Rare diseases in Brazil, the United States of America and the European Union: Comparative analysis of ethical, regulatory, public policy and judicialization aspects
Rare Diseases, Health Policy, Ethics,Research
Aiming to strengthen national public policies and improve access to treatment for patients with rare and ultra-rare diseases in Brazil, this project aims to describe and relate aspects related to ethical regulation in research with human beings, health regulation, and public policies in Brazil , the European Union and the United States of America on the issue of rare and ultra-rare diseases. In Brazil, the process of developing public policies aimed at the supply of medicines and other health services has advanced in recent years, considering specific strategies aimed at caring for people with rare and ultra-rare diseases. The choice of the European Union and the United States of America as references for comparison data for Brazil is justified by the fact that they are the main ones in the world when it comes to regulatory frameworks.