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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.

Resumo A discussão de captura regulatória não é uma agenda recente em estudos do Estado, mas o estabelecimento de critérios para identificação de captura, bem como a definição de protocolos para demonstração e mensuração do fenômeno estão longe de um consenso. O presente artigo tem por objetivo, por meio de uma revisão sistematizada não exaustiva da literatura, identificar as principais estratégias de captura e suas respectivas formas de mensuração. Propõe-se a organização dos estudos de regulação em quatro eixos de estratégias de captura: por incentivos materiais, por incentivos imateriais, por ameaça e por assimetria de informação. Ademais, busca-se examinar a produção sobre o caso brasileiro e discutir os resultados contraditórios de pesquisas recentes sobre o caso da Agência Nacional de Saúde Suplementar (ANS). Identificou-se que, em geral, a literatura brasileira parte de uma abordagem ampla de compreensão de captura e que os trabalhos que se orientam por uma abordagem restritiva exploram, principalmente, o mecanismo de “porta giratória”, seguindo uma tendência da literatura internacional, porém ignorando outros mecanismos com potencial explicativo. Esses achados têm implicações para desenhos de pesquisa em estudos sobre regulação, de forma a avançar as análises além das impressões iniciais e em direção a demonstrações empíricas robustas.

O artigo avalia como a descentralização dos recursos e ações do Programa Nacional de DST e AIDS influenciou as transferências de recursos para os programas de prevenção ao HIV/AIDS entre usuários de drogas injetáveis no Rio de Janeiro, Brasil (1999-2006). Foram avaliados os efeitos da política de descentralização sobre as transferências de recursos para os Programas de Redução de Danos (PRD) no Rio de Janeiro. A descentralização das transferências para os PRD no Rio de Janeiro se efetivou em 2006, com a virtual supressão do financiamento federal direto, obrigando estes programas a buscarem fontes alternativas de financiamento. Constata-se uma fragilidade dos PRD no Estado, agravada pela redução recente do volume de recursos. Dos 22 programas, existentes em 2002, o Estado passou a contar, em 2006, com apenas dois programas, financiados pelo Estado e por um município. A descontinuidade dessas ações pode vir a favorecer a reemergência da epidemia de AIDS nesta população, o que reclama um processo de descentralização mais gradual e melhor pactuado dessas iniciativas.This paper assesses how decentralization of resources and initiatives by the Brazilian National SDT/AIDS Program has impacted the transfer of funds for programs to prevent HIV/AIDS among injecting drug users in Rio de Janeiro, Brazil (1999-2006). The effects of the decentralization policy on Rio de Janeiro's Syringe Exchange Programs (SEPs) are assessed in detail. Decentralization effectively took place in Rio de Janeiro in 2006, with the virtual elimination of any direct transfer from the Federal government. The elimination of direct transfers forced SEPs to seek alternative funding sources. The structure of local SEPs appears to be weak and has been further undermined by current funding constraints. Of 22 SEPs operating in 2002, only two are still operational in 2006, basically funded by the State Health Secretariat and one municipal government. The current discontinuity of SEP operations may favor the resurgence of AIDS in the IDU population. A more uniform, regulated decentralization process is thus needed.

The present study aims to evaluate the current operation of Brazilian syringe exchange programs (SEP). After consulting national and regional networks of people working in projects/ programs aiming to reduce drug-related harm, we identified 134 potential participant programs. Unfortunately, only 45 SEPs answered a survey, even after repeated attempts. The survey addressed: coverage, funding, procurement of basic supplies, managerial capacity, and the local political environment. Findings were triangulated with in-depth interviews with key informants. The main findings included: satisfactory adherence to the initiatives and adequate documentation, but deficiencies in terms of coverage and monitoring, and uneven procurement of resources. Program personnel work mostly on a provisional basis, despite the efforts of local coordinators. Most programs are funded by the National STDs/AIDS Program. A comprehensive agenda aiming to improve current operations should include: concerted efforts to improve local and regional databanks, incentives/sanctions toward full accountability of initiatives carried by the programs, and a genuine culture of monitoring and evaluation.

The present study aims to evaluate the current operation of Brazilian syringe exchange programs (SEP). After consulting national and regional networks of people working in projects/ programs aiming to reduce drug-related harm, we identified 134 potential participant programs. Unfortunately, only 45 SEPs answered a survey, even after repeated attempts. The survey addressed: coverage, funding, procurement of basic supplies, managerial capacity, and the local political environment. Findings were triangulated with in-depth interviews with key informants. The main findings included: satisfactory adherence to the initiatives and adequate documentation, but deficiencies in terms of coverage and monitoring, and uneven procurement of resources. Program personnel work mostly on a provisional basis, despite the efforts of local coordinators. Most programs are funded by the National STDs/AIDS Program. A comprehensive agenda aiming to improve current operations should include: concerted efforts to improve local and regional databanks, incentives/sanctions toward full accountability of initiatives carried by the programs, and a genuine culture of monitoring and evaluation.