New Clinical Research Law in Brazil: Innovation, Agility, and Ethics

Chamber of Deputies (Brazil)

Law No. 14,874, enacted on May 28, 2024, represents a significant milestone in the regulation of clinical research in Brazil. After more than seven years of deliberation in the National Congress, the new legislation introduces crucial innovations aimed at transforming Brazil into a global hub for clinical studies.

Divided into nine chapters, the law covers everything from the National System of Ethics in Research with Human Subjects to the operation of Research Ethics Committees (CEPs), the protection and remuneration of research subjects, and the responsibilities of researchers and sponsors. The law applies to research involving drugs, medical devices, and experimental advanced therapies, encompassing the handling of data, information, and biological material. 

The new law focuses on reducing bureaucracy and increasing the efficiency of clinical study approvals. It establishes shorter and more defined deadlines for the evaluation and approval of protocols by ANVISA and CEPs, eliminating the need for dual review by CEPs and CONEP in many cases. Many cases, reducing the activation timelines for new trials in the country.

The law promotes greater transparency in ethical evaluations and decisions and professionalizes CEPs and CONEP, which will now function more as a regulatory and accrediting body. This is expected to improve the quality and consistency of ethical reviews, contributing to a more reliable, efficient, and safe research environment for participants. The National System of Ethics in Research, composed of a national body and the CEPs, is responsible for standardization, ethical analysis, accreditation, and supervision. This aims to ensure rigorous and ethical control of research conducted in the country. 

Participation in research is conditioned on signing the Informed Consent Form (ICF). Remuneration is prohibited, except in phase I clinical trials or bioequivalence studies, ensuring the integrity and voluntariness of participants. 

The most significant impact of the law is its potential to enhance Global Competitiveness. 

With a more stable and attractive regulatory environment, the new law is expected to position Brazil more competitively in the global clinical research landscape. The ethnic diversity and competence of Brazilian professionals already lend credibility to studies conducted in the country. Coupled with regulatory predictability and security, these factors can attract a greater number of clinical studies to Brazil. 

Presidential Vetoes: 

Two provisions were vetoed by the President for unconstitutionality and conflict with public interest: 

Communication to the Public Prosecutor's Office about the participation of indigenous people in research: Vetoed for violating the principle of equality and suggesting unnecessary state tutelage. 

Provision of experimental drugs for five years after commercial availability: Vetoed to ensure participants continue to have access to effective treatments for an indefinite period, according to the principles of dignity, beneficence, and justice. 

Conclusion 

Law No. 14,874 represents a significant advancement in the regulation of clinical research in Brazil, promising to promote scientific progress and attract more studies to the country. With greater agility, transparency, and protection for participants, the new law establishes a more favorable environment for innovation and ethics in clinical research, solidifying Brazil as an important center for global clinical studies.

Credits:

Fernanda Longo

Medical Relationship Manager

Vitor Hugo Nyari

Associate Director of Patient Feasibility, Enrollment and Retention