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Brazilian President Silva Issues Compulsory License for Merck's Antiretroviral Efavirenz

Brazilian President Luiz Inacio Lula da Silva on Friday issued a compulsory license to produce a lower-cost, generic version of Merck's antiretroviral Efavirenz, the AP/Forbes reports.

World Trade Organization regulations allow governments to declare a "national emergency" and issue compulsory licenses on any grounds without consulting the foreign patent owner. Brazilian Health Minister Jose Gomes Temporao late last month signed a decree declaring that the country would purchase from an India-based drug maker a generic version of Efavirenz if Merck did not offer the drug at a lower price. According to the decree, Efavirenz is a "public interest" medicine.

Temporao at a news conference last month said the country did not issue the decree "as a threat, nor to lower the price of other medicines, but to guarantee its program of attending (AIDS) patients."

Brazil gave Merck seven days to negotiate a lower price for the drug. Officials from the Brazilian Ministry of Health last week rejected an offer from Merck to sell Efavirenz at a 30% discount in the country, an unnamed spokesperson with the ministry said on Thursday. Brazil asked Merck to reduce the cost of Efavirenz to 65 cents per dose from $1.57 per dose.

An unnamed source said that Merck offered to sell the drug for $1.10 per patient daily, but Brazil rejected the offer. Merck sells Efavirenz for $1.80 per daily dose in most middle-income countries.

According to the AP/Forbes, a generic version of the drug would save Brazil about $240 million by 2012, when Merck's patent on Efavirenz expires.


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