Thai Prime Minister Thaksin Shinawatra on Sunday in opening remarks at the XV International AIDS Conference
pledged that his administration would provide antiretroviral drug treatment to all HIV-positive people who need it in Thailand, according to Agence France-Presse (Agence France-Presse, 7/11). However, AIDS advocates and international officials said that U.S. policy on patented drugs could limit access to the medications in developing countries, the Boston Globe
reports (Donnelly, Boston Globe
, 7/12). WHO has established a prequalification review system with standards for safety and efficacy and has approved certain generic drugs for use in developing countries. The United States previously had refused to fund the use of some generics, including fixed-dose combination drugs, because of a lack of scientific evidence supporting their efficacy. However, the United States recently announced plans for a new FDA
fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including generic and brand-name fixed-dose combination drugs -- to countries covered under the President's Emergency Plan for AIDS Relief
. U.S. officials said they developed the review system to ensure that the drugs would not contribute to the development of drug-resistant HIV strains through widespread or improper distribution and use (Kaiser Daily HIV/AIDS Report
U.N. Special Envoy for AIDS in Africa Stephen Lewis said that the Bush administration is attempting a "not-so-subtle" effort to "derail" WHO's prequalification process, adding that although U.S. officials "say they will purchase generic drugs, the fact is those monies are now being used if not entirely, then mostly for brand-name drugs. We are spending two to three times the cost to treat people at a time when dollars are scarce" (Boston Globe, 7/12). Jennifer Brant, a trade policy adviser at Oxfam America, said the Bush administration's policy is "a red herring that is thrown out by the U.S. to get people to buy brand-name drugs" (Agovino, AP/Detroit News, 7/10). Randall Tobias, head of the new State Department Office of the Global AIDS Coordinator, said that the Bush administration is "open to the use of generic drugs," adding, "Our policy is to buy the least expensive drugs we can find anywhere in the world -- without regard to whether they are brand-name or generic" as long as the drugs are safe, according to Toronto's Globe and Mail. Tobias added that the United States does not want to create a "double standard" between antiretroviral drugs used in the West and in developing countries (Nolen, Globe and Mail, 7/12).
Free Trade Agreements
The generic antiretroviral drug industry in Thailand could be "threatened" by a free-trade agreement currently being negotiated between the United States and Thailand, according to Medicins Sans Frontieres, the Associated Press reports (Joshi, Associated Press, 7/12). U.S. trade officials are negotiating a series of agreements to strengthen patent protection of brand-name drugs, including antiretrovirals. In many countries, including the United States, generic drug makers often win approval for their drugs by proving that the products are equivalent to the brand name drug. However, new agreements sought by the United States would prevent countries trading with the United States from approving for five years generic drug applications if data submitted by the generic companies is based on data originally compiled by the brand name manufacturer. The agreements would in effect grant "temporary exclusivity" to brand name drug makers (Kaiser Daily HIV/AIDS Report, 7/6). Paul Cawthorne of MSF said, "If the Thais sign such an agreement they will have to close down their generic drug production" (Associated Press, 7/12). Dr. Jiraporn Limpananont, an associate professor of pharmaceutical sciences at Chulalongkom University, on Monday said that the free-trade agreement could "threaten the lives" of HIV-positive people in Thailand, according to Reuters. He added, "Manufacturers with drugs under patent in Thailand now monopolize the market and prices are 10 times more expensive than generic drugs" (Ee Lyn, Reuters, 7/12). Protestors at Sunday's rally held signs with a variation of the "classic" AIDS slogan "Silence=Death" that said, "Patent Enforcement=Death," according to the Globe and Mail (Globe and Mail, 7/12). Some pharmaceutical companies say that it would be "unfair" for them to spend "billions" of dollars on developing drugs and then not be allowed to profit from the drugs if cheaper generic versions were available, according to the Associated Press (Associated Press, 7/12).
Back to other news for July 12, 2004
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