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Promoting and regulating generic medicines: Brazil in comparative perspective

Massard da Fonseca, Elize and Shadlen, Kenneth C. ORCID: 0000-0003-4010-4835 (2017) Promoting and regulating generic medicines: Brazil in comparative perspective. Revista Panamericana de Salud Pública/Pan American Journal of Public Health, 41 (e5). pp. 1-6. ISSN 1020-4989

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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.

Item Type: Article
Official URL:
Additional Information: © 2017 The Authors
Divisions: International Development
Subjects: R Medicine > RA Public aspects of medicine
Date Deposited: 07 Mar 2016 11:32
Last Modified: 20 Oct 2021 00:32

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