Project transfers volunteer treatment to the government – 12/04/2023 – Science

After eight years of discussions, the Chamber of Deputies approved last Wednesday (29) the bill that creates new rules for clinical research with human beings. With the change, the deadline for approval of clinical trials should be reduced.

The project, presented in 2015 by former senator Ana Amélia, goes back to the Senate with good chances of approval as it had already been previously approved in that house.

The Luiz Inácio Lula da Silva (PT) government, however, made demonstrations against the project, endorsed by the CNS (National Health Council).

For them, the new rules could weaken safeguards that currently defend scientific research with human beings, such as the existence of Conep (National Research Ethics Commission), which, according to them, would lose its functions.

In a position sent to Congress, the current management defends that Conep continues to be at the forefront of monitoring research on human beings.

Created in 1996, the commission has a multidisciplinary composition with the participation of researchers, bioethics scholars, jurists, health professionals, social, human and exact sciences and user representatives.

Another controversial issue in the project concerns the rights of voluntary research participants and the duties of the researcher, sponsor and entities involved.

Under current rules, treatment must be provided by pharmaceutical companies permanently and free of charge to patients who participated in clinical experiments.

The approved text guarantees the continued supply of the medicine to the participating patient by the manufacturers for five years after the research is certified or the medicine is already on the market. After that, it becomes the government’s obligation to guarantee continuity of treatment.

Interfarma (Association of the Pharmaceutical Research Industry) celebrated the approval of the project and considers it to be decisive in placing Brazil among the top ten countries in the global clinical research ranking.

For Renato Porto, executive president of Interfarma, the federal government’s demonstrations against the project are “technical counterpoints”.

“The text approved by the Chamber brings benefits to research centers and researchers, to the industry and, mainly, to patients participating in clinical studies”, he says.

In his opinion, the current rules for clinical research have a number of “technical obstacles”, such as lifetime post-study coverage, dual ethics and research evaluation system, and health and ethics analysis and approval time.

“These are points that put us at a competitive disadvantage in relation to other countries looking for investments in health.”

In 2022, Brazil occupied 20th position in the global ranking, with only 2% of clinical studies carried out in the world. The placement represents a drop in relation to the percentage of studies started in the country, which was 2.3% in 2013.

Countries such as Turkey, Taiwan and Egypt, with a smaller GDP, population and pharmaceutical market, surpassed Brazil in the ranking between 2013 and 2022. “The approval of the PL could help us reach 10th place, currently occupied by Italy”, says Porto.

According to a study by Interfarma, if it reaches 10th position, Brazil will be able to attract an estimated investment of R$3 billion/year, with even greater effects on the economy, around R$5 billion/year.

According to the new project, Anvisa (National Health Surveillance Agency) will have 90 days to analyze primary petitions for clinical trials with human beings for the purpose of health registration of the product under investigation.

The exception will be for complex products, whose deadline increases to 120 days. According to studies in the pharmaceutical sector, the agency’s analysis period currently exceeds 200 days.

Regarding voluntary and unpaid participation in research with human beings, the project says that interested parties will be required to present a free and informed consent form signed by the participant or their legal representative.

If the participant suffers any damages due to their participation in the research, the new legislation also determines compensation. The research sponsor will be responsible for paying this compensation and assistance.

If the research is sponsored by governments, national or international government agencies, or non-profit institutions, the Brazilian research institution may assume responsibility for compensation, exempting the sponsors.

If the research involves phase 1 or bioequivalence clinical trials, such as those carried out to confirm the functionality of vaccines or the effectiveness of generic medicines, volunteers may receive remuneration.

The volunteer may withdraw at any time, at no cost or loss to him or her. In addition, he will be entitled to reimbursement for transportation or food expenses, even if they involve his companions.

According to the project, if the research is of strategic interest to the SUS, it will have priority in ethical analysis and will have special analysis procedures.