- Recently expanded Health Canada Special Access Program (SAP) allows physicians to apply for psychedelic medicines on behalf of patients
- An improvement compared to the section 56 exemption, which had long wait times, poor advocacy and insufficient psychedelic supply
- Limitations remain but the SAP is a positive step forward for psychedelic access in Canada
Psychedelics have come a long way since the “war on drugs” led to restrictions in the United States, Canada and around the world. Since then, through quality research and advocacy, interest in the utility of psychedelics for mental health is growing. Although stigma still exists, public perception of psychedelics has improved. A survey from the Canadian Psychedelic Association in 2022 revealed that 82% of Canadians approve of the use of psilocybin-assisted therapy for people with end-of-life illness (Canadian Psychedelic Association, 2021).
Despite mounting evidence of the efficacy of psychedelic therapy for the treatment of physical and mental disorders, access to these life-saving medications remains limited. Psychedelics are illegal in Canada except when accessed through Health Canada-approved pathways. However, psychedelic access improved this year, thanks to an amendment to the Special Access Program (SAP) on January 5, 2022, through which physicians can now apply for psilocybin, and other psychedelics, on behalf of their patients.
Why is the SAP such a significant step forward?
Health Canada prohibits the possession, sale, import, export, production, transfer and transport of all controlled substances. Previously, the only means of obtaining psilocybin was through an exemption granted by the Minister of Health under the Controlled Drugs and Substances Act Section 56, which allowed patients limited access. Section 56 exemptions are flawed for a number of reasons – most notably because wait times can be up to 300 days and patients often have to illegally source their own psilocybin. To date, although over 60 section 56 exemptions have been granted, over 150 remain unanswered (City of Vancouver, 2021).
“This [amendment] shows that Health Canada is aware of the promise of psychedelic therapy and committed to understanding more through further research,” says Dr. DJ Cook (Dagenhard, 2022)
With the recent SAP amendment, section 56 exemptions are now a secondary pathway to access, and only pursued if an SAP request has been denied. Despite Health Canada making it clear that this program should not be mistaken for medical legalization, the acknowledgment of psychedelic therapy through the SAP amendment is a positive sign.
Eligibility for the SAP
The SAP defines eligible patients as “having serious or life-threatening conditions where conventional treatments have failed.” These conditions may include intractable depression, epilepsy, transplant rejection, hemophilia and other blood disorders, terminal cancer and AIDS. Approvals are assessed on a case-by-case basis and are reserved for “emergency” treatments where conventional treatments have failed, are unsuitable or unavailable (Government of Canada, 2022). It remains to be seen exactly the types of conditions that will be approved through the program.
“I believe that, over time, we’re going to see ’emergency’ classified as people who’ve had consistent drug overdoses, for example, and we’re going to see this expand and morph.” – Kelsey Ramsden, Mindcure CEO (Fractal Fill, 2022)
Factors taken into account when determining eligibility include:
- The need for hospitalization or in-patient care
- The risk of adverse pregnancy outcome
- The risk of persistent disability in absence of treatment
- The prognosis of the condition
On March 21, 2022, Dr. Masuda became the first physician to receive SAP authorization, when she began treating six people with end-of-life distress with psilocybin (TheraPsil, 2022). Additionally, a few companies have received approval to supply patients through the SAP program. On June 16, 2022, Filament Health became the first of these companies to dose a patient through the SAP program. Despite this progress, it is still unclear how many approvals Health Canada will grant.
With a section 56 exemption, patients have to source their own psilocybin which often means acquiring it through illicit means or by growing magic mushrooms themselves. It is difficult for a patient to ensure they are accessing a safe supply of medication.
With the SAP, psilocybin is provided to physicians by Health Canada-approved licensed dealers. Patients are not permitted to possess the psilocybin themselves, but instead receive doses from their healthcare provider.
“This is a momentous occasion, the first legal access to a supply of GMP psilocybin in over 50 years. This is a major win for patients and doctors who have been left in the dark for the past 2 years with legal exemptions but no supply of psilocybin." – Spencer Hawkswell, TheraPsil CEO. (TheraPsil, 2022).
Additionally, this regulation ensures consistent psilocybin potency in the drug candidates ingested by patients, an important factor in order to ensure the best therapeutic effect. The potency of psilocybin can range widely between magic mushrooms, even within the same flush. Having licensed dealers who provide standardized psilocybin mitigates the possibility of adverse effects from the drug.
Despite this significant step forward, limitations remain regarding access to psychedelics in Canada. For example, the SAP does not require that the psilocybin is administered in a controlled setting. Given that “set” and “setting” are so important to the therapeutic process, this can be problematic.
“Having therapists and retreat centers and therapeutic settings where patients can [take psychedelics] in a way that respects the cultural and ceremonial aspects of the therapies is critical.” Dr. Cook (Dagenhard, 2022)”
Additionally, the application process is relatively burdensome, especially for patients who are experiencing debilitating conditions. Thomas Hartle, one of the first Canadians approved through the SAP program, believes that there needs to be more support:
“The vast majority of Canadians who need this therapy do not have access to the level of professional support that TheraPsil provided to me, and that played such a great role in my SAP application being approved. – Thomas Hartle (TheraPsil, 2022).”
The SAP represents exciting progress for both the psychedelic industry and psychedelic access in Canada. It is a signal from regulators that there is medical need for psychedelics. As more research and patient testimonies come in, we may start to see more widespread adoption of these life-saving medications.
- Canadian Psychedelic Association. (2021, Aug 4th). New poll shows a strong base of Canadians overwhelmingly support controlled legal access to psilocybin-assisted therapy; Canadian Psychedelic Association responds with Memorandum of Regulatory Approval (MORA). Global Newswire. https://www.globenewswire.com/en/news-release/2021/08/04/2274436/0/en/New-poll-shows-a-strong-base-of-Canadians-overwhelmingly-support-controlled-legal-access-to-psilocybin-assisted-therapy-Canadian-Psychedelic-Association-responds-with-Memorandum-of.html
- Government of Canada. (2022, Jan 5th). Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/2021-271″. https://www.gazette.gc.ca/rp-pr/p2/2022/2022-01-05/html/sor-dors271-eng.html
- City of Vancouver. (2021, May 28th). Request for an exemption from the Controlled Drugs and Substances Act (CDSA) pursuant to section 56(1) that would decriminalize personal possession of illicit substances within the City of Vancouver”.
- Dagenhard, C. (2022, Feb 1st). How Psychedelic Treatment Through Canada’s SAP Works. Psychedelic Spotlight. https://psychedelicspotlight.com/how-psychedelic-treatment-through-canada-special-access-program-sap-works/
- Fractal Fill. (2022, Feb 2nd). How Psychedelic Treatment Through Canada’s SAP Works. https://fractalfill.com/how-psychedelic-treatment-through-canadas-sap-works/
- TheraPsil. (2022, Apr 4th). Special Access Program requests for psilocybin Approved. https://therapsil.ca/health-canada-approves-first-special-access-program-requests-for-psilocybin/