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The regulation and adoption of health technologies under Brazil’s Unified Health System: barriers to access to medicines for diseases of poverty?

Abstract

The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil’s Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil’s National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health’s Legislation System). The 2014 version of the Brazilian National List of Essential Medicines (RENAME, acronym in Portuguese) contained 132 medicines for diseases of poverty. Over one-third of these (49) had only one national producer, while 24 were not registered in the country. The number of medicines contained in the RENAME dedicated to this group of diseases increased by 46% between 2006 and 2014. Despite advances in the regulation and incorporation of technologies by the SUS, given the lack of market interest and neglect of diseases of poverty, the government has a vital role to play in ensuring access to the best available therapies in order to reduce health inequalities. It therefore follows that Brazil needs to improve the regulation of medicines that do not attract market interest.

Pharmaceutical care; Neglected diseases; Product registration; Pharmaceutical preparations; Unified Health System

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