Borrowing Regulatory Capacity in Middle-Income Countries during Public Health Crises: Brazil, Regulatory Reliance, and the Politics of COVD-19 Vaccine Regulation

Abstract

The COVID-19 pandemic underscored the critical role of states’ regulatory capacities. Countries had to authorize novel vaccine technologies in the context of scientific uncertainty and political pressure, issues particularly acute in middle-income countries (MICs) less familiar with the procedures needed to streamline regulatory processes during a crisis. How did regulatory agencies in countries still building their regulatory capacities expedite the authorization of new COVID-19 vaccines to combat the pandemic? How did they navigate political pressures to expedite vaccine approval while maintaining safety and efficacy standards? We explore these questions through the case of Brazil, which has one of Latin America’s most highly-regarded regulatory authorities, but was subject to acute political conflicts. In response to these tensions, the Brazilian National Health Surveillance Agency (Anvisa) leveraged “regulatory reliance” to expedite the authorization of COVID-19 vaccines. Regulatory reliance, the practice of relying on the decisions and procedures of external advanced regulatory agencies, allowed Anvisa to bolster its internal capacity and navigate domestic political challenges. This paper highlights the dual benefits of regulatory reliance: enhancing regulatory efficiency during crises and mitigating politicization pressures. The findings demonstrate that MICs can better respond to public health emergencies by integrating external expertise, thus contributing to global regulatory resilience. In addition, the implications extend to broader regulatory political economy discussions, suggesting that reliance mechanisms can fortify less mature regulatory systems and promote convergence even in the absence of global harmonization.