Yesterday, for the very first time in Brazilian history, a pharmaceutical company had its patent compulsorily licensed by the Federal Government due to its public interest. Before the issuance of the compulsory license, President Luis Inacio Lula da Silva issued a decree declaring the anti-retroviral Efavirenz of public interest.

The anti-retroviral Efavirenz, used by 38% of Brazilians under AIDS treatment, is currently held by the North-American laboratory Merck Sharp & Dohme, the owner of the patent. According to the Brazilian Government, the measure will allow a decrease of 72% on the drug’s current price now that generic versions of Efavirenz will be imported from Indian laboratories.

Merck will receive from Brazil royalties of 1,5% over the amount invested on purchising of the drug from Indian laboratories. The compulsory licensing is a legal and legitimate instrument recognized by both Brazilian law and international trade agreements, namely the TRIPs agreement of the World Trade Organisation.

According to informations provided by the Brazilian Ministry of Health, "the practice of compulsory licensing for pharmaceutical products is frequently used both by developed (Italia and Canada, for example) and developing countries. In antiviral drugs case, developing countries already used that flexibility: Mozambique, Malasya, Indonesia and, more recently, Thailand".

We from the Center for Technology and Society from Fundação Getulio Vargas School of Law in Rio de Janeiro support the historical decision held by the Brazilian Federal Government, as well as the work of the Brazilian Interdisciplinary AIDS Association and the Medecins Sans Frontiers in Brazil.

Below, we reproduce the document released by the Working Group on Intellectual Property (GTPI) from the Brazilian Network for the Integration of Peoples (REBRIP) on Friday, the 4th of May, 2007.

The Working Group on Intellectual Property (GTPI) from the Brazilian Network for the Integration of Peoples (REBRIP) expresses its support for the federal government’s decision to issue a compulsory licence for the antiviral drug, Efavirenz, whose patent is current held by Merck Sharp & Dohme. This historical decision reinforces the efforts of civil society groups fighting for access to medicines, for the sustainability of public health policies, such as universal and unlimited access to antiretroviral medicines used in the treatment of HIV/AIDS, and for the strengthening of the Brazilian public health care system, the Unique Health System (SUS).

We understand that the use of compulsory license allows the procurement and production of more affordable generic versions, providing the guarantee of fundamental human rights, especially health’s rights. The measure taken by the Brazilian government takes into account the government’s conditions to guarantee the supply, considering the possibility to immediately import medicines with quality and the local production subsequently.

We would like to emphasize that the use of compulsory licences is a legal and legitimate instrument recognized by both Brazilian law and international trade agreements, namely the TRIPS agreement of the World Trade Organisation. The interests behind the drafting and adoption of this agreement are becoming clearer every day and demonstrate how private interests, increasing the profit margins of multinational companies, are appropriating knowledge and technological goods. These profits are extremely high, especially when one considers that they are earned thanks to the protection of products that are essential for human survival – in this case, medicines.

Finally, we consider sovereignty as a central political and legal institution of the State. As such, trade agreements must not prevent States from adopting measures that aim to protect health, safety and the independence of the people. In this sense, the measure adopted by the Brazilian government today represents a victory of common-sense in dealing with the question of access, and can and should stimulate the issuing of licences for other medications that are fundamental for the treatment of various diseases affecting the country.

 Efavirenz is one of the most used for the anti-retroviral therapy. Currently, 38% of the patients are using this medicine. It is estimated that until the end of 2007, 75.000 of the 200.000 patients being treated with anti-retrovirals will be using efavirenz.

 Due to the increasing number of people living with HIV/Aids in Brazil, current price for efavirenz threatens the sustainability of the Brazilian Aids Program. Based on the current prices (US$1,59/tablet), the purchase of efavirenz (600 mg) for the Aids Program accounts for almost US$ 42,9 millions to the Brazilian government. This means about US$ 580 per patient per year. Proposals received by international organizations for the procurement of this medicine, from WHO pre-qualified laboratories, which are between US$163,22 and US$ 166,36 per patient per year. These proposals would mean a reduction of government expenses, in 2007, of US$ 30 millions per year. After issuing the compulsory license for efavirenz, it is estimated that the savings until 2012 will be of US$236,8 millions, when the patent of this anti-retroviral expires.

Brasilia, 4th of May, 2007.

Contacts

Renata Reis: renata [at] abiaids [dot] org - Mobile: (55) (21) 9114-1838

Gabriela Chaves: Gabriela [at] abiaids [dot] org - Mobile: (55) (21) 8879-5680

Michel Lotrowska: access [at] msf [dot] org [dot] br - Mobile: (55) (21) 8111-3666