Brazilian Congress overturns veto on Clinical Research Law

On June 17, 2025, the Brazilian Congress overturned the presidential veto of item VI of Article 33 of the Clinical Research Law (Law No. 14,874/24), which provided for the possibility of discontinuing the post-trial supply of experimental medicines to participants five years after the drug becomes commercially available in Brazil.

Previously, the presidential veto of this article imposed an indefinite post-trial supply obligation on clinical trial sponsors, which unfortunately diminished Brazil’s appeal as a host for clinical trials. With the veto now overturned, sponsors can discontinue the post-trial supply after the five-year period mentioned.

The decision reinforces Brazil’s commitment to developing clinical research locally, establishing the necessary balance to attract investment in the research and development of innovative medicines in the country.

Check out our material on the key aspects of the new Clinical Research Law.

Demarest’s Life Sciences and Healthcare team remains available to provide assistance on this topic.