Policy change and the National Essential Medicines List development process in Brazil between 2000 and 2014 : has the Essential Medicine concept been abandoned?

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Osorio-de-Castro, Claudia Garcia Serpa and Botelho Azeredo, Thiago and Pepe, Vera Lúcia Edais and Cruz Lopes, Luciane and Yamauti, Sueli and Godman, Brian and Gustafsson, Lars L (2017) Policy change and the National Essential Medicines List development process in Brazil between 2000 and 2014 : has the Essential Medicine concept been abandoned? Basic and Clinical Pharmacology and Toxicology. ISSN 1742-7835 (https://doi.org/10.1111/bcpt.12932)

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Abstract

Brazil has had a National Essential Medicines List (EML) since 1964. From 2000 to 2010, five consecutive evidence-based editions were produced, building on the essential medicines concept. In 2012, the government changed course to establish a new paradigm, introducing adoption of new medicines as the main aim within the recommendation process. The objective of the paper is to report efforts to develop Brazil´s national EML, policy changes from 2000 to 2014, discussing results, challenges, and perspectives. Brazilian EML history and development process were collected from legislation, minutes, reports and legal ordinances, from 2000 to 2014. The Brazilian EML and the WHO Model lists were compared using the Anatomical Therapeutic Chemical system. Overlap between lists was verified and linear trends were produced. Type of membership, inclusion criteria, procedures, flow and listed medicines varied greatly between the selection committees acting before and after 2012. Paradigm-changing legislation aiming at linking list compliance to public financing in 2012 produced (i) greater importance given to political and administrative stakeholders, (ii) increasing trends in number of medicines over the years, (iii) decrease in use of WHO Model List as a reference, (iv) substitution of an essential medicines list review and update process by an adoption decision output. Other issues remained unchanged. Insufficient efforts for list implementation, such as lack of physician education, presented consequences to the health system. Substantial efforts were made to produce and update the list from 2000 to 2014. However, continuous and intense health litigation disproves process outcome effectiveness.

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