On December 5, 2022, Health Canada published the following Notice to stakeholders: Health Canada's expectations regarding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy (the "Notice"). The Notice is primarily intended for clinical trial sponsors (the "Sponsors"), physicians and therapists regarding the administration of psychedelic drugs in clinical trials involving psychotherapy.
The publication of this Notice further highlights Health Canada's willingness to acknowledge the use of psychedelic drugs. Nevertheless, the recent openness shown since access to restricted drugs under the Special Access Program (SAP) has been restored is meant to be gradual and highly controlled. In this vein, the Notice serves as a reminder that psychedelic drugs can only be used for very specific purposes.
Health Canada first sets out its expectations regarding the implementation of risk management measures (the "Measures") by the Sponsors. These Measures are mandatory for all Clinical Trial Applications ("CTAs"), which will be evaluated by Health Canada to determine if a clinical trial is in the best interests of participants.1
As stated by Health Canada, the most frequently used psychedelic drugs in Canadian clinical trials at the moment are psilocybin and MDMA.
In addition, for all CTAs involving psychedelic drugs, therapists must be properly trained on evidence-informed protocols for psychedelic-assisted psychotherapy, and be licensed to provide psychotherapy by a regulatory body (where applicable in their jurisdiction). CTAs must include a full description of the qualifications of the therapists that will be recruited for the trial.
Rapport between the clinical trial participant and the therapist is critical to the evaluation of psychotherapies. Therefore, there should be adequate sessions before and after the administration of the psychedelic drug so that trust can be built. During the phase in which the drug is being administered, a licensed physician (identified in the CTA or in the site form) must be present to provide medical oversight of the clinical trial.2
Furthermore, Sponsors should establish contingency plans for potential serious adverse events. There also needs to be check-in visits in the days and weeks following administration of the psychedelic drug.
Lastly, both the physical and psychological risks of psychedelic-assisted psychotherapy, as well as the anticipated benefits arising from such therapy, should be clearly articulated in the informed consent forms given to participants. A copy of the statement, as set out in each informed consent form, that states the risks and anticipated benefits must be included in the CTA.3 The participant's written consent is required before the clinical trial can begin.4
Footnotes
1. The requirement whereby clinical trials must be in the best interests of participants is set out in paragraph C.05.006(1)(b)(ii)(B) of the Food and Drug Regulations, CRC, c. 870 (the "FDR").
2. Paragraph C.05.010(f) of the FDR.
3. Paragraph C.05.005(b) of the FDR.
4. Paragraph C.05.010(h) of the FDR.
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