Health Canada Approves First Special Access Program Requests for Psilocybin
This page summarizes Health Canada’s first known Special Access Program authorization for psilocybin, issued to support treatment for six patients experiencing end-of-life distress. It describes the SAP request process, the clinicians involved, and the supply and legal support used.
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This page explains Health Canada’s first known Special Access Program (SAP) authorization for psilocybin following amendments to the Food and Drug Regulations on January 5, 2022. The article describes how restricted drugs could be accessed through the SAP and provides a concrete example of that process in practice. The main case discussed is the March 21, 2022 authorization received by Dr. Valorie Masuda for six patients experiencing end-of-life distress. The article notes that treatment was delivered with psilocybin and psychotherapy by Roots to Thrive. It also identifies the supporting contributors involved in the request and treatment pathway, including GMP synthetic psilocybin donated by Psygen Labs Inc., access to Apex Labs Ltd.’s investigators’ brochure, and pro bono legal support from R-Group Legal. The content is most relevant to healthcare professionals, patient advocates, and others interested in regulated psilocybin access in Canada.
Who is this for?
Healthcare professionals, patient advocates, and others interested in regulated psilocybin access in Canada.
About the Provider
TheraPsil is a Canadian nonprofit focused on legal access to psychedelic-assisted therapy for people in medical need. Its current public work spans patient navigation, prescriber and therapist training, referrals, and sustained advocacy around federal access pathways. The organization remains one of the clearest Canadian patient-access stakeholders because it links policy work to concrete care pathways. Current materials show active work on Project Solace, ongoing clinician upskilling, and new Manitoba progress around MDMA-assisted therapy.
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- PricePrice on request
- Lifecycle statusNo New Dates
- SkillsPsychotherapyPsilocybin TherapyUnderstanding Canada’s Special Access Program for psilocybinInterpreting regulatory pathways for compassionate accessReviewing clinician and legal roles in SAP applicationsUnderstanding access to psilocybin-assisted psychotherapyUnderstanding Canada’s Special Access Program pathwayIdentifying regulatory access routes for psilocybinRecognizing regulated access pathways for restricted drugsUnderstanding psilocybin access pathways in CanadaInterpreting Special Access Program processesUnderstanding regulated psilocybin access in CanadaReviewing Special Access Program processesIdentifying clinician and legal roles in psilocybin access
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