Brazil Regulates Clinical Research: A Complete Review of Decree #12,651/2025 - Part 2

The Brazilian government has published the long-awaited regulation of the Clinical Research Act. Decree #12,651/2025 establishes the National System of Ethics in Research Involving Human Subjects (SINEP) and seeks to strike a balance between ethical protection for research participants and regulatory efficiency, representing the most significant regulatory milestone for Brazil’s clinical research landscape in decades.

This article is the second part of a two-part analysis review of the Decree’s updates, market expectations, and outstanding regulatory gaps. The first part examined the new ethics architecture, the distinction between credentialing and accreditation of CEPs, the risk-based review model, binding timelines and single-CEP review for multicenter trials.

The first part is available at: https://www.lexology.com/library/detail.aspx?g=b1b655f4-963a-4be7-876c-81afb05caef6

The second part will analyze the post-trial care regime, new transparency mechanisms, transitional provisions and next steps, including what to expect in ADI 7875—which challenges key provisions of the Clinical Research Act—and the status of the recent public consultation on clinical research (CP #69/2025), which gathered broad stakeholder input on Brazil’s clinical-research environment.

1. Analysis of Decree #12,651/2025: What the Decree Effectively Addresses

Post-trial care. While the Act has already allowed sponsors to cease supplying the investigational product to a volunteer five years after its commercial availability. The Decree, in turn, reinforces the sponsor’s obligation to continue providing the product free of charge after trial completion whenever, in the principal investigator’s judgment, it is the best therapeutic alternative for the participant’s condition, based on available evidence and a favorable risk–benefit assessment.

The post-study access program must be prepared by the sponsor and submitted for evaluation by the competent CEP, containing the strategy for the supply of the product after the end of individual participation.

The Decree determines that the National Instance of Ethics in Research (INAEP) will regulate the plan for monitoring and assisting participants in discontinued clinical trials.

Brazil’s approach appears consistent with international practice. The Declaration of Helsinki, which sets out internationally recognized ethical principles for medical research involving human subjects, requires that arrangements for post-trial care be agreed upon before the study begins—involving sponsors, researchers, and governments—and it 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.

Institutional Responsibility. Funding agencies and supporting foundations are not considered sponsors for purposes of the Act; their role is financial only. The measure provides legal certainty to universities and public agencies.

Biobanks and Use of Human Biological Material. Biobanks and biorepositories will be regulated by INAEP. Use of biological material and data is limited to the approved project purpose, unless express consent authorizes future scientific use, consistent with the Clinical Research Act and INAEP rules.

Transparency. The Ministry of Health will maintain a centralized electronic platform for clinical trials, with unified submission for regulatory and sanitary approval, tracking, and a public database.

In its official note announcing the Decree, the government adds that this platform will replace the current site, Plataforma Brasil, by the end of next year.

These measures directly address a long-standing criticism that Brazil has lacked robust, user-friendly transparency tools for clinical studies—current Anvisa search mechanism and Plataforma Brasil contain errors and often make it difficult, for example, to identify the molecule under investigation—underscoring the need to surface core trial fields (molecule, objectives, design, eligibility, primary endpoints) while protecting confidential and IP-sensitive data.

2. Transitional Period

To ensure a smooth transition from the prior legal framework to the new one, the Decree provides that:

• The Ministry of Health must establish a temporary working group with a term of up to three months to support the drafting of complementary procedures and regulations for INAEP’s operation and SINEP’s implementation.
• Recognition of CEPs already credentialed/accredited until INAEP conducts a new assessment.
• National Health Council (CNS) rules will remain in force insofar as it does not conflict with the Act or the Decree, until INAEP issues new regulations.
• National Research Ethics Committee (CONEP) will remain the Appellate instance until INAEP’s members take office.

3. Next Steps

Although the government’s official note celebrates the Decree as “a landmark to attract investments and accelerate access to new medicines”, full implementation still depends on INAEP issuing rules to operationalize key areas.

Items pending INAEP regulation include:

• Post-trial access. INAEP must issue complementary guidelines for the design, submission, and ethical evaluation of Post-Trial Access Programs to be prepared by sponsors and submitted to the competent CEP.
• Discontinued clinical trials. INAEP will regulate the plan for follow-up and assistance to participants of discontinued trials.
• CEP credentialing (low and moderate-risk studies). INAEP will define criteria, requirements, and procedures for granting, renewing, revising, suspending, and canceling CEP credentialing.
• CEP accreditation (high-risk studies). INAEP will also set the criteria and procedures for granting, renewing, revising, suspending, and canceling accreditation.

