In August 2021, Inovatie held, in partnership with institutions supporting the pharmaceutical market, the Clinical Research Summit 2021. The event brought together several industry players to discuss the current scenario and the challenges to be overcome in conducting clinical studies in Brazil.
One of the lectures was given by Sonia Dainese, medical consultant and former president of the Brazilian Society of Pharmaceutical Medicine (SBMF), who brought the issue of access to post-study medicines to the debate. She began her presentation by emphasizing that this step should be thought at the beginning of the rehearsal, not at its end.
According to her, in a clinical research situation, implementing medication delivery after the study is not a simple task. “There is a series of practical, regulatory, ethical, legal, or logistical obstacles that make the process more complex. Who is responsible for the supply? And how long should that supply continue?”
The Bill (PL) 7.082/2017, which provides for clinical research with human beings, authored by Senator Ana Amélia, determines that the researcher must assess the need or not for continuity of experimental treatment in participating patients.
“Obviously, the risk-benefit ratio has to be favorable and the criteria for defining the need for continuity are, basically, the severity of the disease, the availability of satisfactory therapeutic alternatives and whether this experimental drug addresses a clinical need that has not yet been met, and the evidence of benefit must always outweigh the evidence of risk”, she stressed.
This PL also addresses when this supply should be interrupted because, according to Sonia, this is one of the most difficult questions to answer. “We need to have established whether this should occur by the decision of the participant himself, or when there is a cure or health problem, when an adverse reaction occurs that makes its continuity unfeasible, or for technical or safety reasons.” Sonia stressed that this decision should always consider that the study drug has uncertainties as to its efficacy and safety.
RDS No. 38/2013
However, while the PL is not approved, there are three options regarding access to medication: clinical trial extension, expanded access, or post-study drug provision. The last two situations are defined by Resolution of the Collegiate Board (RDC) No. 38/2013, from the National Health Surveillance Agency (ANVISA). Which approves the regulation for expanded access, compassionate use and post-study drug supply programs.
The supply of medication, according to the RDC, must be done free of charge by the sponsor fo the study, and this supply must be guaranteed in cases of chronic disease, The Resolution also mentions the responsibilities of the research center.
“The physician responsible for conducting the clinical trial has a series of attributions, such as formally requestion the product, properly storing the drug, notifying the sponsor of the occurrence of serious adverse events within the time provided by the legislation, in addition to providing the sponsor or the CRO the necessary documentation for all monitoring and assume responsibility for medical care in case of complications that are foreseen or no in the protocol”, explained Sonia.
In the expert’s opinion, it is not fair to transfer the burden of medical care to the industries that develop the drugs, in the same way that it is not fair to transfer the burden of drug development to the state or society. “There is no single recipe for post-study delivery. But the most important thing is that we think about providing this medication at the beginning of the clinical trial, not at the end”, she concluded.