Health Canada’s Special Access Program (SAP) allows healthcare professionals to access drugs not yet authorized for sale in Canada for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable. As of January 2022, this includes the ability to request access to psychedelic substances for psychedelic-assisted therapy.
The primary substances used in this context are psilocybin (found in “magic mushrooms”) and MDMA (“ecstasy”). These drugs can produce altered states of consciousness, potentially lasting for hours and impacting patients’ emotional states. Given these effects, the environment in which these substances are administered is crucial for reducing psychological risks.
Access through the SAP for these substances is considered on a case-by-case basis and is intended for serious, treatment-resistant, or life-threatening conditions when other therapies have not been effective, are unsuitable, or are unavailable in Canada. The program is science-based and requires evidence to support the potential effective and safe use of these drugs for treating specific medical conditions. It’s not intended to promote the early use of these drugs, for research purposes, or to bypass the clinical trial or drug review process.
The SAP office will consider the following in the application:
- Longstanding and serious medical condition
- Treatment Resistant Depression, Major Depressive Disorder, End of Life Distress (Psilocybin)
- Post Traumatic Stress Disorder (MDMA)
- Suicidal ideation may be approved. Family history of bipolar disorder or schizophrenia may not be approved.
- Currently experiencing low mood, fatigue, insomnia, feelings of anxiety, feeling overwhelmed, and so forth not due to work, home, or typical life stressors.
- Compliance with current psychotropic medication.
- Conventional treatments must have failed, be unsuitable, or be unavailable for the patient. This is a crucial criterion, as the SAP is often considered a last resort when other treatment options have been exhausted
- A comprehensive list of treatments tried and NOT tried for medical condition must be provided.
- Must have tried psychotherapy (e.g., Cognitive Behavioural Therapy).
- It is not a requirement that the patient has tried ketamine or neurostimulation treatments (e.g., Electroconvulsive Therapy, Repetitive Transcranial Magnetic Stimulation), however, justification may be requested.
- A comprehensive list of treatments tried and NOT tried for medical condition must be provided.
These criteria are designed to ensure that psychedelic-assisted therapy is only provided to patients who are most likely to benefit from it, under circumstances where traditional treatment options have not been successful. The SAP’s process is rigorous, reflecting the seriousness of allowing access to controlled substances for therapeutic purposes.
