2022 in Review – An Evolving Canadian Psychedelics Landscape
The Canadian psychedelics landscape has noticeably shifted in the past year. However, these changes are not felt equally across the country. The varying provincial perspectives require a closer look.
Federal Steps Taken
As previously discussed here, the federal Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) SOR/2021-271 (the “Amending Regulations”), which came into force on January 5, 2022, restored the ability of healthcare practitioners in Canada to request access to “restricted drugs” (as defined in the Food and Drug Regulations CRC c 870), including certain psychedelics, from Health Canada on behalf of patients with serious or life-threatening conditions in instances where other therapies and treatments have failed, are unsuitable, or are unavailable in Canada. The Amending Regulations represent one of the most significant steps towards regulating and facilitating access to restricted drugs for medical purposes to date. In light of this development, certain Canadian jurisdictions have taken steps towards further expanding access to restricted drugs and particularly psychedelics.
Alberta has stood out as a leader in the progression of the Canadian psychedelic regulatory space in the past year. Amendments to Alberta’s Mental Health Services Protection Regulation, Alta Reg 114/2021, came into force on January 16, 2023 and authorizes the use of certain psychedelics for therapeutic purposes, including psilocybin, psilocin, ketamine, Lysergic acid diethylamide (“LSD”), 3,4‑methylenedioxymethamphetamine (“MDMA”), N,N‑Dimethyltryptamine (“DMT”), and mescaline. These psychedelics may now legally be administered alongside psychotherapy to treat individuals suffering from diagnosed psychiatric illnesses, such as PTSD or treatment resistant depression. With the exception of palliative care, the administration of the psychedelic-assisted therapy must take place at a medical facility (defined broadly as a facility in which health services are provided) or medical clinic and be administered by a team of specially trained medical practitioners, as particularized in the applicable legislation.
British Columbia, as another province that’s moving the dial forward, launched a three-year pilot program, on January 31, 2023, decriminalizing the personal possession of certain substances regulated under the federal Controlled Drugs and Substances Act (the “CDSA”). The cited purpose of this program, made possible through an unprecedented province-wide exemption under s. 56 (1) of the CDSA, is to address British Columbia’s overdose and substance abuse crisis by reducing stigma and harms related to substance use and increasing access to health services for drug users. Under this exemption, adults aged 18 years and older will not be arrested or charged for the personal possession of 2.5 grams or less of certain opioids, cocaine, methamphetamine, and the psychedelic, MDMA.
In Quebec, on May 5, 2022, Montreal-based clinic, Mindspace by Numinus, became the first private health-care facility in the province to have the ability to legally administer psilocybin and MDMA to treat treatment-resistant depression and PTSD, and has since administered psilocybin. Previously, in 2020, Numinus became the first publicly traded company to receive Health Canada approval to conduct research on standardizing the extraction of psilocybin from mushrooms. The team at Mindspace is now also submitting applications, via the revived Special Access Program, on behalf of candidates who hope to be eligible for treatment with psilocybin or MDMA. Once a candidate is approved, the psilocybin or MDMA (accessed through suppliers who manufacture the psychedelics) would be administered at the Numinus clinic with the supervision of a therapist.
New Brunswick, a province expanding access to psychedelics for medical purposes, is now home to one location of Field Trip Health, a chain of private clinics in the United States and Canada that treats PTSD with ketamine. Ketamine is controlled under Schedule I of the CDSA, and regulated as a “narcotic” under the Narcotic Control Regulations (rather than a “restricted drug” under the Food and Drug Regulations like many other psychedelics). It is, therefore, currently permitted for medical use, through a prescription from a general practitioner, nurse practitioner, or psychiatrist. The Fredericton, New Brunswick clinic treats a variety of patients, including veterans suffering from PTSD. The first Canadian location of its kind opened in Toronto in 2021. Field Trip Health’s ketamine-assisted therapy combines ketamine therapy with follow-up talk therapy, and all sessions are conducted with a registered therapist (i.e., psychotherapist or psychologist). Similar clinics have subsequently opened across various provinces nation-wide.
Saskatchewan’s provincial government has suggested that they will be taking a more cautious approach to the regulation of psychedelics, unlike their neighbors. Following Alberta’s announcement regarding the regulation of psychedelics for therapeutic purposes, the Saskatchewan Ministry of Health advised that they are not currently seeking an exemption for the use of psychedelics. The Ministry of Health stated that more research is needed on treatment efficacy before any further regulatory steps are taken. Despite the provincial government not currently wanting to seek an exemption, however, individuals in Saskatoon suffering from treatment-resistant depression or PTSD, for example, can get assistance accessing psychedelics with the help of the Linden Medical Centre. This clinic has successfully assisted patients with the completion of their Special Access Program application.
Manitoba’s Minister of Justice similarly advised on May 31, 2022, that the province will not be following suit after British Columbia to decriminalize the personal possession of controlled substances. Justice Minister Goertzen advised in an announcement that Manitoba will not seek out a federal exemption of their own; instead, choosing to focus their attention on preventing drug trafficking and supporting those struggling with drug addiction.
No Action without Research
As demonstrated above, individual provinces are taking different approaches to regulating psychedelics. However, it is evident that there is a push for increased research at both the federal and provincial level. As research continues to develop, the expertise surrounding this burgeoning field will inevitably flourish. Note that the below are some examples of this flourishing.
- On December 5, 2022, Health Canada released a Notice to Stakeholders (the “Notice”) regarding Health Canada’s expectations surrounding risk-management measures for clinical trials involving psychedelic-assisted psychotherapy. It is significant that the clinical trial process is starting to be defined because there are otherwise no established clinical practice guidelines for psychedelic-assisted psychotherapy in Canada. The Notice articulates best practices as described in the literature. This includes risk-management measures that outline the expectations regarding therapists and clinical settings, informed consent, and good manufacturing practices. The Notice also details Health Canada’s regulatory responsibilities which involve the promotion, monitoring, and enforcement of compliance with both the legislative and regulatory requirements related to clinical trials with controlled substances.
- In Ontario, the Centre for Addiction and Mental Health (“CAMH”), received the first Canadian federal grant to study psilocybin on July 27, 2022, funded through the Canadian Institutes of Health Research (“CIHR”). CAMH’s clinical trial will attempt to answer whether experiencing psilocybin’s psychedelic effects are necessary for the user to experience its potentially antidepressant impacts. The study will recruit 60 adults with treatment-resistant depression over the course of three years, some of whom will receive a placebo. The study aims to lead to future research that will validate this as a potential approach for treatment of depression without the use of intensive psychotherapy.
- On October 25, 2022, it was announced that the University of Guelph became one of the first Canadian universities granted a licence from Health Canada to cultivate mushrooms containing psilocybin. Researchers at the university were approved by Health Canada for a Dealer’s Licence issued pursuant to the CDSA. Such a licence allows an organization or company to possess a controlled substance and conduct certain activities specified under that licence. The researchers intend to create a supply of mushrooms in a high-security facility on campus for preclinical, and possibly clinical, trials involving psilocybin.
Despite a lively research industry into psychedelics, the market response has been cautious, however, as it is still very early days. There is an element of speculation that some investors are averse to. There is an instinctive comparison to the legal cannabis industry, and they face many similar challenges. However, psychedelics have some challenges unique to their industry that have, and will continue to, shape market response.
This is an evolving area of law that will continue to be monitored.