Health Canada has released a Notice to Stakeholders, outlining its expectations regarding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy.
Despite mixed-messaging from Health Canada regarding their support for psychedelic therapy, the arc seems to be bending in the direction of a future of government-supported access. This notice shows that the agency is acknowledging that psychedelic therapy will be a reality going forward, and is thus doing its bureaucratic duties and getting stuff down in writing as to expectations and standards of practice.
From their introduction:
Health Canada recognizes the growing interest in the use of psychedelic-assisted psychotherapy and of the possible psychological and physical risks to clinical trial participants associated with this type of therapy. Because of these risks, Health Canada is publishing this notice to outline its expectations regarding the implementation of risk-management measures by clinical trial sponsors. Although there are no established clinical practice guidelines for psychedelic-assisted psychotherapy, some best practices are emerging in the literature. This document is intended to reflect these best practices.
The notice is broken down into sections, including:
- Risk-management measures for CTAs involving psychedelic-assisted psychotherapy
- Expectations regarding therapists and clinical setting
- Good manufacturing practices (GMP)
This isn’t headline-grabbing news, but shows that the lurching bureaucratic machine is slowly moving in the right direction.