The Lancet apresenta opinião de Donald Light sobre a doação de vacinas a países pobres. A discussão da benemerência merece ser revista à luz de novos fatos como os narrados no textos abaixo. A questão da vacinação para pneumococos entrará em breve em discussão em vários países.
Is G8 putting profits before the world's poorest children? Donald W Light
Several affluent countries have announced donations totalling US$1·5 billion to buy new vaccines that will help eradicate pneumococcal diseases in the world's poorest children. Donations from the UK, Italy, Canada, Russia, and Norway launch what many hope will be a new era to ease the burdens of disease and foster economic growth. Yet only a quarter of the money will be spent on covering the costs of vaccines—three-quarters will go towards extra profits for vaccines that are already profitable.
The Advanced Market Commitment (AMC), to which the G8 leaders and the Bill & Melinda Gates Foundation have committed, is the difficulty. An AMC is a heavily promoted but untried idea for inducing major drug companies to invest in research to discover vaccines for neglected diseases by promising to match the revenues that companies earn from developing a product for affluent markets. By committing to buy a large volume of vaccine at a high price, an AMC creates a whole market in one stroke. However, no money is spent until a good product is fully developed.
In reality, revenue from an AMC depends on whether a new vaccine can be successfully developed, whether there is a second or third competitor, and whether recipient poor countries sign up. These factors undermine not only the revenue-matching basis of the AMC but also a company's ability to predict how much it will earn. There are also several legal and contractual difficulties, none of which are discussed in either the Tremonti report5 or the briefing document prepared for G8 leaders.6 If we exclude these design flaws, however, the idea of an AMC has apparent appeal—the ingenuity of commercial research teams is mobilised by the creation of a market for a neglected disease.
For pneumococcal vaccines, the AMC rationale does not apply: vaccines have already been discovered by Wyeth and GlaxoSmithKline and their clinical trials are already funded because they will generate large revenues and profits in affluent markets. Thus the so-called G8 AMC pilot is really a large long-term procurement and not an AMC or a pilot of one. Yet leaders of the AMC project talk as if it is both.
If G8 leaders and the GAVI Alliance use an AMC approach, there will be three unfortunate consequences. First, I estimate that the new pneumococcal vaccines can be manufactured for a sustainable average cost of $1·25 a dose, including the capital costs of manufacturing capacity. At that price, a long-term procurement contract would justify enlarging capacity and lasting commitments by governments to immunise their children. Thus the $1·5 billion donation could buy 1·2 billion doses of vaccine. The AMC model, however, has set the price at $5 or more (in an appendix it is $7·53), so that only 300 million or fewer children will be inoculated, and 80% of the donations will go towards profits.
Second, because AMCs were designed to match corporate revenues and profits in affluent markets, they transform the humanitarian movement from the eradication of diseases of poor people into a for-profit market that is worldwide. Will donors and poor countries stand for the G8 and GAVI Alliance paying four times the average sustainable cost of these vaccines that are already profitable simply because they are connected to an irrelevant purchasing model?
Third, by commercialising vaccines for poor people, the AMC approach is making the culture of the GAVI Alliance more commercially oriented than it previously was, and it is shifting the Alliance towards becoming the vehicle for making vaccines for poor individuals into the next main market for the drug industry. In a review of five immunisation initiatives, Hardon and Blume concluded that the GAVI Alliance is more corporate-led, less transparent, not really accountable outside of itself, and more oriented to paying profitable prices than were previous initiatives. This worrisome outcome is covered up by the Alliance's dubious claim that the AMC will prevent 5·4 million child deaths—89% of which are projected to take place after the donors' money has been spent.
Political leaders and the Gates Foundation need to press for reaching the maximum number of children whose lives can be changed by being inoculated—ie, 1·2 billion children, not 300 million. Even better than this aim would be to press companies for licences so that manufacturers in developing countries could compete for the long-term contracts. The donated money would then boost the economies of low-income countries, rather than the economies of affluent countries. The lower cost structure in developing countries might get the price down to $1 a dose, so that 300 million more children could be saved. This alternate strategy could be called the Advance Maximum Benefit Commitment (AMBC). G8 leaders should consider replacing the AMC with an AMBC.
