Study investigates policy and governance in the production of medicines
Drug production and technology transfer in low- or middle-income countries are crucial to ensure affordable medicines and strengthen technological capacity. Therefore, the local manufacture of innovative pharmaceutical products is an important goal for health and industrial policies, especially in Latin America. However, there is a knowledge gap about the policy and governance that make these arrangements possible, especially when there is no consent from the company that owns the patent.
Brazil is historically known for promoting policies that encourage the production of generics 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" (PDPs).
Researchers Helena Achcar and Elize Massard da Fonseca, from the São Paulo School of Business Administration (FGV EAESP), analyze this context in a study, in which they discuss the policy and governance in the local production of Sofosbuvir, an innovative and high-cost drug for the treatment of Hepatitis C.
The research involved document analysis and 20 interviews with several key informants and revealed factors that contributed to Brazil's success in producing generic versions of AADs. The study also shows that, despite the investments, the Ministry of Health later chose to purchase medicines from multinational companies to the detriment of local producers.
The PDP studied involved three organizations: one company was responsible for the production of the drug molecule, another for the development of the drug, and a third for the commercialization. Among them, two are private companies and one public.
The research showed that technology transfer is a complex and risky project, 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 procurement of Sofosbuvir, a high-cost drug to treat hepatitis C
As a result of the lack of support and consensus of national production by civil society organizations and the Ministry of Health. It also showed attempts by the patent holder to block domestic production. In addition, there was also the adoption of new treatment guidelines by the Ministry of Health, in line with the austerity measures of the federal government at the time.
Finally, the researchers highlight practical implications for policymakers and governments that want to encourage national production without voluntary licensing. The study offers insights into how actions by national and international stakeholders, as well as governance arrangements, can impact national output.
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