Scientific consensus in the face of court decisions on the granting of medicines not incorporated into the SUS

Abstract

The right to health is one of the most sought-after rights in the courts, particularly the granting of medications not included in the SUS (Brazilian Unified Health System). As a result, there is legal instability, as judges do not always have the parameters to resolve such issues. On the other hand, social, technological, and informational advances make people increasingly aware. With more information, they make demands on the State, requiring positive action from political and legal representatives. In this context, the Supreme Federal Court (STF) established parameters for the granting of medications and therapies not included in the SUS (Brazilian Unified Health System). It was decided that granting of medications and therapies will be subject to high-level scientific evidence: randomized clinical trials, systematic reviews, or meta-analysis. Thus, it is understood that the STF established a standard of proof by establishing the types of evidence that are appropriate for granting the right. The objective of this paper is to analyze the scientific studies required by the Supreme Federal Court (STF) in the context of rare diseases and to question whether the requirement for high-level scientific evidence by the applicant is reasonable. The method used was a qualitative approach, through a literature review of national and international legal, medical literature, and an analysis of the binding precedent of the Supreme Federal Court (STF) and its impact on decisions regarding treatment in rare diseases. This approach is necessary because judges are rarely aware of the production of this scientific evidence and the reasonableness of requiring it in all cases. Finally, the aim is to shed light on the danger of a standard of proof becoming a tariff-based proof.