Defiant Brazil gives go-ahead for copies of anti-Aids drug

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.


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