Affordable Medicines Facility for Malaria (AMFm)

1. Affordable Medicines Facility for Malaria (AMFm) Joy Phumaphi Vice President, Human Development Network The World Bank October 9, 2007 Prepared for meeting with All-Party Parliamentary Malaria Group

2. Outline of Presentation • Brief overview of the World Bank’s engagement in Malaria Control in Africa • Rationale of the AMFm • Current design of the AMFm • Next steps

3. The World Bank Response in the Fight Against Malaria • Engaged in the financing of malaria control operations in Africa under the World Bank Booster Program for Malaria Control in the Africa Region • 10 year initiative : 2005 to 2015 • Mobilized US$ 450 million in IDA resources in its first two years • Currently 17 Booster Projects operating in 18 countries • Projects outside of Africa including a US$ 250 vector management project under development in India • Engaged in extensive policy and partnership work through independent scholarship and various working groups associated with the Roll Back Malaria Partnership • In this context, the Bank has provided intellectual leadership and acted as a co-convener in the development of a high-level subsidy for malaria drugs:the Affordable Medicines Facility for Malaria (AMFm)

4. The Africa Region’s contract with the World Bank’s Board of Directors: The Africa Action Plan • Africa is now the Bank Group’s top priority • In 2006, the Bank’s Africa Region completed a planning and prioritization exercise to focus the Region’s lending program on selected key outcomes across all sectors • The Bank has placed malaria control as a top priority in its Africa Action Plan (AAP) • FY07 (July 2006-June 2007) lending for the AAP: US$5.7 billion AAP PILLARS FLAGSHIP BUSINESS LINES • I. ACCELERATING SHARED GROWTH • Drivers of Growth • 9. Scale up Human Development • HIV/AIDs • Malaria • Primary education and gender equality in education 8. Strengthen national health systems to prevent and treat malaria and HIV/AIDS Anti-malaria drugs and bed-nets used for families with children under 5 Reduced Child Mortality

5. 9-fold Increase in World Bank Financing for Malaria Control in Africa *Prior to the Booster Program, malaria-specific financing was not tracked, so only very rough regional estimates are available.

6. Two pronged approach: Support rapid scale-up of proven interventions Strengthen health systems Flexible: design of each Booster project adapted to country context and lending instrument (SWAp, Stand Alone, etc.) Country-led:supports national malaria control plans Strong results focus: program coverage and investments Emphasizes partnership: embedded into the RBM Partnership, encourages new malaria control partners Regional: addresses multi-country and cross-border issues Key Design Features of the Booster Program in Africa

7. AFMm Purpose: to increase the availability of ACTs and substitute monotherapies across all sectors Note: Other category includes Mefloquine, Amodiaquine and others. ACT data based on WHO estimates and manufacturer interviews. Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for OneWorld Health, WHO, Dalberg.

8. ACT prices are relatively high and affordable to only few in the private sector, presenting a major barrier to usage Note: Ranges indicate variance across countries and products excluding outliers; N (observations): (ACT, 222); (AMT, 227) ; (CQ, 37) ; (SP, 118). Source: Dalberg field research (Kenya, Uganda, BF, Cameroon), Observations by World Bank and Research International (Nigeria). Smaller pricing observations were also performed in Ghana, Rwanda, Burundi, Niger and Zambia), but due to low n not included. Sulfadoxine-Pyrimethamine and Chloroquine data complemented with HAI and IOM observations

9. AMFm will offer ACTs to first-line buyers at a similar price range as CQ and SP through existing channels (illustrative) Co-payment Multiple eligible ACT Manufacturers Global ACT Subsidy Public Buyers (e.g. Ministry of Health) Private Buyers (e.g. National Wholesalers) NGO Buyers (e.g. PSI, MSF) National distributors e.g. Central medical stores Medicines Distributors Money Information Retailers, private clinics and public providers Patients Supporting interventions

10. AMFm update on process to date • Institute of Medicine (IOM) Report outlines economic rationale for ACT subsidy (2004) • RBM Finance & Resource Working Group(FRWG) takes on the task to develop concept • The World Bank (co-chair of FRWG), with funding from Bill & Melinda Gates Foundation, engages Dalberg to develop a detailed design • FRWG leads a Partnership meeting on the topic in Amsterdam in January 2007 • RBM Executive Committee creates a Global ACT Subsidy Task Force to forge consensus in February 2007. A significant work programme is undertaken to prepare a draft technical proposal for the subsidy • APPMG Report released in April 2007 • In May 2007 the Roll Back Malaria Partnership Board agreed to the objectives and design principles for the subsidy and requests that the Task Force prepare a full technical proposal for consideration at its November meeting • In August 2007 a draft detailed technical proposal is submitted to the RBM Task Force and the RBM Executive Committee, as well as potential hosting institutions and donors. • September 2007: the RBM Task Force agrees technical design of the subsidy • September 2007: Global Fund to fight AIDS, TB and Malaria Policy & Strategy Committee requests Board to consider hosting AMFm as a new business line for the organization • September 2007: Senior World Bank management gives full endorsement

11. AMFm objective and design principles AMFm design principles • Pricing & availability – to all sectors and countries • Management – small secretariat • Eligibility - standards for products, suppliers, buyers • In-country supporting activities - ensure responsible introduction and use • Monitoring & evaluation - linked to RBM Strategic Targets for 2015 Objective: Increase overall use of ACTs • Promote the use of ACTs and drive mono-therapies and ineffective drugs from the market by: • Reducing end-user prices to an affordable level • Introducing supporting interventions including those for proper use of ACTs

12. AMFm operational model CORE FUNCTIONS (Executed by Facility) • Negotiation of prices and terms for products • Co-payment for subsidized products purchased by first line buyers • Setting prices and terms for international distribution • Transparent sharing of information and forecasts ELIGIBILITY CRITERIA / REQUIREMENTS (Set by Facility) • Product eligibility • Country preparedness • Buyer eligibility PARTNER / SUPPORTING INTERVENTIONS (Monitored or coordinated by Facility) • National policy and regulatory preparedness • Wholesaler incentives and pricing / margin control mechanisms • Public education and awareness (IEC) • Provider training • National monitoring and quality preparedness (resistance monitoring, pharmacovigilance, and quality surveillance)

13. AMFm funding requirements • A stable, long-term funding commitment will be essential to achieve full impact on market dynamics • Total funding requirement for the first five years estimated at USD 1.4-1.9 billion Note: Funding projections are estimates, subject to updates. Source: Dalberg analysis

14. Going forward: Activities leading up to the November RBM Board meeting Key activities and events September – November 2007 • Continued engagement with potential financiers and hosting institutions • Further work on implementation issues, including operational research, packaging, communications plan, supporting interventions • Presentation to the All-Party Parliamentary Malaria Group in London (9 October) • Briefing to UNITAID Board NGO representatives in Geneva to strengthen NGO support for UNITAID involvement in AMFm (10 October) • Increase awareness of AMFm at Gates Malaria Forum in Seattle (15-18 October) • Global Fund Board decision to prepare business plan for hosting (12-13 November) • Endorsement of final technical proposal sought at RBM Board meeting in Addis Ababa (28-29 November)