboration with Countries on Pharmaceutical Policies Dr Gilles Forte Essential Medicines and Pharmaceutical Policies

Transcript of WHO-Technical Briefing Seminar | 03 November 2010 Gilles Forte 1 |1 | WHO Technical Briefing Seminar...

Page 1: WHO-Technical Briefing Seminar | 03 November 2010 Gilles Forte 1 |1 | WHO Technical Briefing Seminar Geneva 01- 05 November 2010. WHO Collaboration with.

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WHO Technical Briefing Seminar Geneva 01- 05 November 2010.

WHO Collaboration with Countries on Pharmaceutical Policies

Dr Gilles ForteEssential Medicines and Pharmaceutical Policies

WHO Technical Briefing Seminar Geneva 01- 05 November 2010.

WHO Collaboration with Countries on Pharmaceutical Policies

Dr Gilles ForteEssential Medicines and Pharmaceutical Policies

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Regional Office AFRO Regional Office EMRO

Regional Office EURO Regional Office WPRO

Regional Office SEARO Regional Office AMRO

WHO: 193 Member States 6 Regional Offices

WHO: 193 Member States 6 Regional Offices

(Source: http://www.who.int/about/regions/en/index.html)

WHO HQ Geneva

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Coordination mechanisms for a sustainable collaboration with countries

WHO

HSS

EMP

AFRO

AMRO

EMRO

EURO

SEARO

WPRO

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WHO Country Medicines Advisers and Collaborating Centres

WHO Country Medicines Advisers and Collaborating Centres

Collaborating CentreMedicines Adviser

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The WHO Country Medicines Advisers Network for Africa

• Assessing national medicines needs & priorities;• Planning, implementing, monitoring

WHO interventions; • Facilitating coordination of partners;• Contributing to WHO Regional work

on medicines and health systems;

Medicines Advisers in 15 countries in Africa for:

BurundiCameroonCentral African Rep.ChadCongoDemocratic Rep. of the CongoEthiopiaGhanaKenyaMaliNigeriaRwandaSenegalUgandaUnited Rep. of Tanzania

EAC

UEMOA

CEMAC

SADC

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Key principles for collaboration with countries

Key principles for collaboration with countries

Country ownership - planning & implementation is country led - based on country needs and priorities;

Technical collaboration with countries:

-for building evidence base and quality information;

-for sound policies, good practices and advocacy;

-for strengthening pharmaceutical systems & capacity;

Sustainability and continuity;

Promoting regional and subregional collaboration and integration;

Promoting efficient coordination of partners, synergies and aid effectiveness.

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Collaboration framework Collaboration framework

Millennium Development Goals 2000-2015 – Goal 4, 5, 6 & 8;

Resolutions of the World Health Assembly – Endorsed by WHA;

WHO Medium Term Strategic Plan 2008 - 2013 - Endorsed by WHA;

Regional Declarations endorsed by Member States e.g. Abuja, Ougadougou, Talinn etc.

Priorities set by the Director General

WHO Medicines Strategy 2008 -13 :

- Information and Policy– Access– Quality and Safety– Rational Use

Multi Country Programmes e.g. EC/ACP/WHO; MeTA; etc.

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Number of countries supported by result areas

0

10

20

30

40

50

60

Policies Patents Prices Supply Quality Regulation Rational useby

prescribers

Rational useby

consumers

n. of countriessupported

Partnership with ACP countries on Pharmaceutical Policies

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National Medicines PolicyNational Medicines Policy

NMP and implementation plan

0%10%20%30%40%50%60%70%80%90%

Countries with NMP Countries with NMPupdated within 5

years

Countries withimplementation plan

2003

2007

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Medicines regulation and quality assuranceMedicines regulation and quality assurance

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Web-site of MRA Computerized registration system

2003

2007

System in place to report ADR

0%

10%

20%

30%

40%

50%

60%

2003 2007

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Monitoring availability and pricing of medicines )Uganda(

Monitoring availability and pricing of medicines )Uganda(

0%

25%

50%

75%

100%

Apr-04 Oct-04 Apr-05 Oct-05 Apr-06 Oct-06 Apr-07 Oct-07 Apr-08 Oct-08

Median availability basket of key medicines, public & private sectors 2004-8

Private median

Public median

Linear (Private median)

Linear (Public median)

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Selection and rational use of medicinesSelection and rational use of medicines

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

EML updated with 5 years National STGs

2003

2007

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The EC/ACP/WHO Partnership:collaboration with Sudan

The EC/ACP/WHO Partnership:collaboration with Sudan

The National Medicines Policy was updated in 2005.

An assessment of the Pharmaceutical Sector was carried out in 2007 and a Pharmaceutical Country Profile was developed in 2010.

