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Cortex - Life Sciences Insights

| 4 minutes read

New bill establishing rules for clinical trials with humans and instituting the National Ethics System governing clinical research - Brazil

Last Wednesday 29 November, the Chamber of Deputies approved Bill No. 7082/2017 (in Portuguese, “Projeto de Lei n° 7082/2017”), which regulates clinical research with humans and establishes the National Ethics System for clinical research with humans. The text had already been approved by the Senate but returned for Senate analysis due to modifications proposed by the Chamber.

Currently, the subject is regulated by sublegal norms of the National Health Council (CNS) and the National Health Surveillance Agency (Anvisa), and the bill proposes to create a legal framework for this field.

The approved text, authored by federal deputy Pedro Westphalen, establishes the rights of voluntary participants in research, including guarantees of privacy, data treatment, compensation, the need for express and prior authorization for participation, among others. It also outlines the duties assigned to researchers, sponsors, and entities involved in proposing, authorizing, developing, and concluding research.

Among the main changes to the current rules brought by the Bill includes: 

(i) a reduction in the deadlines granted to competent entities for analysis and approvals; 

(ii) the determination by the Executive Branch regarding the registration, training, and oversight of Research Ethics Committees (CEP), no longer by the National Research Ethics Committee (CONEP), an entity linked to CNS; 

(iii) the linking of CEP to the institution responsible for the research, and;

(iv) changes to the rules of access to approved methods and diagnostics in clinical research for participants.

The proposed changes, however, are not unanimously supported by all involved parties.

The lengthy deadlines granted to competent bodies for the approval and development of clinical research in the current regulations make the processes considerably slow compared to those practiced by many European and American countries, as well as in Latin America, hindering investment interest in the country in this sector, despite the capacity, potential, and national relevance for conducting clinical research — clearly demonstrated during the pandemic when clinical studies for four COVID-19 vaccines were developed.

The expectation, therefore, is that the approval of the Legal Framework will lead to a considerable increase and acceleration in the conduct of clinical research in Brazilian territory, benefiting not only patients but the entire health sector.

Regarding other proposed changes to the Legal Framework, especially the possibility of CEPs operating independently with their own regulations, and the Executive Branch determining the body responsible for registering, overseeing, and training them, as well as the linkage of CEPs to institutions responsible for conducting clinical research, some ethical and patient safety concerns were raised by CONEP, an entity responsible for the ethical analysis of high-complexity research protocols, research projects proposed by the Ministry of Health, and protocols of medium and low complexity research after prior approval by the competent CEP.

This restructuring would represent a significant change in the regulation proposed for Brazil. This raises relevant considerations, considering that in the United States and Europe, independent entities such as the Institutional Review Board (IRB) in the U.S. and the Research Ethics Committee (REC) in Europe play a crucial role in ethical evaluation and continuous supervision of research.

Public entities related to CONEP oppose their non-participation in the ethical regulation of clinical research, as provided in the approved bill. They argue that independent CEPs, linked to institutions conducting the studies, would weaken current national ethical guidelines.

Those in favor of the Legal Framework, especially patient groups and the medical community, argue that ethical, technical, and scientific rules will be fully preserved and inherent to the activities of all entities involved in the process, both public and private.

Finally, the rules for access to treatments resulting from completed clinical research for participants proposed by the bill, which differ from those provided in the current National Health Council resolution, were also criticized by those who voted against it, suggesting that participants and the public health system (SUS) would be harmed. However, the approved text does not exclude the patient's right to access treatment but only establishes rules for its acquisition and maintenance.

Despite the differing views among the interested classes and those involved in clinical research regarding the bill approved by the Chamber of Deputies last week, whose repercussions and discussions will continue in the Senate, it is indisputable that updating health regulations and creating a robust and secure Legal Framework to support clinical research is urgent and essential for the development of the sector in Brazil.

The prospect of positioning Brazil among the top ten countries in the global Clinical Research ranking is particularly compelling. The approval of the project is seen as a catalyst to establish a solid, ethical, and scientifically robust legal system in the country. The recognition of the competence of Brazilian researchers, their prominent participation in clinical studies during the pandemic, and the unique characteristics of Brazil, such as ethnic diversity and a robust healthcare ecosystem, will contribute to national competitiveness in this global scenario.

The economic impact will be substantial, with projections reaching multiple billions of Real, reinforcing the idea that the approval of the project will not only boost clinical research but also generate significant benefits for the country.

Last but not least, the harmonization of rules in clinical research plays a crucial role in the context of globalization. The trans-boundary nature of clinical research implies international collaboration, and the presence of diverse regulations can create obstacles and delay scientific progress. The pursuit of internationally aligned legislation not only simplifies the conduct of multi-center studies but also strengthens confidence in the global research system. Given the globalization of information and scientific advances, adopting a unified approach is imperative to ensure participant safety, data integrity, and efficiency in obtaining results. In this context, the approval of the Legal Framework in Brazil represents a significant step toward harmonizing rules in clinical research, promoting ethical and safe scientific advancement.

Certainly, the intersection of scientific advances, economic development, and improvement in the quality of life for patients is undoubtedly a central point in the approval of this bill.

CMA info

This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion. 

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.

Info Authors

  • Bruna B. Rocha (bio), Partner, Life Sciences, Healthcare, Cannabis
  • Juliana Marcondes de Souza, Associate, Life Sciences, Healthcare, Cannabis
  • Victoria Cristofaro Martins Leite, Associate, Life Sciences, Healthcare, Cannabis