OBJECTIVE: To describe the current process of social participation in the incorporation of health technologies in Brazil, within the context of the Unified Health System (SUS). METHODS: A descriptive study was conducted based on the analysis of official records of the actions of the National Committee for Health Technology Incorporation into Unified Health System and its website, from the beginning of its activities in January 2012 until December 2017. RESULTS: The findings indicate that, in Brazil, there are legal instruments related to social participation in health, including the health technology assessment (HTA) field. However, its implementation is relatively recent and has been carried out gradually. In addition to the legal instruments (National Health Council representative, public consultation and public hearing forecast), other information and transparency strategies have been shown to be allied to social participation in the incorporation of health technologies. However, activities such as legally provided public hearings have not yet been carried out. CONCLUSIONS: Several actions to foster social participation were developed over the analyzed period, but they need to be evaluated in order to maintain or improve them. In addition, there is a need for more qualified social participation in the various existing spaces, including those prescribed by law.

Background Patient and public involvement (PPI) in the Brazilian Health Technology Assessment (HTA) process occurs in response to a legislative mandate for “social participation.” This resulted in some limited patient participation activities, and, therefore, a more systematic approach was needed. The study describes the development of a suggested framework for action to improve PPI in HTA. Methods This work used formal methodology to develop a PPI framework based on three-phase mixed-methods research with desktop review of Brazilian PPI activities in HTA; workshop, survey, and interviews with Brazilian stakeholders; and a rapid review of international practices to enact effective patient involvement. Patient partners reviewed the draft framework. Results According to patient group representatives, their involvement in the Brazilian HTA process is important but could be improved. Different stakeholders perceived barriers, identified values, and made suggestions for improvement, such as expansion of communication, capacity building, and transparency, to support more meaningful patient involvement. The international practices identified opportunities for earlier, more active, and collaborative PPI during all HTA stages, based on values and principles that are relevant for Brazilian patients and the public. These findings were synthesized to design a framework that defines and systematizes actions to support PPI in Brazil, highlighting the importance of evaluating these strategies. Conclusions Since the publication of this framework, some of its suggestions are being implemented in the Brazilian HTA process to improve PPI. We encourage other HTA organizations to consider a systematic and planned approach with regular evaluation when pursuing or strengthening involvement practices.

ObjectivesAs more health technology assessment (HTA) bodies seek to implement patient involvement, there is a desire to learn from other HTA bodies about their experiences and understand what approaches can be used and which ones make a real difference to HTA. This is difficult, as the impact of patient involvement in HTA is not well documented. This study aims to promote further discussion about the ways in which patient involvement can impact HTAs by studying stories of impact.MethodsIn a multi-stakeholder workshop, experts leading patient involvement in four HTA bodies shared examples of HTAs where they believed patient involvement made a difference, then they reflected on these impact stories within the wider context of impact evaluation.ResultsThe HTA bodies drew on patient input and patient-based evidence to inform their HTAs. The patient involvement was observed to elucidate patients’ experiences, needs and preferences which, in turn, was observed to influence the HTA recommendations about optimal use of technologies, including taking account of issues for sub-groups, outcomes that matter to patients and educational needs.ConclusionsPersonal stories of patient involvement may enable a wider understanding of different approaches to and impact of patient involvement. The examples relate to both patient input and patient-based evidence and highlight the role that patient involvement can play in reducing uncertainties and complementing the clinical and economic evidence in HTA. They suggest that impact can be seen in recommendations about how and when a technology is used.

A Avaliação de Tecnologias em Saúde (ATS) é um campo multidisciplinar de análise de políticas, que estuda as implicações clínicas, sociais, éticas e econômicas das tecnologias em saúde, levando-se em consideração eficácia, efetividade, segurança, custo-efetividade, etc. Entretanto, impactos éticos, legais e sociais, direcionados a perspectivas de pacientes e sociedade, são postergados em detrimento de atributos clínicos e econômicos. Com a crescente ênfase sobre o engajamento dos pacientes pelo direito aos seus próprios cuidados, há necessidade de determinar meios efetivos para envolver a sociedade nos processo de avaliação e de decisão. O objetivo do presente trabalho foi explorar os desafios presentes no contexto internacional e nacional para envolver o público nos processos de ATS do Sistema Único de Saúde (SUS). Adotou-se método integrativo, composto por revisão da literatura e análise de registro oficiais do Ministério da Saúde. A análise dos resultados mostrou experiências internacionais em franco desenvolvimento, destacando-se Reino Unido e Canadá. No Brasil, existem instrumentos legais para envolver o cidadão na ATS, mas sua implementação é recente e tem sido realizada gradualmente. Os principais desafios em âmbito nacional e internacional estão relacionados aos aspectos culturais. Com base nos resultados foi possível apontar proposições para aprimorar esses mecanismos de envolvimento. Descritores: Avaliação da Tecnologia Biomédica; participação social; participação comunitária.

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