Future of AMFm to Be Decided at Global Fund Board Meeting in November
The future of the Affordable Medicines Facility–malaria (AMFm) will be decided at the Global Fund Board meeting on 14–15 November 2012. The outcome appears anything but certain. The AMFm was launched as a two-year pilot phase in April 2009 and began operations in July 2010. The AMFm is hosted by the Global Fund but its programme funding comes from other donors.
An independent evaluation of the AMFm was generally positive on the impact of artemisinin-based combination therapies (ACTs) in most countries. However, the Board’s AMFm Working Group says that the AMFm should not continue without some changes. In addition, an article in the journal Nature says that many people the journal spoke to said that the AMFm must be changed or be phased out. Finally, the (US) President’s Malaria Initiative publicly stated its concerns with the programme, including what it referred to as “overuse of ACTs” by people who did not need them.
Evaluation of the AMFm
The final report of the independent evaluation of the AMFm, which was released on 28 September 2012, said that the AMFm is a “game changer” for the private sector in most countries. The evaluation showed that as a result of the AMFm, significant quantities of quality-assured artemisinin-based combination therapies (ACTs) have been quickly and widely distributed through pre-existing private sector networks, reducing or closing the gaps in availability between rural and urban areas in a very short period.
The Global Fund commissioned the evaluation to find out whether the objectives of the AMFm’s pilot phase have been achieved. The aim of the AMFm is to increase availability of ACTs, particularly through private outlets where most people seek their treatments.
The AMFm also aims to bring down the cost of ACTs by subsidising the price. To date, the AMFm has subsidized nearly 270 million ACT treatments. This global subsidy is financed through contributions of $336 million from UNITAID, the governments of the UK and Canada, and the Bill and Melinda Gates Foundation. Technical support is provided by members of the Roll Back Malaria Partnership.
There are eight pilots operating in seven countries: Ghana, Kenya, Madagascar, Niger, Nigeria, Tanzania (with Zanzibar as a separate pilot) and Uganda. The independent evaluation covered all eight pilots.
The evaluation was led by a consortium of ICF International and the London School of Hygiene and Tropical Medicine. The Global Fund also contracted Data Contributors to undertake the fieldwork, data analysis and country reports.
The main results of the evaluation can be summarised as follows:
- Availability: The objective of increasing by 20 percentage points the availability of quality-assured ACTs was met in both urban and rural outlets in five of the eight pilots.
- Price: The objective of reducing the price of quality-assured ACT to less than one third of the most popular antimalarial that was not a quality-assured ACT was met in five pilots.
- Market share: The objective of increasing by 10 percentage points the market share of quality ACTs in outlets carrying antimalarials was met in four of the pilots.
While the findings varied considerably across the countries, the report said, there was an overall increase in the volumes of quality-assured ACTs, and a reduction in the volumes for the less effective anti-malarials across the pilot countries.
The Technical Evaluation Reference Group (TERG), an independent group advising the Board of The Global Fund, has established a sub-committee to conduct a technical review of the independent evaluation. The TERG will present a report on the results of this review to the Strategy, Investment and Impact Committee at its October 2012 meeting.
Findings from the evaluation will contribute to the decision by the Global Fund Board on the future of the AMFm project. It is expected that the Board’s discussion will consider the evaluation findings alongside broader recommendations from working groups established by the Board and Roll-Back Malaria to advise on next steps.
Editor’s Note: At its 13–14 September 2012 meeting, the Board decided to continue hosting the AMFm to the end of 2013. The Board considers 2013 a “transition” year because whatever decision the Board makes in November 2012 concerning the future of the AMFm, there will need to be a transition period to implement that decision.
Comments from the Board’s AMFm Working Group
In a paper submitted to the Global Fund Board at its last meeting in September 2012, the AMFm Working Group, which is part of the Strategy, Investment and Impact Committee, noted that there has been several important changes to the malaria landscape since the Global Fund agreed to host and manage AMFm Phase 1 in 2008. These changes are as follows:
- Malaria endemicity has fallen significantly due to the scale-up of malaria prevention efforts over the past several years.
- Countries have begun to scale-up access to diagnosis in the public sector.
- International funding for malaria declined in 2011 for the first time in a decade.
- Resistance to artemisinin has been detected in Southeast Asia, and there have been strong efforts to reduce the availability of oral artemisinin monotherapies in many countries through regulatory intervention.
The Working Group said that any successor to AMFm Phase 1 will need to take these developments into account. It added that AMFm should not be continued without some changes. The Working Group believes that a future AMFm model must ensure more sustainable funding; that quality-assured ACTs must be available to support implementation of regulatory interventions to limit availability of artemisinin monotherapies; and that the model should be flexible enough to account for different country circumstances.
