Health Canada Special Access Program

1. Introduction

Version followed: Health Canada's Special Access Program (SAP) for drugs as reopened to restricted drugs by SOR/2021-271 (in force 5 January 2022), read through Health Canada's Notice to stakeholders: Requests to the SAP involving psychedelic-assisted psychotherapy (27 February 2023) and the CDSA subsection 56(1) class exemption for psilocybin and MDMA authorised through the SAP. The provincial layer is shown with Alberta's rules (Mental Health Services Protection Regulation amendments, in force 16 January 2023; Psychedelic Drug Treatment Services Standards, January 2023) and the Alberta College of Social Workers' Psychedelic Assisted Psychotherapy practice guideline (approved June 2025). Status checked to sources dated up to September 2025. No 2026 changes to the SAP rules were found [uncertain: a 2026 change could exist that the sources do not show].

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. In 2013 restricted drugs such as psilocybin and MDMA were barred from the SAP. That bar was repealed with effect from 5 January 2022. Health Canada now has discretion to authorise them for emergency treatment, but approval is never guaranteed [source: Cassels 2022; Health Canada QP note MH-2022-QP-0026]. Health Canada describes psilocybin and MDMA as the drugs most often requested for psychedelic-assisted psychotherapy (PAP) [source: Health Canada Notice 2023].

How change is thought to happen, and who decides. Health Canada takes no position on a therapeutic mechanism. It notes that these drugs cause an altered state lasting hours that can affect emotional state, and that the environment should be "psychologically safe during the acute drug effects" [source: Health Canada Notice 2023]. The therapy model is not set by the SAP. The prescriber picks it and shows the evidence for it, and provincial law and professional colleges regulate how it is delivered [source: Health Canada Notice 2023; ACSW 2025]. For a psychotherapist, the job is mostly a team role: helping assess whether the pathway fits, providing preparation and integration psychotherapy, being present in sessions where permitted, and supporting referral, documentation and follow-up. Health Canada does not license or train psychedelic therapists. Training and qualifications are set by provinces and colleges, and the Library of Parliament reported in 2023 that there is no national consensus on them [source: Hill Notes 2023].

Legal and regulatory status (as of the sources' dates).

Canada (federal): psilocybin and MDMA are restricted drugs, so lawful activity needs authorisation under both the Food and Drugs Act (SAP letter of authorisation) and the Controlled Drugs and Substances Act (CDSA). For psilocybin and MDMA that second authorisation usually comes from the s.56(1) class exemption. Other psychedelics need an individual s.56 exemption [source: Health Canada Notice 2023].
Uptake: 50 patients had been authorised for psilocybin by 4 November 2022 [source: QP note MH-2022-QP-0026]. In July 2025 the Canadian Press reported that Health Canada had approved more than 300 exemptions for psilocybin-assisted therapy in recent years and linked them to the SAP [source: CFJC/Canadian Press 2025] [uncertain: this is a press figure with an unclear denominator].
Litigation: on 24 May 2024 the Federal Court found Health Canada's refusal of an SAP psilocybin request for cluster headaches (Jody Lance) unreasonable, partly because it did not address the Charter issues, and ordered reassessment. The request was granted on 7 June 2024 [source: psychedeliclaw.ca]. In June 2025 the Federal Court of Appeal ruled that the Minister had not justified refusing TheraPsil's s.56 exemptions for experiential training of 93 health-care workers, and ordered a new decision [source: CFJC/Canadian Press 2025]. The outcome of that new decision is [uncertain].
Clinical-trial take-home: in November 2025 a separate s.56(1) class exemption allowed participants in authorised clinical trials to take home and self-administer MDMA or psilocybin. This is a trial provision, not an SAP provision [source: psychedeliclaw.ca] [uncertain: Health Canada's own text].
Provinces: Alberta licenses psychedelic drug treatment services for psychiatric disorders (in force 16 January 2023) [source: CPSA fact sheet; Alberta licensing page]. Quebec was reported in December 2022 as the first province to publicly fund psilocybin-assisted psychotherapy, with Health Canada approval still needed case by case [source: Hill Notes 2023]. Other provinces' rules were not researched [uncertain].
Outside Canada: the SAP has no effect outside Canada. Other jurisdictions are not covered here.

