Legislative Update: Promulgation of Vetoed Provisions of the Clinical Research Law
07/07/2025
On July 2, 2025, the Presidency of the Republic published in the Official Gazette of the Union (DOU) the promulgation of the vetoed provisions of Law No. 14,874, dated May 28, 2024, marked as the Clinical Trial Law. On June 17, the National Congress overturned the President’s 2024 vetoes.
Promulgated Provisions:
- Article 24, §3 – Requires that the participation of indigenous group members in research be reported to the Public Prosecutor’s Office.
- Article 33, item VI – Establishes that the provision of the experimental drug may be discontinued five years after its commercial availability in Brazil.
Effective Date
These provisions will come into effect 90 days after their publication in the DOU, which occurred on July 2, 2025. Therefore, they will be effective starting September 30, 2025. From that date onward, clinical trials approved in Brazil are expected to comply with these new rules.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to clarify any questions you may have about the legislative update.