Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
Wall Street Journal - March 20, 2002
Rachel Zimmerman, Staff Reporter of the Wall Street Journal
The list, which will include both patented drugs and generic versions, lends legitimacy to generics by offering WHO's seal of approval, regardless of intellectual property rights. The medicines on the list are approved for purchase by U.N. agencies.
"We did not look at patent status" in evaluating the drug list, which includes antiretrovirals, antibacterials, antifungal and anticancer drugs, says Jonathan Quick, director, essential drugs and medicines policy for WHO. "Patents are a national issue. If the drug was legal and registered in the country producing it, that was the entry ticket."
Large drug companies and generic drug makers have tangled over selling cheaper knockoffs instead of expensive patented AIDS drugs in poor countries most hard-hit by the AIDS epidemic.
Two competing manufacturers of lamivudine, the generic name for 3TC, are on the list: Cipla, the Indian generics maker and GlaxoSmithKline PLC, the big United Kingdom drug maker that holds the patent for 3TC. Similarly, both Cipla and Glaxo's version of zidovudine, generic AZT, are on the quality list even though Glaxo's patent on AZT remains in effect until 2005.
"We don't have any objection to generics. They just have to be compliant with world trade regulations," says Glaxo spokeswoman Mary Anne Rhyne. "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."
The list, which will be expanded and updated every two months, so far includes four big drug manufacturers and four generics makers. Mr. Quick says there are between 50 and 100 products still tied up in the evaluation process. Submissions must include basic descriptions of the drugs, clinical data and inspection information. Mr. Quick wouldn't say which manufacturers didn't make the list, or which approvals were pending.
One Indian generics maker, Ranbaxy Laboratories Ltd., says it only recently began exporting its knockoff AIDS medicines but that it is eager to get on the WHO list.
Peter Piot, director of UNAIDS, the organization fighting the global AIDS epidemic, says that once the price of AIDS medicines began to drop last year due to competition by generics and pressure from activists, many countries began fretting over quality. At a meeting last year, he says, people from poor countries living with HIV, the AIDS virus, "were concerned that greater availability of these drugs would not be at the expense of quality." Mr. Piot adds: "They will find the beginning of an answer to their question from this list."
Write to Rachel Zimmerman at rachel.zimmerman@wsj.com
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