Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
Bay Area Reporter - August 31,2001
Liz Highleyman
Compulsory licensing allows countries to produce essential medications in the case of a national health emergency. The provision is included in the World Trade Organization's Trade-Related Aspects of Intellectual Property (TRIPS) agreement.
Serra said that Brazil had been negotiating nelfinavir prices with Roche for six months, but "we didn't get what we thought was fair." Roche officials expressed surprise at Brazil's announcement, saying that negotiations had been "friendly" and were still continuing. Roche offered a 13 percent price reduction earlier this year, but Brazil wants at least a 40 percent cut to match the price of producing generic nelfinavir locally. Serra said Roche could still try to come up with an offer, "but we aren't going to wait anymore."
"By issuing a compulsory license on nelfinavir, Brazil is forcing a crowbar into a crack in the dam," said Paul Davis of ACT UP/Philadelphia and the Health GAP Coalition. "We look forward to a flood of broken patents in developing countries being decimated by AIDS."
Eloan Pinheiros of the state-owned Farmanguinhos laboratory said her facility would be ready to produce and distribute the copycat drug early in 2002. The lab has already succeeded in producing generic nelfinavir, and will begin bioequivalency testing to ensure that the generic version works the same as the patented original.
Brazil, which has the most advanced HIV/AIDS treatment and prevention program in the developing world, provides free anti-HIV medications to some 90,000 people with AIDS. Since 1997, it has reduced new infections and AIDS deaths by half. Farmanguinhos produces generic versions of eight anti-HIV drugs. In 2000, Brazil spent over $300 million on AIDS drugs, more than a quarter of that on nelfinavir alone.
In January, the U.S. had requested that a WTO dispute settlement panel review Brazil's industrial property law, which requires that a foreign company forfeit its patent if it does not produce a product locally. After much international pressure from AIDS treatment advocates and developing country governments, the U.S. withdrew its complaint against Brazil on June 25. The WTO's TRIPS Council is expected to discuss drug access and compulsory licensing at its upcoming meeting in September.
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