Brazilian National Congress Overturns Presidential Veto of the New Legal Framework for Clinical Trials with Humans

In a highly significant move for the clinical trial sector in Brazil, the National Congress has made a decision that could directly impact the future of scientific innovation and access to experimental treatments in the country. The overturning of the presidential veto on the Clinical Trial Law marks a new chapter in the regulation of post-study drug supply, reflecting a balance between participants’ rights and the sustainability of the regulatory environment. Below, understand the implications of this decision and what to expect in the next steps.

What happened?

 On June 17, 2025, the Brazilian National Congress rejected the veto of the current President of the Republic, Lula, to the legal provision that allows the suspension of the mandatory post-trial supply of experimental drugs to participants five years after the drug’s commercial availability in Brazil.

Why did President Lula veto this provision?

The reasons for the veto indicate that setting a maximum time limit for the supply of the post-study drug would be contrary to the public interest, as well as hurting the rights of participants.

Mobilization that led to the rejection of the veto

After the presidential veto, the regulated sector mobilized to raise awareness in the National Congress that the mandatory post-trial supply for an indefinite period would bring economic unpredictability. In addition, the indefinite post-trial supply of experimental drugs would drive away investments of approximately R$2 billion, new clinical trials in Brazil, and the possibility of the country occupying the 10th position in the world ranking of clinical trials, as shown in a study conducted by Interfarma in partnership with IQVIA.

Next expected step

Following the rejection of the presidential veto by the National Congress, it is expected that this legal provision will be forwarded for promulgation by President Lula within 48 hours, as ordered by Article 66, §7 of the Federal Constitution.

Expectation of regulation

It is also expected that Federal Law 14,874/2024 will be regulated soon. Among the main topics that will be subject to regulation, the following stand out:

• Rules on publicity, transparency, and the monitoring of research;
• Rules on the manufacture, use, dispensing, import, export, storage, and disposal of products intended for clinical trial;
• Guidelines on SOPs and good practices;
• Rules for biobanks (organized, non-commercial collection of human biological material and associated information, collected and stored for research purposes);
• Criteria and procedures for the operation, suspension, or termination of the Research Ethics Committees (CEPs);
• Rules on the process of ethical analysis of research before CEPs;
• Rules for the clinical research protocol;
• Mandatory clauses for clinical research contracts;
• Creation of fast-track procedure for ethical analysis of research of strategic interest to the Public Health System (SUS) and relevant to public health emergency care;
• Rules for creation of National Registry of Volunteers in Bioequivalence and Phase I Studies;
• Rules for creating a post-study supply program or continuity of experimental treatment.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to clarify any questions regarding the veto and its implications.