Article in Nature
In an article in the journal Nature on 2 October, Amy Maxmen wrote: “Although no official decision has been announced about whether to continue the programme … many of those familiar with it have told Nature that it must change or be phased out after this year.”
The article quotes Alan Court, senior adviser to the United Nations special envoy for malaria, and chair of the Global Fund Board’s Working Group on the AMFm, as saying: “For me, the problem is that it has not been proven that the AMFm made a difference to malaria. There has to be a public-health purpose or else there is no purpose.”
President’s Malaria Initiative
In an announcement posted on its website at the end of September, the President’s Malaria Initiative, which has a seat on the AMFm Working Group, expressed its concerns about the pilot phase of the AMFm. Among other things, it said that the independent evaluation report provides no evidence on ACT use by vulnerable groups, particularly for children under five; and that the report does not indicate that “the AMFm has played any significant role in ‘crowding out’ artemisinin monotherapies, as was originally intended.”
According to the article in Nature, the US did not support the AMFm pilot directly because officials questioned whether a top-down subsidy to importers would get drugs to the most vulnerable groups.
Editor's Note: This article was revised on 15 October primarily to correct an error in the number of pilots and to replace two mentions of "percent" with "percentage points" in the first set of bullets.
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Although you use slightly different arguments than those I originally referred to, I believe you have proven my assertion that the AMFm debate has been hijacked by ideology rather nicely.
The basic fact that you and OXFAM are trying to wish away is that in many countries with endemic malaria, a significant share of malaria medicines (in some countries more than half) is bought over the counter in private shops. Whether we like it or not, this remains the reality. There are many reasons for this: some bad (people are used to these drugs being available in the market and whenever their child has a fever, it has become a habit to run over and buy the drugs there); and some good (health clinics are far away, they are closed when they are most needed, or health personnel charge fees for consultations or for drugs against government policy), but the fact remains that tens of millions of people rely on this private market to treat malaria.
What happens today is that since they cannot afford ACTs, people buy chloroquine (which in most cases is useless), or worse: they buy arthemisinin mono-therapies or fake drugs. This situation is likely to be killing lots of people and it is a major risk for developing drug resistance.
As Hendrik says, it will take years – even decades – to build health systems that cover everyone everywhere with free services the way most of us (but not all – there are several governments who want to continue relying on private health providers) want it to work. What AMFm is an attempt to do is to ameliorate the situation in the meantime. To dismiss this effort as a waste or somehow having a sinister motive of enriching private sector drug companies, resellers and pharmacies is unfair. It is also disappointing that you (in your OXFAM report) use selective facts and tendentious arguments to do so.
Sadly, in its logic, your argument is most closely associated with the abstinence-only movement’s argument against condoms: “Because we don’t want drugs to be sold in private pharmacies (or don’t want people to have sex with several partners), we will prevent those who do use the private pharmacies to get access to good drugs (or prevent those who do have several partners from getting access to condoms).”
You also are selective in your use of facts: You use Ethiopia and Zambia as examples of countries where malaria drugs reach most people through the public or faith-based health services, and yes, that is perhaps true, but you need to add that most African countries’ health services are not structured in a similar way and even if these governments wanted to go the way of Ethiopia, it will take considerably more than a few months and some money from the Global Fund to get them there.
AMFm is designed for those countries that do have an existing, large private-sector sale of malaria drugs. It is not meant to encourage a larger private sector sale. If a turn-away from public health services indeed was a consequence of AMFm, it should be considered worrying, and steps need to be taken to address it.
You equate ACTs with antibiotics. While resistance is a danger for both, the risks, uses and challenges are very different, and to imply that AMFm opens up for similar use of antibiotics is disingenuous.
So is to demand higher standards for the evaluation of AMFm in terms of public health outcomes than the Global Fund and most others demand of any other intervention they finance. We all know that to determine causality in public health outcomes is extremely difficult and that is why most of what the Global Fund finances is based on output indicators – not outcomes. This does not mean that further evaluations of AMFm (if it continues) should aim to tell us more about who buys the drugs and how they are used, but to equal lack of data with evidence of failure is again disingenuous.
You stay silent on the issue of drug theft and arbitrage. If ACTs are free in the public sector but are valued at $5-10 in private stalls, you have a guaranteed problem with theft and resale. AMFm could address that.
And you do not address what should be done to help the millions who used to buy chloroquine and now can access ACTs for under a dollar and the millions more who still buy chloroquine because AMFm is not yet in their country, if AMFm is to not continue.
