Psilocybin Regulation, Litigation and Fascination in the Law


Psilocybin Regulation, Litigation and Fascination in the Law

Psychedelics were formally “discovered” in 1897 when Arthur Heffter isolated mescaline from the peyote cactus for the first time. Psychedelics have been used for centuries, however, by various cultures in ritual and medical contexts, and these uses have most recently piqued the interest of science and industry for their promising antidepressant, anxiolytic and anti-addictive effects.1 The consensus appears to be that psychedelic therapies offer a very real alternative approach to conventional medical concerns by expanding consciousness and appear to have real physiological benefits for patients.

Public opinion on psychedelics took a relatively negative stance in the 1960s2 and in the 1970s most psychedelics, psilocybin (magic mushrooms) included, became illegal in Canada. An underground culture of psychiatric and therapeutic professionals began and continued to use psychedelics to facilitate talk therapy for many patients. This practice continues today, although in Canada recent legislative amendments have made it possible for this therapy to occur in a legal setting.

Health Canada, the federal regulatory agency in charge of regulating substances such as psychedelics, has indicated repeatedly that clinical trials are the most appropriate method for studying and treating individuals using psilocybin. Health Canada recognizes that access to psilocybin may be appropriate in some circumstances and as such has offered three pathways for patients to access the substance:

  1. Clinical trials;
  2. The Special Access Program (SAP); and
  3. An individual s.56(1) exemption under the Controlled Drugs and Substances Act (CDSA).

There are currently a number of clinical trials underway, some of which have produced positive results thus far. The Special Access Program was introduced for psilocybin in January 2022 when the Food and Drug Regulations were amended. The law now allows for a Licensed Dealer, which holds lawful authority, to possess, purchase, and/or produce psilocybin to ship a quantity of psilocybin to a physician who agrees to receive it on behalf of a patient participant in the SAP. Thus far, physicians have been resistant to this responsibility and access issues exist for many patients seeking relief from treatment-resistant depression, end of life anxiety, substance use disorders, and certain forms of chronic cluster headaches and migraines. Significant numbers of large pharmaceutical companies as well as local coalitions of like-minded researchers, doctors and patients, have been working to study and spread information regarding psilocybin and its effects on patients who may not be able to find relief using any other medicine that is currently available.

In 2020, a number of patients and medical professionals sought and were granted section 56 exemptions under the CDSA to possess psilocybin to use as a treatment for a variety of medical issues, including treatment-resistant depression. Oddly, a significant number of healthcare professionals were also granted these exemptions for the purposes of training — the idea being that they needed to experience the substance if they were to provide psilocybin-assisted psychotherapy to patients. These exemptions have slowed down significantly since then as the government directs more and more individuals and groups to the SAP and clinical trial model, rather than the s.56 exemption route. This has again resulted in significant frustration for patients and caregivers as well as significant gaps in access and delays in access to life-saving healthcare.

In response to these delays, in July 2022 litigation began in the Federal Courts in a case called Thomas Hartle et al v Canada3 challenging the delays as well as the availability of natural versus synthetic psilocybin for participants in the SAP and clinical trial access routes. That litigation is ongoing. Meanwhile, similar to the “Compassion Club” model for medical cannabis, particularly in British Columbia, small psilocybin storefronts began to open in Vancouver, B.C., as well as various locations across the country, offering to provide access to psilocybin for medical patients who are unable to access psilocybin using the federal government’s three proposed routes. Often, these shops will require patients to provide proof of an ailment requiring the substance, and even proof that they hold an authorization or exemption allowing them to possess the substance. The legal issue is relatively clear: by providing lawful authority to possess (and subsequently consume) the substance, but no legal way to purchase or access it, the federal government effectively created a situation in which patients had to break the law in order to access their medicine.

The City of Vancouver, thus far, has elected to manage the issue through their business license bylaw and zoning bylaw, although many shops have sought and received licenses for Limited Service Food Establishment. It remains to be seen whether these licenses will satisfy the City of Vancouver’s licensing and zoning requirements, or if legislative amendments need to occur for the City to introduce a licensing scheme similar to its Medical Marihuana Related Use bylaw, which was used to manage compassion clubs in the city prior to the federal legalization of cannabis.4 On March 5, 2024, I appeared before a special appeal panel appointed by the City of Vancouver’s mayor to decide whether or not a City of Vancouver business licence can be amended or have conditions attached to it, which would allow for medical patients to access their psilocybin and other entheogens from storefronts holding licences within the City of Vancouver. That appeal was successful, and my client now holds a licence authorizing activities involving entheogens. Similar to cannabis, these large constitutional issues appear to ground themselves in the global issue of broad mental health issues across the world brought on in part by the stressors of the COVID-19 pandemic, but curiously in British Columbia are litigated mostly in the “local” space, i.e., the highly regional forum of municipal law, rather than federal criminal law.

At present, there are approximately 20 psilocybin compassion clubs operating in Ontario and at least as many operating throughout British Columbia, with the bulk existing in Vancouver. In Ontario, Quebec and Manitoba, those working at or operating these compassion clubs are subject to raids by police and face criminal charges. In British Columbia, thus far, the focus has been on compliance with municipal business licensing. Meanwhile, the SAP, at last count, had provided for legal access to psilocybin for less than 10 patients since its introduction in 2022. This is clearly not enough given the sheer numbers of patients reporting treatment-resistant depression in Canada, and the consequence has been the rise of unsanctioned compassion clubs across the country.

There is a legal principle known as “subsidiarity” in which it is suggested that the decision maker most closely affected or linked to a legal issue should decide it. It appears, at least to me, that within the City of Vancouver this issue is, according to subsidiarity principles, best decided by City Council who is elected to represent the interests of those residing within the City of Vancouver and who are often affected not only by these shops offering compassionate access to psilocybin as medicine, but also those residing near these shops who may wish for the City to impose a set of rules for their safe and sensible operation. It goes without saying that these decisions will provide a road map potentially for other municipalities, provinces, and, indeed, Canada as a whole.

  1. See for example, online. |
  2. See online. |
  3. Federal Court File Number: T-1560-22. |
  4. Vancouver (City) v Weeds Glass and Gifts Ltd., 2020 BCCA 46 and related litigation. |

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