E-drug: Compulsory licensing of nelfinavir in Brazil
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Dear e-druggers,
After long and unsuccessful negotiations with Roche, the Brazilian
government announced today that it is seeking compulsory
licensing of nelfinavir, used in the treatment of AIDS. May this
serve as an example of what needs to be done when faced with
abusive pricing of essential drugs.
Lynn Silver, MD, MPH
Instituto Brasileiro de Defesa do Consumidor and
Department of Pharmaceutical Sciences
Universidade de Brasilia
Brasilia, Brazil
e-mail: idec@terra.com.br
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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, Jos� 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 antiretroviral 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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