You may be surprised to hear that I have no view on whether AMFm should continue or not. All I would wish is that the debate about its future would be sober, factual and open-minded, and that it will focus on questions like:
• Is a global AMFm effort financeable? For how long? Are there possible savings by possibly integrating it into Global Fund programs or other mainstreaming?
• What is the outlook for permanently lowered ACT prices which will enable a phase-out of subsidies?
• If AMFm is to continue, how can it be improved to address its weaknesses?
• If AMFm is not to continue, will the world accept that millions of people are getting fake, dangerous or ineffective drugs in private stalls as a fact of life and not do anything to address it? Or are there ways other than AMFm that can address it in the short term?
I recently spent some time looking back at the period of innovation that led to the creation of GAVI, the Global Fund and a dozen or so new, clever initiatives which together have saved millions of lives over the past decade. What I found was that the determining factor to get any of this done was pragmatism: a few brave people broke out of the ideological barriers and asked: “What works?” It would be a shame if ideology again were to close people’s minds and that those who need the fruits of innovation to stay alive would be left as collateral damage to such ideological battles.
It's not a question of "either/or" between community health workers and the AMFm. In some contexts, community health workers may be the eventual answer. But until this Oxfam vision is a reality, we need proven interim measures like the AMFm to save lives today.
The fact that antimalarials are provided through the private sector is not ideal - this was the reality before AMFm, during AMFm, and after AMFm. The only difference with AMFm is that now most of the drugs being provided through the private sector are of the highest quality. The alternative to the AMFm is not a world where everyone has perfect access to diagnosis and treatment (through community health workers or any other system). The alternative to the AMFm is Oxfam's photo: low quality drugs or no treatment at all for malaria for patients who need it.
I'm glad you concede that the Oxfam picture of the drug shop is reality. Is the biggest improvement you can suggest for that reality to remove ACTs completely from that photo? Do you truly believe that reality would not be at all improved if a box of quality-assured ACTs was hanging in place of the low-quality, non-ACT in the picture?
1. In 2 years Ethiopia trained 17,000 workers. In 3 years 30,000 were trained.
2.It seems that you saying that shops are so clever that they do not need training or that it is OK to dish medicines by anybody without training.
3. It is puzzling to understand the ideological blockage against giving CHWs -at least- the same training you are giving shopkeepers. Unless, of course, shop keepers are supposed just to sell, never mind to whom
4. You can interpret the picture as you like. The simple fact is that it is a true picture
I found your paper irresponsible in the extreme. You know better than most how long it will take to scale up an at-scale community health worker program, even with all the money in the world. And yet you still call for the immediate end for the AMFm - a program that has done nothing but dramatically improve access to quality ACTs (including, as is coming out in more recent studies, increasing use among rural populations, children, and the poor).
It's hard for me to interpret Oxfam's report and recommendations as anything other than a willful attempt to deny any treatment at all for poor patients until the day that it can be provided by a community health worker. That is wrong.
I believe that the cover photo of the Oxfam report was intended to shock and appall readers with the idea that antimalarials could be sold in such a shop. However, I read it in a different way: in a post-AMFm world, antimalarials being sold in private shops are quality-assured and now a patient is not forced to take the low-quality, non-ACT, potentially-counterfeit antimalarials shown in Oxfam's cover photo. To me, while still less than ideal, this is progress. But until all patients everywhere have the option to walk into a nearby sparkling clean health facility and receive appropriate diagnosis and treatment from a trained medical professional for free, I'll take the post-AMFm world over the Oxfam photo any day.
Easy to attack Oxfam and call it ideologist as if you and the AMFm supporters are not!
Please do not tell me that the start of AMFm was that African countries told you, or anyone else, that they wanted subsidy to sell ACTs in shops. You know very well how countries were influenced to join AMFm and now that wholesalers and retails are making money out of it, they are pushing hard for "country decisions".
You are aware that despite subsidy, Africans paid $105 million in mark ups in one year.
And you want quality antibiotics sold in shops? I guess pharma and donors are wise enough not to risk a global resistance that will render antibiotics useless in the rich North too!
PS: at least I write under my own name and Oxfam is brave enough to say what it thinks publicly.
If you believe in AMFm that much why not get your organisation to host and fund it?!
The reality is that ACTs and antibiotics are already being sold in grocery stores. The question becomes whether we want these to be quality-assured ACTs or antibiotics. Or are we content with continuing to keep higher quality medicines out of reach of patients by restricting them to the public sector only based on ideological preference?