2. Framework

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 [uncertain]. ACSW says only that preparation "typically" takes several meetings [source: ACSW 2025].

Phase A: Pathway decision and team formation [source: Health Canada Notice 2023; QP note; synthesis for sequencing]

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 medical director, or an exemption).
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.

Phase B: Request (Form A) and authorisation [source: Health Canada Notice 2023]

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 but assesses the evidence case by case. Applications are processed quickly once complete [source: Cassels 2022].
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.
Move on when: the authorisation and CDSA cover are in place and the drug is held under the exemption's security terms.

Phase C: Preparation (individual meetings, in person or virtual if the provider allows) [source: ACSW 2025]

Goals: rapport and trust; readiness; informed consent from each team member; self-regulation skills; supports, including a possible "compassionate witness"; touch agreement; suicidality review and safety plan; cultural and spiritual respect; a named emergency contact.
Move on when: consent is documented, the safety plan is in place, the prescriber confirms medical readiness (a medical responsibility), and the client and team agree the client is ready [synthesis for the readiness test].

Phase D: Medicine session(s) [source: Health Canada Notice 2023; CPSA fact sheet; ACSW 2025]

Under the class exemption the patient may not possess or transport the drug, and it must be used in the presence of the practitioner or a delegated health-care professional. In Alberta only an authorised regulated professional administers it, at a listed facility, hospital or accredited medical facility (end-of-life patients excepted). Self-administration is not allowed, and an authorised professional or approved person must monitor and care for the patient throughout the altered state. Medical monitoring belongs to medical staff.
Psychotherapist: present if the team plan provides for it. Non-directive, non-anxious presence; agreed touch policy; end-of-session plan.

Phase E: Integration (individual or group; can start soon after the session and continue over time, inside or outside the facility according to employment and policy) [source: ACSW 2025]

Goals: make sense of the experience, carry it into daily life, monitor wellbeing, and handle emerging material within the agreed confidentiality frame.

Phase F: Outcome reporting and repeat requests [source: Health Canada Notice 2023]

For a repeat request, the prescriber completes Section E of Form A on the outcome of prior use, measured against the initial goals. If no further request is planned, Form C goes to the SAP and the manufacturer. All drug received must be accounted for on request. Serious adverse reactions are reported to Canada Vigilance on CIOMS forms: within 7 days if fatal or life-threatening, within 15 days if serious and unexpected.
Next step: a repeat request only if outcome data support it. Otherwise close, with follow-up psychotherapy as needed [synthesis].

3. Guiding principles

The SAP is exceptional and not a substitute for trials [source: QP note; Health Canada Notice 2023]: consider evidence-based care and trials first, and do not present the SAP as a routine option.
One patient, one authorisation, case by case [source: Health Canada Notice 2023]: every plan is individual. Do not promise access or timelines.
Authorisation is not endorsement [source: Health Canada Notice 2023]: Health Canada says an SAP authorisation is not a finding of safety, efficacy or quality. Say so in consent.
The prescriber holds the request; the psychotherapist works within scope [source: Health Canada Notice 2023; ACSW 2025]: non-prescribers do not procure, hold or administer the drug. They contribute assessment, recommendations and psychotherapy.
Comply at two levels, federal and provincial or college [source: Health Canada Notice 2023; CPSA; ACSW 2025]: check your province's rules and your college's standards before you join a team.
Psychological safety during acute effects [source: Health Canada Notice 2023]: the setting, team and plan must keep the client safe while they are vulnerable.
Supervised use only [source: Health Canada Notice 2023]: under the class exemption, no take-home and no patient possession. Never plan anything outside this.
Work within competence [source: ACSW 2025]: get PAP-specific training, supervised practice and consultation, and refer when the case exceeds your skills.
Consent is specific, ongoing and covers the whole team [source: ACSW 2025]: each team member obtains consent for their own intervention, and every disclosure of information needs its own consent except in an emergency.
Boundaries around touch are explicit; sexual touch never [source: ACSW 2025]: agree touch in advance, and use it only if trained in touch or somatic work.
Cultural humility and respect for Indigenous knowledge [source: ACSW 2025]: ask about and respect the client's traditions without taking them over.
Clients in altered states are vulnerable to abuse [source: Hill Notes 2023]: use safeguards such as team presence, a visible policy and recording where policy requires it [synthesis for the specific safeguards].
Account for outcomes [source: Health Canada Notice 2023]: measure against the initial goals, because repeat access depends on it.
Harm reduction, not facilitation, outside the programme [synthesis]: with clients who use outside the SAP, assess, educate in general terms, plan for safety and refer. Never help them obtain drugs.

