1. Working with Countries, Harmonisation and Regional Initiatives Technical Briefing Seminar MP Matsoso Director Department of Technical Cooperation for Essential Drugs and Traditional Medicine

2. TITLE from VIEW and SLIDE MASTER | 27 July 2006 2 |2 | Background 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

3. TITLE from VIEW and SLIDE MASTER | 27 July 2006 3 |3 | UN 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

4. TITLE from VIEW and SLIDE MASTER | 27 July 2006 4 |4 | Framework for coordination UNDG 30 members Executive committee: UNICEF, UNDP, UNFPA, WFP Harmonisation alignment to reach MDGs

5. TITLE from VIEW and SLIDE MASTER | 27 July 2006 5 |5 | Medicines 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

6. TITLE from VIEW and SLIDE MASTER | 27 July 2006 6 |6 | Pharmaceutical supply system Production Importation Quantification of needs Selection Procurement ( tender, bids, negotiations) Purchasing, payment Finance managements Inventory, tracking, audit, accountability Distribution, transport Information, stock file, electronic data base patents Pharmaceutical supply system Production Importation Quantification of needs Selection Procurement ( tender, bids, negotiations) Purchasing, payment Finance managements Inventory, tracking, audit, accountability Distribution, transport Information, stock file, electronic data base patents Pharmaceutical financing system Budgets and expenditures (public and private) Donor funds Revolving funds Drug benefits in health insurance (public/private) Cost recovery, payment system Out of pocket payments Direct purchase in private sector Pharmaceutical financing system Budgets and expenditures (public and private) Donor funds Revolving funds Drug benefits in health insurance (public/private) Cost recovery, payment system Out of pocket payments Direct purchase in private sector Pharmaceutical information WHO specific--country profile & baseline data, MOH specific -- basic and vital statistics MOF specific--fiscal & budget expenditures, trading, private revenue on pharmaceutical sales Pharmaceutical information WHO specific--country profile & baseline data, MOH specific -- basic and vital statistics MOF specific--fiscal & budget expenditures, trading, private revenue on pharmaceutical sales Human resource Needs, norms and basic qualification Personnel in pharmaceutical sector (licensed, practicing) Population/health worker ratio G/P staff ratio Interns/volunteers Community service recruits, community health workers, middle level workers Managerial/supervisory Financial investment on human resource Human resource Needs, norms and basic qualification Personnel in pharmaceutical sector (licensed, practicing) Population/health worker ratio G/P staff ratio Interns/volunteers Community service recruits, community health workers, middle level workers Managerial/supervisory Financial investment on human resource Medicine regulatory system Enforcement of drug laws and regulations Drug registration Licensing Inspection Post marketing surveillance Quality control Harmonisation (regional) Ethical practices Patents, TRIPS Medicine regulatory system Enforcement of drug laws and regulations Drug registration Licensing Inspection Post marketing surveillance Quality control Harmonisation (regional) Ethical practices Patents, TRIPS Health Systems

7. TITLE from VIEW and SLIDE MASTER | 27 July 2006 7 |7 | 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 & 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

8. TITLE from VIEW and SLIDE MASTER | 27 July 2006 8 |8 | 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, patent landscape, 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

9. TITLE from VIEW and SLIDE MASTER | 27 July 2006 9 |9 | HQ Regional Offices Country Offices Ministries of Health Ministries of Health Partners in Country Support Partners in Country Support WHO operational partners UNAIDS, bilateral and multilateral agencies, public interest NGOs in health, UNDP, UNFPA, UNCTAD WHO scientific partners WHO Collaborating Centres in medicines, TRM, academic and research institutions, international health professional associations WHO strategic partners World Bank and development banks, Donor Agencies pharmaceutical industry, WTO, WIPO, EU WHO Collaborative Partners WHOCountries

10. TITLE from VIEW and SLIDE MASTER | 27 July 2006 10 | SADC/WHO DRA 1 DRA 2 DRA 3 DRA 4 SADC/WHO DRA 1 DRA 3 DRA 2 Sharing basic information: a common data and file repository is 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

11. TITLE from VIEW and SLIDE MASTER | 27 July 2006 11 | A 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

12. TITLE from VIEW and SLIDE MASTER | 27 July 2006 12 | The 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

13. TITLE from VIEW and SLIDE MASTER | 27 July 2006 13 | Strategic 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

14. TITLE from VIEW and SLIDE MASTER | 27 July 2006 14 | Strategic 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

15. TITLE from VIEW and SLIDE MASTER | 27 July 2006 15 | 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