Viewpoint www.thelancet.com Published online October 11, 2010 DOI:10.1016/S0140-6736(10)61189-0 1 In recent years, several constraints have impeded access to effective treatments for malaria due to Plasmodium falciparum. First, the parasite has become increasingly resistant to established cheap drugs, such as chloroquine and sulfadoxine-pyrimethamine. Second, development assistance has been routed largely through public channels, whereas affected individuals seek treatment mostly through the private sector. Finally, new artemisinin-based combination treatments (ACTs), recommended by WHO for uncomplicated falciparum malaria, 1 are too expensive for many people who seek treatment in the private sector. These three restrictions have resulted in low coverage of ACTs and persistent use of oral artemisinin monotherapy, thereby increasing the risk of widespread parasite resistance to artemisinin—the only widely effective first- line treatment. The three constraints noted above have prompted exploration of new approaches to resolve difficulties of low coverage of combination regimens and continued use of inappropriate monotherapy. The Affordable Medicines Facility–malaria (AMFm) is an innovative financing mechanism to expand access to affordable ACTs through the public and private sectors and non-governmental organisations (NGOs) and, crucially, to displace oral artemisinin monotherapies from the market. 2,3 AMFm has the potential to transform the way universal access to new malaria drugs and similar technologies is financed. Managed by the Global Fund, it aims to reduce the cost of ACTs sold in the private sector, from up to US$11 per treatment at present to the same price as chloroquine or sulfadoxine-pyrimethamine (about $0·50) and to less than the cost of oral artemisinin monotherapy (about $3–7). Patients who receive malaria treatment through public-sector clinics and not-for-profit services will also benefit from increased access to free or low-cost ACTs. The origins of AMFm have been described previously, 4,5 and findings of two small pilot projects indicate that its basic design works in practice. 6,7 Here, we present an interim perspective on implementation of AMFm and potential lessons for the architecture of financing universal access to lifesaving health technologies. The design of AMFm incorporates three elements: (1) price reductions through negotiations with manufacturers of ACTs; (2) a buyer subsidy, via a co-payment at the top of the global supply chain; and (3) support of interventions to promote appropriate use of ACTs. 8 The key innovation is the combined approach to reduce prices substantially by negotiation with manufacturers and by global subsidy. This objective entails payment by AMFm of a large part of the post-negotiation price (the co-payment) on behalf of eligible first-line buyers from the public and private sectors and NGOs, who all purchase ACTs directly from the manufacturer. AMFm has two funding streams. A first co-payment fund of US$216 million—financed by the Bill & Melinda Gates Foundation, the UK Government, and UNITAID—covers the subsidies. A second allocation of US$127 million from the Global Fund finances supporting interventions. After Global Fund board approval in November, 2009, phase one of AMFm started in mid-2010 and is scheduled to last for 2 years. It will be implemented in eight countries: Cambodia, Ghana, Kenya, Madagascar, Nigeria, Niger, Tanzania, and Uganda. AMFm will provide co-payments for first-line buyers of ACTs in these countries, but it will only co-pay for the purchases of products that meet quality criteria of the Global Fund’s quality assurance policy. 9 AMFm has concluded master supply agreements with six pharmaceutical companies that met its quality criteria for supply of ACTs to first-line buyers, namely: Ajanta Pharma, Cipla, Guilin Pharmaceutical, Ipca Laboratories, Novartis, and Sanofi-Aventis. This achievement is important because, in a departure from previous practices, manufacturers will sell ACTs to first-line buyers from the private sector at the same reduced prices as they sell to public-sector buyers. Manufacturers have agreed to not market oral artemisinin monotherapy. AMFm has set a maximum acceptable price that manufacturers may charge first-line buyers for each formulation pack size. The subsidy is then applied to each quoted price in the form of a fixed co-payment. Four challenges to implementation of AMFm, which are most directly related to its design, are: (1) passing the subsidy on to patients at the retail level; (2) learning the most effective ways to expand access to diagnostic tests for malaria; (3) reaching poor and remote populations with ACTs; 10,11 and (4) finding the appropriate approach to evaluation and benchmarking of phase one. We examine each of these challenges in turn. First, the risk with a high-level subsidy is that some of its benefits might be captured by first-line buyers and middlemen. To mitigate this risk, the Global Fund requires every first-line buyer to sign an undertaking to pass on to those further down the supply chain the benefits of the buyer subsidy that they (the first-line buyers) will enjoy. First-line buyers commit to addition of no more than a reasonable margin, defined as the margin Universal access to malaria medicines: innovation in financing and delivery Olusoji Adeyi, Rifat Atun Published Online October 11, 2010 DOI:10.1016/S0140- 6736(10)61189-0 Global Fund to Fight AIDS, Tuberculosis and Malaria, Geneva, Switzerland (O Adeyi DrPH, Prof R Atun FFPHM); and Imperial College London, London, UK (Prof R Atun) Correspondence to: Dr Olusoji Adeyi, Global Fund to Fight AIDS, Tuberculosis and Malaria, Chemin de Blandonnet 8, CH-1214 Vernier, Geneva, Switzerland Olusoji.Adeyi@Theglobalfund. org