Judicialização da saúde: critérios para concessão de medicamentos não incorporados pelo SUS na jurisprudência do Supremo Tribunal Federal

Abstract

This article aims to analyze the criteria defined in the case law of the Federal Supreme Court for the judicial granting of medicines not incorporated into the Unified Health System (SUS). This is a qualitative, bibliographic-documentary research with a deductive approach, based on the binding precedents established by the Federal Supreme Court, as well as an analysis of relevant legislation and doctrine. The results show that, in light of the issue of health judicialization, the Supreme Court has established technical and objective parameters. Through Themes 500, 1234, and 006, and Binding Precedents 60 and 61, the Court defined criteria such as proof of the nonexistence of a therapeutic substitute within the SUS, the patient's financial incapacity, and a prior administrative denial. These decisions have guided judges in lawsuits involving the provision of non-standardized medicines, registered or not with ANVISA. It is concluded that, by standardizing these criteria, the Supreme Court acted within its legitimate role as guardian of the Federal Constitution, harmonizing the fundamental right to health with the administrative and financial organization of the State. This promotes jurisdictional effectiveness without disrupting the functioning of the health system. Thus, the Court sought to ensure greater legal certainty by enabling more predictable and balanced judicial decisions, thereby protecting both the individual right to health and the collective interest.