Chamber approves project for research on human beings – 11/29/2023 – Balance and Health

The plenary of the Chamber of Deputies approved a bill that regulates research with human beings in Brazil. The proposal provides for the principles, guidelines and general rules for conducting research with human beings by public or private institutions.

Authored by former senator Ana Amélia, and dated 2017, the project was approved by 305 votes in favor and 101 against. They advised against only the federations PT-PV-PC do B and PSOL-Rede. The text returns to the Senate, as there have been changes to the content.

Deputy Pedro Westphalen (PP-RS) was the rapporteur of the text.

The leader of the PT in the House, Zeca Dirceu (PR), even presented a request to withdraw from the agenda and another to postpone the vote for a session, but both were rejected.

Leader of the PP in the Chamber, deputy Luizinho (RJ) criticized the attempt by parliamentarians to postpone the vote on the matter this Wednesday, stating that it has already been in progress in Congress for years. “What people want is yet another reason to postpone the advancement of clinical research in Brazil. What people want is the corporatism of someone who wants to hinder research in the country,” he said.

Left-wing parliamentarians made a series of criticisms of the approved proposal. One of the points criticized is the one that establishes a maximum period of just five days for Anvisa (National Health Surveillance Agency) to inspect and release imported products for research purposes.

The approved project also establishes that research participants will receive experimental medicines for a specified period of up to five years after the conclusion of the research — currently, a resolution from the CNS (National Health Council) that deals with the rights of clinical research participants determines that they must have free and indefinite access to the products.

“This project is a scandal. It’s using people as guinea pigs and after five years releasing the big companies in the sector from paying for these people’s treatment. This project takes away the rights of people used in research, it’s a shame,” said the deputy Fernanda Melchionna (PSOL-RS).

Another point that was questioned by left-wing parliamentarians is what defines the maximum period of 90 days for health analysis related to primary petitions for clinical trials with human beings, for the purpose of health registration of the product under investigation. In the case of complex products, which will be defined in regulation, the maximum period will be 120 days.

“There is a 90-day deadline to complete the survey… Each survey is a survey, we cannot put into law what may be in the regulations adapting to each measure”, said deputy Jandira Feghali (PC of B-RJ), leader of the party in Home.

Jandira also said that the role of Conep (National Research Ethics Commission), linked to the SUS (Unified Health System) was “in limbo”. Currently, the commission’s main task is to evaluate the ethical aspects of research involving human beings in Brazil. In the approved text, however, there is no mention of the collegiate.

The project determines that research with human beings must be subject to prior ethical analysis carried out in a single instance by the Research Ethics Committee (CEP), but does not indicate which body will register, certify, supervise and train the CEPs. The rapporteur said that this will be determined by an act of the Executive.

Representative Adriana Ventura (Novo-SP) defended the approval of the matter. “It is very important that we approve this project, even if it is late. It is very important to raise technical issues and seek evidence, instead of remaining in this politicking, in this guesswork, in political advice. It is necessary to bring technique, evidence and ethics. Brazil is very behind in relation to other countries”, he said.