Twelve trucks are stationed in the Ministry of Health’s warehouse, in Sao Paulo, with shipments that would allow for the treatment of 15,000 patients who have been waiting for these medicines for a year.
The reason is that Gilead Sciences blocked the delivery of hep C treatment generic medicines, which were purchased on an emergency call for more severe patients. The Court upheld Gilead’s claim that the generic drug value is insufficient. Meanwhile, Gilead has already applied for the medicine’s patent.
The Ministry of Health informed that the medicine public bidding was held in accordance with the law. Gilead has declared it will no longer contest the purchase of the generic version, which a low cost combination of sofosbuvir + dataclasvir ( $ 2,450 per treatment). This represented an economy of 59 percent compared to the last purchase done in 2017, which costed $ 6,000.”
A group of civil society organizations, led by Medecins sans Frontieres (MSF), filed a complaint to the Public Prosecutor Office accusing Gilead Pharma of putting The National Institute of Industrial Property (INPI) under pressure in order to obtain the patent of sofosbuvir and also file lawsuits to hamper the generic’s distribution.
This is the latest chapter of the wrestling between Gilead and the generic sofosbuvir producers, which has been dragging on for months and, consequently, impeding Brazilian public health system (SUS) patients to access their essential medication.
The Ministry of Health announced in 2018 a plan to eliminate hep C by 2030. This means all SUS patients will be treated with the new ARVs, leaving behind the previous policy of serving only the more severely affected patients. The treatment cost per user is estimated in $ 9,050 per patient, which inevitably limits the treatment coverage to fewer people.
An agreement between the public national labs Farmanguinhos-Fiocruz and Blanver obtained a registration from the Brazilian drug regulatory agency Anvisa to manufacture sofosbuvir in its generic form and offer a lower price than that proposed by Gilead at a meeting at the Ministry in July. In several letters to the Ministry of Health, Gilead questioned the generic offering.