Brasília – The federal government publishes Decree No. 12,716/2025, reformulating the composition and internal procedures of the National Committee for Health Technology Incorporation (Conitec). As the body responsible for advising the Ministry of Health on the incorporation, exclusion, and modification of technologies in the Unified Health System (SUS), Conitec gains a redesigned governance model that expands representation, strengthens social control, and modernizes its decision-making framework.

The decree updates the committee’s structure to include 17 voting members in each of Conitec’s committees, adding: a rotating civil-society representative linked to the pathology or specialty under evaluation, the Secretariat of Information and Digital Health, and the Health Technology Assessment Center, now formally recognized as a voting entity. The change grants civil society a deliberative role for the first time, moving beyond purely consultative participation and aligning the committee with the participation model established in Law No. 15,120/2025.

The new rule also redefines Conitec’s operational flow. Regular meetings will take place monthly from February to December, with quorum requirements and flexibility for in-person or virtual sessions. After a committee issues its final recommendation, the process now moves to the Secretariat of Science, Technology and Innovation in Health (SECTIS/MS), which becomes the formal decision-maker on technology adoption in the SUS. This replaces the previous model in which decisions were issued in the name of the committee as a collegiate body.

To reinforce technical rigor, the decree strengthens Conitec’s Executive Secretariat—now housed within SECTIS—and authorizes partnerships with institutions in the REBRATS network for the development of scientific and technical reports. It also formalizes the possibility of extraordinary meetings to accelerate urgent evaluations, broadening Conitec’s responsiveness to emerging health needs.

Source: NK Consultores