Reversal of the recommendations issued by the National Commission for the Incorporation of Technologies in SUS after Public Consultations

Abstract The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.摘要 本研究分析了公众咨询（Public Consultations, PC）的作用及其对国家技术纳入委员会（National Commission for the Incorporation of Technologies, CONITEC）决策建议的贡献。本研究为描述性回顾性研究，采用定性-定量结合的研究方法，使用2012年至2017年间公开可获取的二手数据。研究构建了数据库以表征药物类公众咨询项目及其相关贡献，借此识别出CONITEC初步建议与最终建议出现反转的案例。针对存在建议反转的案例，本研究对其相关贡献展开分析，以归纳论证维度与依据类型。在307项药物纳入申请中，共有205项经历了公众咨询，累计收到23894条公众意见。其中9%的公开公众咨询案例出现了建议反转，涉及15种药物，全部反转方向均为由不予纳入调整为予以纳入。主要论证维度集中于临床获益与轻度不良事件，公众提交的临床经验与意见占比最高。研究发现，通过开展公众咨询，巴西统一卫生系统（Sistema Único de Saúde, SUS）的技术纳入流程得到了优化提升，同时也清晰展现了决策者在制度场域中面临的挑战：即如何完善社会参与机制，以强化公共利益的实现。