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Promoting and regulating generic medicines in Latin America

Grant number: 17/50120-3
Support type:Regular Research Grants
Duration: October 01, 2017 - October 31, 2018
Field of knowledge:Applied Social Sciences - Administration
Cooperation agreement: London School of Economics and Political Science - LSE
Mobility Program: SPRINT - Projetos de pesquisa - Mobilidade
Principal Investigator:Elize Massard da Fonseca
Grantee:Elize Massard da Fonseca
Principal investigator abroad: Kenneth Shadlen
Institution abroad: University of London, England
Home Institution: Instituto de Ensino e Pesquisa (Insper). São Paulo , SP, Brazil
Associated research grant:15/18604-5 - Policies to increase the competitiveness of the pharmaceutical sector: Brazil's experience, AP.JP

Abstract

This proposal aims at strengthening a four-year collaboration between Shadlen and Fonseca on studies related to regulation of pharmaceutical industries. This grant will allow us to fine-tune a typology for comparing national approaches toward the regulation of generic drugs, and to map out a research strategy for applying this typology in the Latin American. 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. Yet despite the widely acknowledged 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/compare. We aim to fill that gap. Our typology considers 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 and in a recent publication (Fonseca and Shadlen 2017), we apply the typology to the case of Brazil. This exchange grant would allow us to: (I) advance our joint research project to further develop this typology and apply it to other countries; (II) map other countries systems based on the typology; (III) identify a network of collaborators; (IV) apply for additional. (AU)