Brazil Decrees Gilead’s Tenofovir in ‘Public Interest’
Brazil's Ministry of Health on Wednesday issued a decree signaling that it might reject Gilead's patent request for its antiretroviral drug tenofovir due to its high cost and import a generic version of the drug, Reuters reports. The decree declared the drug "in the public interest," adding that patenting the drug in the country would generate "expectations of monopoly rights with an impact on the price of the product."
The health ministry said that it had asked for a priority review of the patent filing with the Brazilian patent agency INPI, which must consider the ministry's objections. If Brazil rejects the tenofovir patent, the country could decide to use a World Trade Organization agreement allowing generic importation of patented drugs during public health emergencies, according to Reuters. A health ministry source said Thursday that the case was "not about compulsory licensing" or breaking patents, adding, "If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name." A representative of Gilead in Brazil would not comment on the situation but said top Gilead officials were in talks with Brazilian leaders.
According to the health ministry, tenofovir accounts for 10% of the government's spending on its HIV/AIDS treatment program. The government provides antiretrovirals at no cost to people living with HIV/AIDS in Brazil. This year, 31,300 people in Brazil are expected to be treated with tenofovir at a cost of $1,387 per person. The annual cost per person for the 180,000 people included in Brazil's HIV/AIDS program is about $2,500 worth of medicines each year, Reuters reports (Palermo, Reuters 4/10).