The delivery of essential medicines to the uninsured populations of the world is currently (and in general, poorly) addressed through donations or sale at reduced price of drugs by their manufacturers to public sector distributors (international or national health agencies or NGOs). However, over the past ten years, again thanks in part to the Gates Foundation funding, new organizations have been formed in part to serve as intermediaries between manufacturers and providers with the goal of creating a market in which demand is better forecast, supply is assured, and prices are affordable for both sides. The most prominent and successful example is the Global Alliance Vaccines and Immunization (GAVI) which is using an “advance market commitment” model and funds raised through the International Immunization Funding Facility to greatly improve worldwide childhood immunizations (c.f. lots of other sources and my January 21 posting).
Another variation on the market intermediary concept was initiated about a year ago to address the need for access to effective anti-malarial drugs: the Affordable Medicines Facility- malaria (AMFm). Approximately 860,000 people, 90% of them children in Africa, die of malaria each year despite the existence of effective drugs. The WHO-recommended treatment is a course of one of the several commercially available “ACT” drugs (artemisinin combined therapy) which contain artemisinin and another anti-parasitic to reduce the potential for development of resistance (as happened with the two older, cheaper and widely available drugs) (Artemisinin article). The AMFm is administered by the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund) and its design was supported by the international Roll Back Malaria partnership (RBM) and its launch by the Medicines for Malaria Venture (MMV Achievements). The AMFm will subsidize the purchase of drugs from qualified manufacturers by both public (government health ministries and NGOs) and private sector buyers (wholesalers/distributors) using $215 million given by UNITAID, the United Kingdom, and the Gates Foundation. The subsidy co-payment covers about 90% of the cost and hence, if the program works as intended, will result in retail prices lower that current ACT drugs and cost-competitive with the widely-used cheap but ineffective drugs. To increase the chance of success, the AMFm is launching through a pilot program with a limited number of pre-qualified countries who will also be eligible for a subsidy of their ACT delivery program, including, public education, training of providers, and monitoring for drug quality and resistance (AMFm FAQ). The intended result is greater access to and use of effective therapy.
Like any innovation, the AMFm has its critics. For example, Medecins Sans Frontierers (MSF) is concerned that the AMFm will lead to poor compliance and increased resistance if it distributes “co-blistered” or co-packaged drugs rather than the fixed-dose combinations where the drugs are in one pill (MSF Article). In an study published in July 2009, authors from MSF and Harvard call the AMFm “promising and ambitions,” but describe the risk of over-use for fever and the need for point-of-care diagnostics to confirm malaria infection (Moon et al. 2009). The US government is apparently also skeptical of the AMFm and is with holding support. According to a New York Times article in April 2009, Dr. Bernard Nahlen, deputy coordinator of the President’s Malaria Initiative (PMI), said he wants more proof proving that subsidies will work; “I sometimes joke that this is the biggest faith-based initiative in the world of malaria” (NYT article). For a more balanced of the AMFm I recommend a briefing paper by the Global Subsidies Initiative, a Swiss-based policy group that analyses government subsidies in a wide range of countries and sectors (GSI). Their bottom line is that the AMFm’s subsidy was designed well and, with some tweaking (like enforcing adherence by distributors to the AMFm intent and monitoring results), the program will work and may be model for drug access in other indications (GSI Briefing).
So a year after initiation, where is the AMFm? About to “go live,” according to Dr. Olusoji Adeyi, the AMFm director, who said in an interview last month that the AMFm has completed negotiations on supply with six manufacturers, and they have agreed to sell at the same price to both public and private sector buyers, creating the (partially) level playing field needed for the subsidized sales to work. Also the governments and wholesalers in the nine pilot countries (Cambodia, Ghana, Nigeria, Niger, Kenya, Uganda, Madagascar and Tanzania [mainland and Zanzibar]) are beginning to place their orders. Dr. Adeyi also notes that the program will be independently evaluated by a consortium by contractors and the London School of Hygiene and Tropical Medicine. Yes, there are challenges, he said, but “This is frontier work. It’s about learning to do something by actually doing it.” (Tropika interview).
Two other actors in the AMFm drama need mention. In 2008, the Clinton Foundation, though its Health Access Initiative (CHAI) and its Drug Access Team (c.f. my posting of June 3), negotiated supply agreements between three artemisinin makers and three generic manufacturers to balance API (active pharmaceutical ingredient) supply and demand and reduce retail costs (CHAI Malaria). CHAI also conducted two pilot studies of wholesale price subsidization in Tanzania that were used in the design of the AMFm (Sabot et al. 2009). In addition, the major pharma company, Novartis, has been a consistent supporter of access to its ACT, Coartem, in several ways. Since 2001, Novartis has sold at no profit more than 300 million doses to public sector providers (the Global Fund and the President’s Malaria Initiative) for patients in more than 60 malaria-endemic countries, (Novartis News); brought the production cost (and hence the price) of Coartem down about 100% through manufacturing efficiencies (Coartem article); developed, tested, and launched a child-friendly version (Coartem Dispersible) with the MMV (MMV News); and recently shipped 2.5 million ACT treatments to Nigeria under a multi-year agreement through the AMFm (Novartis News).
I am hoping the success of the AMFm over the next year prods the US to re-think its anti-malaria plan.