E-DRUG: Brazilian Government declares Efavirenz to be of public interest
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Brazilian Government declares Efavirenz to be of public interest
25/04/07
Brazil has begun a process, which may culminate in the compulsory licensing of the patent of the antiretroviral drug Efavirenz. The Minister of Health, José Gomes Temporão, signed Decree 866, published today in the Federal Official Gazette, declaring Efavirenz to be of public interest for the purposes of granting compulsory licensing for non-commercial public use.
As on previous occasions, the Brazilian Government preferred to seek a negotiated solution with the company that provides Efavirenz, Merck, Sharp & Dohme. To this end, the Ministry of Health held a considerable number of meetings with the company from 2006 onwards. To date, however, these meetings have not resulted in an agreement involving reasonable terms and conditions that meet the public interest. Once the Decree has been published and the company has been notified, the President of the Republic may grant, by Decree, the compulsory licensing of the patent of this antiretroviral drug, something which has never happened before in Brazil with regard to medicines.
Efavirenz is indispensable for the treatment of people living with HIV/AIDS and is a fundamental part of the National Sexually Transmitted Diseases and AIDS Programme (National STD and AIDS Programme), which is recognized internationally for providing universal, integral and free access to treatment, in accordance with Law No. 9,313, adopted in November 13th 1996.
Efavirenz is one of the drugs most used in antiretroviral treatment. Currently, 38% of patients take this drug. It is estimated that by the end of 2007, 75,000 of the 200,000 patients having antiretroviral treatment in Brazil will be taking Efavirenz.
Owing to the growth in the number of people living with HIV/AIDS in Brazil, the maintenance of the current prices of Efavirenz places the viability of the National STD and AIDS Programme at risk. At current prices (US$ 1.59/tablet), the purchase of Efavirenz (600 mg) for the National STD and AIDS Programme would cost the Brazilian Government approximately US$ 42.9 million, according to this years purchase estimates, which is the equivalent of around US$ 580 per patient per annum. Proposals received from international organisms for the purchase of this drug, via WHO prequalified laboratories, vary between US$ 163.22 and US$ 166.36 per patient per annum. These proposals would represent a cost reduction for the Government in 2007 in the region of US$ 30 million a year. Following the granting of compulsory licensing for Efavirenz, estimated savings by the year 2012, when the Efavirenz patent expires, would be US$ 236.8 million.
With the aim of ensuring the viability of the National STD and AIDS Programme, the Brazilian Government may make use of the institution of compulsory licensing, in accordance with national legislation and international agreements. Compulsory licensing of patents is provided for, among others, by the WTO Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS Agreement) and by the Brazilian Industrial Property Law (Law No. 9279/96).
If compulsory licensing is adopted, the Brazilian Government will stand by its international obligations whilst also, however, taking into account the terms of the Doha Ministerial Declaration on the TRIPS Agreement and Public Health, adopted at the WTO meeting held in Qatar on November 14th 2001.
Further information
Press Office National STD and AIDS Programme
Tel.: +55 61 3448-8100 / 3448-8088
E-mail: imprensa@aids.gov.br
[submitted by gabriela@abiaids.org.br]