ANALYSIS OF THE IMPACT OF THE IMPLEMENTATION OF THE ACCELERATED HEALTH REGISTRY OF GENE THERAPIES IN COURT CASES IN BRAZIL Veronica Scriptore Freire e Almeida, Esther Dantas de Sá Paiva Gurjão, Rosa Maria Ferreiro Pinto

Abstract

This article will analyze the impact of the implementation of theaccelerated registration mechanism, known as fast track,adopted by the Brazilian Health Regulatory Agency (ANVISA) inrelation to gene therapies, in court cases in Brazil. Exploratoryresearch was used, with a quantum-qualitative approach andembedded methodological design, analyzing the characteristicsof the accelerated health registration regime and the currentsituation of the judicialization of health, through the collection ofbibliographic research, documents and case study, includingexamination of data produced by the Ministry of Health and theAttorney General’s Office (AGU). The research identified themisuse of the primary purpose of establishing fast track throughthe immediate litigation related to newly approved technologiesand the increase of convictions in individual lawsuits to imposeto the federal government the provision of such technologies inrecent years. The evidence obtained points to the need for policyand regulatory adjustments to safeguard greater fairness of thepublic health system and that collective access to newtechnologies is ensured when they are safe, meaningful inoutcomes and cost-effective.