Preclinical and Clinical Trial Requirements
The requirements for conducting preclinical and clinical trials in Brazil. Prepared in association with Trench, Rossi e Watanabe one of Brazil’s most prestigious law firms, this is an extract from The Pharma Legal Handbook: Brazil, which can be purchased for GBP 99, here.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
2. How are clinical trials funded?
Clinical trials are funded by sponsors (an individual or legal entity, public or private, who finances the trial).
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Clinical trials are subject to approval from a CEP and, in certain cases, by CONEP and ANVISA.
4. What are the requirements for consent by participants in clinical trials?
Participants must sign an Informed Consent Form, which must contain all necessary information, in clear and objective language, so the participant and/or his legal representative clearly understand the research in which he/she is willing to participate.
It must contain, for example: a) justification, objectives and procedures that will be used in the research detailing the methods applied, notifying the possibility of their inclusion into control or experimental groups, when applicable; b) explanation of potential side effects and risks resulting from participating in the research, besides the benefits expected from such participation and presenting measures and cautions to avoid and/or lower effects and adverse conditions that may cause damage, taking into account the characteristics and context of the research participant; c) clarification regarding monitoring and assistance that the research participants are entitled to, including the benefits and monitoring following the closure and/or interruption of the research; d) granting of total freedom to the research participant to refuse to participate or to remove his/her consent at any stage of the research, with no penalty; e) assurance of confidentiality and privacy of the participants during all phases of the research; f) clarification regarding reimbursement and how expenses incurred by the research participants will be covered; and g) clarification of indemnification guarantees for any damages resulting from the research.
5. May participants in clinical trials be compensated?
Participants may not be compensated, except those involved in clinical trials in phase 1 and in bioequivalence studies.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
According to Resolution 466/2012, which governs the conducting of clinical trials (from an ethical perspective), the Informed Consent Form must not contain any provision (i) excluding the sponsor’s/investigator’s/institution’s responsibilities; and/or (ii) that leads to a participant’s waiver of their rights to seek indemnification for any damage.
The abovementioned rule does not accept the limitation of responsibility and/or indemnification. The sponsor and the institution are liable for any damages, predicted or not, caused to the patients and with the informed consent contain any disclaimer of liability, such disclaimer may be deemed unenforceable and the judiciary system may impose indemnification due to the damages caused.
Also, the same rule states that the research must guarantee that the benefits of the project are available to research participants, such as access to the proceedings, products or research agents. It may be concluded that study drugs and/or clinical trials must be provided to the research participants even after termination of the clinical trial.
It could be understood that the sponsor must provide and pay for the necessary medical proceedings during the course of the research. This position was confirmed by Brazilian judiciary system, strengthening the obligation of the sponsor to finance the medical proceedings involved in the research. In other words, it is understood that the participant must receive the benefits of the results achieved by the research that he or she was part of, and they should not be used only as a means for achieving the sponsor’s objectives.
According to Resolution CNS No. 563/2017, which regulates the subject’s right to post-study access to clinical research protocols intended for patients diagnosed with ultra-rare diseases, the sponsor must undertake responsibility and guarantee to every subject at the end of the study free access to the best prophylactic, diagnostic and therapeutic methods shown to be effective over five years after its registration before ANVISA. This period is calculated from the issuance of the product registration or, for drugs, from the definition of the price before the CMED.