Health Canada Special Access Program

Domain VII · Transpersonal, psychedelic & altered states · 2022 · Canada

What it is

The SAP is a regulatory access pathway, not a therapy. It lets a licensed prescriber ask Health Canada, case by case, for permission to obtain an unapproved drug for one patient with a serious or life-threatening condition when conventional treatments have failed, are unsuitable or are unavailable.…

Format

• Phase A: Pathway decision and team formation
• If approved: a letter of authorisation goes to the manufacturer for one named patient. The s.56 class exemption (psilocybin, MDMA) or an individual exemption covers the practitioner, nurses and pharmacists, with record-keeping and security terms.

Who practises it, and how they are trained or regulated

• The SAP does not set phases or session counts for psychotherapy. The structure below combines the regulatory sequence, which comes from sources, with the clinical frame that Health Canada expects and Alberta prescribes. Session numbers are not set by any source opened. ACSW says only that preparation "typically" takes several meetings.
• Goals: decide whether the client has a serious or life-threatening condition with failed, unsuitable or unavailable conventional treatments; check whether a clinical trial is available, since Health Canada calls trials "the best method to access experimental therapies"; identify a prescriber licensed in the province or territory; confirm the provincial rules (in Alberta, a licensed provider with a psychiatrist as…
• Move on when: a prescriber agrees to request; a willing licensed manufacturer is identified (Health Canada cannot compel supply, and manufacturers have refused over cost, supply or marketing); the team and venue meet provincial and college rules.

Evidence status, as the guide reports it

• The prescriber submits Form A with the drug and manufacturer details, the treatments considered or tried and why they failed or are unsuitable, the evidence on use, safety and efficacy for this condition, and a shipping address. Health Canada does not second-guess the diagnosis or treatment choice…

Questions to explore with your client

• What drew you to it, and what are you hoping it will change?
• Is there physical contact? Was it explained beforehand, and do you feel free to say no or stop at any point?
• Does it involve any substance, plant preparation, remedy or supplement? Has your doctor or prescriber been told, especially about any medication you take?
• Does it involve intense or unusual breathing? Have you been told about the medical conditions for which that is not advised?
• Is it a group, retreat or community? How do they respond if someone wants to leave or raises a concern?
• Who runs it, and what training or registration do they hold?
• What actually happens in a session or meeting, and how often?
• What does it cost, and is there pressure to commit to more?
• How do you feel afterwards, in the hours and days that follow?
• Does it fit with, or clash with, the work we do here?

What practitioners of it watch for

• splitting between clinicians; unclear crisis responsibility.
• hopelessness and suicidality; impulsive moves to illicit sources.
• minimising history out of eagerness. Flag inconsistencies to the team.
• delayed reactions surfacing only in integration; ask directly about them.
• your own countertransference after intense sessions; bring it to supervision.

When to involve someone else

• New or worsening physical symptoms, or advice to stop or change prescribed medication: involve the client's doctor or prescriber.
• Signs of coercion, isolation from family and friends, escalating costs or secrecy: discuss openly and consider safeguarding.
• A crisis or thoughts of suicide: follow your crisis protocol. In the US, call or text 988; in the UK and Ireland, Samaritans on 116 123.

Drawn automatically from the guide's own sections. Stay curious: neither endorse nor dismiss what the client values, and check anything that matters against the full guide and its sources. Not medical advice.