An overview of recent changes to Canadian psychedelics law
Psychedelics are back! Interest in psychedelics is at its highest since the 1960s. Researchers are increasingly interested in using psychedelic medicines for difficult-to-treat mental health conditions such as post-traumatic stress disorder, depression, and anxiety. There are now about 25 companies on the Canadian Stock Exchange in the psychedelics sector. This growth in psychedelics research and companies is aided by recent attitudinal and legal shifts.
What are Psychedelics?
In this article, I define “psychedelics” as substances that bring on non-ordinary states of consciousness, and alter perception, mood, and cognitive processes. Individuals taking psychedelics typically experience a distorted sense of time (i.e., a feeling that time is sped up or slowed down), visual or auditory illusions, intense positive or negative emotions, and mystical-type experiences (e.g., feeling a strong connection to God, nature, or other humans).
Psychedelics, broadly defined, include classical psychedelics such as LSD (lysergic acid diethylamide) and psilocybin (the psychoactive ingredient in “magic mushrooms”), empathogens (substances that produce strong senses of emotional connection) such as MDMA (3,4-Methylenedioxymethamphetamine), and dissociative anesthetics such as ketamine.
The effects of psychedelics vary greatly by the type of psychedelic, the dosage consumed, the mindset the individual has going into the psychedelic experience, and the physical environment the psychedelic is used in. Psychedelics can be taken at a “macro dose” which produces psychedelic effects (e.g., visual illusions and a distorted sense of time) or a “micro dose” which is too low to produce psychedelic effects but may produce other effects (e.g., improved mood).
Medicinally, psychedelics are often used at a macro dose in combination with psychotherapy. Typically, patients will have a sober psychotherapy session with their therapist to prepare them for exploration therapy sessions where the patient will take a macro dose of a psychedelic. During the exploration sessions, the patient is guided through the trip by their therapist to work on the mental health condition they are trying to address. After the exploration sessions, the patient will have integration psychotherapy sessions with their therapist while sober to integrate the insights they gained from the exploration sessions into their daily life.
Psychedelics are generally considered physically safe and non-addicting. However, it is dangerous for individuals to use psychedelics unsupervised, especially when around physical hazards (e.g., heights and busy roads), as one’s spatial senses and decision-making ability may be affected.
Most psychedelics are controlled substances under the Controlled Drugs and Substances Act (CDSA), meaning it is illegal to possess or manufacture them without authorization. Researchers may possess controlled psychedelics for research purposes by seeking an exemption under the CDSA.
Prior to August 2020, the only way for patients to legally access psychedelics (with the exception of ketamine) was through clinical trials. Now, there are two new pathways for patients to access legal psychedelics for medical use: section 56 requests under the CDSA and Health Canada’s Special Access Program.
Section 56 Requests Under the CDSA
Section 56 of the CDSA gives the federal Minister of Health the broad power to exempt a person or classes of persons from any provision of the CDSA or its regulations if, “in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.”
Section 56 of the CDSA was used to provide legal access to medical cannabis before medical cannabis regulations were created. It has also been used to allow supervised drug consumption services and drug testing services. Section 4 of the CDSA prohibits the possession of a controlled substance without authorization under the CDSA, which makes these services illegal unless they receive a section 56 CDSA exemption.
In August 2020, the federal Minister of Health approved the first section 56 CDSA request to allow a patient to possess psilocybin mushrooms. The terminal patient requested the exemption so they could undergo psilocybin-assisted therapy to address their end-of-life distress. Psilocybin is a psychedelic that is naturally occurring in hundreds of mushroom types and has been shown to be clinically effective to treat end-of-life distress, depression, and anxiety. However, it does not yet have a Drug Identification Number (DIN) and cannot be regularly prescribed in any country.
Since August 2020, the Minister of Health has approved nearly 100 section 56 CDSA requests to allow individuals to possess psilocybin mushrooms. Most of the requests have been to treat end-of-life distress in terminal patients. However, a few requests have been to treat mental health conditions in non-terminal patients and to allow for healthcare professionals to take psilocybin to experience its effects so they can better provide psilocybin-assisted therapy.
TheraPsil, a non-profit organization based in British Columbia, has been helping patients and healthcare professionals make these requests. TheraPsil connects requesting patients with therapists trained to provide psilocybin-assisted therapy and trains healthcare professionals to provide psilocybin-assisted therapy.
