A judicialização do direito à saúde: os novos parâmetros de concessão judicial dos medicamentos off-label após os temas 6 e 1234 do Supremo Tribunal Federal

Abstract

This paper examines the phenomenon of the judicialization of the health law in Brazil, with a particular focus on court-approved access to off-label medications, considering the positions adopted by regulatory agencies and courts, as well as the judicial precedents that have established the legal criteria for adjudicating such claims. The primary objective is to assess whether the foundational principles of Brazil’s Unified Health System (SUS) are being respected in light of Supreme Federal Court (STF) Themes 1.234 and 6, enacted at the end of 2024 and subsequently reinforced through Binding Precedents 60 and 61. Therefore, this study contextualizes the concept of off-label drugs and the regulatory process for pharmaceutical approval in Brazil. It also explores the historical development of the SUS and the application of its guiding principles within the jurisdictional framework. Additionally, it reviews the legal and technical standards previously used by judges in health-related cases, prior to the establishment of the new STF Themes. Ultimately, the study offers a critical evaluation of the requirements set forth by Themes 1,234 and 6, questioning their implications for the realization of the constitutional ideal of the Democratic Rule of Law. Conducted through a qualitative methodology, grounded in bibliographic and documentary research, the findings note that the STF’s newly imposed parameters exceed the reasonable rigor expected in healthcare-related litigation and disproportionately burden the most vulnerable party — the claimant. The study concludes that institutional coordination among the Judiciary, the pharmaceutical industry, and the Ministry of Health’s regulatory bodies is essential for the effective fulfillment of the right to health in Brazil.