Challenges in the Regulation of High-Cost Treatments—An Overview From Brazil

Abstract Regulation of drug prices that ensures adequate access to effective treatments and promotes innovation is a global challenge. In the United States, the government does not regulate drug prices when they come onto market. On the other hand, in countries such as France and Brazil, government agencies are responsible for setting up price limits by leveraging the interests of the companies and the countries’ population. In Brazil, safety and efficacy of drugs are regulated by the Brazilian Health Regulatory Agency, and drug prices are regulated by the Pharmaceutical Market Regulation Chamber with a participation of Brazilian Health Regulatory Agency. Here, we introduce the current challenges faced by the Brazilian government in the drug price regulation and present proposed initiatives aiming to streamline access to innovative treatments for its citizens.