Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
Associated Press - June 27, 2001
Brazil and Roche have been negotiating the price since the beginning of the year, and Brazil is expecting a new offer for Viracept next month. If the price is too high, Brazil will likely issue the license in October, when the country expects to have perfected the manufacturing process.
The World Trade Organization allows countries to either manufacture or import generic versions of patented drugs in times of health emergencies. However, Brazil's patent law also allows the country to issue licenses if a patent holder's policy represents an economic hardship on society.
The United States had filed a complaint with the World Trade Organization over Brazil's law but dropped the action on Monday under immense international pressure.
Pharmaceutical executives contended their problem with the law was over a provision that would allow Brazil to start manufacturing drugs in the country if the company that developed the drug hadn't started to make them locally in three years.
Observers said the U.S. decision is likely to pressure Roche to lower the price. "The drug companies see they can't get their governments to fight their battles," said James Love, director of the Washington-based Consumer Project on Technology. "The threat of compulsory licensing has been very effective in dropping prices."
Roche said it is working with health authorities in Brazil regarding pricing for Viracept, but would not comment further.
Brazil had been developing generic versions of two AIDS drugs manufactured by Merck & Co. when the Whitehouse Station, N.J. company dropped the prices
"I hope we don't have to issue the license but we do what we need to do," said Eloan Pinheiro, director of the Institute of Technology and Drugs at the Brazil's Ministry of Health.
She said Brazil spends $1.08 per pill to buy the drug from Roche. However, Ms. Pinheiro noted the drug can be made for 60 cents.
Brazil has been widely lauded for its AIDS programs, which gives treatment to all patients free of charge. There are currently 12 drugs available to treat AIDS patients and Brazil manufactures seven of them.
Brazil is not breaking any world patent agreements because it began manufacturing the medicines before it adopted patent laws aligned with the WTO.
"We are not against patents," said Brazil's Health Minister Jose Serra. "We are just concerned with access."
Mr. Serra added that Brazil's generic program presents no threat to American and European pharmaceutical companies because the country has no intention of exporting medicine. Brazil could offer other developing countries technical advice and assistance, he added.
However, Mr. Love said that Brazil's generic program and its consistent threat to issue a compulsory license could be a beacon for other countries.
"Brazil has taken on the drug companies and won," he said. "They are organized and they are tough."
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