Working with Countries, Harmonisation and Regional Initiatives Technical Briefing Seminar MP Matsoso...
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Transcript of Working with Countries, Harmonisation and Regional Initiatives Technical Briefing Seminar MP Matsoso...
Working with Countries, Harmonisation and Regional
Initiatives
Technical Briefing Seminar
MP Matsoso
Director Department of Technical Cooperation for Essential Drugs and Traditional Medicine
TITLE from VIEW and SLIDE MASTER | 27 July 20062 |
BackgroundBackground
UN Reform
Working within the UN
Working with countries
Working with partners
Working with Regional Economic Blocs
A case for coordination
The case for harmonisation
TITLE from VIEW and SLIDE MASTER | 27 July 20063 |
UN ReformUN Reform
An objective: Harmonisation to reach MDG– Maximise harmonisation– increase alignment – reduce transaction costs
Why UN– trusted partner– Respected honest broker– Convener– MDG advocate for human rights– Advocate for global norms and standards
TITLE from VIEW and SLIDE MASTER | 27 July 20064 |
Framework for coordinationFramework for coordination
UNDG
30 members
Executive committee: UNICEF, UNDP, UNFPA, WFP
Harmonisation alignment to reach MDGs
TITLE from VIEW and SLIDE MASTER | 27 July 20065 |
Medicines Strategy - the pharmaceutical foundation for improved health outcomes and stronger health systemsMedicines Strategy - the pharmaceutical foundation for improved health outcomes and stronger health systems
WHO medicines strategy 1. National drug policy - guide to coordination of action by all stakeholders
2. Access to essential medicines - financing, pricing, supply systems
3. Quality and safety - standards, effective regulation, information support
4. Rational use - health professionals and consumers, public and private sectors
Health systems • delivery systems• financing• regulatory• creating resources
Health outcomes• malaria - tuberculosis• HIV/AIDS• childhood illnesses• non-communicable diseases
TITLE from VIEW and SLIDE MASTER | 27 July 20066 |
Pharmaceutical supply system
ProductionImportationQuantification of needsSelection Procurement ( tender, bids, negotiations)Purchasing, paymentFinance managementsInventory, tracking, audit, accountabilityDistribution, transportInformation, stock file, electronic data basepatents
Pharmaceutical supply system
ProductionImportationQuantification of needsSelection Procurement ( tender, bids, negotiations)Purchasing, paymentFinance managementsInventory, tracking, audit, accountabilityDistribution, transportInformation, stock file, electronic data basepatents
Pharmaceutical financing systemBudgets and expenditures (public and private)Donor fundsRevolving fundsDrug benefits in health insurance (public/private)Cost recovery, payment systemOut of pocket paymentsDirect purchase in private sector
Pharmaceutical financing systemBudgets and expenditures (public and private)Donor fundsRevolving fundsDrug benefits in health insurance (public/private)Cost recovery, payment systemOut of pocket paymentsDirect purchase in private sector
Pharmaceutical informationWHO specific--country profile & baseline data, MOH specific
-- basic and vital statisticsMOF specific--fiscal & budget
expenditures, trading, private revenue on pharmaceutical sales
Pharmaceutical informationWHO specific--country profile & baseline data, MOH specific
-- basic and vital statisticsMOF specific--fiscal & budget
expenditures, trading, private revenue on pharmaceutical sales
Human resourceNeeds, norms and basic qualificationPersonnel in pharmaceutical sector (licensed,
practicing)Population/health worker ratioG/P staff ratioInterns/volunteersCommunity service recruits, community health
workers, middle level workersManagerial/supervisoryFinancial investment on human resource
Human resourceNeeds, norms and basic qualificationPersonnel in pharmaceutical sector (licensed,
practicing)Population/health worker ratioG/P staff ratioInterns/volunteersCommunity service recruits, community health
workers, middle level workersManagerial/supervisoryFinancial investment on human resource
Medicine regulatory systemEnforcement of drug laws and regulationsDrug registrationLicensingInspectionPost marketing surveillanceQuality controlHarmonisation (regional)Ethical practicesPatents, TRIPS
Medicine regulatory systemEnforcement of drug laws and regulationsDrug registrationLicensingInspectionPost marketing surveillanceQuality controlHarmonisation (regional)Ethical practicesPatents, TRIPS
Health Systems
TITLE from VIEW and SLIDE MASTER | 27 July 20067 |
Type B: Specific technical support
• Ad hoc or regular support Usually focused on a subset of the following areas: policy; access: quality, safety & efficacy; and rational use
Type C: Comprehensive programme support
• Time frame may cover one or more biennia • Usually involves a full-time national programme officer• Covers most or all of the following areas: policy; access, quality, safety & efficacy, and rational use
Type A: Situation analysis & Monitoring
• Assessment of pharmaceutical situation, identify priority needs – recommendations for interventions
Type IC: Inter-country
• Ad hoc or regular support involving two or more countries often in the same region • Usually focused on a subset of the following areas: policy; access; quality, safety & efficacy; and rational use
Activities Driven by Country Needs & PrioritiesActivities Driven by Country Needs & Priorities
Initiation of most activities are in response to requests by member states. Other activities are proposed by WHO based on public health needs of specific countries
TITLE from VIEW and SLIDE MASTER | 27 July 20068 |
Headquarters (TCM):
• Partnerships and technical collaboration and cooperation
• Medicines strategy planning and assist in policy development
• Support specific technical & policy issues
• Strategy in support of HR development & training
Collaborative Activities Across the WHO- Continuum Supporting WHO Medicine Strategy
Collaborative Activities Across the WHO- Continuum Supporting WHO Medicine Strategy
Guidance, Advocacy, Resource mobilization
Regional Office:
• Oversee country operations
• Planning and monitoring
• Technical, policy and management support
• Human resources development & training
• Partnerships and collaborations(Regional economic Blocs)
Country Offices:
Assess needs and identify priorities for technical support(NRA capacity, procurement and supply, patentlandscape, TRM)
• Plan & implement WHO work
• Partnerships & collaborations
•Feed back and reporting
Ministries of Health:
Identify needs & priorities
• Plan, implement and monitor action
• Coordinate with bilateral and multilateral agencies and CSO's.
