Press Office
National STD/Aids Program
Brazilian Ministry of Health

OFFICIAL NOTE

Ministry of Health announces compulsory licensing of Nelfinavir patent


Following six months of negotiations and having exhausted all possibility of arriving at an agreement with Roche Laboratories, the Brazilian Minister of Health, José Serra, has decided to break the patent of the drug Nelfinavir used in the treatment of people with AIDS. Roche Laboratories will continue to supply the drug until December 2001, which is when the contract with the Ministry of Health expires.

The generic version of Nelfinavir will be manufactured by the Brazilian government laboratory Far-Manguinhos and it will begin to be distributed in February 2002. This public laboratory has succeeded in producing the drug at a saving of 40% over that charged by Roche. This will mean a saving for the country of 88 million reais per year.

Nelfinavir is used by 25% of the 100,000 patients who use anti-AIDS drugs in Brazil. Last year, $US 303 million was spent on purchasing drugs which go to make up antivretroviral therapy. Nelfinavir alone accounted for 28% of this expenditure.

Since the beginning of this year the Ministry of Health has been in negotiations with Merck Sharp & Dohme and Roche Laboratories in connection with the reduction of prices for antiretrovirals. These negotiations resulted in a reduction of almost 70% in the price of Efavirenz, a drug manufactured by Merck. The price reduction proposed by Roche for Nelfinavir was not considered to be satisfactory.

The Ministry of Health is currently taking the appropriate legal steps to introduce compulsory licensing of the drug.


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