Special Access Program Requests
The Special Access Program (SAP) is a program run by Health Canada that allows health practitioners (such as licensed physicians) to request, for patient use, drugs that are not sold legally in Canada.
SAP requests will only be granted for patients with a “serious or life-threatening condition” in cases where other conventional treatments have failed, are unsuitable for the patient, or are not available in Canada. There must also be “sufficient evidence of safety and efficacy for the treatment of [a] patient's condition” with a requested drug.
Accessing Psychedelics
On January 5, 2022, Health Canada’s amended SAP regulations went into effect permitting requests for “restricted drugs”, including psychedelics like psilocybin, LSD, DMT, and MDMA. However, a s. 56(1) class exemption in connection with the SAP regulation amendments was only granted with respect to psilocybin and MDMA, thereby effectively limiting SAP requests to those two particular “restricted drugs”.
Health Canada first proposed its amendment in December 2020. A 60 day comment period following the proposal closed on February 10, 2021.
Health Canada published a clarification notice regarding the amendment which can be found here.
Health practitioners can also request ibogaine for patient use through SAP, though Health Canada is reportedly not inclined to grant such requests, on the grounds that insufficient clinical data exists to recommend its medical use.
Submitting a Request
Persons seeking access to psychedelic-therapy through SAP can ask their physician or another appropriately-licensed healthcare professional to submit a request on their behalf.
Alternatively, some organizations and companies are offering assistance:
TheraPsil is a Victoria-based non-profit organization that facilitated the majority of non-research exemptions for legal psilocybin-assisted therapy in Canada. You can contact them here.
Roots to Thrive is a non-profit association of healthcare workers based in Canada providing psychedelic-assisted therapy.
Field Trip Health is a psychedelic-assisted therapy company based in Toronto. "Canadians interested in applying to the SAP for treatment of depression, anxiety, post-traumatic stress disorder as well as disorders affecting the central nervous systems through Field Trip are encouraged to contact the company by email at hello@fieldtriphealth.ca to begin the application process."
The Linden Medical Centre is a medical clinic in Saskatoon that offers ketamine-assisted therapy and now assists with SAP applications. You can contact them here.
Forms
Health Canada has created standardized request forms for health practitioners looking to submit SAP requests. The standard patient-specific request form can be found here. The completed form should be faxed without a cover sheet to Health Canada at 613-941-3194.
You can find more forms and information on Health Canada’s official SAP page, as well our forms page.
TheraPsil has created a helpful template version of the filled out form one can find here.
Obtaining Supply
At this time our understanding is that the only manufacturers licensed to supply psychedelics for SAP requests are Psygen and Filament Health.
Practitioners applying on behalf of patients may want to contact the companies before listing one of them on the SAP form to ensure supply is available.
Health Canada is only permitting the use of synthetic psilocybin at this time, though it has stated its openness to permitting natural psilocybin if it can be shown to “meet GMP quality requirements and be demonstrated to be equivalent to (or better than) purified or synthetic forms of psilocybin from a clinical perspective.”
Psychedelic-Assisted Therapy
Several organizations and companies in Canada now provide or help facilitate access to psychedelic-assisted therapy conducted by qualified practitioners.
Physicians and others looking for more information regarding psychedelic-assisted therapy options for patients may wish to contact TheraPsil (Victoria, BC), Numinus (Vancouver, BC), New Earth Therapy (Saskatoon, SK), or Roots to Thrive (across Canada).
You can find more information regarding the Special Access Program at Health Canada’s official page on SAP here.
We’ve also written a LinkedIn article with more information entitled Q & A: Requesting Psychedelic-Assisted Therapy Through Canada's Special Access Program.