Alerts
- 18 June 2025
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Congress overturns veto of the Law on Research with Human Beings and reestablishes deadline for supply of experimental drugs
In a session held yesterday (June 17), the National Congress decided to override Veto No. 13/2024, which had been partially imposed on Law No. 14,874/2024, which regulates the conduct of research with human beings in Brazil.
With the decision, the following provisions originally vetoed by the Presidency of the Republic come into force:
- Article 24, 3, which determines the mandatory communication to the Public Prosecutor’s Office about the participation of members of indigenous groups in research; and
- Item VI of article 33, which authorizes the sponsor to interrupt the free supply of the investigational drug within the scope of the post-study supply program to the research participant after a period of five (5) years from its commercial availability in Brazil.
The overturned veto comes approximately one year after the enactment of Law No. 14,874/2024, which still requires regulation in certain aspects, such as the rules governing the post-study provision program and the structuring of the National Research Ethics Body — both considered important for the full implementation of the new legal framework.
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