On World Malaria Day (25 April), the United Nations Secretary General posited a vision of halting malaria deaths by ensuring that effective control measures be available to everyone by the end of 2010. The interventions are, broadly, prevention with long-lasting insecticidal bed nets; spraying interior walls of dwellings with insecticides; and treatment with effective drugs. The delivery of nets and spraying-which can be planned and rolled out systematically-presents certain logistical problems, but these are dwarfed by the challenge of improving access to drugs.

In response to the challenges of malaria drug delivery-particularly through the private sector, where most people acquire malaria drugs-the global health community has been considering a proposal for the Affordable Medicines Facility - malaria (AMFm), a global high-level subsidy for antimalarial medicines recommended by the US Institute of Medicine (IOM) in 2004. The IOM Committee concluded that a global high-level subsidy was the best way to make effective antimalarial drugs - currently artemisinin-based combination therapies (ACTs) - widely available at affordable prices, and at the same time substantially delay the emergence and spread of artemisinin-resistant strains of falciparum malaria, the most dangerous form of malaria.

The malaria death toll has always been unacceptably high-currently about one million each year, mainly African children. For a long time, the reasons were extreme poverty and inadequate health-care systems, rather than the lack of a cheap, effective drug, which from the 1940s to the 90's was chloroquine. But the emergence and spread of chloroquine-resistant strains of falciparum malaria in Asia and eventually throughout Africa has changed the reality. The development of artemisinin derivatives, spearheaded by Chinese scientists in the 1960s, stands as the single best hope to replace chloroquine on malaria's front lines for the near term. If their manufactured price were not 10 or more times more expensive than chloroquine, many products would be on the market in all malaria-endemic countries, and the transition would be well under way.

That was the situation in 2001 when the IOM was asked by the United States Agency for International Development (USAID) to study the malaria drug situation. The central recommendation of the IOM committee in their 2004 report is this: Within 5 years, governments and international finance institutions should commit new funds of US$ 200-300 million per year to subsidize co-formulated ACTs for the entire global market to achieve end-user prices in the range of US$ 0.20-0.50 per course of treatment, the current cost of chloroquine. This recommendation describes a global subsidy that enters the system high in the drug distribution chain, meaning that highly subsidized drugs would be available to all high-level purchasers, both public and private sector. In this way, drugs would enter the existing public sector and private commercial channels much as any other drug - including chloroquine.

The subsidy would be available to manufacturers of all ACTs meeting pre-specified efficacy, safety, and quality criteria. Buyers would pay very low prices, allowing drugs to flow through existing channels, with the aim of reaching consumers at a similar price to chloroquine, the most frequently used (although no longer effective) malaria drug. Unsubsidized artemisinin monotherapies would be more expensive than subsidized ACTs (co-formulations), thereby largely eliminating their use through market forces. Conditions favoring the emergence of artemisinin-resistant malaria-namely, the widespread use of artemisinin monotherapy-would thereby be greatly reduced.

Since publication of the IOM report, the "global subsidy" idea has been analyzed, examined and developed. No alternatives with anything approaching the reach of a global subsidy have been proposed. As the idea has taken hold, further refinement and planning has involved a host of actors in the global malaria community, led by the Roll Back Malaria Partnership with Dalberg Global Development Advisors and funded by the Bill & Melinda Gates Foundation. A name has been given: the Affordable Medicines Facility-malaria, going by AMFm.

Recently, the Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) asked its Secretariat to prepare plans for hosting and managing AMFm as a separately-financed business line within the Global Fund. An implementation plan for an initial launch of AMFm is under preparation, but the full support of the Global Fund Board, hence an actual launch, is not assured. Reservations still exist among a few key parties. The concerns revolve around the impact of AMFm on access to ACTs by the poorest of the poor; whether AMFm will, in fact, crowd out artemisinin monotherapies; and overuse of ACTs when they are widely available in the private sector, and the effect of overuse on the emergence and spread of artemisinin-resistant parasites.

These concerns are being taken seriously, leading to further analysis and data-gathering. The IOM Committee Chairman, Professor Kenneth Arrow, has also commented on these issues recently, in a letter to the Global Fund Board. He wrote:

"Let me start with two general observations: (A) The best is often the enemy of the good; (B) Delay has costs.

(A) There are many desirable aspects of any scheme for improvement of the lot of mankind, such as the wide distribution of effective antimalarial therapies. No proposal can meet all the conditions one can think of. It is no objection to a proposal that it cannot meet a criterion if there is no other proposal that can meet it.

(B) Asking for further evidence or asking that every conceivable difficulty be anticipated before starting a program risks imposing another cost, that of delay. Previously used antimalarials are losing or have lost their ability to control malaria. The value of delay to better meet some objections has to be weighed against the additional morbidity and mortality caused by that delay."

Professor Arrow does not offer these thoughts as a means of evading real issues. He stresses that the concerns must be taken seriously but that the counterfactual-not acting and its attendant costs- has not been given equal weight.

All evidence to date supports the original notion of how the global subsidy will work. Because every malaria-endemic country will not be prepared to make use of AMFm as soon as it is available (for example, because of drug procurement schedules and prescribing laws), it will, of necessity, be taken up over a period of a few years. This ramp-up experience will be monitored closely and adjustments made as needed. In the absence of other good ideas (despite having searched for them) and with all expectations positive, it is time to tune in to AMFm and let it play.
 
Hellen Gelband, Resources for the Future, Study Director, Institute of Medicine Committee on the Economics of Antimalarial Drugs