U.S. May Cut Access To Generic AIDS Drugs In Poor Nations

At a conference in Botswana scheduled for Monday, the U.S. government may challenge the World Health Organization's approval of generic copies of patented AIDS drugs, a move that would prevent poor countries from buying cheaper antiretrovirals, Human Rights Watch said yesterday.

Although the drugs meet the WHO's standards for generic drugs, they have not been approved by the U.S. Food and Drug Administration, and according to the United States, "there are no uniform principles, guidelines or international standards addressing the development" of generic drugs.

"WHO has made enormous headway in verifying the quality of generic AIDS drugs that are the only hope for millions of low-income people with AIDS," said Joanne Csete, director of the HIV/AIDS program for Human Rights Watch. "But to protect brand-name pharmaceutical interests, the United States may dash that hope."

With the generic drugs, HIV/AIDS patients take just two pills a day at a much lower cost than brand-name drugs, with the cheapest regimen costing just $140 per year per patient compared to the brand-name equivalent of six pills a day at $600 per year.

"The United States stands alone in opposing these safe, inexpensive and WHO-certified generic medicines," Csete said. "The Bush administration should dispel all accusations that it is protecting the interests of brand-name drug companies, and instead it should endorse and purchase these cheaper drugs, which would maximize the return on its investment in fighting AIDS" (Human Rights Watch release, March 25).

Medecins Sans Frontieres, which provides antiretroviral therapy to more than 11,000 HIV/AIDS patients in more than 20 countries in Africa, Asia, Latin America, and Eastern Europe, on Wednesday demanded that the U.S. organizers explain the objectives of the conference.

In an open letter to organizers, dated March 22, MSF said, "We question what this meeting will add to the processes that are already underway and whether it will in any way contribute to the urgent task of expanding access to affordable essential medicines for HIV/AIDS and other illnesses."

According to MSF, fixed-dose combination drugs are crucial to antiretroviral therapy, and the organization expects the number of patients on antiretrovirals to reach 25,000 in 25 countries by the end of this year (South African Press Association, March 24).