The Politics of Strengthening Regulatory Capacity in Latin America: A Comparative Analysis of Pharmaceutical Regulation in Brazil and Colombia

• Grant number: 24/18622-2
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: May 01, 2025
• End date: February 28, 2029
• Field of knowledge: Applied Social Sciences - Administration - Public Administration
• Principal Investigator: Elize Massard da Fonseca
• Grantee: Vitória Lopes de Oliveira Silva
• Host Institution: Escola de Administração de Empresas de São Paulo (EAESP). Fundação Getúlio Vargas (FGV). São Paulo , SP, Brazil
• Associated research grant: 21/06202-0 - The politics of the health industry complex in times of change, AP.JP2

Abstract

The capacity of states to regulate medicines and vaccines is one of the most important functions of health systems, yet it remains under-researched in public administration literature. The World Health Organization (WHO) and its regional offices have been working to strengthen regulatory capacities in countries of the global South, where low institutional capacity can compromise safe access to medicines and vaccines. This study explores why and how two middle-income countries with similar challenges and contexts, such as Brazil and Colombia, have developed distinct regulatory capacities in the pharmaceutical sector, despite both being influenced by global guidelines like those of the WHO.The concept of regulatory capacity is grounded in the literature on organizational reputation and studies on the regulatory state and global regulatory convergence to investigate how international harmonization forums influence such capacities. Through a qualitative methodology of process tracing and a most similar systems design (MSSD) comparative approach, this doctoral research will analyze how the regulatory authorities of both countries have developed in terms of structure, autonomy, and reputation by examining the differences in the trajectories of pharmaceutical regulation and the influence of global governance.The study contributes to the emerging literature on the regulatory state in the Global South and the understanding of the political economy of the pharmaceutical sector. Additionally, it offers an analysis of the institutional conditions for strengthening regulation in contexts of unequal capacities.