Brazil enacts a law to regulate clinical trials
Camila Martino Parise
Pinheiro Neto Advogados, São Paulo
Anna Luiza Bertin
Pinheiro Neto Advogados, São Paulo
Renowned for its ethnically diverse population, Brazil is ideally positioned to lead in clinical research. The country’s population diversity plays a key role in generating representative data of broader populations. However, the lack of consolidated legislation and legal certainty has long hindered Brazil’s potential in this field. This scenario is set to change with the enactment of Law No 14,874/2024, which is the first law regulating human subject research in Brazil.
Ethical framework
Despite the discussions about the lack of jurisdiction, until the enactment of Law No 14,874/2024, clinical trials in Brazil were overseen by the National Health Council (CNS), an advisory body within the Ministry of Health. The main regulatory framework for clinical trials in Brazil was Resolution 466/2012, which was based on international documents such as the Declaration of Helsinki. Its aim was to safeguard the rights and obligations that concern research participants, the scientific community and the state.
The new law marks a significant shift by transferring regulatory oversight to the Secretariat of Science, Technology and Innovation (SECTICS), also within the Ministry of Health, signalling a more centralised and structured regulatory framework.
The former CEP/CONEP system, established by CNS to protect research participants in Brazil and consisting of the National Research Ethics Commission (CONEP) and local research ethics committees (IRBs), has now been replaced by the National System of Ethics in Research.
This system introduces the National Research Ethics Board (INEP), which will be responsible for issuing research ethics regulations and overseeing the new framework, and the Research Ethics Review Board, which will be represented by IRBs.
In contrast to CONEP, INEP will primarily handle appeals, avoiding duplicate evaluations of high-risk projects. IRBs, on the other hand, will continue to be the administrative body responsible for reviewing research studies involving human subjects, ensuring participant protection and compliance with regulations.
A significant challenge for researchers in Brazil was the timeline for obtaining approvals, which often exceeded one year for review by the Ethics Committee and the National Health Surveillance Agency (ANVISA) in case of clinical trials for pharmaceutical products or medical devices. The new law introduced clear timelines and cut red tape. Ethical reviews, which previously involved multiple layers, will now be consolidated into a single approval process handled by local ethics committees, expediting project evaluations.
Redefining sponsor roles and responsibilities
The new law also modified sponsor responsibilities for healthcare and post-trial access, aiming to reduce the burden on sponsors while still ensuring the safety and wellbeing of participants. With respect to healthcare, under previous CNS regulations, sponsors were required to provide emergency healthcare to participants, regardless of whether the need was related to their participation in the trial. Now, in line with civil liability principles, sponsors are responsible for providing healthcare to participants and for compensating them for any harm that occurs and is directly related to their participation in the trial.
Post-trial access
Post-trial access, previously one of the strictest global standards, is now limited to investigational products – and no longer to the best prophylactic, diagnostic and therapeutic methods that have proven effective. As part of the ethics approval process, sponsors must submit access plans, and any refusals must be justified and are subject to oversight. The law also permits the termination of post-trial access under certain conditions, including: (1) the introduction of a satisfactory therapeutic alternative; (2) the impossibility of obtaining or manufacturing the investigational product for technical or safety reasons (duly justified), provided that the sponsor offers an equivalent or superior therapeutic alternative on the market; and (3) the availability of the investigational product in the public health system.
Data protection and accountability
The new law places greater emphasis on data protection. Researchers must store data for five years after the study (or ten years for advanced therapies), while sponsors are responsible for ensuring data integrity and compliance with the Brazilian General Data Protection Law (LGPD). This has sparked debate, as sponsors may now be considered data controllers, even when they do not directly handle personal data.
Violations and penalties
For the first time, a law introduces penalties for violations in clinical research. Offenses are categorised as sanitary or ethical violations, with penalties ranging from warnings to fines and licence suspensions. However, detailed processes for reporting and investigating violations are still being developed, leaving gaps in the enforcement.
A promising yet uncertain future
Law No 14,874/2024 positions Brazil as a potential global hub for clinical research, promising legal certainty and a streamlined regulatory environment. Expected benefits include increased investment, improved healthcare standards, job creation and faster access to cutting-edge treatments. However, critical aspects remain pending, such as the formal establishment of INEP and the clarification of rules for post-trial access plans. As a result, many stakeholders are continuing to rely on the previous CNS framework until further guidance is issued, underscoring the need for swift and clear implementation measures.
As Brazil navigates this transitional period, the new law marks a significant milestone in advancing a more efficient and globally competitive clinical research landscape.