WHO to Unveil List of 40 ‘Quality’ AIDS Drugs, Lending Support to Some Generics
The World Health Organization today will unveil a list of 40 "quality" antiretroviral drugs approved for use in U.N. programs that includes both patented and generic medications, a move that promises to "throw the group into the fray" over drug patents by "lend[ing] legitimacy to generics," the Wall Street Journal reports. The list, which will be updated every two months, includes products from four multinational drug makers and four generic drug makers (Zimmerman, Wall Street Journal, 3/20). Among the generic makers to receive approval was Cipla, the Indian company that "shook the pharmaceutical industry" in February 2001 when it offered to sell generic versions of the drugs stavudine, lamivudine and nevirapine in developing countries for less than $1 per patient per day, one thirtieth of the retail price in the United States at the time. Cipla, which can legally produce the patented drugs because Indian law protects only the process and not the end product in drug manufacturing, received WHO approval for four antiretroviral drugs and two drugs used to treat AIDS-related opportunistic infections (Reuters, 3/20). Jonathan Quick, WHO's director of essential drugs and medicines policy, said the agency "did not look at patent status" when considering drugs for the list. "Patents are a national issue. If the drug was legal and registered in the country producing it, that was the entry ticket," he explained. UNAIDS Executive Director Peter Piot said the WHO review board paid particular attention to drug quality when making its selections. According to Piot, after pressure from generic competition and AIDS activists last year forced price concessions from major drug manufacturers, many nations became concerned that greater antiretroviral drug availability not come "at the expense of quality." Piot said concerned nations "will find the beginning of an answer to their question from this list." Major drug makers said that the threat of generic competition does not worry them as much as generic manufacturers' production capacity. "We don't have any objection to generics. They just have to be compliant with world trade regulations," GlaxoSmithKline spokesperson Mary Anne Rhyne said, adding, "But the other issue is supply and sustainability. Obviously you can't put patients on a medicine if you can't continue to provide that medicine for the future" (Wall Street Journal, 3/20). The full list of WHO-approved AIDS drugs will be available online.This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.