Access to HIV/AIDS Medicines The 3x5 strategy WHO/EDM Technical Briefing Seminar 15-19 March 2004

Three by Five The goal is universal access to anti-retroviral therapy as a human right The target is three million people on treatment by the end of 2005 The treatment gap was declared a global health emergency Sept 22nd at UNGA

Pillar 1: WHO and global level activities 1. Visible WHO leadership and commitment to urgent action to reach the goal of universal access to ART 2. Locate the rights-based 3x5 initiative within the broader development context 3. Support all national efforts whilst focusing WHO resources on high-burden and strategic countries to achieve maximal impact of 3x5 initiative 4. Align and mobilize partner support to achieve 3x5 target at global level Momentum created Country owned process Member States UNAIDS Co-sponsors Other partners

Pillar 2: Country Support Efforts 5. Secure the key elements required at the national level to deliver the 3x5 target as part of a comprehensive response to HIV/AIDS 6. Strengthen and support the renewal of health systems and national operational capacity for scaling up ART programs 7. Strengthen and build human capacity for scaling up ART 8. Expand capacity of communities to be fully involved in ART program planning and delivery National Medicines Policy (Selection, procurement, regulation, supply chain management, rational use)

Pillar 3: simplified, standardised tools 9. Simplify and standardize procedures to identify individuals in need of therapy and facilitate entry to ART programs 10. Simplify and standardize ARV therapy to facilitate adherence and enable rapid scale-up to be implemented 11. Simplify and standardize tools for tracking ART program performance including drug resistance surveillance Rapid test based approach 4 First-line treatments FDCs and Blisters Standardized M&E Guidelines

Pillar 4: Effective medicines and diagnostics supply 12. Support country access to , and efficient distribution of high quality, low cost medicines and diagnostics

Pillar 5: Success stories and learning by doing 13. Build on success 14. Continuously learn by doing - with ongoing evaluation and analysis of program performance and a focused operational research agenda.

AMDS objectives Ensure that the supply of quality commodities is never an obstacle to expanding treatment, care and support Use improved commodity supply to catalyze rapid expansion of treatment, to promote equity, to support prevention

AMDS general principles Use partners to best capacity Don’t develop new structures/systems All partners involved in planning and further expansion Support all available channels (government, NGOs, insurances)

What the AMDS will do Assist/support a country-driven process…… Create information hub Bring together strategic information from existing sources (ensure ease of access) Develop new tools as needed (self or contracted) Serve as “one-stop-shop” for specific support Initiate and act as gateway for information and Technical Assistance by partners inside and outside WHO Support operational staff (Recruit), train and support dedicated procurement and supply chain management staff

What the AMDS does not plan to do……… No procurement itself but Support countries to buy/manage supplies Direct to appropriate services ARVs: PQ Procurement agencies Diagnostics: WHO bulk procurement scheme No repeat /duplicate effort Use ongoing work, available expertise and information No new structures MOH, NGO. No funding to purchase commodities

Examples of EDM action and guidance on Access to HIV-Related Medicines* 13th WHO Model List of Essential Medicines, including (since 12th edition including ARVs) 2nd WHO Model Formulary, including section on ARVs Pre-qualification of HIV medicines and manufacturers (R&D and generic) Annual Reports on “Sources and Prices of Selected Drugs and Diagnostics for People Living With HIV/AIDS; jointly with UNICEF, UNAIDS, MSF Operational Principles for Good Pharmaceutical Procurement – IPC group Globalization, TRIPS and Access to Pharmaceuticals. WHO Policy Perspectives on Medicines * Available on EDM web site (http://www.who.int/medicines/)

For further information………. Peter Graaff graaffp@who.int