At the end of August, new legislation will come into force regulating scientific studies involving human beings in Brazil. The federal law, which was passed by the government on May 28, seeks to speed up the approval of research proposals, including clinical trials of new drugs and treatments. Brazil’s Ministry of Health is still working on the regulatory framework that will be implemented. The new law promises to decentralize and accelerate the analysis of research proposals, which will be carried out in one single process, with research ethics committees (RECs) at hospitals and universities given more autonomy than they have today. At the same time, existing mechanisms that allow for societal participation in reviewing proposals may be reduced.
The law, which covers all fields of knowledge, establishes a nationwide ethics system for research involving humans, made up of ethics committees based at research institutions and a national body, which will be overseen by the Ministry of Health. The current system’s composition is almost identical, but with different responsibilities. Today, in addition to being reviewed by RECs, all proposals considered high risk, such as projects involving human genetics or new drugs, or that are coordinated or sponsored from abroad, must also be evaluated and approved at a federal level by the National Research Ethics Commission (CONEP), run by the National Health Council (CNS). Under the new rules, these proposals will only need to be reviewed by accredited RECs. The new national body will evaluate any appeals against REC decisions and will be responsible for training, accrediting, and supervising RECs.
Deadlines similar to those already stipulated by recent CNS resolutions will continue to apply — 30 working days for ethical analysis of a study after approval of the documentation by an REC, and 90 days for the Brazilian Health Regulatory Agency (ANVISA) to authorize the import of any drugs needed through a parallel review of the substances to be used in the research. The whole process should be shorter thanks to the removal of the CONEP assessment stage, which currently adds another 60 days. “The RECs will have more autonomy in this new framework. This is important because they are an integral part of the culture of their institution — they really understand the hospital or academic environment,” says pharmacist and biochemist Fernando de Rezende Francisco, executive director of the Brazilian Association of Clinical Research Organizations (ABRACRO).
Dr. Paulo Hoff of the São Paulo State Cancer Institute (ICESP) and Rede D’Or São Luiz in São Paulo says the two levels of approval led to unnecessary delays. “There have been improvements in recent years, led by CONEP. But the process could be more efficient,” says Hoff, who spoke before the committees analyzing the bill in National Congress due to his role as a research scientist and member of the Brazilian Society of Clinical Oncology (SBOC). According to the Industry Association for Pharmaceutical Clinical Research (INTERFARMA), it took an average of 215 days for a clinical trial to be approved in Brazil in 2018, while the average times taken in Argentina and the USA were 113 days and 32 days respectively. “We are the eighth biggest pharmaceutical market in the world, but we are 20th when it comes to those that initiate the most clinical research. We have great potential to grow,” says Renato Porto, executive president of INTERFARMA.
The current system, known as CEP/CONEP, was created in 1996 and is run by the CNS, an independent body linked to the Ministry of Health, with many representatives of civil society involved.
Léo Ramos Chaves / Revista Pesquisa FAPESP | Eduardo Cesar / Revista Pesquisa FAPESPProjects considered high risk, such as those involving new medicines, will be analyzed by accredited RECs onlyLéo Ramos Chaves / Revista Pesquisa FAPESP | Eduardo Cesar / Revista Pesquisa FAPESP
The new law will establish a new national body that will perform the role currently fulfilled by CONEP, managed by the Ministry of Health’s department of science and technology, with no involvement of the CNS. This potential change, which would reduce societal control over the system, has been the subject of questions and criticism. “In our opinion, this part of the new law is a big mistake,” says Laís Bonilha, a professor at the Federal University of Mato Grosso do Sul (UFMS) and current head of CONEP. “This is not the best approach for this process, the primary function of which is to protect the interests of research participants. By moving away from societal control and into areas with conflicting interests, there is a greater chance that conflicts of interest will arise,” she adds.
She believes the new body, which is yet to be fully defined, should be CONEP itself. “We propose that the CNS should retain this responsibility. In our interpretation of the law, this would be possible,” emphasizes Bonilha.
Bioethics specialist Ronildo Alves dos Santos, head of the Ribeirão Preto School of Nursing’s REC at the University of São Paulo, says the new law has both benefits and drawbacks. “We finally have legislation that deals with ethics in research involving humans in Brazil,” he states. “The great loss is the lack of participation by society as a result of the removal of the CNS from the system,” he notes. Another negative point, according to Santos, is the number of “research participants” — representatives of volunteers who take part in clinical trials — required to sit on ethics committees. “Currently, CONEP requires at least two per committee, but the new law will reduce this number to just one,” he says.
The final bill was subject to two presidential partial vetoes, and it could still be overturned by Brazil’s National Congress. The first change was to remove a requirement that the public prosecutor be informed whenever Indigenous people participate in clinical trials, after it was argued that the rule makes it difficult for Indigenous people to take part in trials. The second veto related to post-trial medication and treatment provided to patients when a study is suspended or completed. The bill originally stated that participants would receive treatment at the expense of the trial funder for five years after the study. After this period, if the product is on the market, it would be provided by a private health insurance plan or Brazil’s public health system (SUS). “No patient would be left without treatment,” says ABRACRO’s Rezende. After the line-item veto, the current rule of providing treatment indefinitely will be maintained. “People who participate in clinical research have the right to access their benefits for as long as they need them. There are cases where people have rare diseases and often only survive thanks to these treatments,” points out Bonilha.
When sought for comment by Pesquisa FAPESP, the Ministry of Health stated that the regulations to be established when the new law is passed are still under development. “For now, until the law comes into force, the CEP/CONEP system continues to function as normal,” adds Bonilha.
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