A survey on medicines prices was carried out and, as a result, advocacy work was conducted to reduce taxes on medicines and increase public funding. The effectiveness of the drug revolving fund as a mechanism for financing medicines was assessed.

The supply system was evaluated and strengthened through the establishment of a national forecasting and surveillance unit, the purchase of IT material and training of personnel.

The situation of human resources for the pharmaceutical sector has been assessed.

The Adverse Drug Reaction Centre has been supported. Software Vigiflow has been purchased.

The National Quality Control Laboratory (NDQCL) was assessed and personnel was trained on use of equipment.

The Medicines Regulatory System was assessed in 2008. Software SIAMED for registration installed. Guidelines for quality assurance developed in July 2006 and personnel trained. Guidelines and SOPs for key regulatory activities developed. Equipment and training provided to inspectors.

A number of training sessions and workshops held to promote rational use of medicines.

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The EC/ACP/WHO Partnership:collaboration with the CaribbeanThe EC/ACP/WHO Partnership:

collaboration with the Caribbean

Support provided to carry out pharmaceutical sector surveys (Level 1 2007,Facility and Household surveys in Barbados, Jamaica, Saint Lucia and Suriname), regional meta analysis (report published in 2009) and development of regional medicines policy (June 2010 draft available);

Support provided to the Caribbean Regional Network of Pharmaceutical Procurement and Supply Management Authorities (CARIPROSUM). The network includes the Organization of Eastern Caribbean Countries Pool Procurement Service (OECS/ PPS) which received support through training sessions, participation to workshops and assessment of its procurement system.

Support was provided for the assessment of Medicines Regulatory Authorities and establishment of regulators network as part of PANDRH;

Information on counterfeit medicines was collected and a position paper with options for actions was developed. A campaign was conducted in 2008-9 to sensitize the public;

The Caribbean Regional Drug Testing Laboratory (Jamaica) was supported and used to conduct training courses. The laboratory is currently working to achieve WHO pre-qualification status.

A regional network for Pharmacovigilance (VIGICARIB) was established in 2008 for monitoring of adverse drug reactions.

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Synergies for increased efficiency and aid effectiveness in countries

Synergies for increased efficiency and aid effectiveness in countries

Opportunities for synergies in countries:– With programmes aimed at supporting countries to deliver on MDGs

4, 5 and 6 e.g. GFATM etc.

– With other initiatives for improving access to medicines (e.g. Medicines Transparency Alliance (MeTA), Southern Africa Regional Programme on Access to Medicines (SARPAM) etc.;

– With other activities aimed at strengthening health systems and improve coordination of development partners e.g. EC/WHO on HRH; NHPSP; IHP+;

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DFID/WHO/HAI-A Regional Collaboration DFID/WHO/HAI-A Regional Collaboration

MoH Pharm DeptGhana, Kenya, Uganda

WHOCountry Medicines

Adviser

HAI Africa

Collaboration to improve policies

and practices for access to medicines

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MeTA multi stakeholders approachMeTA multi stakeholders approach

Ministries & Gov. agencies

Civil society

Private sector

Int. institutions

DPs

Pharmaceutical companies (generic and patent)

•Access to more information on medicines needs•Active role in national policy agenda•Visibility & concerned by public health issues•Address quality matters

•Improve health systems efficiency & access to medicines •Commitment to good governance & transparency agenda•Promote multi stakeholders inclusive approach

• Active role in national policy agenda

•Supportive environment for advocacy•Financial and other support•Improved dialogue with public and private sectors

Good governance agendaTackle corruptionIncrease access to medicinesSupport responsible business

•Promote transparency & good governance agenda•Improve health systems efficiency & access to medicines

Wholesales, distributors, retailers

•Access to more information Opportunity for building capacity & improve business practices•Active role in policy agenda

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Some readingsSome readings

WHO Medicines Programme Coordination (MPC) web page

http://www.who.int/medicines/areas/coordination/en/index.html

Evaluation of WHO/DFID/HAI Regional collaboration for Action on Essential Medicines in Africa

http://apps.who.int/medicinedocs/documents/s16564e/s16564e.pdf

Evaluation of the Government, civil society and WHO Partnership

http://apps.who.int/medicinedocs/documents/s16564e/s16564e.pdf

Medicines Transparency Alliance (MeTA) web pages

http://www.who.int/medicines/areas/coordination/meta/en/index.html

MeTA assessment report (summary):

http://www.medicinestransparency.org/fileadmin/uploads/Documents/Evaluation/MeTA_Evaluation_Summary_Report.pdf

EC-ACP-WHO Partnership web pages

http://www.who.int/medicines/areas/coordination/ecacpwho_partnership/en/index.html

Web page on Medicines Adviser in the African Region (key products available):

http://www.who.int/medicines/areas/coordination/medicinesadvisers/en/index.html