The Future of Psychedelics in Canada: What Changed and What's Next?
Throughout this series of posts, we have discussed the history of psychedelic research, the neuropharmacology of psychedelics, and the excitement that researchers have for the future as we enter the psychedelic renaissance (1,2). What spurred this newfound excitement and our series of posts? We will take a closer look at the recent change by Health Canada to increase access to psychedelic therapy and where there may be room for improvement.
Original image by Pixabay
In 2021, there was an amendment to the Food and Drug Regulations allowing access to psychedelics for therapeutic purposes through the Special Access Program (3). The Special Access Program has been in place for a number of years, so what changed? The recent amendment is an alteration of an amendment made in 2013, that modified the substances that could be requested under the Special Access Program, specifically to no longer allow access to restricted drugs, listed in Part J of the Food and Drug Regulations (3). Psychedelics are listed in this section of the Food and Drug Regulations. Health Canada stated the original amendment in 2013 that removed restricted drugs from the Special Access Program was due to the limited clinical potential for these substances, while the reversal is due to the emerging evidence of potential therapeutic benefit (3). (If you want to know more about how psychedelics act on the brain, you should check out the post by Jessica: Over the counter and outside the box)
The history of psychedelic research has shown some promise, however, there have been some concerns about the way some of the research was conducted which may have prompted the 2013 amendment to remove restricted substances from the Special Access Program. (If you want to know more about this history, you should check out the previous post by Emine: The Good, the Bad, and the Ugly - of Psychedelics Research)
Prior to the recent amendment allowing access to restricted substances through the Special Access Program, access to psychedelics was available through another strictly monitored exemption process, under section 56 of the Controlled Drugs and Substances Act. The section 56 exemption must be approved by the Federal Minister of Health, and is granted under three specific circumstances: for scientific purposes, medical purposes, or otherwise in the public interest (4). Applications for a section 56 exemption are reviewed by Health Canada considering the balance of benefits and potential harms, the evidence of the need for the controlled substance, and the storage precautions (4). Psychedelics may still be accessed through this individual exemption, however, the Special Access Program is now the primary approved way to access psychedelics.
While there is excitement surrounding the recent revival of access to psychedelics through the Special Access Program, there seem to be ongoing issues that need to be addressed to ensure that those who could benefit from psychedelic therapy are able to access it. (If you want to know more about psychedelic therapy and mental health, check out the post by Tanisse: Women in Psychedelics Panel, Hosted by UBC Psychedelic Society: A review). Below is a recent story from CBC news that speaks to some ongoing challenges with accessing psychedelic therapy.
If the intention of the recent amendment is to increase access to psychedelic therapy via the Special Access Program, it is important to continue ongoing monitoring to ensure the program is meeting the need as intended. Hopefully, as the evidence grows for the psychedelic therapy thanks to exemptions issued under the Special Access Program, ongoing issues with regard to access will be addressed to make psychedelic therapy available to all those who could benefit.
Written by Claire
Hadar, A., David, J., Shalit, N., Roseman, Leor., Gross, R., Sessa, B. & Lev-Ren S. (2021). The Psychedelic Renaissance in Clinical Research: A Bibliometric Analysis of Three Decades of Human Studies with Psychedelics. Journal of Psychoactive Drugs, 1-10. https://doi.org/10.1080/02791072.2021.2022254
Ball, H. (2021). What is the Future of the “Psychedelic Renaissance” in Canada? McGill Journal of Law and Health. Available at: https://mjlh.mcgill.ca/2021/11/01/what-is-the-future-of-the-psychedelic-renaissance-in-canada/
Government of Canada. (2021). Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/ 2021-271. Canada Gazette, Part II, Volume 156, Number 1. Available at https://www.gazette.gc.ca/rp-pr/p2/2022/2022-01-05/html/sor-dors271-eng.html
Government of Canada. (2022). Exemptions from provisions of the Controlled Drugs and Substances Act. Health Canada: Controlled Substances and Precursor Chemicals. Available at: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/exemptions.html