4. Intervention inventory

The SAP specifies regulatory procedures, not psychotherapeutic techniques. The items below are what a psychotherapist does inside or around an SAP request. Each item says which parts come from Health Canada, Alberta or ACSW and which are [synthesis]. Every item marked (prescriber) is the prescriber's legal responsibility, and the psychotherapist only supports it. No drug amounts, routes or schedules appear here, and none are needed for any psychotherapy task.

4.1 Pathway screening: is the SAP the right route?

Purpose / when: at the first conversation, when a client asks about "getting psychedelic therapy legally" [source: Health Canada Notice 2023; QP note; synthesis for steps].
Steps: (1) Check the three SAP conditions: a serious or life-threatening condition; conventional treatments failed, unsuitable or unavailable; evidence for this drug in this condition. (2) Write down the treatment history (adequate trials of evidence-based psychotherapy and medication, with dates and outcomes), because Form A needs it. (3) Check whether a clinical trial would suit the client (Health Canada prefers trials). (4) Explain that only a prescriber can apply, that approval is case by case and not guaranteed, that the manufacturer must agree to supply, and that the client may have to pay. (5) Check provincial rules (for example, Alberta licensed providers). (6) If the client does not meet the conditions, discuss evidence-based alternatives.
Example language (illustrative): "This is a federal exception route, not a standard treatment. Let's see whether your history fits what Health Canada looks for, and whether a research study might be a better door."
Watch for: pressure to overstate severity or treatment failure. Keep the record accurate. The client may see the SAP as a last hope, so prepare them for a refusal.

4.2 Building the case with the prescriber (Form A support) (prescriber)

Purpose / when: once a prescriber agrees to request [source: Health Canada Notice 2023; ACSW 2025].
Steps: (1) With consent, give the prescriber a clinical summary: diagnosis, functional impact, treatments tried and why each failed or was unsuitable. (2) Describe the psychotherapy you will provide (approach, preparation and integration plan, your qualifications and training, venue, team), because the prescriber has to justify the overall plan. ACSW notes that social workers contribute recommendations while the prescriber chooses the medicine [source: ACSW 2025]. (3) Agree treatment goals and baseline measures, because Section E later asks for the response against the initial goals. (4) Help the prescriber assemble published evidence for this condition [synthesis].
Example language (illustrative, to the prescriber): "Here's a one-page treatment-history table and our proposed preparation and integration plan, with the baseline scores we'll re-measure."
Watch for: the application asks for evidence, not testimonials. If a request is refused, see 5.1.

