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Human Research Law Challenged in STF: Bioethics Warns of Health Risks, Failures in SUS and Threats to Autonomy Guarantees.
The Federal Supreme Court (STF) received Direct Action of Unconstitutionality (ADI) 7875, which questions Law 14.874/2024, responsible for regulating scientific research involving human beings.
The Brazilian Society of Bioethics proposed the action, and Minister Cristiano Zanin was appointed to report the case.
Right to Health Under Threat
The organization highlighted that the new law restricts the right of vulnerable individuals to continuous access to effective treatments after the conclusion of clinical studies.
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As a consequence, this restriction directly impacts one of the most relevant constitutional pillars: the fundamental right to health.
Initiative Vice and Encroachment of Powers
The legal action argues that the Legislative branch, by creating an agency linked to the Ministry of Health through the law, exceeded its legal authority.
According to the authors of the action, this initiative should belong exclusively to the Executive branch, responsible for organizing public administration and proposing the creation of internal agencies.
By assuming such a role, the Legislative would have encroached upon powers that the Constitution reserves for the Executive, characterizing what is known as initiative vice.
This vice, according to the action, compromises the very validity of the law, putting the legality and legal security of the measures it proposes at risk.
Additional Costs Without Budget Forecast
The Brazilian Society of Bioethics stated that the law imposed new financial responsibilities on the Unified Health System (SUS) and various public institutions. However, the lawmakers did not define any budget forecast to cover these additional costs, creating an immediate execution problem.
Furthermore, the organization accused Congress of creating a scenario of institutional insecurity by transferring responsibilities without indicating funding sources.
As a result, the law jeopardizes the autonomy of research participants and weakens the informed consent process, especially in emergency situations where quick decisions become essential.
Therefore, instead of protecting individuals, the norm puts their integrity and the fundamental rights guaranteed by the Constitution at risk.
Fragility of Social Participation
The organization emphasized that the ethics governance process in research ignored effective social participation and, as a result, failed to listen to civil society, healthcare professionals, and representatives of SUS users.
Additionally, in the petition, the Brazilian Society of Bioethics accused those responsible for drafting the law of violating the constitutional directive that requires social control in the Unified Health System.
Consequently, according to the organization, by excluding popular participation, the legislator weakened one of the structuring principles of SUS, which guarantees transparency, legitimacy, and collective oversight of decisions that affect public health.
Request for Suspension of the Law
The Brazilian Society of Bioethics requested that the STF immediately suspend the law. The organization warned that its validity would compromise fundamental constitutional and ethical principles.
Moreover, the organization emphasizes that the measure goes beyond a mere formality. It directly protects participants in scientific research in Brazil and ensures that their rights, safety, and dignity are respected.
In this way, the Society preserves the ethical safeguards that guide scientific investigation. It also reinforces that all legislative norms must comply with constitutional standards and the best international practices in bioethics.
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