The Global Fund and the Affordable Medicine Facility-malaria (AMF-m)

1. The Global Fund and the Affordable Medicine Facility-malaria (AMF-m) Dr Stefano Lazzari Senior Health Advisor The Global Fund to Fight AIDS, Tuberculosis and Malaria APPMG London 9 October 2007

2. The new context of malaria control • After decades of neglect, there is renewed interest in malaria • This has led to establishment of major global initiatives including the RBM Partnership in 1998, the Global Fund in 2002 and the US President Malaria Initiative in 2005. • An effective, integrated strategy has been developed, based on evidence-based approaches and taking advantage of new technical solutions. The strategy is based on a combination of: • Indoor residual spraying (IRS), • Long-lasting insecticide treated nets (LLINs), • Intermittent preventive treatment for pregnant women (IPTp), • Effective treatment for malaria according to the national treatment guidelines • The importance of strengthening health systems and of the role of non-public sectors in the delivery of interventions has been fully ecognized.

3. Challenges • Strengthen national malaria programs while also addressing health systems bottlenecks to malaria control. • Ensure the continuous availability of essential commodities, including drugs, diagnostics and LLINs. • Make optimal use of the non-governmental and private sector • Achieve universal access to prevention and treatment by the population at risk, including the rural poor. • Delay the emergence of drug resistance • Ensure sustainable, long-term financing • Continue the research and development of new drugs, diagnostics and effective vaccines • Coordinate efforts, align with national priorities and harmonize international support

4. Raise it Prove it The Global Fund is an independent public-private partnership mandated:- To raise and to disbursesubstantial new funds - To operate transparently and accountably- To achieve sustained impact on HIV/AIDS, TB, and malaria What is the Global Fund? Spend it BG/290607/1

5. Guiding Principles • Operate as a financial instrument, not an implementing entity • Make available and leverage additional financial resources • Support programs that reflect national ownership • Operate in a balanced manner in terms of different regions, diseases and interventions • Pursue an integrated and balanced approach to prevention and treatment • Evaluate proposals through independent review processes • Establish a simplified, rapid and innovative grant-making process and operate transparently, with accountability BG/290607/2

6. ResourcesSeptember 2007 Funding to the Global Fund • Total pledges available through 2008 = US$ 10 billion • Approximately US$ 8.6 billion has been paid in Global Fund funds approved and disbursed • Total proposals approved • 2-year budget of US$ 4.7 billion • 5-year budget of US$ 11.7 billion (proposed total) • Grant agreements signed • 2-year agreement of US$ 4.4 billion • Phase 2 agreement of US$ 2.4 billion • US$4.4 billion disbursed BG/011007/5

7. The Global Fund and malaria • In 6 rounds the Global Fund has approved funding for 117 malaria grants in 85 countries (41 in Africa). • To date, $2,600 million has been approved and $ 950 million disbursed. Malaria grants represent 22% of the GF portfolio. • Support provided for the initial two years includes: • ACTs: $285 million • ITNs: $109 million • IRS: $ 82 million • Commodities represent about 40% of GF malaria grants

8. GF malaria grants performance

9. Initial results in malaria prevention Tanzania: In pilot districts ITN coverage has reached 60%, resulting in under-5 mortality decline of up to 50% Zambia: Distribution of 900,000 ITNs and access to ACTs has resulted in 90% decline in malaria deaths. Lubombo region of Southern Africa: A multi-country programme has contributed to 90% reduction in malaria incidence and 53-94% reduction in malaria prevalence in some areas. Kenya: LLNI coverage rose from 7% in 2004 to 67% in 2005. This was associated with a 44% reduction in child mortality. Rwanda: Reports of rapid decrease in ospitalization in pediatric wards and reduced uptake of ACTs associated with increased coverage with ITNs.

10. Barriers to scaling-up ACTs • High cost • Limited number of products and manufacturers • Prescription Only Drug • Only available (fully subsidized) in public health facilities with limited coverage of population • Prescribers and consumers habits

11. Rationale: to increase the availability of ACTs and replace monotherapies across all sectors Note: Other category includes MQ, AQ, and others. ACT data based on WHO estimates and manufacturer interviews. Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for OneWorld Health, WHO, Dalberg.

12. AMF-m +2 years A scenario for ACTs coverage taking into consideration the different sub-sectors, the impact of prevention and the expansion of home-based care Malaria cases prevented CQ or SP CQ or SP CQ or SP CQ or SP ACTs ACTs Coverage by ACTs ACTs ACTs Total malaria treatments = 440 million ACT treatments = 286 million ACT coverage = 65% Home-based treatment of malaria

13. AMF-m Objectives • Increase the overall use of ACTs and drive out monotherapies and ineffective drugs from the market by: • Reducing end-user prices to an affordabel level through a properly supported global subsidy of ex-manufacturer prices (CIF basis) – in line with IOM recommendations • Introducing (in country) supporting interventions, including the support for the proper use of ACTs.

14. Benefits of the AMF-m • Ensure a regular supply of cheap and effective antimalarial drugs to all sectors • Facilitate the involvement of the private sector in ACT distribution • Promote, through the supporting interventions, the strengthening of national capacities in • Procurement and drug management, • Drug quality assurance • Pharmacovigilance • Drug resistance monitoring. • Improve forecast of ACT needs, stabilize the ACT market and reduce ACT price.

15. Several issues still need to be addressed • Improved analysis of what the facility can actually achieve, in what timeframe and at what cost. • Approach to defining, managing and financing of supporting interventions for a “responsible introduction” of the facility. • Making sure that the benefits of the facility are carried forward to the consumer, the rural poor in particular. • Definition of operational model for distribution of ACTs through the informal private sector (through further operational research) • Definition of a clear operational model for price negotiation with manufacturers, that would reduce prices while encouraging innovation and the entry of new manufacturer in the ACT market. • Sources and sustainability of financing for the AMF-m.

16. Global ACT Subsidy / Affordable Medicines Facility - malariaPSC Discussion Summary • RBM Partnership has requested the Global Fund to consider hosting the AMF-m • Initial analysis shows strong complementarity and potential synergies of between Global Fund and AMF-m objectives and design. • Global Fund Board to consider at its November meeting whether to support hosting the subsidy as an integrated business line within the Global Fund