The Brazilian Federal Court of Accounts (“TCU”) reviewed an audit conducted at the National Committee for Health Technology Incorporation into the Unified Health System (“Conitec”), as well as the related health technology assessment workflows, and ordered several measures aimed at improving controls and procedures.

On March 18, 2026, the TCU examined the findings of an audit intended to assess the process for incorporation, modification, or exclusion of technologies in the Brazilian Public Health System (“SUS”), as well as the preparation of Clinical Protocols and Therapeutic Guidelines (“PCDT”), within Conitec, covering the period from 2021 to 2023. The audit sought to contribute to the improvement of the evaluations carried out by Conitec, ensuring that public resources are allocated efficiently, based on technical studies and scientific evidence of efficacy, accuracy, safety, and cost-effectiveness, thereby enhancing the provision of healthcare services to SUS users.

After reviewing the applicable legislation, examining information, documents, and technical reports requested from the responsible authorities, holding meetings with managers, and assessing responses to questionnaires distributed to the stakeholders involved in the Health Technology Assessment (“HTA”) process, the Specialized Health Audit Unit (“AudSaúde”) identified the following shortcomings in Conitec’s activities:

1. appointment of members without proper evidence of professional experience, training, or academic background related to HTA;

2. performance of Conitec members in situations involving potential conflicts of interest;

3. general deficiencies in the drafting of reports and technical studies;

4. specific flaws in the preparation of economic evaluations and budget impact analyses;

5. recommendations for the incorporation of health technologies based on lower-quality clinical evidence or lacking cost-effectiveness, without the adoption of mitigating measures;

6. lack of evidence of participation of specialists from the Brazilian Medical Association (“AMB”) and the Federal Council of Medicine (“CFM”) in discussions regarding proposals for technology incorporation;

7. absence of participation by holders of the assessed technologies and of comparators in the HTA process;

8. lack of justification for not conducting public calls aimed at enabling SUS users to participate in Committee meetings;

9. low level of recorded participation by representatives of the National Council of Justice (“CNJ”), the National Council of the Public Prosecutor’s Office (“CNMP”), and the Public Defender’s Office in Conitec meetings;

10. low engagement by full members appointed to Conitec committees and insufficient quorum in meetings;

11. change of an initial recommendation for technology incorporation following public consultation, without the presentation of new facts or recorded reasoning justifying the change in the original proposal;

12. casting of votes without an express statement of reasoning by Conitec members in meetings held between 2021 and 2023;

13. incorporation recommendations issued between 2021 and 2023 based on prices that were not maintained after incorporation;

14. conclusion of processes for inclusion, modification, or exclusion of health technologies beyond the statutory deadlines;

15. delays in making incorporated health technologies available to SUS users after their respective incorporation; and

16. deficiencies in the monitoring process of health technologies incorporated into the SUS.

Based on these audit findings, the TCU Justices, sitting in Plenary Session, issued Ruling #674/2026 – TCU – Plenary, in which they determined and recommended, among other measures, the following:

I. To be complied with within 90 (ninety) days, the Ministry of Health shall:

• prepare and submit to the TCU an action plan for the implementation of the necessary measures regarding conceptual definitions and the adoption of specific methodologies for the assessment of health technologies aimed at ultra-rare diseases;

• prepare and submit to the TCU an action plan for the implementation of measures to monitor acquisitions of incorporated health technologies, in order to verify whether the prices actually practiced remain consistent with those presented during the Conitec evaluation process, over a five-year post-incorporation horizon;

• define responsibility for monitoring and controlling the timeline for the effective offering to the SUS of newly incorporated health technologies, as well as for ensuring that such technologies are made available as quickly as possible.

II. The Department of Management and Health Technology Incorporation (“Dgits”), linked to the Ministry of Health’s Secretariat of Science, Technology and Innovation and the Health Economic-Industrial Complex, shall, within 90 (ninety) days:

• prepare and submit to the TCU an action plan to implement measures aimed at mitigating deficiencies in controls related to the requirements for appointing Conitec members and to addressing potential conflict-of-interest situations;

• prepare and submit to the TCU an action plan, in coordination with the AMB and the CFM, to ensure the presence of specialists in the area of the technology under assessment at all Conitec meetings (internal and external demands), with such specialists appointed as AMB and CFM representatives at those meetings;

• implement controls to ensure the removal of any appointed full member who does not comply with the legal requirements set forth in Ministry of Health Consolidation Ordinance GM/MS #1/2017;

• adopt measures aimed at ensuring the effectiveness of economic evaluations and budget impact analyses carried out by Conitec based on prices proposed by the holders of the assessed technologies, as well as compliance with the economic evaluation and budget impact analysis methodological guidelines issued by the Ministry of Health;

• require that proponents who hold the marketing authorization for the requested technology present maximum prices for the supply of the health technology under incorporation assessment for each of the five years following potential incorporation;

• require that proponents who hold ANVISA registration provide all necessary clarifications that may affect proposed prices over a five-year horizon (including, for example, differentiated prices for centralized and decentralized procurement, risks related to tax exemptions or their absence, logistics, among others);

• prepare and submit to the TCU an action plan to implement measures aimed at mitigating deficiencies identified in the coordination of monitoring actions and in the evaluation of the effectiveness of health technologies incorporated into the SUS;

• order the Department of Health Logistics (“Dlog/MS”), in coordination with Dgits and the technical areas responsible for the incorporated technologies, to establish, within 90 (ninety) days, administrative controls ensuring that centralized procurements of medicines and other health technologies adopt as a price ceiling the amounts presented by suppliers for the five-year horizon during the Conitec incorporation process, with any exceedance of such values requiring due justification within the procurement process.

Finally, the TCU issued several additional recommendations aimed at improving and enhancing the transparency of the processes for incorporation, modification, or exclusion of technologies within the SUS, as well as the preparation of Clinical Protocols and Therapeutic Guidelines (PCDT).

Our team is available to assist in interpreting the applicable legislation and the ruling discussed herein, as well as in adapting to the new regulatory scene.

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