4.3 Psychological assessment contribution to medical and psychiatric screening

Purpose / when: before the request is filed and again before the session. Medical eligibility and contraindications are the prescriber's call. In Alberta, a psychiatrist or a physician consulting one prescribes for psychiatric disorders [source: CPSA fact sheet].
Steps (psychological side) [synthesis, informed by published trial practice; the SAP sets no exclusion list]: (1) A structured diagnostic and risk assessment: suicidality and self-harm history, any personal or family history of psychosis or bipolar disorder, dissociation, substance use, trauma load, and current stability. (2) Assess supports, housing and capacity to consent. (3) Share findings with the prescriber so they can decide on exclusions. (4) Document readiness and any flags.
Example language (illustrative): "Some histories, such as psychosis or bipolar disorder in you or close family, change the safety picture. The physician makes the medical call, so I need to ask carefully."
Watch for: minimising history out of eagerness. Flag inconsistencies to the team.

4.4 Informed consent (each team member)

Purpose / when: before preparation is completed and before any session [source: ACSW 2025 (Alberta Standards s.4 and ACSW Standard B.4); Health Canada Notice 2023].
Steps: (1) Explain your own role and intervention and obtain consent for it. Every team member does the same for theirs. (2) Cover the drug's characteristics, risks and benefits, and refer medical questions to the prescriber. (3) State that an SAP authorisation is not a finding of safety or efficacy [source: Health Canada Notice 2023]. (4) Explain interdisciplinary care: with whom information will be shared, with specific consent for each disclosure, and seek consent even where law allows sharing without it, unless there is an urgent need such as a medical emergency. (5) Say whether therapeutic touch is part of the plan and why. (6) Explain any recording policy: storage, retention, access, and what happens if the client declines (if they decline, consult the prescriber about benefit and risk). (7) Warn that unexpected or forgotten material may surface, agree how it will be handled during the session and in integration, and explain the limits of confidentiality. (8) Confirm a named emergency contact before the session. (9) Explain the federal conditions: use only in the practitioner's presence, no possession or take-home, and the outcome reports to Health Canada [source: Health Canada Notice 2023].
Example language (illustrative): "If a memory comes up that you didn't expect, we've agreed we'll note it and work with it in integration. Here's what I'd be required to share and with whom."
Watch for: consent obtained only by the prescriber. ACSW requires each member's own consent. Recheck consent if the plan changes [synthesis].

4.5 Preparation sessions

Purpose / when: several meetings before the medicine session. These may be virtual or private only if the provider's policy and the medical director allow it [source: ACSW 2025].
Steps: (1) Build rapport and trust. (2) Explain the process: setting, team, what the day looks like, the presence requirement and the end-of-session plan. (3) Teach self-regulation skills: breathwork, mindfulness and self-soothing [source: ACSW 2025]. Rehearse them in session [synthesis]. (4) Identify supports and, if wanted, a "compassionate witness", and clarify that person's role. (5) Discuss and agree touch (4.8). (6) Review suicidal ideation and write a safety plan (warning signs, coping steps, contacts, crisis lines, and lethal-means counselling on safe storage or removal) [source: ACSW 2025 for the topic; synthesis for the components]. (7) Explore cultural, ancestral and spiritual frameworks with humility. (8) Set intentions or goals linked to the treatment goals in 4.2 [synthesis]. (9) Confirm readiness with the team.
Example language (illustrative): "Let's practise the breath we'll use if things feel intense, so it's already familiar." / "Who would you want to know you're doing this, and what would you want them to do afterwards?"
Watch for: rising anxiety, unrealistic expectations of a cure, or ambivalence. Also prepare yourself: ACSW asks clinicians new to PAP to practise non-anxious presence.

4.6 Planning the setting and the session day

Purpose / when: before the session [source: Health Canada Notice 2023; CPSA fact sheet; ACSW 2025; synthesis for details].
Steps: (1) Confirm the venue is lawful: under the class exemption, use in the presence of the practitioner or a delegated professional; in Alberta, a listed licensed facility, hospital or accredited medical facility. (2) Confirm the staffing: who is the authorised monitor (medical staff) and whether you will be present. (3) Arrange a calm, private, psychologically safe room [source: Health Canada Notice 2023] with comfort items and alternatives to touch [source: ACSW 2025]. (4) Agree the end-of-session plan with the prescriber and team: how the client is assessed as settled (medical staff), who accompanies them, and how to reach the team. (5) Rehearse escalation: which team member to alert, and where emergency resources are [synthesis].
Example language (illustrative): "On the day, the physician's team handles all medical checks. My role is to be present and steady with you."
Watch for: any plan that would involve the client taking the drug away or using it unsupervised. That is not permitted under the class exemption and must be refused.

