WHO 3 x 5 Strategy Davidson Hamer MD

WHO 3 x 5 Strategy Davidson Hamer, MD Center for International Health Boston U. School of Public Health Tufts University School of Medicine

Three by Five Initiative Access to HIV/AIDS Medicines § Goal is universal access to antiretroviral therapy as a human right § Target is three million people on treatment by the end of 2005 § Treatment gap was declared a global health emergency Sept 22 nd at UNGA

Pre-Treatment with ART Photo courtesy of Serena Koenig, Partners in Health

Post-Treatment with ART Photo courtesy of Serena Koenig Partners in Health

Strategic Objectives of the WHO 3 x 5 Strategy

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 3 x 5 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 3 x 5 initiative 4. Align and mobilize partner support to achieve 3 x 5 target at global level § Member states, UNAIDS co-sponsors, other partners

Pillar 2: Country Support Efforts 5. Secure key elements required at the national level to deliver the 3 x 5 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 • National Medicines Policy (Selection, procurement, regulation, supply chain management, rational use) 7. Strengthen and build human capacity for scaling up ART 8. Expand capacity of communities to be fully involved in ART program activities

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

Pillar 4: Effective, Reliable Supply of Medicines and Diagnostics 12. Support country access to, and efficient distribution of high quality, low cost medicines and diagnostics • Will utilize the newly established AIDS Medicines and Diagnostics Service (AMDS)

Three by Five Initiative AIDS Medicines and Diagnostics Service (AMDS)

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 • Promote equity • Support prevention

AMDS Will 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 Will Not 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

Challenges Facing the Three by Five Initiative • Funding shortage – Estimated need for project is $5. 5 billion but only $2. 3 billion secured – Only the UK, Sweden, and Spain have provided money thus far – Global fund money may not be available for: • Necessary technical support • Health systems development

Challenges Facing Three by Five • Lack of international support – United States balking at supporting the project • Opposition by multinational pharmaceutical companies and others (? US government, FDA) to generic FDC • Optimal approach to integrate into other programs (e. g. , PEPFAR, Global Fund)

Challenges Facing Three by Five • Development of effective programs for monitoring and managing serious drug toxicities – Nevirapine – Steven’s Johnson syndrome Fulminant hepatitis – Stavudine -acidosis lipodystrophy, lactic • Need for second and third-line regimens

Acknowledgements • • • ICIUM organizers Peter Graaf, WHO Serena Koenig, PIH