Exemption for Four Patients Opens Door Further for Therapeutic Use of Psilocybin 


August 2020

Capital Markets Bulletin

Four Canadians with late stage cancer were recently granted approval by the federal Minister of Health, Patty Hajdu, to use psilocybin, a psychedelic compound obtained from certain types of mushrooms, in the therapeutic treatment of their end-of-life distress.[1] By obtaining a section 56 exemption under the Controlled Drugs and Substances Act (“CDSA”), they now have approval to possess and use psilocybin, which in typical circumstances, is prohibited.[2] These four patients are the first known individuals to legally use psilocybin since it became illegal in Canada in 1974.

Our recent article regarding the legal landscape of psychedelics in Canada here anticipated an increased likelihood of the use of the section 56 exemption of the CDSA based on an evolving knowledge of the therapeutic benefits of psychedelics.

In 2017, the same four individuals, led by Dr. Bruce Tobin and his non-profit coalition at TheraPsil, made a group application for a section 56 exemption to use psilocybin however, this application was denied in March 2020.[3] Each of the four individuals then made direct applications to the Minister of Health, and such applications were reviewed, and approved on compassionate grounds, within months.

The use of psilocybin to treat the fear and anxiety associated with end-of-life distress is not new to the scientific community. Many experiments and clinical trials were conducted in the 1960s and 70s before a prohibition on psychedelics put a stop to them. Now we are seeing recent studies in this area from institutions like Johns Hopkins University[4] and Imperial College London[5] gaining traction and legitimacy with their promising results.[6]

The recent grant of the section 56 exemption by the Minister of Health for the legal use of psilocybin may represent a watershed moment for further exemptions on a similar basis. TheraPsil is currently in the process of filing for more exemptions and is accepting applications on their website here. We anticipate that others may follow suit.

by Leila Rafi, Sasa Jarvis and David Jol Summer Student


[1] Alexandra Mae Jones, “Four terminally ill Canadians get special exemption to use psychedelic therapy” (4 Aug 2020), online: CTV News: here.

[2] Controlled Drug and Substance Act, SC 1996, c19, s4-7.

[3] Jackie Dunham, Avis Favaro, and Elizabeth St. Philip, “Terminally ill Canadians apply for legal access to 'magic mushrooms' drug” (8 June 2020), online: CTV News: here.

[4] Roland R Griffiths et al, “Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial” (30 Nov 2016), J Psychopharmacol, 2016 Dec; 30(12): 1181–1197, online: National Centre for Biotechnology Information: here.

[5] R L Carhart-Harris et al, “Psilocybin with psychological support for treatment-resistant depression: six-month follow-up” (8 Nov 2018), Psychopharmacology, 235(2), 399–408, online: APA PsycNet: here.

[6] Simon Reiche et al, “Serotonergic hallucinogens in the treatment of anxiety and depression in patients suffering from a life-threatening disease: A systematic review” (2018), Progress in Neuro-Psychopharmacology and Biological Psychiatry Volume 81, 2 February 2018, Pages 1-10, online: ScienceDirect: here.

a cautionary note

The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.

© McMillan LLP 2020