Paula Munderi Department of Essential Drugs and Medicines Policy World Health Organization Access to essential medicines for HIV/AIDS - update on WHO activities within UN framework

Access HIV 2 Department of Essential Drugs and Medicines Policy Aims n enhance access to affordable HIV/AIDS medicines of assured quality n promote rational use of these drugs by professionals and consumers n provide technical support to the most affected countries towards integration of HIV/AIDS medicines into national essential drugs programmes

Access HIV 3 Department of Essential Drugs and Medicines Policy 1. Rational selection and use Recent developments: n WHO guidelines for a public health approach to on scaling up antiretroviral therapy in resource limited settings : ä standardized and simplified regimens ä simplified patient monitoring n 12 ARVs on WHO Model EML & WMF

Access HIV 4 Department of Essential Drugs and Medicines Policy 2. Affordable prices for governments, healthcare providers and consumers - strategies: n National policy exemption from taxes, import duties price regulation (producer prices, distribution margins) WTO/TRIPs provisions n Market dynamics generic competition n Procurement management price information price negotiation group purchasing (public, NGO - national, regional)

Access HIV 5 Department of Essential Drugs and Medicines Policy n MSH-WHO essential drugs price indicator n Drugs and diagnostics for HIV/AIDS n Pharmaceutical starting materials n Antiretroviral drugs in the Americas n AFRO Essential Drugs Indicative price information promotes transparency and competition Affordable prices

Access HIV 6 Department of Essential Drugs and Medicines Policy UN Drug Access Initiative Generic competition in Brazil 5-company offer Generic company offer Advocacy, corporate responsiveness, & market forces have reduced antiretrovial prices 95% in 2 years UNDCP UNDP UNESCO UNFPA WIPO

Access HIV 7 Department of Essential Drugs and Medicines Policy

Access HIV 8 Department of Essential Drugs and Medicines Policy WHO policy and technical support on TRIPS to over 60 countries - health, trade and patent officials

Access HIV 9 Department of Essential Drugs and Medicines Policy 3. Sustainable financing In over 38 countries public drug expenditures are <US$2 per capita - inadequate by most estimates Key actions: n Increase public funding for cost-effective drugs n Expand drug benefits in health insurance n Seek external funding for the poorest populations (e.g. Global Fund)

Access HIV 10 Department of Essential Drugs and Medicines Policy Pilot Procurement, Quality and Sourcing Project n Objective: ä Establish a Model Quality Assurance System for Procurement of Pharmaceuticals ä Pre-qualification of suppliers of HIV/AIDS-related pharmaceutical products ä Quality standards of newer HIV medicines ä Improved capacity of national regulatory bodies n Partners: ä UNAIDS, UNFPA, UNICEF, WHO, World Bank Reliable systems

Access HIV 11 Department of Essential Drugs and Medicines Policy 4. Summary n UN framework for access includes rational selection, affordable prices, sustainable financing and reliable systems n UN, WHO and partners are active in all aspects of access n Key tools available to governments and NGOs: ä Treatment guidelines and essential medicines list ä Price information; pre-qualified suppliers and products ä Guidance on use of TRIPS safeguards ä Policy and training tools in supply management (pricing, donations, procurement and supply management)

Access HIV 12 Department of Essential Drugs and Medicines Policy what remains to be done n Adaptation of National Standard Treatment Guidelines n Adaptation of National Essential Medicines Lists n Training in Rational Use for Health Workers & Consumers n Updated review of Global Patent Status of HIV medicines n Specific guidance and country support on patents, IPR and procurement of limited-source HIV medicines n More in area of financing options n Technical assistance for in-country supply systems n Systems of Drug Safety Monitoring