Updates on the Brazilian Clinical Research Landscape: What’s at Stake in ADI 7875

The enactment of Statute No. 14,874/2024, known as the Clinical Research Act - or as the Legal Framework for Clinical Research - marked a long-awaited regulatory milestone for the scientific community and the pharmaceutical industry in Brazil. By setting new rules for research involving human volunteers, the Act seeks to modernize procedures and provide greater predictability for investment in health innovation.

However, the Act has recently become the subject of constitutional scrutiny: the Brazilian Society of Bioethics (SBB) recently filed Direct Action of Unconstitutionality No. 7875 (ADI 7875) before the Brazilian Supreme Court, requesting a preliminary injunction to suspend the challenged provisions and ultimately have them declared unconstitutional. The SBB argues that the Act rolled back protections previously guaranteed to research participants under the National Health Council (CNS) Rule #466/2012.

This article examines the main arguments raised by SBB in ADI 7875, focusing on the constitutional claims, the provisions under challenge, and the broader implications for Brazil’s health system, its clinical research environment, and legal certainty.

1. Background of Clinical Research Act

The regulatory environment has historically been one of the principal disincentives to conducting clinical studies in Brazil. The Clinical Research Act (Statute No. 14,874/2024), enacted in May 2024, was conceived in response to the need to confer greater legal certainty on the system governing clinical research involving human volunteers in Brazil. Previously, the subject was governed by regulations and guidance documents, and the ethical review process was regarded as inefficient and slow.

Thus, the Act represents a significant step forward in consolidating a modern regulatory environment, harmonized with international standards.

2. ADI 7875

Filed by the Brazilian Society of Bioethics (SBB), ADI 7875 challenges several provisions of the Clinical Research Act, organized into the following main grounds of unconstitutionality:

Alleged formal defect of initiative (separation of powers violation)

The Act would have created a new federal administrative body (the national instance of ethics in research), which would be a prerogative reserved exclusively for the President of the Republic. However, the Act actually seems to establish a National System of Ethics in Research Involving Human Subjects, within which it provides for the creation of a national instance of ethics in research, whose concrete establishment and organization will be regulated by an act of the Executive Branch (article 5, I of the Clinical Research Act).

Alleged retrogression in post-trial care

The Act is said to infringe the principle of non-retrogression, that is, the prohibition against reducing protective standards already in place, by limiting post-trial care to five years from the date the investigational drug becomes commercially available in Brazil. The Petitioner contends that this amounts to an unconstitutional regression, since the previous framework - CNS Rule 466/2012 - required sponsors to fully cover the costs of post-trial treatment for research participants indefinitely.

The provision was initially vetoed by President Lula on the grounds that it contravened the public interest and the principles of dignity, beneficence, and justice. Congress, however, overrode the veto and reinstated the five-year period. The underlying rationale is that an indefinite supply obligation will undermine sponsors’ economic predictability, discouraging investment in clinical research in Brazil.

In addition, it is alleged that the new Act conflicts with Supreme Court case law (Themes 6 and 1234), which set criteria for the judicial supply of drugs not yet incorporated into the Unified Health System (SUS), precisely to curb uncontrolled litigation. In Brazil, as a rule, the SUS only provides free access to medicines once they are formally incorporated into official lists, through a technical process led by CONITEC (National Committee for Health Technology Incorporation), which assesses efficacy, cost-effectiveness, and budgetary impact. Until then, patients relying exclusively on the public health system often resort to judicial remedies.

The claim is simple: by imposing a fixed timeframe for sponsor-funded post-trial care, the Act would push patients into litigation, while existing Supreme Court precedents severely limit judicial orders for non-incorporated drugs.

It is worth noting, however, that the Declaration of Helsinki, which sets out internationally recognized ethical principles for medical research involving human subjects, merely requires that arrangements for post-trial care be agreed upon before the study begins - involving sponsors, researchers, and governments - but does not mandate indefinite supply. In the United Kingdom, for instance, continuity of treatment must be negotiated in advance (including with the NHS, the “British SUS”) and approved by research ethics committees. There, no perpetual duty is imposed on sponsors to provide full treatment indefinitely, as this would significantly raise research costs.

The debate on post-trial access illustrates the challenge of reconciling the protection of research participants with the need to foster innovation and attract investment. Although SBB argues that the five-year limit represents a constitutional regression, comparative experience and international ethical standards show that indefinite supply obligations are neither required nor sustainable. Protecting participants and fostering innovation are not mutually exclusive; rather, they are complementary goals that the Act seeks to harmonize.

Emergency situations

Another sensitive point is the possibility of including participants in emergency situations without prior consent. The Act requires that participants or their legal representatives be informed as soon as possible and asked whether they wish to remain in the study. While SBBargues that this provision violates autonomy and informed consent — both considered essential principles under the Constitution, and the Universal Declaration on Bioethics and Human Rights — it is worth noting that the Declaration of Helsinki itself allows for this practice.

Paragraph 30 of the Declaration provides that research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be carried out if this incapacity is an inherent characteristic of the research group. In such cases, informed consent should be sought from a legally authorized representative. However, if no representative is available and the research cannot be delayed, it may proceed without prior consent, provided that the reasons are stated in the protocol and the research has been approved by a research ethics committee. Importantly, free and informed consent to remain in the research must be obtained as soon as possible from the participant or their representative once capacity is regained or a representative becomes available.

Alleged Financial Burden on the SUS

The Petitioner also challenges provisions that would potentially shift responsibility for post-trial care and indemnities to the SUS and public institutions (article. 26, §3 and 33, VII of the Clinical Research Act). According to the claim, this would violate the constitutional provision requiring that any statute creating new public expenses be accompanied by a budgetary impact assessment. In practice, it is argued that such rules would allow private sponsors to externalize costs onto the public sector, an outcome deemed unconstitutional and socially unjust.

This may not be the case. The provision assigning responsibility for post-trial care to the SUS applies only once a drug has already been incorporated into the public system. Moreover, the Act does not exempt sponsors from liability for damages arising from research, but merely recognizes that the institutions where the research is conducted — including public institutions — also bear responsibility for any harm caused. In fact, there does not appear to have been a substantial change on this point. Under the previous framework, CNS Rule #466/2012 already established that liability for any adverse event in clinical research is shared jointly by the sponsor, the investigator, and the institutions and/or organizations involved in the study.

3. Conclusion

The request for a preliminary injunction in ADI 7875 raises risks for Brazil’s research environment. If granted, it will create legal uncertainty for sponsors and investors who have recently committed to long-term research in the country. his situation is further aggravated by the fact that the long-awaited regulation of the Clinical Research Act - highly anticipated by the industry - is already close to publication.

Fernanda De Negri, Secretary of Science, Technology and Innovation and of the Health Economic-Industrial Complex (SECTICS) at the Ministry of Health, recently confirmed that the decree is under review and should be released in the coming days. She stressed that the lawsuit in the Supreme Court will not affect the regulatory timetable until the Court issues a decision and highlighted that the regulation aims to modernize the system of ethical review in research, making it more efficient both in protecting participants and in streamlining evaluations.

What the SBB seems to overlook in ADI 7875 is that a robust and well-drafted regulation can directly address its concerns about participant protection. In this way, effective regulation functions not only as a guarantee of human dignity but also as a bridge between ethical imperatives and the promotion of innovation in Brazil.

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