Brazil: Legal Framework for Clinical Research with Human Subjects

Known as the Clinical Research Law, Federal Law # 14.874/2024 came into force on August 28^th, 2024. 

1. Main Objectives of the Clinical Research Law: 

• Foster technical-scientific development. 
• Improve legal security for those involved in clinical research. 
• Reduce approval times for conducting clinical research in Brazil. 
• Protect the dignity, safety, and well-being of research participants. 

2. Is the Clinical Research Law fully in effect? 

• The law came into effect on August 28^th, 2024, but several of its provisions still depend on further regulation. 
• There are 2 presidential vetoes to the text of the law that are still pending review by the National Congress. Therefore, the law may still be adjusted. 

3. Why does this matter? 

• Clinical research is a very important activity for various health-related industries, such as pharmaceuticals and medical products, and is now regulated by law. Previously, there were only scattered rules from the National Health Council, but no general regulation. 
• With a greater degree of autonomy for Institutional Review Boards (known as CEPs, for its acronym in Portuguese), the need for double approval that occurred before will no longer happen. 
• By bringing principles, guidelines, and rules for conducting research, as well as defining responsibilities among researchers, sponsors, and research institutions, the enactment of the law suggests a deep understanding and adjustments in both protocols and research contracts, which must comply with the provisions of the law and regulations. 

4. Who needs to be aware of it? 

• Companies sponsoring clinical research. 
• Companies providing clinical research services. 
• Researchers and Research Institutions. 
• Institutional Review Boards. 

5. Some points that still need regulation: 

• Accreditation and/or certification of CEPs. 
• Definition of the degree of risk of the research. 
• Auditing
• Biobank and Biorepository. 
• National Registry of Volunteers for bioequivalence or phase I studies. 
• Rules on publicity, transparency, and monitoring of research. 
• Rules on the manufacture, use, dispensing, importation, exportation, storage, and disposal of products intended for clinical research. 

Souto Correa’s Life Sciences & Healthcare team is available to provide more information on the subject and assist in adapting to the new Regulation.