The European Union's drug regulatory authority has pulled out of an upcoming U.S.-initiated meeting where the U.S. hoped to reach an "international consensus" on restrictions on generic AIDS medications, underscoring the growing rancor over White House opposition to permitting countries to procure low-cost, quality assured generics. Canadian officials also are rumored to be considering not participating in the "Conference on Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical Issues related to Safety, Quality, and Effectiveness" (Gaborone, Botswana, March 29-30, 2004).

Critics contend the Bush Administration is using the meeting to justify its policy of maintaining a monopoly for research-based pharmaceutical companies through its AIDS programs in the developing world. Ambassador Randall Tobias, Bush's Global AIDS Coordinator, has used misleading arguments to cast doubt on the quality of quality assured generic AIDS drugs. The State Department is insisting the U.S. FDA perform its own assessment on safety and efficacy of medicines rather than accept the World Health Organization's (WHO) internationally supported program for 'pre-qualification" of generic and brand name medicines of assured quality. The principles of the WHO pre-qualification program mimic FDA standards. However, no generic antiretrovirals are registered by the U.S. because of patent barriers.

White House officials are particularly opposed to the already-common use of fixed-dose combinations (FDCs) of antiretroviral AIDS medications, which combine drugs from multiple originators into single pill combinations. "The Bush Administration wants to use the upcoming meeting to justify their exclusion of cheaper, quality assured generic medicines," said Jen Cohn of Health GAP. "But Bush's policy will cost the lives of people with AIDS�millions of dollars will be wasted on expensive medicines, fewer people will get treatment�all to please Bush's big pharma cronies."

The WHO Pre-qualification Project (http://mednet3.who.int/prequal/default.shtml). currently lists 86 AIDS medicines�including 55 generic antiretrovirals and several generic fixed-dose combinations�as meeting its standards for quality. The WHO's standards for prequalification are supported by UNICEF, the World Bank, the Global Fund to Fight AIDS, TB, and Malaria, many national governments in developing countries, and international humanitarian organizations such as M�decins Sans Fronti�res (MSF).

"Bush would rather force African countries to treat fewer dying people than permit U.S. money to be used on quality assured generic fixed dose medicines," said Asia Russell, Director of Federal Policy for Health GAP. "The WHO has shown the quality of these products, but science doesn't matter to Bush when politics are at stake."

Single-pill combinations promote adherence, decrease the risk of resistance, and facilitate stock and procurement management, and are widely recognized as a core element in efforts to scale-up ARV treatment in developing countries. WHO recommended FDCs currently available are one pill, taken twice daily. These are by far the least expensive option: the Clinton Foundation negotiated a price for generic triple combination medications from generic manufacturers for less than $140 per person per year. In the developing world, the same combination from brand-name companies costs a minimum of $562 per person per year and must be taken in the form of six pills a day.

CONTACT FOR MORE INFORMATION:
TEL: +1 646 645 5225 Sharonann Lynch
TEL: +1 267 475 2645 Asia Russell

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