The Politics of Pharmaceutical Policy Reform

A Study of Generic Drug Regulation in Brazil

verfasst von: Elize Massard da Fonseca

Verlag: Springer International Publishing

Buchreihe : SpringerBriefs in Political Science

Enthalten in: Springer Professional "Wirtschaft+Technik" , Springer Professional "Wirtschaft"

Einloggen, um Zugang zu erhalten

Über dieses Buch

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. This book innovates by analysing the generic drug reform in Brazil, demonstrating that pharmaceutical regulation is only partially influenced by non-state actors. Little is known about the institutional antecedents and policy process that channeled this regulatory reform. This is particularly intriguing because a regulatory shift in the pharmaceutical sector requires the participation of a number of stakeholders and interest groups in the policy process. Fonseca examines the generic drug reform’s causes and consequences. No study has approached the generic drug regulation in Brazil from this perspective.

The Politics of Pharmaceutical Policy Reform: A Study of Generic Drug Regulation in Brazil, explores the following:

· The politics of pharmaceutical regulation in Brazil over the last 25 years.

· The political negotiations to approve the Generic Drug Act, which involved a hard-to-reach agreement between the pharmaceutical industry (national and multinational), the Ministry of Health, and Congress

· The controversial decisions to regulate packaging and pharmaceutical equivalence.

· The surprising success of Brazilian pharmaceutical firms, which became market champions in a sector largely dominated by multinational firms.

· Comparative lessons from the Brazilian case for the political construction of regulatory standards to regulate generic drugs and its effects on global health.

This book will interest political scientists and health policy scholars concerned with the political conflicts in the pharmaceutical sector. It argues against well-established approaches to regulatory capture such as control of the regulatory process by interest groups and policy diffusion. It can be used as evidence for graduate courses in public policy, health policy and political science. Because Brazil is one of the largest markets for pharmaceuticals in the world, business leaders and consultancy firms would also be interested.

Inhaltsverzeichnis

Frontmatter

1. Introduction

Abstract

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 Brazilian Congress, with the support of the Ministry of Health (MoH), approved the Generic Drug Act in 1999. A generic drug is a pharmaceutical product that is no longer protected by a patent, and is interchangeable with an innovator drug. A generic drug policy is an intervention to foster market competition, which would prompt price declines and increase access to safe and affordable medicines. In Brazil, pharmacies are the main channel for dispensing medicines to the population and over 80 % of drug expenses are paid for by patients themselves, resulting in pricing being a core determinant of access to medicines. Studies suggest that generic drugs enter the market with an average price of 40 % lower than its patent version, and this difference has increased over time, making medicines more affordable to the Brazilian population and governmental programmes.

Elize Massard da Fonseca

2. Contextualising Drug Regulation

Abstract

This chapter aims to provide a critical analysis of the literature on policy studies on generic drug regulation and contextualise the Brazilian case. Very few studies of the political process to implement generic drug regulation were identified. This type of study is particularly important in clarifying how the drug policy is discussed, approved and implemented. Because of the limited supporting literature, this section expands the scope of the review to explore broad studies on the regulatory process of the pharmaceutical sector. The last part of this chapter focuses on contextualising the case of Brazil. The country has one of the most stringent regulatory regimes for generic drugs in Latin America and has promoted significant reforms in its pharmaceutical regulation. This section provides background information about this reform by revising previous studies on this topic and identifying avenues for investigation.

Elize Massard da Fonseca

3. The Generic Drug Reform in Brazil

Abstract

This chapter traces the period of the generic drug reform in Brazil and its institutional antecedents. The first part provides background information about the local production of medicines to contextualise the pharmaceutical sector in Brazil. The second part assesses the three antecedent events to the Generic Drug Act that happened together in the 1990s: the initial attempts to introduce a generic drug regulation, the enactment of an intellectual property law, and the HIV/AIDS epidemic. Tracing these events helps in identifying the circumstances that led to this regulatory reform, the participants of the pharmaceutical sector, their preferences and demands. The third part deals with the critical period of generic drug reform between 1999 and 2002. It presents the contingent events that led up to the crisis in the pharmaceutical sector and thus triggering this regulatory transformation, and the political entrepreneurship of the minister of health, who used the opportunity to implement his ambitious regulatory agenda. This third section is divided into two parts for clarity purposes. First, it deals with the parliamentary bargain to enact the Generic Drug Act in 1999 and, second, assesses the Ministry of Health and the Health Surveillance Agency efforts to put this legislation into practice.

Elize Massard da Fonseca

4. Assessing the Generic Drug Regulatory Process in the 2000s: Governmental Intervention, Market Demand and Local Pharmaceutical Industries

Abstract

This chapter explores the development of the generic drug policy. We know that generic drug regulation persisted even after Serra left the government, but we know less about how this happened. In what ways has the generic drug regulation influenced the governance of the pharmaceutical sector in Brazil? The first part presents the economic outcomes of this regulatory policy, reviewing the vitality of generic drugs in the pharmaceutical sector. The second part assesses how government advocacy for generic evolved after the Serra administration and the market demands for generic drugs. Governments have been less politically active on this matter, and there is controversial and conflicting information about how health professionals and the population received these products. The third part of this chapter discusses the role of suppliers. Private local pharmaceutical producers have been leading the rank of the generic drug sector. Particularly puzzling is that, as demonstrated in the previous chapter, local pharmaceutical producers repealed this government intervention in their business. This chapter concludes by summarising how the new institutional context empowered local pharmaceutical producers and the structure of the interest group in this sector in Brazil.

Elize Massard da Fonseca

5. Public Production of Medicines and HIV/AIDS Activists: New Actors in the Generic Drug Regulatory Process

Abstract

This chapter turns now to assess the stakeholders that question the current architecture of the pharmaceutical regulation in Brazil. There is an increasing apprehension among AIDS activists about the stringency of Brazil’s regulation for generic medicines, citing that these rules might limit competition and undermine access to medicines. Similarly, public pharmaceutical factories have voiced their struggle to adapt to this norm for different reasons and questioned the necessity of such strict regulation. The first section analyses the effects of generic drug regulation on the public production of medicines. This also serves as background information to the following section that assesses AIDS activists’ preferences and demands.

Elize Massard da Fonseca

Backmatter

Titel: The Politics of Pharmaceutical Policy Reform
verfasst von: Elize Massard da Fonseca
Verlag: Springer International Publishing
Electronic ISBN: 978-3-319-12565-7
Print ISBN: 978-3-319-12564-0
DOI: https://doi.org/10.1007/978-3-319-12565-7