Again, I look forward to reading Oxfam's reality-based proposal to getting ACTs and other health technologies to those who need them in Nigeria without a private sector mechanism like the AMFm.
The AMFm is not the only tool out there to expand access to ACTs and it may not be appropriate everywhere, but we have an evaluation that clearly shows it works quickly and effectively to increase availability and decrease price. Shouldn't those who know their contexts best have every evidence-based tool at their disposal? Oxfam is of course free to continue flogging this ideological horse, but in the meantime why shouldn't Kenyan policymakers be trusted to look at the evidence and make their own decision?
So today shops sell malaria treatment to any fever, tomorrow they will sell antibiotics to any fever. What a nice future awaiting all of us!
There are other options though.
PS: although I do work in Oxfam based in Oxford, I am from a developing country and I have first hand experience of what poor people do when they have a sick kid and also what decision makers have to weigh before making decision.
Your soundbytes are great, but I am more interested in evidence I look forward to reading Oxfam's paper. I hope that it offers a reality-based way forward for countries where the majority of the population seeks care in the private sector, instead of further ideological stone-throwing against the AMFm. I assume Oxfam will also integrate the perspectives of countries that participated in AMFm phase 1? The Minister of Health of Ghana doesn't have the luxury of issuing critiques-from-on-high in Oxford. Policymakers from AMFm Phase 1 countries deal with their realities every day and have lived the success of the AMFm - they have repeatedly called for the continuation of the AMFm, including on the floor of the last Global Fund Board meeting. Does Oxfam know better?
AMFm was never intended to single-handedly end malaria. Nor is it likely to be appropriate in all contexts (e.g., Zambia, where most patients first seek treatment in the public sector). Access to quality treatment is one of several interventions to control malaria, including bednets, IRS, vaccines, treatment of severe malaria, etc - and, before AMFm, overall access to ACTs was low and not increasing through the traditional channels of international development (i.e., the public sector). What AMFm has proven is that it is possible to quickly and dramatically increase availability and decrease the price of ACTs - including for rural populations. Is it so far-fetched to think that this same mechanism could be improved so as to reach even further? Or to include malaria diagnostics? Or to include treatment for non-malarial fevers? We all want the same thing: to diagnose and treat all patients appropriately. But when we have a proven tool like the AMFm, is it fair to tell patients in rural areas that they have to wait for the public sector to eventually expand coverage before they can access treatment? What worked in Ethiopia or Zambia may not be appropriate in Nigeria or DRC - and countries should have the option to use a tool like the AMFm if they think it is appropriate for their context.. Although the sale of ACTs in grocery shops is not ideal, it is a lot better than the pre-AMFm reality in Phase 1 countries: low-quality antimalarials or, more likely, no treatment at all for most patients with malaria. AMFm Phase 1 countries don't want to go back to this reality - why does Oxfam?
It was not feasible to assess changes in malaria morbidity and mortality during the short time frame of AMFm Phase 1 - so we cannot say conclusively whether or not AMFm "made a difference to malaria." However, as mentioned in this blog post (http://humanosphere.kplu.org/2012/10/threatening-to-pull-the-plug-on-a-global-anti-malaria-project/), "absence of evidence is not evidence of absence." I believe that if AMFm is improved and continued and is part of an integrated package of interventions to fight malaria, we will indeed start to clearly see the "difference to malaria" Alan Court mentions above.
Just 2 points:
“For me, the problem is that it has not been proven that the AMFm made a difference to malaria,” says Alan Court, senior adviser to the United Nations special envoy for malaria. “There has to be a public-health purpose or else there is no purpose.”
“You don’t need a huge independent evaluation to calculate that a huge subsidy will permit shopkeepers to buy and sell more of a drug,” she says. “Sales don’t mean anything unless you know who the sales are for.” (My quote in Nature)
I leave you, Jon and others to continue accusing anybody daring to criticise the holly AMFm, as being ideological. For us it is about finding the route to diagnosing and treating kids from both malaria and non malaria fevers.
What decreased malaria mortality in Ethiopia, Zambia among others, was certainly not dishing ACTs in grocery shops.
PS: Oxfam is launching a paper on this very topic this Tuesday. You may find it useful.
Where is the outrage that the Global Fund cannot provide information on use of ACTs through its public sector grants amongst the most vulnerable? Or that presumptive malaria diagnosis is still the norm in the public sector? Why no hard questions on the sustainability of 100% donor funded community health worker programs? Why is the AMFm held to a totally different standard than these public sector programs? Where is the "fairness" there?
The answer: Ideological opposition to private sector solutions. An unquestioning acceptance that public sector is the answer, in spite of any evidence pointing to the contrary.
