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The local manufacture of advanced pharmaceutical products has been a long-standing objective of health and industry policy in many developing countries, including in Latin America. This strategy has been applied to fight epidemics such as HIV/AIDS, malaria, and the COVID-19 pandemic. However, we still know little about the politics and governance that enable such arrangements, especially when there is no consent from the originator company. This study focuses on the case of Brazil, a country that is well-known for its health-industry policy, which includes the local production of direct-acting antivirals (DAAs), a new treatment for hepatitis C. We seek to explain the factors that have contributed to Brazil’s successful production of generic versions of DAAs, and, later, to the decision by the Ministry of Health (MoH) to procure drugs from multinational pharmaceutical companies rather than from local laboratories. A lack of support for domestic production by important stakeholders, the patent holder’s attempt to block domestic production and the MoH’s adoption of more modern treatment guidelines under a different procurement logic all created an unfavourable environment for local production and procurement of DAAs. Our study draws implications for middle-income countries that wish to produce drugs domestically without voluntary license agreements. [ABSTRACT FROM AUTHOR]

The discussion of regulatory capture is not recent in state studies. However, the criteria to identify capture and the definition of the research protocols to demonstrate and measure the phenomenon have still not reached a consensus. This article carries out a non-exhaustive literature review to identify the main regulatory capture strategies and their respective measurement methods. We organize the regulation studies in four axes of regulatory capture strategies: capture by material incentives, capture by immaterial incentives, capture by threat, and capture by information asymmetry. Furthermore, the study examines the Brazilian case and discusses the contradictory results of recent research on the case of the National Supplementary Health Agency (ANS). We identified that, in general, Brazilian literature starts from a broad approach to understanding regulatory capture. Also, the studies adopt a restrictive approach mainly to explore the “revolving door” mechanism, following a trend in international literature but ignoring other mechanisms with explanatory potential. These findings have implications for research designs in studies of regulation in order to advance analyses beyond initial impressions and toward robust empirical research. [ABSTRACT FROM AUTHOR]

Brazil is well-known for its vigorous AIDS advocacy [1,2]. During the 1990s, AIDS activists in Brazil centred their agenda on demanding the provision of medicines by pressuring the government through [...]

Brazil has encouraged an ambitious set of policies towards the pharmaceutical industry, aiming to foster technological development while meeting health requirements. We characterise these efforts, labelled the 'Complexo Industrial da Saúde' (Health-Industry Complex, CIS), as an outcome of incremental policy change backed by the sustained efforts of public health professionals within the federal bureaucracy. As experts with a particular vision of the relationship between health, innovation and industry came to dominate key institutions, they increasingly shaped government responses to emerging challenges. Step by step, these professionals first made science and technology essential aspects of Brazil's health policy, and then merged the Ministry of Health's new focus on science, technology and health with industrial policy measures aimed at private firms. We contrast our depiction of these policy changes with a conventional view that relies on a partisan orientation of the executive. [ABSTRACT FROM AUTHOR]

The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood. Brazil’s experience suggests that progressive healthcare bureaucrats can create innovative practices for technology and knowledge transfers. It also demonstrates that highly competitive pharmaceutical firms can collaborate with each other, if a government provides them the right incentives. Reforming regulatory policies is crucial for guaranteeing high-quality products in developing countries, but governments must play a crucial role in supporting local firms to adapt to these regulations. These findings send a strong message to global health policymakers and practitioners on the conditions to create a suitable environment for local production of medical products. [ABSTRACT FROM PUBLISHER]

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Copyright of Cadernos de Saude Publica is the property of Escola Nacional de Saude Publica Sergio Arouca and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)