Authorization for use of medicines with forbidden principles in Brazil

Abstract

The study aims to analyze the possibility of obtaining authorization for use of drugs that have as active principle banned substances in Brazil. Through a methodology of research in interdisciplinary bibliographic material, legislation and judgments, this study covers from the historical evolution of medicinal use of forbidden substances to even a concrete proposal for use of those drugs, despite of the actual prohibition with criminal reprimand. We begin to revisit such prohibitions of substrates and recognize the possibility of using new drugs, as occurred with cannabidiol: this substance previously prohibited, has already been removed from that list, and it was also created an administrative procedure for its importation trough analysis by the National Sanitary Surveillance Agency (ANVISA). Thus, it's necessary to analyze the concession of these drugs by administrative way, legislative and also judicial approach. It's also necessary to analyze the criteria proposal made for judgement of the General Repercussion Thesis n. 500, for medicines without ANVISA's registration. The granting of authorization must comply proof of need for treatment and the confirmation of drug effectiveness, aiming to consolidate the fundamental right to health and life from a non-traditional perspective, for patients who need these drugs with forbidden active principles in Brazil.