THE JUDICIALIZATION OF HEALTHCARE AFTER THE BRAZILIAN SUPREME FEDERAL COURT’S THEME 6 RULING: AN ANALYSIS OF THE CRITERIA FOR PROVIDING MEDICINES NOT INCORPORATED INTO THE SUS

UMA ANÁLISE DOS CRITÉRIOS PARA O FORNECIMENTO DE MEDICAMENTOS NÃO INCORPORADOS AO SUS

Abstract

This article examines the legal implications of the Brazilian Supreme Federal Court’s Theme 6 ruling for the court-ordered provision of medicines registered with the Brazilian Health Regulatory Agency (Anvisa) but not incorporated into the Brazilian Unified Health System (SUS). It examines the ruling’s rationale and its evidentiary, substantive, and institutional restrictions in comparison with the Superior Court of Justice’s Theme 106 ruling. The study adopts a qualitative approach and deductive reasoning, drawing on bibliographic and documentary research and a narrative literature review. It identifies stricter requirements for scientific evidence and limits on judicial review of administrative action, while recognizing that judges retain their powers to order the production of evidence. It concludes that access to scientific information and technical support may help establish compliance with the requirements but cannot compensate for the absence of the required evidence. Effective judicial protection depends on individualized, reasoned assessments of claims within the ruling’s parameters. The conclusions identify potential barriers to access to healthcare and justice without measuring their frequency or severity.