The politics and governance of drug production in public-private partnerships: Brazil's response to hepatitis C.

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.

The comparative politics of COVID-19: The need to understand government responses.

COVID-19 has created a ramifying public health, economic, and political crisis throughout many countries in the world. While globally the pandemic is at different stages and far from under control in some countries, now is the time for public health researchers and political scientists to start understanding how and why governments responded the way they have, explore how effective these responses appear to be, and what lessons we can draw about effective public health policymaking in preparation of the next wave of COVID-19 or the next infectious disease pandemic. We argue that there will be no way to understand the different responses to COVID-19 and their effects without understanding policy and politics. We propose four key focuses to understand the reasons for COVID-19 responses: social policies to crisis management as well as recovery, regime type (democracy or autocracy), formal political institutions (federalism, presidentialism), and state capacity (control over health care systems and public administration). A research agenda to address the COVID-19 pandemic that takes politics as a serious focus can enable the development of more realistic, sustainable interventions in policies and shape our broader understanding of the politics of public health.

How can a policy foster local pharmaceutical production and still protect public health? Lessons from the health-industry complex in Brazil.

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.

Evolution of HIV/AIDS response in Brazil: Policy innovations and challenges in the fourth decade of the epidemic.

Brazil was the first low- and middle-income country to provide universal treatment access to people living with the acquired immunodeficiency syndrome (AIDS), becoming a widely acclaimed model for best practice to managing this epidemic. However, we know little about important challenges to the key pillars of Brazil's response. This article discusses how the evolution of the country's health system institutions and international advancements in AIDS treatment and prevention affected the national response. Decentralization of health system resources and policy making brought fresh challenges to the centralized governance of the national AIDS program and to civil society, weakening their coordination and advocacy capacity. Regardless, AIDS treatment and prevention strategies in Brazil remain aligned with the current international protocols, but unfortunately have been restricted in some geographic areas and/or populations.

Promoting and regulating generic medicines: Brazil in comparative perspective.

Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution. Furthermore, this report examines how the diverse interests of public and private sector stakeholders might shape generic drug policy and its implementation. To illustrate the challenges and conflicts behind policy development and implementation, this report focuses on the case of Brazil.

Implementing Intellectual Property of Pharmaceuticals in Middle-Income Countries: A Case Study of Patent Regulation in Brazil.

The protection of pharmaceutical intellectual property (IP) rights is one of the most controversial debates in contemporary public health as countries have to balance incentives for drug development with the necessity of providing life-saving drugs. Compliance with IP protections is mandatory for members of the World Trade Organization (WTO). However, because of the costs associated with IP implementation we should expect late and/or poor implementation in middle-income countries. Surprisingly, this was not the case in Brazil. The country not only just fully implemented the WTO's requirement but declined the grace period granted for countries to adapt and included extra IP protections, going against a coalition of local industrialists and activists. Notwithstanding, as the consequences of IP regulations unfolds, Brazil also promoted new alliances that tailored and adjusted the regulations toward public health. We demonstrate that arguments of foreign pressure and lobbying are exaggerated and call attention to domestic shifts, long-term processes of regulatory decision, and political dynamics happening at the local level. By analyzing the case of Brazil, we provide a nuanced contribution to the discussion of IP implementation in middle-income countries and call attention to new models of government-society interactions in regulatory policy.

Federalism, the economic-industrial health care complex and high-cost pharmaceutical assistance in Brazil.

Brazil has a relevant, although relatively unknown, special medicines programme that distributes high-cost products, such as drugs needed for cancer treatments. In 2009, the purchase of these medicines became the responsibility of the Brazilian Federal Government. Until then, there were no clear norms regarding the responsibilities, in terms of the management/financing of these medicines, of the Brazilian Federal Government and of the states themselves. This qualitative study analyses the policy process needed to transfer this programme to the central government. The study examines the reports of the Tripartite Commission between 2000 and 2012, and in-depth interviews with eleven key informants were conducted. The study demonstrates that throughout the last decade, institutional changes have been made in regard to the federal management of these programmes (such as recentralisation of the purchasing of medicines). It concludes that these changes can be explained because of the efficiency of the coordinating mechanisms of the Federal Government. These findings reinforce the idea that the Ministry of Health is the main driver of public health policies, and it has opted for the recentralisation of activities as a result of the development project implicit in the agenda of the Industrial and Economic Heal.

AIDS treatment in Brazil: impacts and challenges.

Brazil has one of the developing world's largest, and arguably most successful, AIDS treatment programs. In this paper we review the treatment program, including controversial policies that Brazil has used to promote widespread local and global access to AIDS treatment. We also examine the lessons learned from this program and highlight the challenges Brazil faces, including the rising costs of AIDS treatment and changes in donors' funding priorities. Finally, we explore the relevance of Brazil's treatment program for other countries and its broad implications for global AIDS and health policy.