Reforming pharmaceutical regulation: a case study of generic drugs in Brazil

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. As part of these reforms, the Generic Drug Act was introduced in 1999. This policy mandates that pharmaceutical products that are no longer protected by a patent must be interchangeable with an innovator (reference) drug. This thesis examines how and why Brazil promoted this large-scale regulatory policy. The literature on pharmaceutical policy often invokes international guidelines that inspire countries to reformulate their regulatory regimes or argues that regulations emerge in order to serve the interests of powerful interest groups. In contrast, this thesis examines how changes in the regulatory environment affect actors’ policy preferences. It argues that as actors adapt and respond to new regulatory environments, they also push the policy path further along the way. This historical qualitative case study relies on in-depth interviews and documentary research to trace the policy process of generic drug regulation in Brazil. It finds that Brazil’s generic drug reform can be attributed to a convergence of the evolution of pharmaceutical regulation, unexpected events (AIDS epidemic and scandal of fake medicines) and political activity of the Minister of Health. In turn, this study demonstrates that the new regulatory development altered the preferences of local pharmaceutical firms, who now support and uphold a policy they once opposed because of the high costs associated with adapting their industrial plants and processes. The regulation of generic drugs has also culminated in other unintended consequences. Public pharmaceutical factories were still unable to fully adjust to the new regulatory environment and patient groups slowly became aware of these limitations. Paradoxically, the generic drug regulation introduced in the name of patients and opposed by local pharmaceutical firms, is today opposed by important patient advocacy groups but solidified by the strong support of local and multinational pharmaceutical firms. These findings suggest although pharmaceutical firms strongly support the generic drug regulation today; they did not control the policy process that created it. Although Brazil’s norms resemble international guidelines, they were developed locally. Brazil’s case demonstrates that evolution of domestic political institutions were the most important determinant of the timing and direction of the regulatory policy. Thus, this thesis concludes that the state still matters for pharmaceutical regulation and that pharmaceutical regulation is only partially influenced by non-state actors

How political conflicts and a lack of coordination hampered Brazil’s vaccine rollout

Rows between Brazilian leaders slowed down Brazil’s vaccination programme, but the regulatory process and lengthy negotiations over technology transfers also played a part. Elize Massard da Fonseca and Ken Shadlen (LSE) look at the lessons for other middle-income countries

Promoting and regulating generic medicines: Brazil in comparative perspective

Generic drug substitution may constitute a core instrument of countries’ National Pharmaceutical Policies, a way to reduce the price of drugs while expanding access to health care. Despite the potential importance of policy in this area and observed differences in national practices, scholars embarking on comparative analysis lack a roadmap of which dimensions of generic drug policy to assess and compare. We consider countries’ rules and regulations across four dimensions: (1) the demonstration of therapeutic equivalence, (2) pharmaceutical packaging and labelling, (3) drug prescription, and (4) drug substitution. We maintain that to be able to understand and compare national approaches toward generic drug promotion, it is crucial to carefully distinguish among these four dimensions. Furthermore, we suggest that analysis must also consider how the diverse interests of actors in public and private sectors shape the design and implementation of generic drugs policies. To illustrate both the dimensions of policy and the conflicts around generics policies, we focus on the case of Brazil

Reforming pharmaceutical regulation: a case study of generic drugs in Brazil

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. As part of these reforms, the Generic Drug Act was introduced in 1999. This policy mandates that pharmaceutical products that are no longer protected by a patent must be interchangeable with an innovator (reference) drug. This thesis examines how and why Brazil promoted this large-scale regulatory policy. The literature on pharmaceutical policy often invokes international guidelines that inspire countries to reformulate their regulatory regimes or argues that regulations emerge in order to serve the interests of powerful interest groups. In contrast, this thesis examines how changes in the regulatory environment affect actors’ policy preferences. It argues that as actors adapt and respond to new regulatory environments, they also push the policy path further along the way. This historical qualitative case study relies on in-depth interviews and documentary research to trace the policy process of generic drug regulation in Brazil. It finds that Brazil’s generic drug reform can be attributed to a convergence of the evolution of pharmaceutical regulation, unexpected events (AIDS epidemic and scandal of fake medicines) and political activity of the Minister of Health. In turn, this study demonstrates that the new regulatory development altered the preferences of local pharmaceutical firms, who now support and uphold a policy they once opposed because of the high costs associated with adapting their industrial plants and processes. The regulation of generic drugs has also culminated in other unintended consequences. Public pharmaceutical factories were still unable to fully adjust to the new regulatory environment and patient groups slowly became aware of these limitations. Paradoxically, the generic drug regulation introduced in the name of patients and opposed by local pharmaceutical firms, is today opposed by important patient advocacy groups but solidified by the strong support of local and multinational pharmaceutical firms. These findings suggest although pharmaceutical firms strongly support the generic drug regulation today; they did not control the policy process that created it. Although Brazil’s norms resemble international guidelines, they were developed locally. Brazil’s case demonstrates that evolution of domestic political institutions were the most important determinant of the timing and direction of the regulatory policy. Thus, this thesis concludes that the state still matters for pharmaceutical regulation and that pharmaceutical regulation is only partially influenced by non-state actors

Integrating science, technology and health policies in Brazil: incremental change and public health professionals as reform agents

