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This is a joint post with Rachel Silverman.

As the Global Fund’s November board meeting approaches – where the future of the Affordable Medicines Facility for Malaria (AMFm) hangs in the balance – there is much anxiety that AMFm will be terminated in 2013. The reason for such anxiety is clear: no donors have pledged funding commitments for after December 2012. But there’s another elephant in the room: the US government’s apparent lack of support, particularly its legislated “opt-in” stance on AMFm: “the Global Fund should not support activities involving the ‘Affordable Medicines Facility-malaria’ or similar entities pending compelling evidence of success from pilot programs as evaluated by the Coordinator of United States Government Activities to Combat Malaria Globally.” (Conversely, an opt-out stance would be to support AMFm unless no compelling evidence is presented.) This very specific and strict provision makes the AMFm’s continued survival all but impossible without an explicit endorsement by US Global Malaria Coordinator (currently Rear Admiral Tim Ziemer) who leads the US President’s Malaria Initiative (PMI) housed in the US Agency for International Development (USAID).

What is AMFm? It is a financing initiative to (1) increase the supply of antimalarial drugs, specifically quality approved the artemisinin-based combination therapies (ACTs), through negotiations and co-payments at the top of the supply chain and (2) to increase demand for ACTs through country-specific supporting interventions.

So where does this provision come from? One possibility is that the AMFm would challenge the interests of powerful political stakeholders with the ear of congressional drafters, in which case big pharma might be a usual suspect. But because the purchase of a large volume of pharmaceuticals is a core component of AMFm and because the AMFm is willing to subsidize high artemisinin-based combination therapies (ACT) prices, one might expect the pharma industry to be supportive of the AMFm and not of this provision. Yet there might be significant downward pressure on prices due to negotiated price reductions, and hence big pharma may be ambivalent. So it is not obvious what big pharma would have to gain from this provision. Moreover, most of the AMFm eligible manufacturers are not American, making lobbying in the US government perhaps more difficult.

If not big pharma, who else might “lose” from AMFm scale-up? A second possibility is the “Development Industry”* and “Beltway Bandits”, whose indefinite quantity contracts (IQCs) with PMI for supply chain management of ACTs to the public sector might be crowded out by private-sector distribution channels, a potential effect of AMFm. (For more information on these contractors, see our consultative draft of our PMI background paper) These contractors may have much to lose from the AMFm – and have some political clout to make their voices heard. But we emphasize that both of these possibilities are pure speculation.

There is the third and most obvious possibility (and not a mystery): the provision was pushed not by those with the most to lose, but by the stakeholder with the most to gain from its inclusion. In this case, the “winner” is the US Global Malaria Coordinator, who has almost sole discretion regarding the AMFm’s continued existence and hence holds an immensely powerful role. Even though it was initially USAID who had approached the Institute of Medicine to develop the report “Saving Lives, Buying Time” (see p. 20) in 2004 which eventually catalyzed AMFm, it is clear that many within PMI are ambivalent about, or even hostile, to the AMFm. Ziemer has publicly expressed his skepticism about the AMFm’s theory of change and ‘proof of concept’. Deputy coordinator of PMI, Bernard Nahlen, had also expressed skepticism on AMFm as a ‘faith-based initiative’ and its expansion based on only 2 small-scale pilots. Further, according to the PMI’s recent external evaluation, several people from the Global Fund and Roll Back Malaria (RBM) Partnership noted that “PMI asks for a higher level of proof than other initiatives and seems antagonistic to AMFm. The perception expressed was that PMI/USAID works against AMFm approval by Global Fund Board and tends to undermine the facility.” Contrary to expectations, the US lack of support of AMFm goes against general US inclinations to value private sector over public sector, which explains in part the USG's general reliance on contractors, even if those contractors support the public sector in other countries. In the end, Phase 1 funding for AMFm was mainly born by UNITAID (which is not supported by the United States), the United Kingdom, and the Global Fund (for which the US is by far the largest bilateral supporter – see our background paper on the Global Fund).

It is worth noting that the US provision in requiring “compelling evidence of success” is quite reasonable and is consistent with PMI’s smart modus operandi of relying on four proven, cost-effective interventions. Indeed, one can sympathize with the US government’s reticence – prior to the start of AMFm – in participating in such an experiment of such multi-country scale. But the fact is that AMFm has started, a bit like letting the genie out of the bottle. Termination of AMFm is akin to forcing the genie back into the bottle; it probably can be done, but very painfully. The question that the US government must face is not only whether there is compelling evidence of AMFm’s success, but whether the termination of AMFm would be more disastrous than AMFm’s continuation, albeit modified. The costs and benefits of terminating need to be weighed carefully to the costs and benefits of continuing. The Global Malaria Coordinator is no doubt carefully assessing the AMFm evaluation (which suggested relatively large effects, even if not entirely attributed to AMFm). Regardless of what the Coordinator decides, he will need to transparently offer persuasive reasons for his decision. The reasons for the US decision should not be left a mystery.

Regardless of the behind-the-scenes story of the USG position, those supportive of AMFm will need to be better in communicating AMFm’s success for it to be renewed. Of course, opposition to the AMFm is only one side of the coin in the political economy. On the other side, who supports AMFm’s success and continued existence and why? AMFm supporters may have conflicts of interest of their own with potential financial and reputational ties. AMFm supporters and detractors alike would be wise to understand the political economy of AMFm and to adjust their respective strategies accordingly. Most importantly, personal biases and potential conflicts of interest need to be put aside – if not made transparent – for the benefit of evidence-based debate and decision-making and for the many people and children that would have died without AMFm.

*The Coalition of International Development Companies was launched in 2011 – well after the relevant time frame for this particular piece of legislation. Nonetheless, their willingness and ability to lobby Congress on matters of self-interest is not a new development.

The authors thank Heather Lanthorn, Mead Over, Amanda Glassman, and Jenny Ottenhoff for excellent comments as well as helpful conversations from participants in the CDDEP/IOM meeting on AMFm and febrile illness held on September 17 and 18, 2012.