September 24, 2025 | Clara Fagundes | Ascom/Cofen

https://www.cofen.gov.br/lei-que-reduz-direitos-de-participantes-de-pesquisas-clinicas-e-questionada-no-stf/ 

Brazilian Society of Bioethics files Direct Action of Unconstitutionality

The Brazilian Society of Bioethics (SBB) filed a lawsuit with the Federal Supreme Court (STF) questioning the constitutionality of Law 14.874/2024, which regulates scientific research involving human subjects. Direct Action of Unconstitutionality (ADI) 7875 was assigned to Minister Cristiano Zanin.

For the SBB, restricting continued access to effective treatments after the end of studies violates the fundamental right to health, which is a constitutional principle.  The law stipulates that, after the volunteer's participation in clinical research, the researcher must assess the need to provide the researched drug and limits the obligation to provide it free of charge to five years. Previously, infra-legal norms determined that the provision of the researched drug could not be interrupted after the end of the study.

The SBB also highlights the lack of effective social participation in the governance of research ethics, which contradicts the constitutional guideline of social control in the Unified Health System (SUS). The bill was approved despite opposition from the National Research Ethics Commission (Conep), the National Health Council (CNS), and public health experts. The regulation and monitoring of research involving human subjects was carried out by a system of 890 Research Ethics Committees (CEP), under the guidelines of the National Research Ethics Commission, known as the CEP/Conep System.

ADI 7875 also argues that the rule, which originated in parliament, created a body linked to the Ministry of Health, usurping powers reserved for the executive branch, leading to its unconstitutionality due to procedural flaws. It further argues that the legislation imposes additional costs on the Unified Health System (SUS) and public institutions without budgetary provision and undermines guarantees of autonomy and informed consent for research participants, especially in emergency situations.

Background – The law originated in PL 200, known as the Human Guinea Pigs Bill, which began to be processed in the Senate in 2015. Cofen approved an opinion contrary to the bill, classifying it as an “unprecedented setback” for reducing social control. After approval in the Senate in 2017, PL 200 was sent to the Chamber of Deputies, where it was processed as PL 7082 and underwent several changes.