The Brazilian Society of Bioethics (SBB) has filed a Direct Action of Unconstitutionality (ADI 7875) before the Federal Supreme Court (STF), assigned to Justice Cristiano Zanin, seeking a preliminary injunction and subsequent annulment of key provisions of Law No. 14,874/2024, which regulates clinical research involving human subjects in Brazil.

Key Legal Challenges Raised by SBB

The ADI claims that the law suffers from both formal and substantive constitutional flaws, including:

• Legislative competence – The creation of the National Research Ethics Body, within the Ministry of Health, originated from a congressional bill, allegedly infringing the President’s exclusive constitutional prerogative to propose legislation on federal administrative organization (Constitution, art. 61, §1, II, “b” and “e”).
• Right to health and non-retrogression – Articles 30 to 37 limit post-trial access to investigational drugs to five years, whereas the previous framework (Resolution CNS No. 466/2012) required indefinite supply. SBB argues this constitutes an unconstitutional rollback of health rights and breaches Brazil’s commitments under international human rights treaties.
• Unfunded financial burden – The law shifts responsibility for post-trial treatments and indemnities to the Brazilian Unified Health System (SUS) and public institutions (arts. 26, §3 and 33, VII), without any prior budgetary impact assessment, contrary to art. 113 of the Transitional Constitutional Provisions Act (ADCT).
• Informed consent – Article 18, §6 allows enrolling participants in emergency situations without prior consent, which SBB argues violates the dignity of the person, STF’s precedent on informed refusal (Theme 1,069), and the Universal Declaration on Bioethics and Human Rights.
• Social participation – The law weakens the role of civil society in research ethics oversight, reducing the participatory governance historically exercised by CONEP/CNS, in breach of art. 198, III of the Constitution.
• Conflict with STF precedents – Restrictions on post-trial access allegedly contradict Themes 6 and 1,234 of general repercussion, likely increasing litigation while undermining effective judicial protection.

Potential Regulatory Implications

If the Federal Supreme Court grants interim relief or ultimately strikes down the provisions, the following consequences may arise:

• For sponsors and the pharmaceutical industry – possible reinstatement of indefinite post-trial supply obligations.
• For public institutions and hospitals – exposure to financial liabilities absent budget allocation.
• For governance structures – potential re-empowerment of the CONEP/CNS system as the central oversight body for clinical research ethics.

Next Steps

The Federal Supreme Court will first examine the request for a preliminary injunction to suspend the challenged provisions while the case is pending. The outcome will be critical for stakeholders in Brazil’s clinical research landscape, including sponsors, CROs, public institutions, and regulators.

We will continue monitoring the progress of ADI 7875 and its developments regarding regulation and the conduct of clinical research in Brazil, and we are available to clarify any questions on the subject.