Governing High-Cost Health Technologies in a Universal Health System: Actors, Institutions, and Risk-Sharing in Brazil

Universal health systems face growing pressure to incorporate high-cost health technologies while preserving equity, fiscal sustainability, and public legitimacy. This paper examines the formal rules, institutional arrangements, and internal and external actors involved in the incorporation of high-cost health technologies in Brazil, focusing on how these elements shape decision-making processes and its outcomes. The Brazilian case offers a particularly relevant setting for comparative health politics: it is one of the largest universal health systems in the world, fully free at the point of care, covering more than 210 million people, and has a longstanding record of successfully incorporating and distributing high-cost medicines for major public health challenges, such as HIV/AIDS and viral hepatitis. The paper pursues two interrelated objectives. First, it provides a systematic, descriptive mapping of the formal procedures governing health technology assessment (HTA) in Brazil, as well as the key actors involved across different institutional arenas. These actors include not only national-level bodies – most notably CONITEC within the Ministry of Health – but also a broad and decentralized HTA community composed of state-level HTA units, technical advisory bodies, judicial actors, patient organizations, and industry stakeholders. Second, the paper uses this empirical mapping to test and refine an analytical framework focused on actors and institutional structures, inspired by Olga Löblová’s work on HTA epistemic communities in Europe, but adapted to the political, institutional, and territorial specificities of the Brazilian health system. To probe the framework in a context of heightened political and regulatory tension, the narrative analysis centers on the recent development of national risk-sharing agreements (RSAs) in Brazil. After more than a decade of debate, Brazil implemented its first national RSA in 2025. RSAs are treated here as “extreme cases” that make visible the interaction between innovation governance, regulatory politics, fiscal constraints, and competing forms of expertise. The paper examines how different actors mobilize evidence, technical knowledge, legal instruments, and political resources in the design of RSAs, and how existing institutional arrangements enable or constrain their involvement. Methodologically, the study draws on document analysis of laws, regulations, HTA reports, and policy guidelines, complemented by process tracing of the RSA policy trajectory with interviews with key stakeholders. By combining descriptive mapping with theory-informed analysis, the paper contributes to broader debates on the politics of health technology regulation, stakeholder engagement, and the governance of innovation in universal health systems. More broadly, it offers insights into how actor configurations and institutional design shape access to high-cost technologies. While empirically centered on Brazil, the paper is explicitly comparative in ambition. By adapting and testing an analytical framework originally developed in the European context, the study enables structured comparison across universal health systems that differ in institutional design, territorial organization, and market size. The Brazilian case allows for comparison with European systems regarding the role of epistemic communities, stakeholder engagement, and governance arrangements in health technology incorporation, while also highlighting how features such as federalism, judicialization, and large-scale public procurement shape distinct patterns of regulation and access to high-cost technologies.