News

The Brazilian Society of Bioethics (SBB) filed a Direct Action for the Declaration of Unconstitutionality (ADI No. 7,875) before the Federal Supreme Court (STF), seeking a preliminary injunction and, ultimately, a declaration of unconstitutionality of several provisions of Law No. 14,874/2024, which establishes the legal framework for clinical research involving human subjects in Brazil.

The law, sanctioned with presidential vetoes, was initially celebrated as an important milestone for the research and development sector. On June 17, 2025, the National Congress overturned the presidential vetoes (VET 13/2024), fully reinstating the provisions into the legal text. The legislature’s decision was seen as a response to demands from the regulated sector, which had warned about legal uncertainty and potential disincentives for conducting research in Brazil, particularly due to unclear rules on post-study access obligations.

In its statement of claim, the SBB makes the following points:

• Formal initiative defect, claiming that the law, originating in Congress, created a “national ethics body for research” within the Ministry of Health, which SBB claims falls under the President’s exclusive authority;
• Social regression and violation of the right to health, arguing that Articles 30 to 37 restrict post-study access previously guaranteed under CNS Resolution No. 466/2012;
• Financial burden on the public health system (SUS), which would then bear the costs of treatments and compensation without budgetary allocation, allegedly in violation of Article 113 of the Transitional Constitutional Provisions Act (ADCT);
• Violation of autonomy and informed consent, since Article 18, paragraph 6, allegedly allows the inclusion of participants in emergency research without prior consent;
• Restriction of social participation in ethical oversight mechanisms, arguing that the law fails to ensure effective and deliberative community participation in research ethics governance;
• Limitations on post-study access, allegedly inconsistent with STF Themes 6 and 1,234, potentially increasing litigation without adequate legal protection.

A key change introduced by Law No. 14,874/2024 concerns post-study provision obligations. Under CNS Resolution No. 466/2012, sponsors were required to ensure free and open-ended access for participants to effective preventive, diagnostic, and therapeutic methods identified during the study. With the legislative change, following the congressional override of vetoes, the new law establishes objective criteria and limits post-study provision to a maximum period of five years.

Stakeholders in the research sector argue that once incorporated into the Unified Health System (SUS), funding responsibility should shift to the public sector, particularly in research involving rare diseases. In this context, CNS Resolution No. 563/2017 had already provided for up to five years of free provisions by sponsors in cases of ultra-rare diseases, aligned with expectations of regulatory approval or incorporation into the SUS.

International context

Comparative analysis suggests that the Brazilian model aligns with global practices:

• In the United States, post-study provisions are private and time-limited;
• In France, the State assumes the provisions until regulatory approval or incorporation decisions, with an additional one-year extension if approval is denied;
• In Argentina, the obligation persists until the drug becomes commercially available, with possible extension through expanded access programs.

Within this framework, the Brazilian legislation is considered consistent with international standards and does not, in and of itself, constitute social regression. The five-year limit seeks to balance patients’ clinical needs with the economic sustainability of research, ensuring continuity of treatment until the product becomes available in public or private systems.

Procedural status

On September 24, 2025, the rapporteur ordered that the National Congress, the President’s office, and the medical schools of USP, Unicamp, and Unifesp submit their information within 10 days. The case is currently awaiting these submissions. At a later date, the Attorney General’s Office and the Prosecutor General’s Office will be granted access to render their opinions.

The Life Sciences and Healthcare team at BRZ Advogados continues to closely monitor developments related to human research regulation and remains available for further clarification.