By: Mike Shanahan
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In an apparent policy u-turn, the United States has announced that it will soon allow generic drugs for the treatment of HIV/AIDS to be used in its US$15 billion aid programme for Africa and the Caribbean.
Up to now, the United States has refused to allow its aid money to be used on cheap generic drugs made in India and Brazil that combine three pills into a single ‘cocktail’ of drugs. Instead, it has said that the money must be used to purchase patented drugs, which are about five times more expensive.
The move has been widely applauded for increasing the availability of cheaper drugs in poor countries. But others have criticised the announcement, arguing that the World Health Organisation (WHO) has already approved the generic drugs, and that a second level of approval by the United States is unnecessary.
Announcing the shift in policy, Tommy Thompson, US secretary of health and human services, said that the United States would speed up the review process of these generic drugs, which currently lack approval from the Federal Drug Administration (FDA). He said that approval would take two to six weeks, and that the usual US$500,000 fee would be waived.
“We are clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in developing countries,” he said.
According to executive director of the Global Fund to fight AIDS, Tuberculosis and Malaria, Richard Feachem, “recipients of Global Fund grants already have the opportunity to buy generic fixed-dose combinations, but clearly FDA approval of these drugs would lead many more countries to choose them”.
But Salih Booker, executive director of US-based advocacy group Africa Action, describes the Bush administration’s announcement as “a callous manipulation of the truth”. He claims that the US government “is telling African and Caribbean nations that they cannot use US funds to buy cheaper and easier to use ‘fixed-dose-combinations’ of anti-AIDS drugs that have already been approved by the WHO and accepted by governments throughout Africa and the Caribbean”.
Paul Zeitz, director of the Global AIDS Alliance, which campaigns for cheaper AIDS drugs for poor countries, is also critical of the move, arguing that approval will take much longer than two to six weeks. “There are multiple hurdles the manufacturers must jump through,” he says. “Meanwhile, agencies already using US funds may find themselves locked into continued use of brand-name medications. It is far from clear this new process will lead to greater access to low cost medication.”
Link to United States Department of Health and Human Services news release
Link to Global AIDS Alliance press release
Link to Africa Action press release
Link to Global Fund to Fight AIDS, Tuberculosis and Malaria press release
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