4.7 Presence during the medicine session (non-directive support)

Purpose / when: during the acute altered state, where the team plan includes the psychotherapist. Monitoring and medical care are the responsibility of the authorised professional [source: CPSA fact sheet; ACSW 2025].
Steps: (1) Take part in the team briefing. (2) Offer calm, non-anxious, non-directive presence. Follow the client's process rather than steering it [synthesis]. (3) When distress rises, cue the rehearsed skills (breath, grounding) and reassure gently [synthesis]. (4) Use only the agreed touch or alternatives. (5) Note significant material for integration without interpreting it in the moment [synthesis]. (6) Alert medical staff at once to any physical or psychiatric concern. (7) Support the agreed end-of-session plan.
Example language (illustrative): "You're safe. We're right here. Breathe with me for a moment." / "Let it unfold. We'll make sense of it together later."
Watch for: distress that does not settle, agitation, confusion, or medical signs (escalate to medical staff). Also your own urge to fix or interpret.

4.8 Touch policy

Purpose / when: agreed during consent and preparation, applied in session [source: ACSW 2025].
Steps: (1) Expect requests such as hand-holding and raise the topic during consent. (2) Use touch only if you are trained in somatic or touch-based psychotherapy. Without that training, do not touch even when asked. (3) Offer alternatives agreed in advance: a cushion, a comforting object, fidget items. (4) Sexual touch is never permitted, and ACSW's prohibited-relationship standards apply. (5) Record what was agreed and anything that happened in session [synthesis].
Example language (illustrative): "If you reach for a hand, I won't take it. That isn't a rejection, it's our safety agreement. The cushion is right here."
Watch for: blurred boundaries after the session, such as a client feeling especially close. Address it in integration and supervision [synthesis].

4.9 Handling emergent and disclosed material

Purpose / when: when trauma memories or other new material, or disclosures of risk or abuse, arise during or after the session [source: ACSW 2025; synthesis for steps].
Steps: (1) During the session, acknowledge and contain; do not probe or build a narrative. (2) Follow the handling and confidentiality limits agreed at consent. (3) Disclosures that trigger mandatory reporting, such as child protection, are handled under the usual law and policy [synthesis]. (4) In integration, explore the material carefully and avoid suggesting meaning or treating it as fact [synthesis].
Example language (illustrative): "That sounds important. Let's hold it gently, and we'll come back to it when you're clear-headed."
Watch for: the client treating vivid session content as literal memory. Stay neutral and use trauma-informed pacing [synthesis].

4.10 Integration sessions (individual or group)

Purpose / when: after the medicine session, starting soon afterwards or later and continuing over time, inside or outside the licensed facility as policy allows [source: ACSW 2025].
Steps: (1) Hold the first contact soon after the session to check wellbeing, sleep, mood and safety-plan status [synthesis for content]. (2) Invite a free account of the experience; reflect it back without imposing meaning [synthesis]. (3) Link insights to the treatment goals and daily-life changes, and agree concrete behavioural steps [synthesis]. (4) Use your usual evidence-based approach; ACSW mandates none and asks clinicians to stay skilled in their chosen approach [source: ACSW 2025]. (5) Offer group integration where available [source: ACSW 2025]. (6) Repeat outcome measures (4.11). (7) Respect spiritual or cultural meanings the client gives the experience, attributing them to the client's framework, not stating them as fact [synthesis].
Example language (illustrative): "What from that day still feels alive for you? What, if anything, do you want to do differently this week because of it?"
Watch for: destabilisation, new or worse suicidality, persisting distress or perceptual changes (refer to the prescriber), or the client feeling an urgent need for another session.

