Accelerated assessment of orphan drugs by the European Medicines Agency and its impact on the judicialization of health in Brazil: analysis of the specific case “Upstaza” Rosa Maria Ferreiro Pinto, Esther Dantas de Sá Paiva Gurjão

Abstract

ontextualization: in a scenario of budgetary difficulties and increased expenses resulting from the judicialization of health, drugs not registered with ANVISA have been requested in lawsuits, based on accelerated registration granted by regulatory agencies abroad, as is the case of eladocagene exuparvovec (Upstaza), which received accelerated registration by the European Medicines Agency, whose value is approximately R$20,000.00.00 (twenty million reais). Problem: the existence of lawsuits in which the granting of drugs is requested based on registration granted by regulatory agencies abroad, without such drugs having authorization from the National Health Surveillance Agency, the national body responsible for granting health registration in Brazil. Objective: to analyze the possible effects of the granting of accelerated registration of drugs by regulatory agencies abroad on the judicialization of health and how such effects can affect the equity of access to public health by the general population. Method: Exploratory research, with a qualitative approach, with analysis of bibliographic and documentary collection. Results: Three court decisions were identified, issued after the granting of accelerated registration by the European Medicines Agency, which ordered the supply of eladocagene exuparvovec (Upstaza), with a total value of approximately R$60,000,000.00 (sixty million reais). Conclusions: the granting of accelerated registration of a drug by agencies abroad has the potential to impact the judicialization of health in the country, with repercussions that may affect equity in access to health due to the allocation of tens of millions of reais to serve only the authors of the respective actions.