Bill (PL) 200/2015 was proposed by the senate on April 07, 2015 and has raised an intense debate within the Brazilian Scientific Community. Public and private institutions substantially differ in their opinions on the draft law which provides for new rules on the conduction of clinical trials on human beings.
Debate on this matter began as early as 2014 after a public hearing in the Committee on Social Affairs initiated by the Senate. At the hearing, several problematic issues were discussed and the bureaucracy involved in the clinical trial protocol analysis appeared to be a motivational factor for change to the system. The problems highlighted at the hearing prompted the creation of a non-profit organization1, whose work led to the introduction of Bill PL 200/2015.
Although the bill seeks to expedite the procedure in the clinical trial protocol analysis, its provisions are seen as polemic and find strong resistance from institutions connected to the government. The National Health Council (CONEP), the Oswaldo Cruz Foundation (FIOCRUZ), the Brazilian Bioethics Society (SBB) and other institutions oppose the bill, arguing that several provisions allow for the predominance of health industry interests in a way that is detrimental to the protection of life and health of participants to clinical trials.
A number of controversial issues regarding Bill PL 200/2015 are as follows:
- Drug supply after the study is closed:
Present position: If the use of a drug is beneficial to the participants, the sponsor must provide the drug gratuitously and for the time that it is necessary, even if the study is closed (Resolution CNS 466/2012).
Changes proposed in PL 200/2015: After the studies are closed the participant would only have the right to the use of the drug in exceptional situations (for example, if the interruption of the drug use implies risk of death or aggravation of relevant health conditions and in addition there is no therapeutic alternative treatment available in Brazil).
- Use of placebo:
Present position: The National Health Council (CNS) and Federal Council of Medicine (Conselho Federal de Medicina – CFM) only allow the use of placebo in clinical trials in Brazil if there is no available treatment for a certain diseases.
Changes proposed in PL 200/2015: If scientific justification can be shown, the placebo could be used in trials even when treatment is available for the disease in question.Another controversial aspect of the bill is that it does not mention the role of the CONEP in the clinical trial procedure. The current protocols provide for a system for ethical analysis of clinical trials on human beings and are overseen by the CONEP and CEPs from the whole country. All research related to human beings must be submitted for analysis and approval through this system. PL 200/2015 appears to delegate this ethics supervision mechanism to the sanitary authorities, a position which has been heavily criticized by those institutions arguing against the bill.
In addition, PL 200/2015 does not explain how the Committees on Ethics in Research (CEP) will be regulated. The bill provides for the creation of two kinds of CEPs: the institutional and the independent. This latter of these would be dependent on internal or external financial resources.
The bill is now with the Committee on Constitution, Citizenship and Justice of the Senate, where a rapporteur will be assigned. A report on the approval, amendment or dismissal of the bill is expected in due course.
1 This non-profit organization was named Aliança Pesquisa Clínica Brasil and brings together representatives of patients, doctors, researchers, labs and public and private institutions such as the Brazilian Research-based Pharmaceutical Manufacturers Association (Interfarma), the Federal University of Rio de Janeiro (UFRJ) and the Brazilian Medical Association (AMB), among others.
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