4.11 Outcome measurement and follow-up reporting (prescriber reports; psychotherapist supports)

Purpose / when: at baseline, after each session and at closure [source: Health Canada Notice 2023].
Steps: (1) Take baseline measures tied to the goals in Form A using validated instruments you are licensed to use [synthesis]; no particular instrument is named by Health Canada. (2) Re-measure after the session(s). (3) Give the prescriber a short outcome summary for Section E of Form A (repeat request) or Form C (no further requests), with consent. (4) Keep records consistent with the provider's record policies (Alberta requires written policies on records) [source: Alberta licensing page].
Example language (illustrative): "These questionnaires let us show Health Canada, honestly, how you've responded, which matters if a further request is considered."
Watch for: outcome reporting shading into advocacy; report accurately, including non-response.

4.12 Adverse events and critical incidents

Purpose / when: any physical or psychiatric adverse reaction during or after treatment [source: Health Canada Notice 2023; Alberta licensing page; ACSW 2025].
Steps: (1) In session: alert medical staff immediately; medical management is theirs. (2) After: tell the prescriber promptly about any adverse reaction you learn of (for example in integration), so they can meet federal reporting duties: CIOMS form via Canada Vigilance within 7 days (fatal or life-threatening) or 15 days (serious and unexpected), plus Form C to the manufacturer and the SAP. (3) In Alberta, the licensed provider must report critical incidents (serious injury or death, or threat of it) to the Ministry of Mental Health and Addiction, and must give duty-to-notify reports. (4) Activate the safety plan and crisis services if risk rises. (5) Document and debrief in supervision [synthesis].
Example language (illustrative, to prescriber): "At our integration session the client reported [symptom] starting [when]; I've done a risk check and want you to review medically today."
Watch for: delayed reactions surfacing only in integration; ask directly about them [synthesis].

4.13 Referring or supporting a client from outside the programme

Purpose / when: you are the client's ongoing therapist but not on the SAP team [synthesis; legal frame from Health Canada Notice 2023 and CPSA].
Steps: (1) Explain the pathway and its limits (4.1). (2) With consent, give a referral letter with diagnosis, treatment history and current risk to a prescriber or licensed provider (or point the client to clinical trials). (3) Agree roles with the SAP team: who does preparation and integration, how information is shared, and who holds crisis responsibility. (4) Keep your ongoing therapy going and coordinate around the session dates. (5) Provide or share integration only within your competence and the team's plan.
Example language (illustrative): "I'll keep seeing you for our regular work; the team will handle the preparation and session, and with your OK we'll share updates both ways."
Watch for: splitting between clinicians; unclear crisis responsibility.

4.14 Harm-reduction support for clients using outside legal frameworks

Purpose / when: a client is ineligible, refused or impatient, and plans or reports use outside the SAP (unregulated retreats, illicit supply) [synthesis; no source gives specific guidance; ACSW lists harm reduction only as a training area].
Steps: (1) Assess non-judgementally: what, why, where, with whom, history of use, and risk factors (psychiatric history, medications, physical health). (2) Inform in general terms: unregulated products may be mislabelled or adulterated; serious psychiatric reactions can occur; interactions with prescribed medicines can be dangerous, so the client should talk to a physician or pharmacist about their medicines; legal risk. (3) Safety-plan: a sober trusted person present, no driving, a crisis plan, and a way to reach help. (4) Refer to a physician for a medical review and to lawful options (trials, SAP). (5) Offer to help make sense of any experience afterwards. (6) Do not help with sourcing, preparation, amounts or administration, and do not attend or facilitate. (7) Document the discussion and your advice [synthesis].
Example language (illustrative): "I can't help you do this, but I care about you being safe. Can we go through the risks and what you'd do if things went badly?"
Watch for: high-risk features such as a psychosis or bipolar history, current suicidality or interacting medications; escalate to medical review and safety planning.

