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Legal actions and incorporation of medicines into SUS: the performance of Conitec

ABSTRACT

This study was aimed at analyzing the influence of lawsuits on the process of evaluating requests for the incorporation of biological medicines into the Unified Health System (SUS), by the National Committee for Health Technology Incorporation in SUS (Conitec), from 2010 to 2015. The research investigated the performance of Conitec focusing on the analysis of the recommendation of incorporation or not of biological medicines to SUS. The following were used as data collection strategies: document analysis, interviews with members of the Committee, and non-participant observation of the plenary meetings. The data analysis has shown that, although the lawsuits were often part of the plenary discussions, the existence of legal actions is not a decisive factor for the Committee’s decision-making. No evidence of a direct relationship between health lawsuits and the incorporation of biological medicines into SUS was found, as members strictly follow the technology incorporation flow as established by the Law No. 12.401/2011 and by Decree No. 7.646/201. However, the existence of an indirect influence of the phenomenon of health judicialization on the process of incorporation of technologies in SUS became evident when the motivations for the formulation of the law and the rules that regulate the operation of Conitec were analyzed.

KEY WORDS:
Biological products; Health’s judicialization; Unified Health System

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