The Brazilian government announced yesterday that it had taken the first step towards issuing a compulsory license to import Indian generic copies of the anti-HIV drug efavirenz. The decision came after efavirenz’s manufacturer Merck & Co refused to sell the drug to the Brazilian government at the same price recently agreed with the Thai government.
The Brazilian government is asking Merck to sell efavirenz at US$0.65 a day, compared to a price of around $1.60 at present – a price reduction of almost 60%. Efavirenz is currently used by 75,000 patients in Brazil, and costs the Brazilian government $43 .8 million a year.
Merck says it is committed to reaching an agreement with the Brazilian government, but does not believe compulsory licensing is in the best interests of patients.
Yesterday’s announcement declared efavirenz to be a `medicine of public interest`, which means that Merck has seven days to negotiate a new price. If agreement is not reached, further moves towards compulsory licensing could lead to the grant of a license that allows imports of Indian generic versions of efavirenz, and eventually, production of a generic version by Brazilian companies.
Brazil is entitled to issue a compulsory license under World Trade Organisation rules, which allows countries facing a public health emergency to override patents where they see it as a necessary step in addressing a public health problem.