4.15 Clinician competence, training and authorisation

Purpose / when: before joining any SAP or provincial PAP team [source: ACSW 2025; CPSA fact sheet; Hill Notes 2023].
Steps: (1) Check your college's rules. In Alberta, PAP providers must be psychiatrists, clinical psychologists or regulated professionals authorised for psychosocial intervention from named colleges (occupational therapists, physicians, psychologists, registered nurses, psychiatric nurses, social workers). ACSW cites regulatory minimums of a clinically related master's or doctorate, at least five years treating PTSD, mood or related disorders with evidence-based therapy (assessed by the medical director), and PAP training as the medical director requires. (2) Get PAP-specific education. ACSW's recommended content: history and effects of psychedelics, neuro- and psychopharmacology, law and ethics, equity and inclusion, cultural humility and Indigenous knowledge, preparation, sessions and integration, advanced trauma therapy, harm reduction, and outcome measurement. ACSW gives examples of training programmes (TheraPsil, ATMA, Vancouver Island University, CIIS); the guideline text was summarised as "Victoria Island University", which we read as Vancouver Island University [uncertain]. (3) Get supervised practice and record PAP in your continuing-competence plan. (4) Consult your liability insurer (ACSW suggests at least $5,000,000 cover including legal defence). (5) Experiential training with psilocybin for clinicians is not part of the SAP. It has needed separate s.56 exemptions, which were granted to TheraPsil for 19 workers in 2020, refused for 93 in 2022, and sent back for redecision by the Federal Court of Appeal in June 2025 [source: CFJC/Canadian Press 2025] [uncertain: current status].
Example language: not applicable.
Watch for: practising PAP without the required authorisation; relying on training from programmes not recognised by your college.

4.16 Supervision, consultation and documentation

Purpose / when: throughout [source: ACSW 2025; Alberta licensing page].
Steps: (1) Have ongoing supervision or a consultation group. (2) Consult the prescriber, primary care, peers and legal advisers as needed. (3) Document consent (each component), the touch agreement, the safety plan, session notes, disclosures and outcomes, following the provider's written record and retention policies. (4) Follow CASW or your college's privacy rules.
Watch for: your own countertransference after intense sessions; bring it to supervision [synthesis].

4.17 Supporting the client after a refusal

Purpose / when: Health Canada refuses a request, or a manufacturer will not supply [source: QP note; psychedeliclaw.ca; synthesis for steps].
Steps: (1) Process the disappointment and review risk, since refusal can be a crisis point for clients who saw this as a last resort [synthesis]. (2) With the prescriber, review the reasons and whether a stronger request is possible (more evidence, a clearer treatment history). (3) Note that refusals can be judicially reviewed: in Lance (Federal Court, 24 May 2024) a refusal was found unreasonable and the request was granted on reassessment. Legal advice is for a lawyer, not the therapist. (4) Restate the alternatives: trials and evidence-based care. (5) Discuss harm reduction if the client signals they will look elsewhere (4.14).
Example language (illustrative): "This 'no' is hard. Before deciding what's next, let's make sure you're safe tonight, then look at what the refusal actually said."
Watch for: hopelessness and suicidality; impulsive moves to illicit sources.

5. Handling problems

The regulator sources say almost nothing about clinical difficulties. Unless tagged otherwise, everything in this section is [synthesis] built on the legal frame above and on general psychotherapy practice.

