Abstract
In 2014, as Brazil entered a severe economic, financial and political crisis, a new class of antiviral medicines for hepatitis was put on the market at unaffordable prices. The civil society organizations that had led the struggles for access to HIV/AIDS medicines since the 1990s urged the government to invest in the local production of sofosbuvir and called for the cancellation of the patent owned by Gilead Sciences. Three private laboratories coordinated their technological and industrial capabilities to produce a generic medicine. In 2016, a consortium was formed, coordinated by the private company Microbiologica, which had become, in 1992, the first to copy AZT in Brazil. Microbiologica had also contributed to the development of sofosbuvir in the early 2000s, in collaboration with the US company Pharmasset and had mastered the technology perfectly. As soon as the patent is declared invalid by the Brazilian National Industrial Property Institute (INPI), the Brazilian consortium will be able to produce the drug and supply it to the Ministry of Health. Once again, in the context of the Brazilian crisis, this story mobilized the industrial and civil society actors set up to produce HIV/AIDS medicines in the 1990s and now involved in the local production of molecules to treat hepatitis C, which affects two million people in Brazil.
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- 1.
“The price of Sovaldi and its impact on the US Health Care System”, Committee on Finance, United States Senate, December 2015, 144 pages.
- 2.
CÂMARA DOS DEPUTADOS, COMISSÃO DE SEGURIDADE SOCIAL E FAMÍLIA, June 2014, p. 78.
- 3.
GTPI/Rebrip : “Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples”: cf. Chap. 8.
- 4.
Statement of Brazilian CSO (GTPI) on Gilead VL on sofosbuvir, September 22, 2014.
- 5.
We studied the formation of this consortium from 2014, through ongoing interaction with the main protagonists: Jaime Rabi from Microbiologica, the consultant Karin Bruening, the company Blanver, the head of innovation at the Oswaldo Cruz Foundation, Jorge Costa, the patent expert Wanise Barroso, who had prepared the opposition document to Gilead’s patent for Fiocruz , and Eloan Pinheiro, the DNDI’s consultant who had worked for several years with viral hepatitis patient organizations.
- 6.
Application for the priority examination of the sofosbuvir patent, Ministry of Health, 20 April 2016.
- 7.
This was the case of the opposition filed in India by I-MAK and in Europe by Médecins du Monde.
- 8.
“Conhecendo a Lei de Patentes e a posicão do Brasil no atual cenário da incorporação de medicamentos”, 2 March 2015.
- 9.
Sociedade civil realiza ato público em defesa do tratamento da Hepatite C em João Pessoa, July 2015, ABIA.
- 10.
“Difícil acesso à cura das hepatites é debatido no Encontro Regional de Inovações na Prevenção, em Santos”, Avril 2016.
- 11.
Letter dated 8 April 2016, F iocruz.
- 12.
The National Health Council was founded in 1990. It participates in the discussion and government of the public health policies in Brazil, in interaction with the Ministry of Health. Composed of representatives of movements of users (50 percent), healthcare professionals (25 percent) and representatives of the Ministry of Health (25 percent), it represents an institution of the sanitary democracy of Brazil.
- 13.
Not everything is blocked in this field. A few months earlier, in January 2017, the INPI in Brazil invalidated Gilead’s patent on Truvada, thus making generics production legal.
- 14.
We will see later that Gilead followed this strategy with regard to the list of PDP projects published by the Ministry of Health on 10 August 2017.
- 15.
“Sofosbuvir is registered by the originator company in Argentina but is not under patent as the applications are under review. This has allowed a local company to produce generic sofosbuvir. In Argentina, the price per patient-month for sofosbuvir from the local generic producer is US$ 501 (versus US$ 2086 for sofosbuvir from the originator company)”, WHO, Global Report on Access to Hepatitis C Treatment: Focus on overcoming barriers, October 2016.
- 16.
Methods of manufacture of 2’-deoxy-beta-L-nucleosides, US Patent Application No: 2004/0266996.
- 17.
The federal laboratory nevertheless reappeared as an industrial partner in March 2017 when ANVISA issued a negative opinion for the granting of Gilead’s patent. A declaration by the Oswaldo Cruz Foundation highlighted this point: “Anvisa e Farmanguinhos são contra a patente do sofosbuvir”, 28 March 2017. In February 2017, FM also filed an opposition to Gilead’s patent, with the INPI . In August 2017, FM was involved in three PDP with the BMK consortium, to produce hepatitis C antivirals.
- 18.
There has nevertheless been a change in Gilead’s stance regarding intermediate countries: at the end of August 2017 it added four intermediate countries to the list of those that benefit from generic sofosbuvir: Malaysia, Thailand, Ukraine and Belarus. And it has just negotiated a partnership with a private-sector firm and a Brazilian government laboratory (Ministry of Health, 13 August 2017).
- 19.
Gilead’s patents cite the Zika virus as one on a list of potential targets, but without any further demonstration of this therapeutic application.
- 20.
Informacões sobre as novas propostas de Parcerias para o Desenvolvimento Produtivo para o ano de 2017, Brasília, 10 August 2017.
- 21.
In September 2011, Brazil’s president, Dilma Roussef, reaffirmed at the UN the advantages of using the “flexibilities” of the TRIPS agreements in the public health field, and especially compulsory licences: “Brazil guards the compromises regarding intellectual property but we are convinced that the flexibilities foreseen in the TRIPS of the WTO, in Doha’s Declaration about TRIPS and Public Health and in the global strategy for public health are indispensable for policies that guarantee the right to health.”
- 22.
Hepatitis C drugs re-energize global fight over patents, Nature 543, 17–18 (2 March 2017).
- 23.
Preliminary list of generics manufacturers with an interest in sofosbuvir production, MSF , May 2015. MSF also published an article in The Lancet on the prices and competition of generics: “Disparity in market prices for hepatitis C virus direct-acting drugs”, The Lancet, vol. 3 November 2015.
- 24.
An alternative research and development strategy to deliver affordable treatments for Hepatitis C patients, DNDI, April 2016.
- 25.
The DNDI had already collaborated with Farmanguinhos in the 2000s to develop an artemisinin-based combination for malaria: “Needs driven versus market driven pharmaceutical innovation: the consortium for the development of a new medicine against malaria in Brazil”, K. Kameda, Developing World Bioethics, 2014.
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Cassier, M., Correa, M. (2019). A Consortium in Times of Crisis: Producing Brazilian Sofosbuvir? (2014–2017). In: Cassier, M., Correa, M. (eds) Health Innovation and Social Justice in Brazil. Palgrave Macmillan, Cham. https://doi.org/10.1007/978-3-319-76834-2_6
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