New law governs clinical trials in Brazil

May 31, 2024

New law governs clinical trials in Brazil

On May 28, 2024, President Luiz Inácio Lula da Silva approved Law #14,874/2024, which now regulates clinical trials in Brazil, establishing the National System of Ethics in Clinical Trials (SNEPSH). Law #14,874/2024 is the result of a lengthy legislative process that began in 2017 with the introduction of Bill #200 by then-Senators Ana Amélia (PP/RS), Waldemir Moka (MDB/MS), and Walter Pinheiro (PT/BA). After approval in the Senate, Bill #200/2017 was sent to the House of Representatives for review, where it was approved in the form of a substitute, becoming Bill #6,007/2023. More than six years later, the bill returned to the Senate on December 13, 2023, where it was approved with further amendments.

Law #14,874/2024 was promulgated with 65 articles, organized into nine chapters: (i) chapter I, which presents the scope and guidelines that must be followed in conducting clinical trials (Articles 1 to 4); (ii) chapter II, which creates SNEPSH, dividing it into a national level and a local level of ethical review instance, the latter represented by the Ethics Committees (CEPs) (Articles 5 to 17); (iii) chapter III: which establishes mechanisms to protect the participants, such as the need for obtaining their consent, the conditions for the use of placebo, and the guarantee of compensation in case of injuries suffered arising out of the participation in the clinical trial (Articles 18 to 25); (iv) chapter IV, which establishes the responsibilities of the sponsor and the researcher (Articles 26 and 27); (v) chapter V, which establishes the need for obtaining prior authorization from the health authority for the manufacture, use, import, and export of experimental products (Articles 28 and 29); (vi) chapter VI, which regulates the conditions for the supply of post-trial experimental products (Articles 30 to 37); (vii) chapter VII, which addresses the storage and use of human data and biological material in so-called biobanks and biorepositories (Articles 38 to 51); (viii) chapter VIII, which addresses the need for transparency and monitoring of trials, as well as regulating its eventual discontinuation (Articles 52 to 57); and (ix) chapter IX, with final provisions (Articles 58 to 65).

Most of Law #14,874/2024’s provisions consolidate existing regulations, particularly those established by Rule #466/2012 of the National Health Council (CNS). This applies to the procedural conduct of clinical trials, researcher and sponsor responsibilities, and ethical requirements for participants protection. It's important to note that while Law #14,874/2024 provides a general framework, it delegates specific regulations on sensitive topics. These include, for example, the criteria for compensating healthy volunteers in Phase I or in bioequivalence studies (a new provision introduced by the Law in Article 20, Paragraph 2, Item I) and the criteria for using experimental products in post-trial access programs (Article 28, Paragraph 1).

Among the novelties brought by Law #14,874/2024, some stand out. One significant change is the decentralization of the trial protocol review. Local CEPs now have sole responsibility for protocol analysis, eliminating the need for review by the National Ethics Commission (CONEP). The Law also eliminates the requirement for multi-center trials to be reviewed by multiple CEPs, instead favoring review by the CEP associated with the trial's coordinating center. Another procedural novelty is the establishment of time limits for protocol review: 10 business days for initial protocol analysis, 20 business days for requesting additional information or requesting protocol modifications, and 30 business days for issuing a final decision.

Law #14,874/2024 also introduces a detailed regulation for the sponsors’ obligation to provide the experimental products after a trial is concluded, which is no longer automatically mandatory, although its waiver still depends on due justification by the sponsor and prior approval by the CEP. However, in cases where such obligation remains applicable, Law #14,874/2024 now requires the responsible researcher to conduct an individualized assessment of each participant's situation. Additionally, it establishes specific circumstances under which the obligation can be automatically discontinued (e.g., from the inclusion of the product in the Brazilian public health system). Originally, the bill included the passage of 5 years after product approval in Brazil as one of such circumstance. However, President Luiz Inácio Lula da Silva vetoed this provision, arguing that a fixed deadline would violate participant rights and ethical trial principles of dignity, beneficence, and justice. The Brazilian Congress now has 30 days to consider overriding the veto, potentially reinstating this provision in Law #14,874/2024.

Finally, another noteworthy aspect of the Law is the allowance for enrolling participants even without their prior consent in emergency situations, provided consent is obtained at the earliest possible opportunity.

Law #14,874/2024 enters into effect 90 days after its publication date of May 29, 2024. Therefore, it will become effective on August 26, 2024.

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