What do we hope to accomplish with this forum? A modest proposal, with apologies to Mr. Swift :)

Is the Advanced Market Commitment (AMC) a good model for technology transfer, and why we should care?
Background link: http://en.wikipedia.org/wiki/Advance_market_commitments
I am genuinely hopeful that the forum provided by the mother-child.org web site will become a useful vehicle for those of us who labor in the trenches of pediatric, reproductive, and mother-child health worldwide. By making it easier to share our results, ideas, and frustrations, I hope it allows us to support each other in a mutually beneficial way and to better co-ordinate our widely dispersed efforts to improve the lot of those entrusted to our care. While I am not a fan of new technologies for their own sake, I am optimistic that new information and communication technologies will allow us to do things that we couldn’t even contemplate under the old paradigms. For this reason, I would really like to see this forum become more than just a talking shop, as useful as that can be. Inspired by the speed with which communication and reaction can be organized electronically, I wonder whether it might someday become a vehicle for canvassing mother-child health workers in a formal way and --- more importantly --- for bringing our opinions to the very policy makers and politicians that control the resources we need to do our jobs. It seems to me that the membership of this list represents a considerable mass of pooled expertise and experience, and that through vigorous on-line discussion and debate, our forums could easily brings a valuable perspective to any discussion of how to best deploy health resources and dollars. In addition to providing an opportunity to forge consensus among ourselves, it might also allow us to respond in a timely and effective way to proposed public-health initiatives before they are written in stone, to lobby for more useful priorities and resource allocations, and to focus attention on looming failures before they attain crisis proportions.
Let me give an example where I think we ought to have an opinion and make it known, vigorously. The thorny question of how we transform scientific advances into concrete progress has always troubled me, particularly since it tends to be ignored in academic research circles in the developed world. Yet billions of dollars get consumed in white-elephant policy initiatives, often with foreseeable and disastrous consequences. I was reminded of this recently by an article I stumbled across on the subject of the Advanced Market Commitment, announced with much fanfare by G8 finance ministers, such as Gordon Brown (UK), Paul Martin (Canada), and Tommaso Padoa-Schioppa (Italy). Since I am unlikely to do it justice here, I refer anyone interested in background to the nice review cited above.
As many of you will already know, this first AMC is intended to serve as a model for future efforts at technology transfer, and its implementation should therefore be a matter of genuine concern to many of us on this list. In conjunction with the Gates Foundation, five countries (Canada, Italy, Norway, Russia, and the United Kingdom) committed US$1.5 billion to speed the development and availability of a new conjugated pneumococcal vaccine. With pneumococcal deaths claiming 1.6 million lives a year, the program was trumpeted as the key to saving the lives of 5.4 million children by 2030, by specifically targeting pneumococcal strains prevalent in developing countries and assuring vaccine developers of stable, long-term, guaranteed markets underwritten by the donor countries. In announcing his nations commitment, the Italian finance minister described it thus: “The AMCs are an absolutely innovative approach which combines market-based financing tools with public intervention. This innovative instrument opens a new frontier in the financing of the fight against poverty and endemic diseases.” The role of private industry was further emphasized by World Bank president (the controversial Washington appointee Paul Wolfowicz), who characterized the effort as one where “we can save lives, and we will do it with the investment and expertise of industry”. From the beginning, the AMC was intended to accelerate the development of affordable vaccines by covering the cost of manufacture and making a “modest contribution to profits”, a guaranteed market to engage a for-profit industry that otherwise could not envision a global market for a vaccine that originally sold for $232 per dose in the US market. The idea itself has a long and curious pedigree, but gained real traction in the public eye only after being embraced by Bill Gates at Davos, subsequently finding support among finance ministers from several countires (with Mr. Brown and Mr. Martin continuing to promote the effort after becoming Prime Ministers).
So is this a good way to transfer technologies to poor countries? Or is it --- as its critics contend --- simply a way to enrich western pharmaceutical interests out of the public purse while patting ourselves on the back for our humanitarian selflessness? The 7-10 year pilot project is now sufficiently far along to be judged in terms of concrete results, and worrisome concerns are being expressed. For instance, despite advanced manufacturing facilities in areas of the globe specifically targeted by the initiative (e.g. Asia and Africa), critics claim that most of the money has in fact gone to two western manufacturers, GlaxoSmithKline and Wyeth. The director of the Indian Serum Institute has charged that the current rules ensure ‘there is no provision for AMC money for developing-world manufacturers’, this despite world-class vaccine production facilities in India, China, Cuba, Brazil, etc. Others, including the vocal US critic Donald Light of Princeton University have described the profit provisions of the AMC as “morally indefensible” given the $1.7 billion sales generated annually from just two such vaccines in the developed world. Professor Light in fact states rather unambiguously that the donor countries “have donated taxpayers money and that money is going in profits and not to save children’s lives”, arguing that the profits should be re-invested to provide more vaccine doses. Moreover, and this troubles me a great deal given the source of the funding, it is impossible to seriously examine claims that the vaccines remain overpriced, since details of costs and profit margins are kept secret, with no requirement for full and transparent disclosure despite the public financing, a practice which has been criticized sharply by Médecins Sans Frontières and others. Now I'm certainly no econonomist, but I'm reliably told that in allowing a duopoly, we have accepted all the inefficiencies and shortcomings of the monopoly scenario, while failing to insist on the oversight and transparency that would normally be required of a public utility subsidized by taxpayer largesse.
