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

Lara C Pereira; Daniela V R Sturzenegger; Juliana Ortiz; Nadia M E Ayad; Wilian A Cortopassi; Leandro P Safatle; Natalia Khuri

doi:10.1016/j.vhri.2019.07.006

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

Value Health Reg Issues. 2019 Dec:20:191-195. doi: 10.1016/j.vhri.2019.07.006. Epub 2019 Nov 13.

Authors

Lara C Pereira¹, Daniela V R Sturzenegger², Juliana Ortiz³, Nadia M E Ayad⁴, Wilian A Cortopassi⁵, Leandro P Safatle¹, Natalia Khuri⁶

Affiliations

¹ SCMED, Brazilian Health Regulatory Agency, Brasilia, Brazil.
² General Office for Regulation and Good Regulatory Practices, Brazilian Health Regulatory Agency, Brasilia, Brazil.
³ Pharmaceutical Market Regulation Chamber, Brasilia, Brazil.
⁴ Graduate Program in Bioengineering, University of California, Berkeley and University of California, San Francisco, CA, USA.
⁵ Department of Pharmaceutical Chemistry, University of California, San Francisco, CA, USA.
⁶ Department of Bioengineering, Stanford University, Stanford, CA, USA; Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, San Francisco, CA, USA. Electronic address: natalia.khuri@wfu.edu.

PMID: 31733406
DOI: 10.1016/j.vhri.2019.07.006

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.

Keywords: Brazil; drug pricing; judicialization of health.

MeSH terms

Brazil
Cost Control / legislation & jurisprudence*
Cost Control / methods
Delivery of Health Care / legislation & jurisprudence
Delivery of Health Care / organization & administration
Drug Costs / legislation & jurisprudence*
Government Regulation*
Humans
International Cooperation
Rare Diseases / drug therapy
Rare Diseases / economics