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Canada Opens Access for Psilocybin and MDMA Therapy

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Canada recently amended its Controlled Drugs and Substances Act (CDSA) to allow for psilocybin and MDMA therapy in limited circumstances. Subsection 56(1) of the CDSA will exempt medical providers from enforcement of the CDSA when providing psilocybin and MDMA treatment to patients suffering serious or terminal health conditions. Thus, providing a new pathway for patients to access psychedelic treatment, and another example of the medicinal approach to psychedelic legalization.

Timeline of Medicinal Legalization in Canada

Canada’s Special Access Program (SAP) allows health care professionals to request drugs for patients with serious or life-threatening conditions where other available treatments fail to work (analogous to the Right to Try (RTT) program in the United States). Pursuant to subsection C.08.010(1) of Canada’s Food and Drug Regulations (FDR) statute, the Minister of Health can issue a “letter of authorization” allowing for the use of a new drug for emergency treatment. Once a letter of authorization is issued for a new drug, a physician must become a “licensed dealer” under subsection J.01.015 of the FDR before providing the new drug to a patient. Each request is decided on a patient-by-patient basis and approval is usually only given to drugs with successful phase II or phase II clinical trials.

In 2013, section C and J of Canada’s FDR statute were amended so that “restricted drugs” were inaccessible through SAP. Restricted drugs are controlled substances with no approved medical uses (think “Schedule I” in the United States) and are only available for scientific or research purposes. The 2013 amendment cut off access to SAP for psychedelic drugs like MDMA and psilocybin, leaving clinical trials as the only vehicle for patients to access psychedelic services.

Subsection 56(1) Exemption

In January 2022, the FDR statute was amended to give healthcare professionals access to restricted drugs through SAP. Subsection 56(1) of the CDSA comes into play because the exemption protects medical professionals and pharmacists from certain CDSA regulations when dealing specifically with MDMA or psilocybin. The changes to the FDR and CDSA do not outright legalize MDMA or psilocybin for medicinal use. Physicians still need SAP approval on a patient-by-patient basis and SAP approval is only granted when other available treatments prove ineffective.

The new exemption reflects the emerging global renaissance of psychedelic treatment. In 2020, Health Canada published a Notice of Intent alerting the medical community of the plan to reopen SAP to restricted drugs. A public comment period opened, and submissions overwhelming supported the exemption with 80% of respondents associating the 56(1) exemption with increasing access to psychedelic drugs. While the Canadian government maintains this exemption is not a step toward legalization, a publication from Health Canada discussing public support of 56(1) specifically highlights MDMA and psilocybin’s designation as a “breakthrough therapy” by the United States FDA.


Canada’s 56(1) exemption does not give the immediate green light for patients to access psilocybin and MDMA . 56(1) only restores the possibility of accessing restricted drugs though SAP. Publications from Health Canada stress that clinical trials are still the best avenue to access drugs like psilocybin and MDMA. Regardless, subsection 56(1) is an important landmark in expanding psychedelic access globally.

Brett Bio Block
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