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Study investigates policies and governance in medicine production

The study identified an unfavorable environment for the local production and acquisition of Sofosbuvir, a high-cost drug to treat hepatitis C

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Study investigates policies and governance in medicine production

The production of medications and the transfer of technology to low- and middle-income countries are crucial to guaranteeing affordable medicines and strengthening technological capacity. As such, the local manufacture of innovative pharmaceutical products is an important goal for health and industrial policies, especially in Latin America. However, there is a gap in knowledge about the policies and governance that make these arrangements viable, especially when there is no consent from patent-holding companies.

Brazil is well known for promoting policies that encourage the production of generic drugs and the development of the local pharmaceutical industry. For 20 years, the country has promoted public-private technology transfer initiatives, called “partnerships for productive development.”

Researchers Helena Achcar and Elize Massard da Fonseca from Fundação Getulio Vargas’ Sao Paulo School of Business Administration (FGV EAESP) analyze this situation in a study in which they discuss policies and governance for the domestic production of Sofosbuvir, an innovative and expensive drug to treat hepatitis C.

The research, which involved document analysis and 20 interviews with various key informants, revealed factors that contributed to Brazil’s success in producing generic versions of direct-acting antiviral drugs. The study also shows that, despite making investments, the Health Ministry subsequently chose to purchase medicines from multinational companies to the detriment of local producers.

The researchers looked at a specific partnership for productive development, which involved three organizations: one company was responsible for producing the drug molecule, another for developing the drug, and a third for marketing. Of these, two are private sector companies and one is in the public sector.

The research showed that technology transfer is a complex and risky endeavor, which requires political negotiation skills, as well as the support of state and non-state actors, especially when there is no voluntary licensing of patents.

The study identified an unfavorable environment for the local production and acquisition of Sofosbuvir, due to a lack of support and consensus for domestic production among civil society organizations and the Health Ministry. It also noted attempts by the patent holder to block domestic production. In addition, the Health Ministry adopted new treatment guidelines, in line with the austerity measures of the federal government at the time.

Finally, the researchers highlight some practical implications for policymakers and governments wishing to encourage domestic production without voluntary licensing. The study offers insights into how actions by national and international stakeholders, as well as governance arrangements, can impact domestic production.

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