10/31/2025 | Gazeta do Povo

https://www.gazetadopovo.com.br/vida-e-cidadania/sociedade-brasileira-de-bioetica-stf-lei-pesquisa-em-seres-humanos/ 

A dispute of ethical and constitutional relevance will be decided by the Supreme Federal Court (STF) after the Brazilian Society of Bioethics (SBB) requested the Court to suspend the law regulating research involving human beings. On one side, the SBB argues that the new law presents unconstitutionalities that diminish the protection of research participants.

On the other hand, the Chamber of Deputies and the Federal Senate defend the full constitutionality of the text, arguing that the law was the result of a broad democratic debate and aims to fill a regulatory vacuum in the country. The Direct Action of Unconstitutionality (ADI 7.875), filed in September, is being overseen by Justice Cristiano Zanin.

The judgment of the case will define the limits of the regulation of clinical research in Brazil, weighing the right to health, patient autonomy, and the need for legal certainty for scientific development. The SBB requests that the STF grant an injunction to immediately suspend the effectiveness of the contested articles, especially those relating to patient access to post-study treatments.

The entity's objective is to restore the previous regime provided for in Resolution 466/2012 of the National Health Council (CNS) until the merits of the case are judged. For the SBB, the injunction is necessary due to the risk of irreversible damage to health, patient autonomy, and financial harm to the SUS (Brazilian Unified Health System).

Congress, in turn, requests that the injunction be denied, alleging that the immediate suspension of the law would create a risk of reverse harm, generating regulatory discontinuity that would be difficult to remedy in the country's research environment. The presidential decree regulating the creation of the National System of Ethics in Research with Human Beings and establishing the National Ethics in Research Instance (Inaep), as foreseen in the new law, was published in the Official Gazette of the Union (DOU) at the beginning of October. These two structures are intended to replace the National Ethics in Research Commission (Conep), coordinated by the National Health Council (CNS).

On October 9th, the CNS met to discuss the changes and, with "broad consensus," considered that the regulation represents a "setback and threat" to the national system of research ethics. In a statement released after the meeting, the council's president, Fernanda Magano, pointed out that the law "reflects a conservative attitude of the National Congress, poorly aligned with the principles of defending public policies and social protection."

According to the CNS, Conep is responsible for coordinating and supervising ethics in all clinical research conducted in the country, acting in the accreditation and de-accreditation of Research Ethics Committees (CEPs), in the training of its members, and in the analysis of complaints. The council is expected to decide whether to join the action as amicus curiae after another meeting with the Minister of Health, Alexandre Padilha.

Last week, the Chamber of Deputies and the Senate sent opinions to Zanin contesting the SBB's accusations. The Legislative branch defends the full constitutionality of Law 14.874/2024, emphasizing that the debate lasted almost a decade. The text approved in 2024 was a substitute bill from the Chamber of Deputies to the project presented in 2015 by former senators Ana Amélia (at the time, from the PP of Rio Grande do Sul), Waldemir Moka (MDB-MS), and Walter Pinheiro (at the time from the PT of Bahia).

Before deciding on the injunction, Zanin also requested, "due to the nature of the controversy," information on the subject from the Faculty of Medicine of the University of São Paulo (FMUSP), the State University of Campinas (Unicamp), and the Federal University of São Paulo (Unifesp). The FMUSP (Faculty of Medicine of the University of São Paulo) requested a 30-day period from the minister to submit its opinion. See below the main points questioned in the law.

Patient access to treatment after the research
The main point of contention concerns the continuation of treatment after the clinical trial. The SBB (Brazilian Society of Bioethics) argues that the new legislation imposes significant restrictions that constitute a step backward compared to the previous protective level established by CNS Resolution 466/2012, which guaranteed free and indefinite access to participants.

The law allows for the interruption of free post-study provision after a period of five years, counted from the commercial availability of the drug in the country; in the event of an adverse reaction that, at the researcher's discretion, makes continuation impossible, even in the face of potential benefits; and from the availability of the experimental drug in the public health system (SUS).

The SBB argues that, by providing for the interruption of supply by the sponsor when the drug is available in the SUS, the law transfers to the public system the financial burden that was previously the sponsor's responsibility.

The Senate's Legal Department emphasizes that “there is no setback” when establishing “fair and proportionate guidelines for post-study access, in order to, in turn, provide security to research promoters and incentives for more research to be carried out in our country.”

Investments in research
According to Congress, the new regulation could even “attract a greater number of investments, given the global interest and the increase in worldwide investment in research and development (R&D) in the biopharmaceutical sector.”

During the vote on the proposal, Senator Dr. Hiran (PP-RR), the project's rapporteur, said that the regulation could bring more incentives to the sector and accelerate the approval of clinical research in Brazil, especially for serious diseases such as cancer.

“Today we are giving these people a legal framework comparable to that of the countries that conduct the most clinical research in the world. With this, we will facilitate access, bring more innovation, and bring more resources to our country. The National Congress has once again fulfilled its function,” said the rapporteur after the Senate approved the text.

Prerogative of the Union and Congress
The SBB points out that Congress usurped the prerogative of the Executive Branch by creating the National Research Ethics Body as a collegiate body "part of the Ministry of Health." The entity states that the creation of federal public administration bodies and administrative organization are the exclusive initiative of the President of the Republic.

The National Research Ethics Body is defined as an interdisciplinary and independent collegiate body, of a normative, consultative, deliberative and educational nature, competent to regulate, supervise and ethically control research. The legislature denies having encroached upon the government's prerogative, as the law does not establish rules for the federal public administration, but only deals with general rules on clinical research with human beings, a matter of "concurrent competence" with the Union.

Congress emphasizes that the National Ethics in Research Instance does not constitute the creation of a new autonomous administrative body, as it is a "technical collegiate body of a normative, consultative and deliberative nature, inserted in the context of the national research policy," and that Congress "can legislate on public policies and the creation of consultative bodies."

Violation of patient autonomy
The law allows the inclusion of participants in emergency situations in research, even without prior consent. For the SBB, this possibility is an affront to patient autonomy and the informed consent regime, contradicting the jurisprudence already established by the Supreme Federal Court (General Repercussion Theme 1.069).

The entity also criticizes the insufficiency of the provision for "social control" in the governance of research ethics, alleging that it does not guarantee the effective and deliberative participation of the community at all levels.

The legislature argues that inclusion in research without prior consent is an exceptional measure justified by the urgency and the need to save the life or health of the participant when they are unable to express their will. The Senate's legal counsel points out that the law does not exclude authorization, but only defers it to the "first possible opportunity," thus being compatible with the medical duty to save lives.

Costs for the SUS (Brazilian Unified Health System)
The SBB argues that the norm creates mandatory expenditure without the proper estimate of budgetary impact by making public institutions co-responsible for comprehensive assistance and damages. The Chamber of Deputies and the Senate refute the accusation of lack of budgetary provision, stating that the questioned provisions deal with rules of responsibility and do not create "mandatory expenditure." According to the legislature, "the obligations to compensate and assist arise from uncertain and specific events, without automaticity or a continuous character, distinguishing themselves from 'mandatory expenses' in the sense of Article 113 of the ADCT and the LRF." Furthermore, Congress points out that it is "perfectly reasonable" to allow the interruption of supply when the medication is available through the public health system (SUS), since the cost of the medication is already included in the public health budget.