Several affluent countries have announced donations totalling US$1·5 billion to buy new vaccines that will help eradicate pneumococcal diseases in the world's poorest children. Donations from the UK, Italy, Canada, Russia, and Norway launch what many hope will be a new era to ease the burdens of disease and foster economic growth. Yet only a quarter of the money will be spent on covering the costs of vaccines—three-quarters will go towards extra profits for vaccines that are already profitable.
The Advanced Market Commitment (AMC), to which the G8 leaders and the Bill & Melinda Gates Foundation have committed, is the difficulty. An AMC is a heavily promoted but untried idea for inducing major drug companies to invest in research to discover vaccines for neglected diseases by promising to match the revenues that companies earn from developing a product for affluent markets. By committing to buy a large volume of vaccine at a high price, an AMC creates a whole market in one stroke. However, no money is spent until a good product is fully developed.
In reality, revenue from an AMC depends on whether a new vaccine can be successfully developed, whether there is a second or third competitor, and whether recipient poor countries sign up. These factors undermine not only the revenue-matching basis of the AMC but also a company's ability to predict how much it will earn. There are also several legal and contractual difficulties, none of which are discussed in either the Tremonti report5 or the briefing document prepared for G8 leaders.6 If we exclude these design flaws, however, the idea of an AMC has apparent appeal—the ingenuity of commercial research teams is mobilised by the creation of a market for a neglected disease.
For pneumococcal vaccines, the AMC rationale does not apply: vaccines have already been discovered by Wyeth and GlaxoSmithKline and their clinical trials are already funded because they will generate large revenues and profits in affluent markets. Thus the so-called G8 AMC pilot is really a large long-term procurement and not an AMC or a pilot of one. Yet leaders of the AMC project talk as if it is both.
If G8 leaders and the GAVI Alliance use an AMC approach, there will be three unfortunate consequences. First, I estimate that the new pneumococcal vaccines can be manufactured for a sustainable average cost of $1·25 a dose, including the capital costs of manufacturing capacity. At that price, a long-term procurement contract would justify enlarging capacity and lasting commitments by governments to immunise their children. Thus the $1·5 billion donation could buy 1·2 billion doses of vaccine. The AMC model, however, has set the price at $5 or more (in an appendix it is $7·53), so that only 300 million or fewer children will be inoculated, and 80% of the donations will go towards profits.
Second, because AMCs were designed to match corporate revenues and profits in affluent markets, they transform the humanitarian movement from the eradication of diseases of poor people into a for-profit market that is worldwide. Will donors and poor countries stand for the G8 and GAVI Alliance paying four times the average sustainable cost of these vaccines that are already profitable simply because they are connected to an irrelevant purchasing model?
Third, by commercialising vaccines for poor people, the AMC approach is making the culture of the GAVI Alliance more commercially oriented than it previously was, and it is shifting the Alliance towards becoming the vehicle for making vaccines for poor individuals into the next main market for the drug industry. In a review of five immunisation initiatives, Hardon and Blume concluded that the GAVI Alliance is more corporate-led, less transparent, not really accountable outside of itself, and more oriented to paying profitable prices than were previous initiatives. This worrisome outcome is covered up by the Alliance's dubious claim that the AMC will prevent 5·4 million child deaths—89% of which are projected to take place after the donors' money has been spent.
Political leaders and the Gates Foundation need to press for reaching the maximum number of children whose lives can be changed by being inoculated—ie, 1·2 billion children, not 300 million. Even better than this aim would be to press companies for licences so that manufacturers in developing countries could compete for the long-term contracts. The donated money would then boost the economies of low-income countries, rather than the economies of affluent countries. The lower cost structure in developing countries might get the price down to $1 a dose, so that 300 million more children could be saved. This alternate strategy could be called the Advance Maximum Benefit Commitment (AMBC). G8 leaders should consider replacing the AMC with an AMBC.
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