The Brazilian Health Surveillance Agency (Anvisa) has asked Congress to change the bill that establishes rules for clinical research in humans (PL 7082/2017). Despite being favorable to the proposal, the agency argues that the deadline for authorizing the use of experimental medicines is greater than that predict in the bill, which was approved in the last week of April by the House of Representatives.
By the current version, Anvisa would have a 60-day deadline to evaluate experimental medications and 30 days to suggest modifications and amendments in clinical research. The Agency may apply for clarifications once through requirement.
According to Anvisa, the proposed bill can bring serious risks to the health of research volunteers and highlights that it is critical that the deadlines for authorization of clinical research comply with the operational capacity of the regulatory body and are in line with the deadlines by international authorities with regulatory action. The Agency does not suggest a specific period for evaluations, but quotes as an example the case of vaccines, whose minimum period defined by the European Regulatory Authority (EMA) is 180 days for the first demonstration.
Another critical point of the bill involves the free supply of the experimental drug within the so-called post-study supply program. The change limits in five years the period in which the patient will be entitled to the drug at the end of the research, as well as providing situations in which this supply may be interrupted. Currently, research participants have free and indefinite access to drugs that are effective.
This information involves clinical trials of protected drugs and the subject matters to pharmaceutical companies with interest in industrial property protection.