The Governance and Politics of Pharmaceutical Regulation

• Grant number: 24/00811-3
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• Start date: July 01, 2024
• End date: June 30, 2026
• Field of knowledge: Applied Social Sciences - Administration - Public Administration
• Principal Investigator: Elize Massard da Fonseca
• Grantee: María Alejandra Costa
• 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
• Associated scholarship(s): 25/12985-9 - Strategic Communication of Health Regulatory Agencies in Latin America on Twitter during the COVID-19 Vaccination Campaign: Responding, Remaining Silent, or Aligning?, BE.EP.PD

Abstract

This research has two objectives: (1) Analyze the governance and politics of drug regulation in Argentina, aiming to draw lessons for Brazil and Latin America. This involves a comprehensive examination of the myriad factors that influence decision-making processes within the sphere of drug regulation. Concretely, my research will scrutinize state bureaucracies and the organizational structures of governmental health agencies, encompassing their relationships with both local and international entities. (2) Investigate the regulatory landscape governing COVID-19 vaccines in Latin America. This will be conducted in partnership with Prof. Fonseca during the project's first year. This undertaking will encompass an exhaustive exploration of the dynamics, challenges, and principal stakeholders involved in the regulation of vaccines, particularly against the backdrop of the ongoing COVID-19 pandemic. This research endeavor is motivated by the need to discern the network and capacities of the state actors involved in the regulation process, thereby shedding light on the factors contributing to variations in regulatory timelines across countries. This investigation is aimed at revealing the complexities of governmental network structures and resource mobilization within the process of pharmaceutical regulation by state actors. A country's fundamental capacity to organize its bureaucracy and allocate societal resources significantly influences the timing and structure of government responses to health policies reforms (Yen et al., 2022). The central premise of this proposition is based on the idea that middle-income countries often encounter limitations in terms of resources and capabilities when it comes to regulating health policies (Fonseca et al., 2021). Consequently, gaining a comprehensive understanding of how resources are mobilized and capacities are utilized will be vital in comprehending the evolution of preferences and capabilities among the actors involved in the regulatory process, both over time and across different countries. Furthermore, grasping the concept of state capacity becomes crucial as it serves as a key factor that explains a state's resources in addressing wicked policy challenges, such as reforms in public health (Christensen et al., 2016; Greer et al., 2020; Head & Alford, 2013).