Anvisa, the National Health Surveillance Agency in Brazil, has registered a generic version of the medicine sofosbuvir on May 21, which is used for the treatment of hepatitis C and also for patients co-infected with HIV/AIDS. The medication has proved to be highly efficient, attaining an efficacy rate of 97 percent in clinical cases of hepatitis C.
The pharmaceutical company Gilead Sciences issued a request to patent the sofosbuvir, which was then contested by GTPI (The Intellectual Property Work Group), coordinated by ABIA (The Brazilian AIDS Interdisciplinary Association) in the aim of dismantling the monopoly over the drug.
So far, important patent requests were repeatedly denied by the exam authorities, as was the case for the PI0809654-6 request, which was refuted by the INPI (National Institute for Intellectual Property) on May 4. (Read here in Portuguese)
“The registry of the national generic medication is paramount for its price reduction in Brazil. The people are victims of extortion by Gilead since 2015” argues Pedro Villardi, GTPI’s coordinator.
Released in 2013 by the North American company Gilead Science, the Sovaldi (trade name for the sofosbuvir) was embedded in the SUS (the Brazilian National Public Health Service) in 2015.
An example of the big pharma greed
The sofosbuvir became known for its nickname “the thousand dollars pill” – the value amount Gilead charges for a single medication tablet – which comprises an amount of 84 thousand dollars for the entire treatment per person.
The GTPI organized one of the rallies in front of the Gilead headquarters in Brazil on October 30, 2017, the eve of the Hepatitis World Cup on September 2017, both in São Paulo.
In Brazil, the medication was originally traded for 7,5 thousand dollars per person. “With the registry released yesterday, the GTPI demands Gilead to waive its usual juridical stunts that serve to delay the process of concluding the patent rejection.
The Brazilian authorities, as other foreign authorities, understand Gilead does not present any inventive activity in the production of the Sovaldi, which would justify the patent request.
“The company is trying to hijack a public collective and global effort that developed a cure for Hepatitis C. We also demand that the Ministry of Health next medication purchase terminates Gilead’s monopoly in order to make room for a level playing field for market competitors” as Villardi weighs.
The registry is expected to consolidate the role of public laboratories as market regulators against abusive profits, promoted by GTPI’s efforts to guarantee universal access to the sofosbuvir in Brazil.
Effective against zika and yellow fever
Studies conducted by Fiocruz (Oswaldo Cruz Foundation) and other research centers in the states of Minas Gerais and São Paulo reveal that Sofosbuvir might be effective to the treatment of zika virus and yellow fever.
The drug, distributed in Brazil via SUS, is not available in drug stores and its use is restricted to medical management only. In comparison to other treatments, the Sofosbuvir offers a near 100 percent chance of efficacy, as well as the reduction of side effects and the oral route of administration.