This ideological position prevents some people from comparing "game-changing" initiatives like the AMFm to reality. I agree that the reality that antimalarials are commonly sold without diagnosis in grocery shops is not the ideal situation. Whether we like to admit it or not, in many countries an overwhelming majority of people seek care in the informal sector and are currently using inappropriate treatments - isn't it preferable that they get a quality-assured ACT through AMFm than a low-quality drug or something that can generate resistance? The AMFm has recognized that we have to work towards improvements within this imperfect reality. Ideological opponents of the AMFm attempt to compare this improved but stillimperfect reality to their ideal world with a perfectly functioning public sector with 100% coverage with free-of-charge care. Whether or not this should be the eventual goal is a whole other debate, but the fact remains that this is not our current reality.
Shouldn't a country's investment in healthcare reflect the reality of where people seek treatment, rather than where we would like them to seek treatment? Is it evidence based that nearly all international donor funding goes to the public sector, when in countries like Nigeria the public sector only covers 5-10% of the population?
Our overall goal is the same: to ensure patients have access to the treatment they need - it shouldn't matter whether that comes from a public health facility or a private drug shop. The AMFm has been proven to be a powerful tool to improve access to ACTs. Why not try to build on that for other products like malaria RDTs and other treatments? Why not continue to work to improve this imperfect reality? As a global health community, we need to remove the ideological blinders and work to find solutions that are appropriate for the world as it is, not the world as we would like it to be.
I wonder who is ideological here? Those who are asking for evidence or those who are promoting selling precious medicines in grocery shops come what may?
Some fairness please!
CGDev raised these same issues on PMI's opposition to the AMFm in the following blog post:
The AMFm independent evaluation clearly showed that AMFm virtually eliminated the large urban/rural differences in availability of ACTs within a very short time period. Further, it dramatically reduced availability of proscribed treatments (oral artemisinin monotherapies) in all countries that were found to have significant quantities of these drugs at baseline.
It's true that the data on ACT use is not yet available. Howevever, these data are also not available for the traditional Global Fund grants (or other traditional public sector suppliers, like PMI). We know that public sector does not reach the most rural populations. We know that the public sector is a long way from achieving universal access to malaria diagnosis. Yet where are the cries to stop funding ACTs through this channel? They are absent, in spite of (or perhaps because of?) decades of investment and billions of dollars, because the ideological resistance to private sector solutions.
AMFm has shown that it is possible to move ACTs quickly and efficiently to places which the public sector is still struggling to reach and at a price that is affordable to patients. This was achieved after less than 12 months of implementation. This kind of success is unheard of - truly gamechanging.
AMFm implementing countries have seen this success and want AMFm to continue.
What remains to be seen now is whether the US will accept this reality or find a way to continue blocking the AMFm.
Very provocative! Shamefully, your comment questions the motives and integrity of all dedicated public servants and health experts in the U.S. Government who are committed preventing and managing major health challenges of poor, underserved, and vulnerable people.
And in doing so you also indict every technical representative in the AMFm working group, for if an anti-private sector case management scheme or ideological battle is at play, all would be party to it -- complicit in silence.
What has been said over and over is that no data indicates whether those at risk of malaria, particularly, poor children and pregnant women living in remote rural areas, benefited from the subsidy; whether the pilot drove out ineffective and proscribed treatments; or demonstrated any benefit to the public sector.
A more logical conclusion is that all parties are absolutely committed to supporting evidence-based strategies for malaria diagnostics, treatment, and referral support for suspected severe febrile illnesses in children through the public and private sector, when included in national malaria control strategies.
It is disappointing that GFO, which has been known to be acutely aware of such things in the past, fails to point out in this article that AMFm has since its start been a victim of an ideological fight between those who have created and funded the pilot (the B&M Gates Foundation, the UK and Canadian governments and UNITAID) on the one hand, and the U.S. government representatives from the Bush era on the other.
PMI, supported by the U.S. representatives in the Department for Health and Human Services and PEPFAR on the Global Fund Board during the Bush administration, have consistently opposed AMFm on ideological grounds since its conception. Through the Global Fund Board, through other technical fora and in the media, they have done what they can to undermine AMFm's ability to function - and then criticised it for not functioning well enough.
The fact that the same individuals are close advisers to the United Nations Special Envoy for Malaria who also serves as the chair of the Global Fund Board’s Working Group on the AMFm - one of these former representatives also consults for the Global Fund's General Manager - should have been mentioned in the article. GFO should let its readers understand that much more is going on here than a sober and objective evaluation of the facts.