After a group of CSOs that struggle to increase the availability of essential medicines – the Intellectual Property Working Group (GTPI), coordinated by Brazilian Interdisciplinary AIDS Association (ABIA), the Brazilian Center for Health Studies (Cebes), the Brazilian Association for Collective Health (ABRASCO) and the National Health Council (CNS) – stated their position against the Brazilian Institute for Intellectual Property’s (INPI) decision to grant a patent for sofosbuvir, filed by US big pharma company Gilead, Brazilian presidential candidates rushed to also stand against INPI’s decision.
Rede Party candidate, Marina Silva, was the first to tweet on the issue.
“The Sofosbuvir patent case is one that concerns public health interests. The generic production, which can be carried out by our own Fiocruz and has been authorized by Anvisa, should kick off immediately. If the government refuses to do so, Eduardo Jorge (Silva’s VP candidate) and I will break this patent“, she promised.
Sofosbuvir reaches the Presidential debates
On September 20, during the debate on Aparecida TV Network, Marina insisted on the matter and promised to break all patents of high-cost drugs, similar to what was done with AIDS in Brazil with the drug Efavirenz. “A decision was just issued ruling against breaking the patent for an essential medicine for Hepatitis C that kills millions and millions of people… we are going to break the sofosbuvir patent. If it had already been broken, Farmanguinhos lab could produce the medicine at much lower costs“, she said.
Marina also filed a lawsuit at the Federal District court requesting for a preliminary injunction to suspend INPI’s judgement and claiming “clear violation of the constitutional right to health”, which was later approved on September 23.
Ciro Gomes (PDT), in the same broadcast, called the INPI’s decision “an aberration”. “This was this week’s scandal… it balkedat the possibility of Farmanguinhos/Fiocruz’s production, because the technology in question is safeguarded under the pretext of protecting an international patent.”
Leftist candidate Guilherme Boulos (PSOL) also declared to be in favor of the patent infringement. “The decision to grant the sofosbuvir patent to Gilead is absurd. The only solution is to break it and authorize the generic drug production via Fiocruz, at a cost four times less expensive. Thousands of lives are at stake.”
The presidential debate at the Federation of Industries of the State of São Paulo (Fiesp) was also the stage for debating the patent issue.
Artur Chioro, the Health Coordinator in PT’s Haddad campaign, criticized the agency’s change of opinion after it had already declared in a technical report the patent request was “seemingly unjustifiable”.
“The government remained silent while the public interest was belittled. There is something strange, even extraterrestrial, that cannot be justified by technical principles.” To reverse the situation and guarantee a wider access to the drug, Chioro argued compulsory licensing can be used as a legal instrument in favor of public health.
Henrique Javi, Health Coordinator in Ciro Gomes’ (PDT) campaign, who was once his Health Secretary in the state government of Ceará, criticized actions taken so far, explicating that it is the government’s job to appeal international trade agreements when this is necessary to preserve the right to health.
Liberal party PSDB on the fence
Doctor David Uip, Health coordinator in Alckmin (PSDB) campaign, seemed less emphatic about the technical aspects when he argued that governments should negotiate with aim of reducing costs, but also preserving investments that enable new discoveries and medicines that are more efficient.
On Twitter, Senator José Serra (PSDB/São Paulo) declared he filed arequest for INPI to explain the decision in an Upper House Special Commission, in addition to requesting explanations from the Ministry of Industry and Commerce on the impediment to producing the sofosbuvir generic nationally.
Civil society bets on compulsory licensing
Following INPI’s contentious decision, civil society organizations that advocate for the access to essential medicines concentrate all their efforts towards a legal decision for compulsory licensing.
Recognized internationally, the compulsory licensing mechanism is used by governments to defend the public interest and the right to health from abuse in pricing by patent-holding companies. The measure suspends exclusivity rights and allows manufacturing of generic versions or their imports while ensuring royalties are paid to the company.
“We will rally and mobilize so that the governmentis pressured into granting the compulsory license for sofosbuvir. The measure has been successful in Brazil for the last 11 years with the drug Efavirenz, when a different government and civil society members joined forces to ensure the population’s right to health. As it was then, ‘public interest’ is clear in this case where we have a context of large need for public health, patients without access to medicine and a competition blockade that has earned $ 55 billion dollars for a single company with the sale of sofosbuvir around the world” argued Pedro Villardi, ABIA’s representative and GTPI’s coordinator.