5.1 Request refused or stalled; manufacturer will not supply. Health Canada cannot compel supply, and manufacturers have refused for reasons of cost, supply or marketing [source: QP note]. Response: see 4.17. Check for risk, review the refusal with the prescriber, consider trials, and remember that judicial review exists [source: psychedeliclaw.ca]. Keep up evidence-based treatment meanwhile.
5.2 Client is ineligible but insistent (for example, a non-serious condition, or standard treatments not yet tried). Be clear and kind about the criteria. Offer the untried evidence-based options as real treatment, not hoops to jump through. Watch for the client exaggerating history to qualify, and keep documentation accurate.
5.3 Pressure on the team to bend the rules (take-home use, unsupervised use, handing the drug to a client or family). Refuse. The class exemption bars patient possession and transport and requires the presence of a practitioner or delegated professional [source: Health Canada Notice 2023], and Alberta bars self-administration and direct sale [source: CPSA fact sheet]. Do not confuse this with the November 2025 trial-only take-home exemption [source: psychedeliclaw.ca].
5.4 Scope creep for non-prescribers. You may be asked to obtain, store or give the drug. Psychotherapists outside prescribing professions do not do this. ACSW says so explicitly for social workers [source: ACSW 2025]. Pass the request back to the prescriber or pharmacist.
5.5 Anticipatory anxiety, or ambivalence before the session. Slow the preparation, rehearse skills, and review expectations. Make clear that the client can postpone or withdraw at any point without penalty, and recheck consent. Do not proceed because of sunk cost or authorisation deadlines.
5.6 Overwhelm during the session. Grounding and reassurance through the rehearsed skills (4.7). Call medical staff for any medical concern or for distress that will not settle; medical management is theirs. Afterwards, debrief and adjust the integration plan.
5.7 Destabilisation after the session (worse mood, anxiety, sleep loss, new trauma memories, depersonalisation, suicidal thoughts). See the client earlier and more often, carry out a risk assessment, activate the safety plan, refer to the prescriber for medical review, and report through the adverse-event pathway (4.12). Pace trauma work and use stabilisation first.
5.8 Stuck or non-responding client. Review the goals and measures honestly. Explore what was or was not taken from the experience. Consider whether ordinary psychotherapy should take over. Report the non-response accurately in Section E or Form C [source: Health Canada Notice 2023 for the reporting duty], and do not imply that another session is bound to help.
5.9 Non-adherence (missed preparation or integration, use of other substances). Make preparation completion a team-agreed condition before scheduling. Explore the reasons without blame. Flag any other substance use to the prescriber for medical review.
5.10 Ruptures and boundary strain (idealising the therapist, feeling abandoned when sessions end, touch requests, romantic feelings). Name and explore these in integration. Keep the touch agreement (4.8). Take it to supervision. Remember that people in altered states are vulnerable to abuse, especially women [source: Hill Notes 2023], so a team presence and a clear, visible policy protect both client and clinician.
5.11 Spiritual or culturally framed experiences. Explore their meaning within the client's own framework, and attribute those views to the client rather than presenting them as fact. If the client wants guidance from their own tradition, refer them to its elders or authorities. Do not run ceremony [source: ACSW 2025 for cultural humility.
5.12 Information-sharing conflicts in the team. Use the specific-disclosure consent agreed at 4.4 [source: ACSW 2025]. Where information is shared without consent in an emergency, tell the client afterwards.
5.13 Client plans or reports use outside the SAP. Use the harm-reduction response in 4.14. Never facilitate or attend.
5.14 Cost and equity barriers. Clients may have to pay for the drug unless an insurer, public plan or manufacturer covers it [source: QP note]. Quebec was reported to publicly fund psilocybin-assisted psychotherapy [source: Hill Notes 2023]. Help the client explore funding without promising access.
5.15 Rules differ by province or territory. Check the local regulator and your college before practising. Alberta's licensing model is not national. Other provinces were not researched for this guide [uncertain].

Sources

Sources:

Further reading (not drawn on) [uncertain]:

Health Canada's s.56(1) class exemption for psilocybin and MDMA under the SAP (the proxy refused the URL as too long). Its terms are taken from the Health Canada Notice.
Canada Gazette Part II, SOR/2021-271 (5 January 2022) and its Regulatory Impact Analysis Statement.
Health Canada, Expectations for risk management measures in clinical trials of psychedelic-assisted psychotherapy (December 2022).
The full text of Alberta's Psychedelic Drug Treatment Services Standards. Its consent section is cited only through ACSW.
psychedeliclaw.ca, 2023 State of Canadian Psychedelic Law.

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