OUTLINE

1. ESSENTIAL MEDICINES IN THE AMERICASRegional and sub-regional perspective and experiencesJorge Bermudez, MD, PhD (Unit Chief)/Nelly Marin, Pharmacist (Regional Adviser)WHO/UNICEF Technical Briefing on Essential Medicines PoliciesSeptember 2006 Pan American Health Organization

2. OUTLINE • STRUCTURE AND PROCESS • SYNERGY, ADDED VALUE AND SHARING EXPERIENCES • CHALLENGES AND THE WAY FORWARD Pan American Health Organization

3. STRUCTURE AND PROCESS Pan American Health Organization

4. What is PAHO? • One of the oldest health organization with 103 years in existence • Part of the United Nations System (WHO/AMRO) • Also part of the Inter-American System • PAHO's directing council is made up of Ministers of Health who establish technical and administrative policies • There are 35 member governments from the Americas Pan American Health Organization

5. Office of the Assistant Director Pan American Health Organization

6. Technology and Health Service Delivery Pan American Health Organization

7. Goods Services Vulnerable populations Technology and Health Service Delivery Framework Essential medicines Ocular Health Vaccines & Biologicals Hospitals ACCESS Technologies Primary Health Care QUALITY Radiological Services Oral Health Safe Blood Network of services Laboratories Disabilities Indigenous health Elderly EQUITY Mental Health Alcohol & Drugs Pan American Health Organization

8. Situation analysis • Medicines represent the largest public spending in healthcare after personnel costs (represents less than one-fifth of total public and private health spending in most developed countries, 15 to 30% of health spending in transitional economies and 25 to 66% in developing countries). • Lack of access to essential drugs, irrational use of drugs, and poor drug quality remain serious global public health problems. • In rich and poor countries alike, health technologies form the backbone of health services. • Access to health technologies is one of the most distinct differences among rich and poor countries. • Some technologies are inherently safe, but the vast majorities are not. Therefore they require established quality assurance and quality control. Pan American Health Organization

9. Our Framework For Technical Cooperation Strategy Implementation Addressing the Unfinished Agenda “For the last time” National Health Development Facing New Challenges Protecting Achievements “For the first time” “Forever” Pan American Health Organization

10. Examples of working our cooperation framework in AMRO • Addressing the unfinished agenda: • Supporting the National Medicines Policy in the Dominican Republic (a Presidential effort) • WHO/EC project for ACP countries; • Protecting achievements: • ARV price negotiation involving 11 MoH and 27 pharmaceutical companies, price reductions from 15 to 55%. • PANDRH and the SF • Facing new challenges: • Mechanism of informal dialogue with NRA from MEX, CUB, BRA, ARG, CHI (joint inspections with PANDRH guidelines, addressing new products) • Negotiation, approval and implementation of FTA in the Region (TRIPS Plus) Pan American Health Organization

11. Strategic clustered lines of action: • Access to products of quality • Policies and regulation • Essential health technologies • Unit Management and inter-programmatic initiatives Pan American Health Organization

12. Access to medicines (AMRO) Strategic lines of action (Document CD45/10, 2004) • Promoting coherent generic medicines strategies as a means to increase the availability and use of quality essential medicines • Developing cost-containment strategies for Essential Public Health Supplies, with focus on two areas: pricing and intellectual property • Strengthening public health commodity supply systems to ensure continuity and availability • Strengthening regional pooled negotiations and procurement mechanisms, including PAHO Strategic Fund Pan American Health Organization

13. SYNERGY, ADDED VALUE AND SHARING EXPERIENCES Pan American Health Organization

14. HTP/PSM HTP/TCM HTP/EHT HTM/HIV THS/EV Areas of synergy between AMRO and WHO WHO AMRO Pan American Health Organization

15. Areas of synergy between AMRO and WHO • Medicines Strategy 2004-2007 • Development and use of WHO frameworks on Essential Medicines: • Model List for Essential Medicines • National Medicines Policies • Rational Use of Medicines • Medicines indicators (levels I and II) • Technical documents: GMP, BE • WHO:EC project (ACP countries) • Trade and Health Pan American Health Organization

16. AMRO’S ADDED VALUE • Experience in sub-regionalization • Strong support from the Collaborating Centers • Facilitate resource mobilization for inter-country horizontal cooperation (South-South) • Solid regional programs and initiatives: • Pan-American Network on Drug Regulatory Harmonization (PANDRH) • Strategic Fund for Procurement of Essential Public Supplies • Regional negotiation of ARV prices (11 countries and 27 pharmaceutical companies) Pan American Health Organization

17. Cont…. AMRO’S ADDED VALUE • Inter-programmatic initiatives (FCH/AI, DPC/NCD, DPC/CD) • Ad-hoc Working Group on Access to Medicines with two subgroups: • Generic strategies • Intellectual Property Rights Pan American Health Organization

18. WHO CC Policies Regional Office WHO CC Supply Subregional post Central America Subregional post Intl Caribbean WHO CC Supply WHO CC information Andean (Pending) Subregional post Intl MERCOSUR Sub-regionalization of the Program of Essential Medicines, Vaccines and Technologies WHO CC Policies WHO CC Rational Use Pan American Health Organization

