On January 5, 2022, Health Canada made a historic amendment to its drug laws to allow restricted drugs, such as MDMA and Psilocybin, to be accessible, under special conditions, through the Special Access Program.
This amendment paves the path for MDMA-Assisted Therapy to be available for those in need, under special circumstances, outside clinical trials.
Here are the relevant details
The Special Access Program provides potential access to restricted drugs that are not approved for general clinical use, such a MDMA or Psilocybin.
Special Access is for emergency treatments only.
Special Access only applies to people with serious or life-threatening conditions.
Special Access only applies after the available conventional therapies have failed.
Prescribing practitioners have to apply for treatment on a case-by-case basis.
There has to be sufficient clinical research data on the safety and effectiveness of the treatment being applied for. Here, the amendment explicitly mentions that both MDMA-Assisted Therapy for PTSD as well as Psilocybin-Assisted Therapy for treatment-resistant depression have been granted “breakthrough status” by the FDA, a very rare designation reserved for new treatments that show better promise than anything currently available.
Practitioners are obliged to provide clients with information on the potential risks and benefits.
If granted special access, practitioners are obliged to monitor for and report any adverse effects.
If granted special access, practitioners are obliged to report the results of treatment to the drug manufacturer and to Health Canada.
This amendment is not a move towards the decriminalization or legalization of psychedelics.
This amendment to Canada’s drug laws is a result of the hard work, research, and advocacy by many individuals and organizations, including the Multidisciplinary Association for Psychedelic Studies, as well as an overwhelmingly positive response to Health Canada’s Notice of Intent inviting public feedback to the proposed amendment.
So what’s next?
As far as we understand, nobody in Canada (or elsewhere in the world) has yet received MDMA-Assisted Therapy through the Special Access Program outside of the clinical research trials. This world-wide precedent is waiting to be set.
Subscribe @ enhancedtherapy.ca to hear an interview with Scott Bernstein (drug policy and human rights lawyer and Executive Director of MAPS Canada) unpacking this new development.