In addition, the sector awaits the update to the Clinical Research Action Plan. Between July and August 2025, the Ministry of Health conducted Public Consultation No. 69/2025 to collect input for the Plan’s update. The focus was on identifying bottlenecks (bureaucracy, regional disparities, scarcity of financing) and opportunities (digitalization, regulatory harmonization), thereby strengthening the legitimacy of policies and their alignment with the sector’s actual needs.

The contributions received were released in early October and include suggestions for the following areas of improvement in the clinical research sector:

• Strengthen infrastructure and integrate digital platforms across ethics, regulatory, and research workflows.
• Improve the regulatory environment by simplifying processes and harmonizing requirements across competent authorities.
• Expand technical capacity through targeted training, certification, and exchange programs.
• Advance equity, diversity, and inclusion (EDI) in clinical studies, with measurable participation goals and safeguards.
• Foster innovation and public–private partnerships (PPPs) in the development of new health technologies.

Based on the contributions, the Ministry of Health will define the guidelines for the new Action Plan.

Priority areas for strengthening the industrial base include biotechnology, biopharmaceuticals, and advanced therapies, with a focus on clinical trials in phases 1, 2, and 3, as well as expanding the participation of startups and technology centers and supporting projects in artificial intelligence, big data, genomics, and precision health.

The enactment of rules by the National Instance of Ethics in Research (INAEP) and the developments of the new Action Plan must be closely monitored by the market, as they have the potential to bring significant impacts to the strengthening of the clinical research landscape in Brazil.

ADI 7875. Another development that should be closely monitored is ADI 7875, filed by the Brazilian Society of Bioethics (SBB), which challenges several provisions of the Clinical Research Act, including an alleged formal defect of initiative (separation of powers violation), the five-year limit for sponsors to provide post-trial care after the product’s marketing, as well as the provision that recognizes that the institutions where the research is conducted—including public institutions—also bear responsibility for any harm caused.

The request for a preliminary injunction to suspend the challenged provisions 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.

However, 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. To this end, Brazil took a major step forward in protecting participants with the publication of Decree #12,651/2025, while also ensuring the promotion of innovation in Brazil.

Status. More recently, on October 8, the Chamber of Representatives submitted its statement to the Supreme Federal Court (STF), upholding the full constitutionality of the Clinical Research Act.

The defense primarily focuses on refuting the formal constitutional defects alleged by SBB, asserting that the Act adhered to the due legislative process and falls within the legislature's margin of conformation.

• Absence of Formal Initiative Flaw in the Creation of the National Instance (INAEP). The Chamber argues that the Act does not concern the administrative organization of the federal government. The INAEP is a consultative and deliberative collegiate body with a merely technical and functional link to the Ministry of Health and therefore does not constitute a new administrative entity endowed with its own structure, staff, or budget, which would require the exclusive initiative of the President of the Republic.
• Compliance with Due Legislative Process. The defense affirms that the legislative process of the Act’s approval fully complied with constitutional and procedural requirements.
• Principle of Legislative Discretion. The defense maintains that the Judiciary must recognize and respect the legitimate “margin of discretion” granted to the Legislative Branch. The Constitution functions as a “framework” or “outline”—drawing on Hans Kelsen’s theory—that leaves a reasonable margin of discretion to lawmakers, whose creative freedom is the broadest among the state powers, limited only by constitutional principles.

The Chamber concludes that the allegation of unconstitutionality raised by the Brazilian Society of Bioethics (SBB) should be entirely dismissed. Before ruling on the preliminary injunction requested by SBB—which will decide whether the challenged provision will be suspended until final judgment—the Supreme Court is still awaiting the statements of the Federal Senate, the Office of the President, and the medical schools of USP, UNICAMP, and UNIFESP.

4. Conclusion

Decree #12,651/2025 marks a defining moment for Brazil’s clinical research ecosystem. By establishing the National System of Ethics in Research (SINEP) and introducing clear rules on post-trial care, transparency, and institutional responsibility, the regulation fills long-standing gaps and modernizes the country’s ethical and regulatory framework.

The National Instance of Ethics in Research (INAEP) will now play a central role in implementing the Act. Its upcoming regulations on post-trial access, discontinued studies, and CEP credentialing will determine how effectively the new framework works in practice. Meanwhile, the new Clinical Research Action Plan, shaped by the recent public consultation, is expected to set clear priorities for expanding Brazil’s scientific and industrial capacity in biotechnology, advanced therapies, and precision health.

Legal debates continue as ADI 7875 moves forward before the Supreme Federal Court (STF). Still, the Chamber of Representatives’ recent statement defending the constitutionality of the Clinical Research Act reinforces confidence in the Act’s stability and legitimacy.

Together, these developments point to a new phase for Brazil: one of stronger governance, greater transparency, and renewed international credibility in clinical research.