O FORNECIMENTO DE MEDICAÇÕES PARA USO OFF LABEL PELO JUDICIÁRIO: UMA ANÁLISE DA JURISPRUDÊNCIA DOS TRIBUNAIS SUPERIORES BRASILEIROS

Abstract

The present study aims to analyze how the Brazilian judiciary, particularly its higher courts, deals with the provision of medications for off-label use, that is, for use in conditions not approved by ANVISA (Brazil's health regulatory agency), which is a common practice in the medical community and widely considered valid. This way, it aims to investigate the role of the judiciary in ensuring the right to health concerning the provision of off-label medication. To do so, it first constructs a theoretical framework regarding how the right to health is manifested in Brazil, which will serve as the basis for the main analysis of how the judiciary addresses this issue. Then, the study will examine key cases judged by the Superior Court of Justice (STJ) and the Supreme Federal Court (STF), as well as the legal provisions concerning the right to health, allowing the study of the evolution of the jurisprudence of the higher courts, which went through three distinct phases until reaching a consolidated and binding understanding to define the necessary requirements for the judiciary's role in consolidating the right to health, which includes a prohibition on the provision of medications for off-label use unauthorized by ANVISA. However, some cases are presented where the rationale behind this understanding is questioned due to legislative changes and even newer and conflicting interpretations by the courts themselves, seeking a balance between patient safety and the possibility of providing the best possible treatment.