Participação social na incorporação de medicamentos no Sistema Único de Saúde (SUS): uma análise documental

Abstract

Public consultations function as a means of obtaining the social perspective on a given topic, serving as a basis for decision making related to the incorporation of health technologies into the Brazilian National Health System (SUS). Thus, the objective of this study is to understand the importance of social opinion in the process of incorporating medications through the analysis of these consultations. The work is a documentary research, encompassing data from 2012 to 2019, of various documents found in the electronic portal of the National Commission for the Incorporation of Technologies of the Unified Health System (CONITEC), especially the Recommendation Reports and the Contributions of the Public Consultations. These documents did not receive any previous analytical treatment or were prepared with data that could still be reorganized. The chi-square test and Fisher's exact test were used in the data analysis. Thus, the study evaluated the incorporation of 286 drugs (227 proposals), of which the government (46.18%) and the pharmaceutical industry (44.73%) were the main applicants. Of the proposals, 14.10% had their initial recommendation changed after the demand was submitted to public consultation. These proposals accounted for 30,360 contributions received, 96.64% of which were sent by individuals. Analyzing the arguments considered for changing the recommendation, it was found that, in most cases, the reasons were related to the analysis of the budget impact resulting from the inclusion of the drug in SUS. There was an association (p<0.0001) between the number of contributions and the change in CONITEC's recommendation. For cases with up to 100 contributions, there was a high frequency of CONITEC recommendation maintenance (95.08%). In cases with more than 1000 contributions, the change in these recommendations, after public consultation, happened in a more balanced way, with 42.31% of cases with modification and 57.69% of cases with maintenance. Thus, it is evident the importance of public consultations not only as a gain of transparency for decisions involving Health Technology Assessment (HTA) studies but also in obtaining elements for better substantiation of the decisions of CONITEC and the manager in the process of incorporating technologies into SUS.