A new bill has been hailed as a “significant step” towardsharmonizing rules in clinicalresearch and promoting safeand ethical scientific advances.
A Brazilian bill to regulate clinical research in humans and establish a Clinical Trials National Ethics System could help make Brazil become a top 10 market for conducting clinical research, according to Interfarma, which represents the research-based pharmaceutical industry in Brazil.
Bill 7082/2017 would create a legal framework for clinical research in humans, which is currently regulated by the National Health Council (CNS) and the country’s medicines agency (Anvisa).
The bill was approved with amendments on 29 November in the Chamber of Deputies
and must next go to the Senate for approval. It will also need presidential approval to transpose it into law.
The bill proposes that a new national body should be in charge of issuing regulatory rules on ethics in clinical trials, accrediting ethics committees, and monitoring and supervising the committees with regard to analyzing trial protocols and ensuring compliance with regulations. It would also be responsible for supporting and training ethics committee members.
The body would be linked with the health ministry and coordinated by the Secretariat for Science, Technology and Strategic Input. It would take over work done by CONEP, the National Research Ethics Committee, which is part of the National Health Council (CNS).
The bill proposes linking ethics committees to the institution that will be responsible
for carrying out the research, with researchers having to submit research protocols to the committee connected to the relevant research institution.
It also proposes to reduce the deadlines for granting research approvals. Committees would have 30 days to examine research protocols and reach one of three conclusions: approval of the research; non-approval; pending approval if there is a need to amend the protocol; or suspension if the research is approved but needs to be halted for safety reasons.
Research that is of strategic interest to the national health system will be prioritized.
The bill also sets out the rights of trial participants. For example, it stipulates that
voluntary and unpaid trial participants, or their legal representatives, will have to sign
an informed consent form, which must be written in a clear and legible manner.
According to the bill, participants are entitled to reimbursement for transportation and food as well as other expenses associated with taking part in the research. They can also withdraw fromresearch at any time.
Reactions
Interfarma, which represents Brazilian research-based industry said the bill could help make Brazil one of the top 10 global clinical research markets. It said the bill created a safe legal system and ensured ethical standards and patient protection were maintained, adding that the bill would harmonize Brazilian procedures with those in other top clinical research markets.
According to Interfarma, in 2020 Brazil ranked 20th in terms of the best markets for conducting clinical research, and a total of 2% of clinical studies carried out across the world were conducted there. Countries with smaller pharmaceutical markets, populations and
GDP, including Egypt,Taiwan and Turkey, have climbed above Brazil in the rankings,
but approval of the bill could still see Brazil climb to 10th position, said the association.
Legal experts agree the bill will be good news for Brazilian clinical research. “The
approval of the project is seen as a catalyst to establish a solid, ethical, and scientifically
robustgal system in the country. The 9recognition of the competence of Brazilianresearchers, their prominent participationin clinical studies during the pandemic,and the unique characteristics of Brazil,such as ethnic diversity and a robusthealthcare ecosystem, will contribute tonational competitiveness in this globalscenario,” said lawyers from the Brazilianlaw firm Campos Mello Advogados.
"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," they added.
Source: Francesca Bruce at http://pink.citeline.com/PS149543