Anvisa’s decision would allow the purchase of generics, and increase access to quality Hep C treatment – but a simultaneous fight to reduce Anvisa’s powers leaves the decision stalled.
On 20 March 2017, Anvisa (Brazil’s National Health Surveillance Agency) published its official decision rejecting Gilead’s patent application for the medicine sofosbuvir, a drug considered essential in the treatment of Hepatitis C. However, in the same week, news was circulated about an agreement between the patent office (INPI) and Anvisa that intends to remove the binding nature of Anvisa’s decisions, therefore undermining, and effectively stalling, the decision.
1.6 million people are living with Hepatitis C in Brazil, but by the end of 2016, less than 30,000 people had received treatment with sofosbuvir. The reach is limited by the fact that Gilead charges US$ 6,293 per patient. In countries with the best treatment coverage, generics have been sourced and prices are significantly less, between US$ 300 and US$ 900 per patient.
Anvisa’s rejection of the sofosbuvir patent is the result of efforts from civil society. The Working Group on Intellectual Property (GTPI/Rebrip), coordinated by our partner, the Brazilian Interdisciplinary AIDS Association (ABIA), submitted sound technical arguments in favor of the rejection of the patent. Opposing arguments were presented by Gilead, yet the arguments made by civil society remained valid. Awareness was further raised at national and international conferences, and through protests, letters and debates. Despite all the lobbying efforts and the evidence presented, Anvisa’s thorough decision is now at risk of being seen as mere opinion rather than enforcable.
“It is common sense for Brazilian law to continue instructing Anvisa in analyzing the technical requirements of patent applications, since the agency has a specialized structure of pharmaceutical examiners,” says Pedro Villardi, GTPI coordinator. “However, it’s exactly because it is a safeguarding process that favors public health by preventing large corporations prolonging monopolies and charging high prices, that removing the Anvisa’s role has always been a central objective of the multinational corporations lobby. This agreement would reflect that the lobby has won and public health has lost,”
Villardi continues: “The decision on sofosbuvir demonstrates how vital Anvisa’s participation is. We hope that it will serve as a warning and prevent a weakened agreement being finalized. The rejection of the patent on sofosbuvir would immediately translate into greater access to life-saving drugs, as there are cheaper versions of the medicines available that could be purchased based on Anvisa’s decision.”
Anvisa’s decision must be final
In cases involving antiretroviral medicines, for example Truvada, used in HIV prevention, and TAF, a less toxic option for initial treatment of HIV/AIDS, Gilead is appealing Anvisa’s decisions. According to the GTPI, the same strategy could be used to try to further weaken Anvisa’s decision on sofosbuvir. “We cannot accept any kind of appeal from Gilead and no turnaround from the INPI, the rejection of the patent by Anvisa is already grounded and must be the end point. The Brazil’s response to the Hepatitis C epidemic depends on it,” said Villardi.