Brazil Declares Patented AIDS Drug Of Public Interest, Could Expand Access 22/04/2008 by Claudia Jurberg for Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)By Claudia Jurberg for Intellectual Property Watch The Brazilian government recently declared the drug Tenofovir, used against HIV/AIDS, to be of public interest. The announcement signals the country’s interest in using an option to avoid the patent on the drug and possibly beginning the process of issuing a compulsory license for the antiretroviral which is produced by the Gilead Science biopharmaceutical company. [Editor’s Note: Two steps remain before a compulsory licence could be considered: granting of the patent, and another declaration of public interest] The Brazilian patent office, the National Institute of Industrial Property (INPI), released a technical opinion in the Revista de Propriedade Industrial (Industrial Property Magazine) on 8 April, on patent application number PI 9811045-4, the patent for Tenofovir. The technical opinion explains that Tenofovir is inconsistent with Articles 8, 10 (VIII), 13, 24 e 25 of the Law nº 9279/96, the Brazilian patent law. The decision was published in the Official Daily. Gilead was notified about the decision on 8 April and has 90 days to express its opinion. At the end of this time, the INPI will publish the final decision in accordance with the Brazilian law. With the declaration of public interest by the Health Ministry, INPI could give priority to the examination of an appeal by Gilead. Tenofovir is one of the most expensive antiretrovirals in Brazilian national AIDS programme. According Health Ministry, the drug is used by 30,000 patients. The annual cost of this antiretroviral is U$1,387 per patient per year. The overall annual cost is approximately US$40 million, or 10 percent of the total cost of drugs in the Brazilian programme. In Brazil, patients with AIDS receive free treatments. India produces a generic version of Tenofovir and this treatment cost US$170 per patient per year. If Brazil imported from India, the yearly savings could be more than US$30 million. According to official data from the Health Ministry, 474,273 people were infected with HIV-1 in the country from 1980 until 2007. Of these individuals, 67 percent are male and 33 percent are female, and around 190,000 people had died as of 2006. Data from Health Ministry and others sources reveals a reduction of the mortality rate by around 50 percent with the use of antiretrovirals. Researcher Jane Galvão, senior program officer for HIV/AIDS/STI and International Planned Parenthood Federation/Western Hemisphere Region (IPPF/WHR) in New York, said that since the present policy of coordinated distribution of antiretrovirals began, the number of people living with HIV/AIDS receiving treatment has steadily increased. An estimated 35,900 individuals received these drugs in 1997 and the number jumped to 175,000 in 2005. Government spending on antiretrovirals has also followed an upward trend: US$34 million in 1996 compared with US$438 million ten years later. Although the Brazilian policy of antiretroviral distribution has had notable success, it remains threatened by the high cost of acquiring the drugs, which has led to disputes with international pharmaceutical companies over prices and patents. Since 1996, the Brazilian Health Ministry has created an anti-AIDS programme that is recognised all over the world. Implementation of this policy has had political, financial, and logistical challenges. The country has received much acclaim for its multifaceted national HIV/AIDS program, with strong leadership from the government and civil society, the program includes care, education, prevention, and epidemiological monitoring. But the most distinctive element of Brazil’s program is free and widespread distribution of antiretroviral drugs to all HIV-infected people. When Brazil announced for the first time its intention to break patents on drugs for AIDS, in 2001, much progress was made in the negotiations with the pharmaceutical companies, said Galvão. She was general coordinator of the ABIA, a non-governmental and non-profit organisation founded in 1986 to take action against AIDS. After that, she worked at the Brazilian AIDS Programme of the Health Ministry. For her, there was a change in the way negotiations were conducted between the National AIDS Programme, of the Health Ministry, and pharmaceutical companies. “Nowadays, we have more strategies,” she said. Galvão said Brazil is acting within its rights with its latest action. “This is a right to the country in using this measure to declare the Tenofovir in the ‘public interest,’ she said. Therefore, there is no risk.” According to Lucia Motta, an INPI press advisor, the patent application of Tenofovir was requested through the Patent Cooperation Treaty, in 2000. This reduced the process to eight years. Motta said that the time to analyse an application for a pharmaceutical is long and complex and the time to finalise the process in Brazil is on average equal with the rest of the world. “Up to this moment, INPI and the Brazilian government acted strictly within the rules established by Law no. 9279/96, Therefore, there are no grounds for international sanctions,” said Motta. From the perspective of the Brazilian government, there are at least two arguments for continuing the distribution programme. First, the clear effect of antiretroviral treatment in reduction of deaths, and second, the substantial reduction in hospital admissions and treatment costs. The reduction of costs of hospital admissions and of treatment of opportunistic infections was also great. For 1996-2002, cost savings throughout Brazil have been estimated by the Health Ministry to be close to $1.23 billion, said Galvão. Despite the fact that the United States already suspended the patent on Tenofovir substance, Gilead said that the Brazilian decision was equivocal because the United States has not banned the patent and the Brazilian decision could be appealed. Claudia Jurberg may be reached at email@example.com. 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