Special report: Aids
Alex Bellos in Rio de Janeiro and James Meikle Friday August 24, 2001 The Guardian
Brazil has declared that it will allow generic copies of a brand-name anti-Aids drug to be made without the permission of the patent-holder - because the company, Swiss pharmaceutical giant Roche, refused to cut its prices.
Brazil's decision will make it the first country to violate the patent of an anti-Aids drug and represents an aggressive move in the developing world's battle for cheaper prices.
Jose Serra, the health minister, said he had begun the process of issuing a licence to produce nelfinavir, which is sold by Roche under the name Viracept.
Nelfinavir is one of the 12 drugs used in the anti-Aids cocktail that Brazil distributes free to almost 100,000 patients.
Mr Serra said that the government bought 82m units of nelfinavir a year at a cost of $88m (£60m) - about 28% of the total anti-Aids budget.
"It's ridiculous that one of the 12 drugs in the cocktail would account for more than 25% of the cost," Mr Serra said.
"We spend more on that one drug than on all of the transplants performed in Brazil each year."
He added that domestic production of the drug would save the government 40%, about $35m a year.
Roche had offered this year to cut the price of nelfinavir by 13%, but Brazil rejected that as too low, and the two sides had been negotiating. Mr Serra said talks broke off about two weeks ago.
He said the government invoked an article in the constitution that allowed for the breaking of a patent in cases of a national emergency or when companies employed abusive pricing policies.
In June, the US dropped its attempt to have Brazil disciplined by the World Trade Organisation because of the patent law.
Brazil has been one of the strongest voices in the developing world in the fight for cheaper prices and has threatened the pharmaceutical multinationals that it would break their patents.
The pressure worked with Merck Sharp & Dohme, which agreed in March to reduce the price of efavirenz, another drug in the anti-Aids cocktail, by 64%.
Mr Serra said: "We tried to get a price cut [for nelfinavir] but we didn't get what we thought was fair so we're going to grant a compulsory licence so that it can be produced more cheaply in Brazil."
"Our idea is to have the medication available in February of 2002," he said.
Although Brazil has a high Aids incidence in absolute numbers it has managed to keep infection to less than 1% of the 170m population with an aggressive prevention campaign. It has succeeded in cutting the Aids death rate by half in five years and reduced the number confined to hospital by 80%.
Thanks largely to the drug handout, which costs the state about $15,000 per patient, since 1996 the mortality rate in Brazil from HIV/Aids has fallen by half and there has been an 80% fall in number of patients hospitalised, according to Oxfam. The programme has been hailed by doctors as a model for other developing countries, where few can afford expensive treatment.
In Switzerland, Roche spokesman Daniel Piller said the company was surprised by the news and denied that negotiations had broken down.
He said: "In our negotiations with the ministry of health we had already given them discounts very close to what they wanted." The company had also made some of the drug available free of charge.
The South African government won a significant victory last April when it defeated multinational drugs manufacturers who were attempting to block the import of cheap drugs. But Pretoria intends not to use that to fight Aids, on the grounds that the costs are too high and the country lacks the infrastructure to distribute the drugs safely.