Universidade de São Paulo. Faculdade de Medicina. Programa de Pós-Graduação em Saúde Coletiva. São Paulo, SP, Brasil.
Universidade de São Paulo. Faculdade de Medicina. Departamento de Medicina Preventiva. São Paulo, SP, Brasil.
Rev Saude Publica. 2020 Dec 11;54:136. doi: 10.11606/s1518-8787.2020054002453. eCollection 2020.
The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil.
This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions.
The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received.
There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.
本研究旨在对巴西卫生监管机构（Anvisa）、国家卫生技术整合委员会（Conitec）和国家补充健康机构（ANS）中患者和公众参与（PPI）的过程进行描述和讨论。
这是一项探索性、描述性和比较性研究，通过分析这三个机构的公共文件和法规进行研究。
PPI 的机制包括公众咨询、公开听证、参与咨询委员会和卫生技术评估请求。Anvisa 在 1999 年至 2018 年期间进行了 187 次公众咨询，共收到 10699 条意见。共有 76 次（41%）公众咨询未提供有关收到意见的信息。Conitec 在 2011 年至 2018 年期间进行了 234 次公众咨询，共收到 53174 条意见。发现有 70 项（23%）Conitec 的建议未经过公众咨询，26 项（8%）建议在公众咨询后发生了变化。建议的变化似乎尤其发生在公众咨询过程中收到更多意见的情况下。ANS 在 2000 年至 2018 年期间就健康保险涵盖的健康程序和事件清单进行了八次公众咨询，共收到 31498 条意见。对于三次公众咨询，没有收到意见数量的信息。
巴西在高度技术性的决策过程中存在监管进展和机构活动，支持 PPI，但在分析的机构之间存在异质性。PPI 影响卫生技术审议过程的力量仍需要深入研究，包括利益相关者的特征和决策的合法性。
