The Brazilian government published today (May 7) a decree that renews, for five years, the compulsory license for the antiretroviral drug Efavirenz used in the treatment of AIDS. Currently, about 104,000 people use this drug in their therapeutic regimens, representing almost 50% of those in treatment in Brazil.
After decreeing compulsory licensing in 2007, the Ministry of Health began to import generics pre-approved by the World Health Organization (WHO) from India. This measure produced immediate savings of US$31.5 million for Brazil.
At the same time, domestic development of Efavirenz was begun. The federal government decided to develop the formulation of the drug and encourage the production of its active component. In order to do this, the Farmanguinhos and Lafepe laboratories signed a partnership agreement to form a consortium with private companies Globequímica (SP), Cristália (SP), and Nortec (RJ).
Since 2009, Brazil has produced the most widely used pharmaceutical version of generic Efavirenz. An Indian laboratory supplied the drug until 2010, and these stocks lasted until 2011. At that point, production became entirely domestic. In 2012, 57 million pills of Efavirenz were ordered from Farmanguinhos, at a cost of R$76.9 million to the Ministry of Health.
Public interest: compulsory licensing is a legal measure laid out in Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This practice is used by developed countries such as Italy and Canada, as well as by developing countries, for pharmaceutical products. In the case of antiretroviral drugs, Mozambique, Malaysia, Indonesia, and Thailand have made use of this legal device.
In Brazil, compulsory licensing may be implemented based on circumstances described in the Brazilian Industrial Property Law, such as the abuse of civil rights, abuse of economic power, local non-development, unsatisfactory commercialization, national emergency, and public interest.
In the case of the antiretroviral drug Efavirenz, compulsory licensing was based on the public’s interest in ensuring that a viable HIV/AIDS treatment was provided by the Brazilian National Health System (SUS).