On March 21st, 2022, Dr. Valorie Masuda MD received authorization under the Special Access Program (SAP) to treat six patients experiencing end-of-life distress with psilocybin and psychotherapy. GMP synthetic psilocybin was donated by Psygen Labs Inc., and Apex Labs Ltd. provided access to its psilocybin investigators’ brochure, in support of the SAP application. This is the first known case of psilocybin being accessed through Canada’s SAP since the Food and Drug Regulations were amended on January 5th, 2022 to allow access to psilocybin and other restricted drugs through the SAP. The six patients were treated in early April of 2022 by Roots to Thrive, co-led by Dr. Masuda
Some of the six patients were referred to Dr. Masuda by TheraPsil. Dr. Masuda is an TheraPsil-associate physician and TheraPsil Board member. With pro bono legal support from David Wood PhD at R-Group Legal, Dr. Masuda prepared and filed these patients’ SAP requests after their section 56 exemptions for compassionate access to psilocybin were either denied, or went unanswered, by the Minister of Health Jean-Yves Duclos. Dr. Masuda describes:
“We worked collaboratively with the SAP team at Health Canada as well as the team at Psygen to make this happen”
One patient who was approved for SAP access, supported by Dr. Masuda and TheraPsil, is Thomas Hartle from Saskatoon Saskatchewan. Thomas Hartle was the first Canadian to access legal psilocybin-assisted psychotherapy in August 2020, after receiving one of the first four section 56 exemptions to legally use and possess psilocybin. Thomas re-applied for his section 56 exemption after it expired and has yet to hear back from Minister Duclos after waiting 176 days, to date. Now that Thomas has one-time access to synthetic psilocybin through the SAP he will be flying from Saskatoon to Vancouver Island for treatment.
Thomas Hartle had this to say:
“Getting access to this proven treatment through the SAP is bittersweet for me. While I’m grateful to be in line for one treatment, it has taken a whole team of people helping me to make that happen. This is not the reality for the vast majority of people needing access to this therapy. I’m hoping an awareness of the extraordinary effort expended by everyone involved will help to highlight how challenging, if not impossible, the current system makes things for the majority of patients. It also does nothing to address ongoing treatment. Any process that requires months to complete for a terminally ill individual, cannot be considered a success.”
Patient rights advocate and TheraPsil CEO, Spencer Hawkswell, had this to say:
“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. Now that has changed and allowed for safe, Canadain made psilocybin to reach those who need it. There are thousands of patients and doctors on our waiting list eager to receive the same safe access and we look forward to helping them.
Patients who are in medical need of psilocybin and psilocybin-assisted psychotherapy are encouraged to learn more about pathways to access on TheraPsil’s website here.
Canadian prescribers who want to learn more about how to support patients in legally accessing psilocybin-assisted psychotherapy through the SAP are encouraged to email email@example.com with the subject line “SAP Prescriber Inquiry”.
TheraPsil is a Canadian non-profit organisation dedicated to advocating for patients in medical need of psilocybin and psilocybin-assisted psychotherapy. Learn more at therapsil.ca.