A efetivação do direito à saúde na judicialização de medicamentos através da medicina baseada em evidência.

Abstract

This monographic study focuses on the judicialization of healthcare as a means of securing access to medications not registered with Anvisa, through the framework of evidence-based medicine. The objective of this monograph is to analyze the enforcement of the right to health through litigation involving unregistered medications in Brazil. The central research question is as follows: Is it legally permissible to compel the State to provide a medication that lacks registration with Anvisa? To address this issue, the study adopts a hermeneutic research method, interpreting legal norms and principles, combined with an analysis of Brazilian case law concerning the judicialization of health. The research techniques employed include bibliographic and documentary analysis. It is concluded that judicial intervention must be limited to a review of legality and should not interfere with the substance of administrative decisions. The judicial granting of access to unregistered drugs is only permissible in cases of unreasonable delay by the regulatory agency in processing a registration request that has already been submitted in Brazil and not yet denied by Anvisa, the exception being made for orphan drugs intended for rare and ultra-rare diseases. Furthermore, the drug must be approved by a reputable foreign regulatory agency, and it must be demonstrated that there is no equally effective alternative medication legally available in Brazil, even if their levels of efficacy differ. Once these requirements are met, the State must facilitate the importation of the medication; however, it will only be obligated to bear the cost if the petitioner’s financial incapacity is proven. Jurisdiction over such cases rests with the Federal Government, as the matter concerns an unreasonable delay by a federal regulatory agency.