•Coordination with other sectors
Implementation
TITLE from VIEW and SLIDE MASTER | 27 July 20069 |
HQHQ Regional Offices Regional Offices Country OfficesCountry Offices Ministries of HealthMinistries of Health
Partners in Country SupportPartners in Country Support
WHO operational WHO operational partnerspartners
UNAIDS, bilateral UNAIDS, bilateral and multilateral and multilateral agencies, public agencies, public interest NGOs in interest NGOs in health, UNDP, health, UNDP, UNFPA, UNCTADUNFPA, UNCTAD
WHO scientific WHO scientific partnerspartners
WHO Collaborating WHO Collaborating Centres in medicines, Centres in medicines, TRM, academic and TRM, academic and research institutions, research institutions, international health international health professional professional associationsassociations
WHO strategic WHO strategic partnerspartners
World Bank and World Bank and development banks, development banks, Donor Agencies Donor Agencies pharmaceutical pharmaceutical industry, WTO, industry, WTO, WIPO, EUWIPO, EU
WHO Collaborative PartnersWHO Collaborative Partners
WHO Countries
TITLE from VIEW and SLIDE MASTER | 27 July 200610 |
DRA 4
DRA 3
DRA 2
DRA 1
SADC/WHO
DRA 2
DRA 3
DRA 1
SADC/WHO
Sharing basic information: a common data and file repositoryis created for a limited number of participating countries
Adding scope and functionality: additional countries participate and make available selected national medicines registration data (off-line)
Shared information repository on regulatory and pharmaceutical activities and data
Angola
Botswana
Democratic Republic of Congo
Lesotho
Malawi
Madagascar
Mauritius
Mozambique
Namibia
South Africa
Swaziland
Tanzania
Zambia
Zimbabwe
TITLE from VIEW and SLIDE MASTER | 27 July 200611 |
A case for coordinationA case for coordination
Changing aid environment
Principle of better ways of working together
High level of trust
Other initiatives may be linked
Pursuit for better country support
Opportunity for achieving MDG's
TITLE from VIEW and SLIDE MASTER | 27 July 200612 |
The case for harmonisationThe case for harmonisation
There are regional and subregional approaches and global initiatives that are considered for pooling resources to deal with capacity challenges
Current regional medicine regulatory initiatives:– AFRO (EAC,ECOWAS,CEMAC,SADC,UEMOA)– AMRO (PAHNDRA, ANDEAN, MECOSUR)– SEARO/WPRO (ASEAN)– EURO (EMEA,NIS, CADREAC)– EMRO (GCC)
Global Initiatives :– WHO Prequalification (supports procurement, but has strong regulatory focus) – DCVRN (vaccine regulatory network of 9 countries established by WHO)– EU Article 58, Scientific Opinion for medicines exported from EU but not for sale
in EU, partnership with WHO– FDA Tentative approval of PEPFAR linked products, confidentiality agreement
with WHO– ICH GCG- Participation of some subregional blocs, SADC, ASEAN, PANDRA
TITLE from VIEW and SLIDE MASTER | 27 July 200613 |
Strategic ThrustStrategic Thrust
Medicines regulatory issues – Quality, Registration; Joint action, inspections, dossier evaluation and information exchange. Translation of WHO normative work to implementation at subregional and country level
Strengthen medicine regulation both at country and regional levels
Deliberate efforts to support quality and increase confidence in local products
Legal issues - including intellectual property rights and TRIPS compliance; and Strengthen patent searching capacities of national and regional offices.
Patent data on essential medicines is a key component for decision-making.
Review regulatory requirements to facilitate patent searching as in the case of developed countries
TITLE from VIEW and SLIDE MASTER | 27 July 200614 |
Strategic ThrustStrategic Thrust
Policy issues - a review of public health and access to medicines issues in the regions, and also industrial policy objectives in the regions
Utilization of spare capacity and ensuring economies of scale
Infrastructural needs - industrial and infrastructural requirements, need for complementary and support industries such as packaging, bottling, etc.
Facilitate technology transfer
Encourage investment in domestic sources for essential medicines for economic development
TITLE from VIEW and SLIDE MASTER | 27 July 200615 |
Conclusion: What can a partnership bring?Conclusion: What can a partnership bring?
Partnerships:
Provide a mechanism: each partner brings specific skills, competencies and interests, common problems or opportunities
Mobilize more resources: combines technical, human, physical and financial resources as well as information
Ensure greater awareness: of the priorities, needs and roles Create dynamic contact networks: offer channels of influence that both engage a wider community and impact policy agendas
Replace conflict with cooperation: the cost of conflict is greater in time and resources than the cost of cooperation