Brazil has encouraged an ambitious set of policies toward the pharmaceutical industry, aiming to foster technological development while meeting health requirements. We characterize these efforts, labeled the “Health-Industry Complex” (Complexo Industrial da Saúde, 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 Healths’s new focus on science, technology, and health, with industrial policy measures aimed toward private firms. We contrast this depiction of these policy changes with a conventional view that relies on partisan orientation of the Executiv

Vaccine technology transfer in a global health crisis: actors, capabilities, and institutions

The COVID-19 pandemic, which featured international pharmaceutical firms seeking to build global manufacturing networks to scale-up the supply of vaccines, has generated heightened interest in understanding the role of firm-to-firm technology transfer. While considerable attention has been given to tracking the extent of international vaccine technology transfer, we know little about how partnerships were established and work in practice. Understanding the challenges that such projects face, and how such challenges may be overcome, is crucially important. This paper provides an account of the partnership between the British-Swedish multinational pharmaceutical company AstraZeneca, the vaccine developer that has engaged in the most technology transfer and built the widest global manufacturing network, and Bio-Manguinhos, a public laboratory linked to Brazil’s Ministry of Health. The case study demonstrates the importance of capabilities and regulatory flexibility. Moreover, the analysis highlights the role of political factors that affect the process of technology transfer, and innovation more broadly. Because of the risks involved and the need to quickly mobilize existing capabilities and build new ones, as well as the imperatives of coordinating among manufacturing and regulatory processes and allocating resources to make such arrangements feasible, technology transfer projects need to be enabled politically. Looking forward, the case study has implications for initiatives to expand technology transfer for broadened production of vaccines in the Global South

Brazilian response to the epidemic of HIV / AIDS among injecting drug users, 1995-2007: milestones, progress and challenges

Made available in DSpace on 2012-09-05T18:24:04Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 323.pdf: 935373 bytes, checksum: debce1f2d9d2dbd1773cdbec7ad77c79 (MD5) Previous issue date: 2008Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.O Programa Brasileiro de AIDS é internacionalmente reconhecido pela adoção de políticaspúblicas controversas e bem sucedidas para conter o avanço da epidemia de AIDS no país. A integração de ações de tratamento e prevenção resultaram na redução da mortalidade, morbidade, hospitalizações, e aumento da expectativa de vida das pessoas vivendo com HIV/AIDS no Brasil. Iniciativas de prevenção à AIDS entre usuários de drogas injetáveis (UDI) compreendem, entre outras, a troca de seringas usadas por novas com o propósito de retirar de circulação seringas potencialmente contaminadas pelo HIV (vírus da AIDS). A presente tese de doutorado buscou analisar os marcos, avanços e desafios da resposta brasileira referentes à prevenção do HIV/AIDS entre UDI ao longo dos últimos 12 anos. Procurou-se analisar as principais inter - relações entre as políticas anti-drogas no nível supranacional e doméstico, bem como as alterações nas políticas públicas de prevenção à AIDS entre UDI no Brasil, nesse período. Essa pesquisa realizou uma análise da experiência brasileira no combate à epidemia de AIDS entre UDI. O método utilizado foi o rastreador de processo análise histórica com vista aexplorar a cadeia de eventos envolvidos na formulação e implementação das políticas de prevenção ao HIV / AIDS entre UDI no Brasil, no período 1995-2007. Esse corte temporal baseou-se no fato de que esses projetos foram efetivamente implementados no país a partir de 1995. As informações foram coletadas através de bases de dados secundárias, provenientes do Programa Nacional de DST AIDS, e de pesquisa documental. A tentativa de implementação dos projetos de prevenção a AIDS entre UDI no Brasil se deu no âmbito local, mas foi somente com os recursos do acordo de empréstimo com o Banco Mundial ao Programa Nacional de AIDS que esses programas ganharam impulso e âmbito propriamente nacional. Os pilares da resposta brasileira para prevenir a epidemia de AIDS entre UDI foram: 1) os recursos do Banco Mundial, que enfatizava a adoção de medidas de prevenção com essa população, como estratégia custo-efetiva de combater a epidemia de AIDS em países em desenvolvimento; 2) o caráter centralizador, verticalizado e o poder indutor de políticas do Programa Nacional de AIDS que priorizou essas ações pragmáticas de saúde pública e; 3) a implementação dos projetos através de organizações da sociedade civil. É evidente que nesses últimos 12 anos houve mudanças no posicionamento do governo brasileiro - tanto executivo quanto legislativo - em prol de uma política de drogas menos repressora em nível nacional e supranacional; um realinhamento das ações de prevenção a AIDS entre UDI para o âmbito do próprio sistema de saúde; e o fortalecimento de uma coalizão de interesses em prol dessas políticas públicas no Brasil. Os estudos epidemiológicos do HIV/AIDS em UDI no Brasil evidenciam uma redução expressiva da epidemia nessa população, na maioria das regiões brasileiras. Porém é difícil afirmar qual o papel específico dos projetos de prevenção a AIDS no controle da epidemia nessa população, uma vez que, praticamente, não foram realizadas ações de monitoramento e avaliação destes projetos. Os principais desafios às ações de prevenção a AIDS entre UDI atualmente são: a transferência da responsabilidade por financiar e implementar esses projetos para os estados e municípios; a inserção dessas ações no âmbito das ações regulares do Sistema Único de Saúde e; a ausência de uma política de monitoramento e avaliação destes projeto