19. Pan American Network forDrug Regulatory Harmonization Pan American Health Organization

20. Good Manufacturing Practices • Bioequivalence and Bioavailability • Good Clinical Practices • Drug Classification • Counterfeit Drugs • Good Laboratory Practices • Pharmacopoeia • Medicinal Plants • Drug Registration • Pharmacovigilance • Vaccines • Promotion and Marketing Working Groups PANDRH: Pan American Network for Drug Regulatory Harmonization • Establishes a Pan American Forum of Drug Regulatory Agencies (DRA) to discuss and search for solution of common problems, with DRAs leading and participating in the process. • Strengthens the establishment of priorities in drug regulatory harmonization processes and encourage convergence of drug regulatory systems in Region. • Improves access to quality, safety & efficacy drugs to improve quality of pharmaceutical markets. • Promotes technical cooperation where more developed DRA share knowledge and experiences with less advanced DRA Pan American Health Organization

21. The Strategic Fund: A Country Initiative: • 2000: established by the Director of PAHO at the request of Brazil during the 42nd Meeting of the Directing Council • 2004: Resolution CD45R7 of the 45th Directing Council on Access to Medicines: • Strengthen capacity in programming and planning of supplies • Facilitate the achievement of economies of scale • Promote continuous availability of Strategic Public Health Supplies • 2004 & 2005: Resolutions of the 45th and 46th Directing Councils in HIV/AIDS: • Critical Line of Action #4 of the Regional Plan in HIV/AIDS for the Health Sector, 2006 – 2015. Pan American Health Organization

22. PAHO Strategic Fund Objectives • To improve national capacity in procurement and supply management of Strategic Public Health Supplies • To improve availability and affordability of Strategic Public Health Supplies in Member States • To promote concepts of quality assurance in procurement and supply management • To strengthen national priority health programs and facilitate the application of PAHO/WHO normative mandates Pan American Health Organization

23. Technical Cooperation &The Strategic Fund • Evaluation of national supply systems for strategic public health supplies • Information on suppliers and products • Price referencing • Definition and estimation of needs (products and technical support) • Estimation of budget requirements and resource programming • Procurement planning and programming of deliveries The Procurement Plan Pan American Health Organization

24. A New Perspective - 2005 • 17 Countries now participating: Barbados, Belize, Bolivia, Brazil, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Jamaica, Nicaragua, Panama, Paraguay, Peru, Trinidad & Tobago, Surinam. • A renewed focus on technical cooperation: procurement and supply management of Strategic Public Health Supplies • Implementation of a Sub-regional strategy: Central America, Andean, Caribbean and the Southern Cone • Integrated work program with key partners, COHAN and MSH. Key coordination with WHO and Clinton Foundation. • Coordination of activities through PAHO country offices and with PAHO Washington / Brazil, involving technical staff in medicines and disease management, as well as administrative personnel. Pan American Health Organization

25. www.paho.org/StrategicFund Pan American Health Organization

26. Inter-programmatic initiatives • PAHO HIV/AIDS. Regional HIV/STI Plan for the Health Sector. Critical Line of action 4:improving access to medicines, diagnostics, and other commodities • Pandemic influenza preparedness and response • Supply systems, pooled procurement and the PAHO Strategic Fund • NDC Regional Strategy Pan American Health Organization

27. CHALLENGES AND THE WAY FORWARD Pan American Health Organization

28. Main challenges tabled for PAHO • Protect the achievements: • Sustainability of the Sub-regional approach, increasing decentralization • Sustainability of PANDRH, Strategic Fund • Adequate funding for staffing (HQ, sub-regions and countries) • Expand access and sustainability in a multi-diverse Region and changing environment: • Support all countries: Canada, Brazil vs Haiti, Nicaragua • Address, with other organizations (WHO, UNAIDS, UNDP, UNICEF), Trade (FTA) and Health • Building capacity to reach national technological infrastructure in Health (negotiating loans, donations, etc) Pan American Health Organization

29. Cont…. Main challenges tabled for PAHO • Public Private Partnership as many stakeholders are available (and NGO partnerships) • Pharmaceutical Industry, Technology Industry, Academia, Funding Agencies and Foundations, Public-based NGOs, networks, etc. • Respect the inter-regional and intra-regional diversity and cultures • Joint programming especially with WHO, increasing reallocation of WHO funds and collaboration for resource mobilization. • Learning lessons from inter-regional sharing of experiences (WHO retreats, GMC, EHT, multiple dialogues). • Can we rebuild shared agendas (PAHO-WHO-UNAIDS-UNDP [Trade and Health]; PAHO (SF)-UNICEF [procurement and supply]; PAHO-WB-IDB [Health Regulation])? Pan American Health Organization

30. THE WAY FORWARD • Clear and permanent channels of communication • Resource mobilization • Support for minimum structure for RO and country support • Decentralization of resources (human and financial) • Lessons such as ICDRA and RO participation • Support for inter-programmatic and inter-regional actions and activities (sharing experiences) Pan American Health Organization

31. THANK YOU!!!!! MUCHAS GRACIAS!!!!! marinnel@paho.org Pan American Health Organization