In defense of the current structure, proponents will argue that without incentives, industry will not produce vaccines fast enough or in sufficient quantity, arguing that the goals of the project are worthy even “at the risk of not saving every penny”*, a case made by both pro-industry think tanks and child health workers in endemic areas, who argue that millions of children under the age of two are dying in rural villages even as we argue about details. And despite its shortcomings, they still believe that the availability of new conjugated pneumococcal vaccines will have been accelerated by 10-20 years as a result of this initiative, with important consequences for future efforts tackling HIV/ influenza/ and other pandemics.
Certainly, this is an important subject for members of this list. There are billions of dollars at stake, and few of us are indifferent to the scarcity of resources and the question of their optimal use. Surely, an informed consensus opinion can be developed through discussion and debate here, and perhaps communicated decisively to the national and international policy makers seeking to address the health needs of women and children at highest risk, even if we don’t always agree with their motives and priorities. For the developers of mother-child.org, I can hardly imagine a more fitting use of the platform and the community they seek to create. But then again, perhaps you will tell me I’m dreaming unrealistically. Either way, I look forward to your response(s), since the really marvelous thing about ‘discussion, debate and consensus’ is that the outcome will never be a foregone conclusion.
Sincerely,
Atul Sharma MD,FRCP(C)
Department of Pediatrics,
McGill University, Montreal, QC
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AMC comments off base
Pneumococcal infections are one of, it not the leading cause of death in children under the age of five in the world. US$1.5 billion to start addressing this problem is not that much money.
And stop bashing drug companies. They need to be rewarded for their efforts and risks:
-pneumococcal conjugate vaccines are actually separate vaccines for each serotypes.
-each serotype needs to be produced (conjugated) separately, with separate QC'ing, etc. When one serotype production line goes down, the whole production shuts down.
-efficacy needs to be tested for each serotype separately
-to introduce a new manufactured products, one needs to show equivalence
-contrary to other pathogens, antibody testing is complicated by artifacts and has variable correlation with efficacy.
If one thinks this is money not well spent, I would suggest that instead of doing an armchair off the cuff negative commentary, to research the issue (with references) and come up with a constructive proposal on how to better spend $1.5 billion on the #1 killer of children.
Tim
A billion here, a billion there...
While probably apocryphal, I am reminded of the line usually attributed to former Senate Minority leader Everett Dirksen i.e. "A billion here, a billion there, and pretty soon you're talking real money" :)
The point is that resources are not unlimited and questions of access, transparency, accountability have been raised by credible and knowledgable critics, like Médecins Sans Frontières and the Indian Serum Institute.
I know the question is currently being debated in other contexts, of the extent to which the taxpayer should subsidize profits (as opposed to costs). But the fact remains that the pilot project is not an AIDs vaccine, where industry would be taking a real risk of never having a product and therefore never seeing the market materialize. The 'pilot project' is as close to risk-free as could be contrived.
Without insider insights, I admit to being limited by what I read in the popular press, where concerns were also expressed by the director of the Serum Institute about increasingly complex rules working to preclude international players. I would be curious if anyone has more insight into the type of problems being encountered access-wise, if any.
Atul Sharma MD, FRCP(C)
Pediatric Nephrologist,
McGill University
re: A billion here
In regards to AIDS, as you probably know, this disease gets the lion share of funding in the developing world, even though malaria, pneumococcal infection, diarrhea disease, TB account for far more mortality. This is in large part due by who sets the agenda. That there is finally a focus on something else then AIDS does not mean one needs to shoot it down either, however.
I don't know what Dr Jadhav (director of the Indian Serum Institute ) is complaining about when he says the rules are biased against non-western facilities, which I did see him quoted as saying in the Guardian piece you refer to. But if you just look at the AMC site
http://www.vaccineamc.org/mechanism.html
What is the problem with that? Companies like ISI can apply.
Tim
"anonymity makes better neighbors"
Re: theoretical underpinnings of AMC
As I noted above, the AMC concept was first brought to popular attention by Bill Gates at Davos. While not a new idea, it is now being promoted under the guise of so-called 'Creative Capitalism', which has been described as 'harnessing the power of greed to promote humanitarian interests' (reminiscent of Adam Smith and the invisible hand :). This theme resonated with a number of finance ministers in attendance, who subsequently sought to implement the pneumococcal vaccine AMC as a test case. In a Harvard commencement address, Mr. Gates later explained the notion as follows:
"If we can find approaches that meet the needs of the poor in ways that generate profits for business and votes for politicians, we will have found a sustainable way to reduce inequity in the world". Much of the theoretical foundation is provided by a Harvard economist Michael Kremer, whose fascinating book 'Creative Capitalims' can be read on-line at his web site
http://creativecapitalism.typepad.com/creative_capitalism/
By coincidence, Professor Kremer holds the Gates chair of Economics at Harvard, a curious convergence of interests that reminds me of Medici patronage in the middle-ages :)
In the midst of the current global economic crisis, criticizing 'capitalist greed' seems to me somewhat akin to shooting fish in a barrel, so I leave that debate to others. My major concern is whether this makes sense as paradigm for technology transfer, since I can't help but wonder if the guaranteed profits would be better spent in the purchase of additional vaccine doses. And if a guarantee to cover costs is not enough, surely an open and transparent accounting of costs and margins is the least that the donors can expect for their relatively 'string-free' support.
Atul Sharma MD, FRCP(C)
Pediatric Nephrologist,
McGill University