Malaria programme gets kiss of death from Global Fund.

It appears that the Affordable Medicines Facility — Malaria (AMFm) is being scuttled by the Global Fund to Fight AIDS, Tuberculosis and Malaria. The AMFm is a multimillion-dollar programme to get effective drugs — artemisinin-based combination therapies (ACTs) — to remote rural villages, where local stores are often the main providers of medicines.

That’s my first take on the Global Fund’s announcement this afternoon, delivered towards the end of a two-day meeting of its board, which began yesterday in Geneva, Switzerland. The fund intends to end AMFm’s stand-alone status, and instead “integrate” the AMFm into its existing core system of providing grants to countries to purchase drugs, bed nets and other malaria-control measures.

Meanwhile, just in: the Fund announced a few minutes ago that it has nominated as its new executive director Mark Dybul, a former head of the President’s Emergency Program for AIDS Relief (PEPFAR), who now co-directs the Global Health Law Program at the O’Neill Institute for National and Global Health Law at Georgetown University in Washington DC. It follows the resignation of Michel Kazatchkine in February (see ‘Global health hits crisis point‘).  More on that later.

The idea behind the AMFm was to make ACTs the frontline treatment, something which has been badly hindered by their much higher price than older antimalarials. Although these older drugs, such as chloroquine, are cheap, they are often ineffective because the parasite has developed resistance to them.

AMFm’s strategy was to first guarantee a market of large bulk orders, allowing it to negotiate large cuts in the price of the drugs from pharmaceutical companies. It then gave importers in affected countries — both in the public and private sector — a subsidy on their purchases, to bring the final price to the consumer down to a level competitive with older drugs. It was also intended to compete with artemisinin monotherapies, which are a recipe for generating drug resistance against the only drug class that is truly effective against malaria.

A full-blown country-level trial of the AMFm concept in eight countries — Cambodia, Ghana, Kenya, Madagascar, Niger, Nigeria, Tanzania (including Zanzibar) and Uganda — began in July 2010 and runs until December 2012. It has had its critics — see ‘Malaria plan under scrutiny’ — but in anyone’s reasonable terms it has already been remarkably successful in many important ways within a very short period ( see the 31 October Lancet paper ‘Effect of the Affordable Medicines Facility—malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data’).

The Global Fund’s press release detailing its plans is entitled ‘Board approves integration of AMFm into core Global Fund grant processes‘, and much of its soothingly reassuring content would perhaps have many thinking that the AMFm’s integration into the Global Fund’s core grants system is good news. But it is in effect being killed. There’s will be no new money ringfenced for the AMFm once it runs through its current funding up to the end of 2013, which means that any countries wanting to set aside cash for the private sector will be required to take this from their country grants from the Global Fund. In reality, that will probably translate into AMFm activities simply being terminated in most countries, leading to local price rises in ACTs, and the drugs disappearing off the shelves of local pharmacies. AMFm’s clout in negotiating bulk pricing deals internationally will also probably be weakened.

Here’s what a group of AMFm’s supporters wrote in the Lancet on 31 October about what ‘integration’ of the AMFm into the Global Fund would mean (from’The Affordable Medicines Facility—malaria: killing it slowly‘):

“In November, 2012, the Board of the Global Fund will vote to either continue AMFm in a modified form after December, 2013, or terminate the programme. There is a strong push from donors (though not from countries) to integrate AMFm into the regular Global Fund model, whereby countries would choose how much of their country budget envelopes, which are already committed to other priorities supporting the public sector, to reallocate to AMFm. We believe that this approach will create instability in artemisinin demand, lower the number of ACT manufacturers, increase ACT prices, and abandon the millions who depend on AMFm-subsidised ACTs. Most importantly, it will kill a programme that, when fully implemented, rapidly met its benchmarks despite the many constraints, expectations, and unrealistic timelines imposed on it. We must acknowledge that an efficient approach to subsidising antimalarial drugs has worked, making them available in the private sector where people go to buy them.”

The Global Fund’s board has decided AMFm’s fate, and there is probably no going back on that. But the world now urgently needs a strategy that works with the private sector to keep down ACT prices, particularly in Africa.

Souce: Nature blog