Requests under section 56 of the CDSA offer a new legal avenue to access psilocybin-assisted therapy, but TheraPsil does not have the capacity to help the thousands of interested Canadian patients and healthcare professionals. Currently, there is also no legal way for requestees to purchase psilocybin—they are left to forage for mushrooms on their own.
The Special Access Program
The Special Access Program (SAP) is a Health Canada program that allows healthcare professionals (usually physicians) with prescribing privileges in their province or territory to request drugs for their patients that are not currently approved and available for sale in Canada. Normally, drugs must be approved by Health Canada for safety, effectiveness, and quality before they can be sold in Canada.
To be eligible for the SAP, patients must have a “serious or life-threatening condition” and conventional treatments for their condition must be unsuitable, have failed, or are not available in Canada. The SAP is typically used for patients with rare conditions to access drugs that are approved in other countries but not yet in Canada.
To date, no psychedelic medicine has ever been approved under the SAP. Drugs that are not available for sale in Canada, including psychedelic medicines, used to be eligible for the SAP before 2013. In 2012 to 2013, a small number of patients used the SAP to access prescription heroin. In response, Health Canada, under the Harper government, amended the SAP to prohibit any medicines containing drugs that the Food and Drug Regulations classified as restricted from being accessed through the SAP. This change effectively prevented heroin, psychedelics, and all drugs commonly referred to as “illegal drugs” from being accessed through the SAP.
Prohibiting “restricted drugs” from being accessed through the SAP was an arbitrary barrier and was not supported by clinical evidence. Even in 2013, there was clinical evidence that providing prescription heroin to some individuals with heroin use disorder enhanced their lifespan and reduced societal costs compared to conventional treatments.
After 2013, there were substantial advances in the clinical research of psychedelic medicines. For example, the United States Food and Drug Administration designated MDMA-assisted therapy for post-traumatic stress disorder and psilocybin-assisted therapy for treatment-resistant depression as breakthrough therapies in 2017 and 2018, respectively. This demonstrates that the preliminary clinical evidence indicates that psychedelics provide substantial improvements in health outcomes over currently available treatments.
In 2019, the Multidisciplinary Association of Psychedelic Studies Canada, a Canadian psychedelics charity sponsoring clinical trials for MDMA-assisted therapy, and other psychedelics and drug policy organizations began advocating for Health Canada to reverse the 2013 changes to the SAP.
On January 5, 2022, Health Canada amended the Food and Drug Regulations to reverse the 2013 changes to the SAP. Now all drugs, including psychedelic medicines, are potentially eligible under the SAP. However, this does not guarantee that psychedelic medicines will be approved or that producers will supply psychedelic medicines.
Health Canada reviews each SAP request on a case-by-case basis and evaluates if there is credible information on the safety and efficacy of the drug to support the decision to prescribe it. This means that initially, only the more researched psychedelics—such as MDMA and psilocybin—will likely be approved under the SAP.
The Future of Legal Psychedelics
Neither the recent changes to the SAP nor the trend towards granting section 56 CDSA requests to access medical psilocybin will open the floodgates to psychedelics. Both of these pathways to legal psychedelics are currently limited to patients with serious medical conditions or to healthcare professionals training to provide psychedelic-assisted therapy.
Even if patients receive legal authorization to obtain psychedelics, they are experiencing difficulty purchasing psychedelics from authorized dealers. This issue will hopefully address itself this year as dealers seek to serve growing SAP and section 56 CDSA patients.
Psychedelics-assisted therapy still remains cost-prohibitive for most Canadians as psychedelic medicines and psychedelic-assisted therapy is costly to access. Even regular (sober) therapy has no or limited coverage under most public and private health insurance plans.
Using psychedelics for other beneficial purposes such as spirituality, creativity, or social bonding remains illegal in Canada and the Government of Canada seems unlikely to change this soon.
Still, we are seeing the stigma of psychedelics dissipate and our laws changing to allow more access to psychedelic medicines.
Editor’s Note: Taylor Rodrigues is the National Drug Policy Lead for the Multidisciplinary Association of Psychedelic Studies Canada and advocated for the recent changes to Health Canada’s Special Access Program.
