Special Access Program (SAP)
The Special Access Program (SAP) in Canada allows health care professionals, typically licensed physicians, to obtain unapproved drugs for patients with serious conditions when standard treatments have failed, are unsuitable, or unavailable in the country. The SAP is the primary pathway in Canada to legally obtain psychedelics. Applications to SAP to Health Canada are comprehensive and backed by solid evidence. The SAP’s patient eligibility criteria cater to those in urgent need and decisions are made on a case-by-case basis. This program indicates a recognition by Canadian regulators of the medical necessity for such drugs, potentially paving the way for expanded access to novel and emergent treatments, including psychedelics. For practitioners with limited time, the SAP program can seem complex and cumbersome. However, ATMA/Cena Life Services offers a comprehensive service that streamlines the entire process, from initial application through to treatment assistance, providing a simple, efficient solution. If you have a clinic and are wishing to join ATMA’s licensed and accredited network of clinics, please request a meeting on our Services Page.
Section 56 Exemption
Under Section 56(1) of Canada’s Controlled Drugs and Substances Act, the Health Minister can exempt individuals or groups from the Act’s provisions for medical, scientific, or public interest reasons. Section 56 Exemption is now a secondary pathway in Canada to legally obtain psychedelics. Applicants seeking to engage with controlled psychedelic substances for scientific studies, clinical research, or medical purposes must complete specific government application forms and submit them to the designated email. Within the framework of Section 56(1) exemptions, there is a particular significance for patients in palliative care. These exemptions have been instrumental in pioneering efforts to integrate psychedelics, such as psilocybin, into palliative therapy, offering new avenues for easing end-of-life distress.
ATMA’s training and clinics are designed to meet the highest psychedelic-assisted therapy training standards of the industry. ATMA offers patient, practitioners, and clinics a one-stop solution to implement psychedelic-assisted therapy in which ever province you live in.
Canada's Psychedelic Assisted Therapy Efforts by Province
Click on each province to learn more. Alberta's detailed requirements, regulations and guidelines can be found down below.
Health Canada. (2022, June 20). Health Canada’s special access programs: Request a drug. Canada.ca.
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
Rasha. (2023, August 17). Recent updates in the Canadian psychedelics landscape. McMillan LLP
. https://mcmillan.ca/insights/recent-updates-in-the-canadian-psychedelics-landscape/
ALBERTA FIRST IN CANADA TO OVERSEE PSYCHEDELICS FOR THERAPY
On October 5, 2022, Alberta’s government shared its plans to be the first in Canada to oversee therapy using psychedelics for mental health disorders. This move was marked by changes to the Mental Health Services Protection Regulation, which started on January 16, 2023.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
Below you can find more detailed information on Alberta’s Regulations and Guidelines for Psychedelic-assisted Therapy.
BC IS THE FIRST PROVINCE-WIDE SECTION 56 EXEMPTION
In November 2021, British Columbia applied to Health Canada for a province-wide exemption under Section 56. This exemption, granted on May 31, 2022, allows adults in the province to possess certain quantities of substances like opioids and MDMA without criminal penalties. This marked the first instance of Health Canada approving such an exemption for an entire province. The exemption took effect on January 31, 2023, and is set to remain until January 31, 2026.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
TORONTO – DECRIMINALIZATION
On January 4, 2022, Toronto’s city officials sent a request to the Health Minister seeking a Section 56 Exemption. This request aimed to decriminalize the personal possession of all substances currently deemed illegal under the CDSA. As of the latest information open to the public, Health Canada has yet to issue a reply to this application.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
SPECIAL ACCESS PROGRAM (SAP)
Health Care Professionals can request a drug from Health Canada that is not yet available for sale through the Special Access Program (SAP) to treat a patient with a serious condition where conventional treatments have failed, are unsuitable or are not available in Canada.
SECTION 56 EXEMPTION
People with medical needs for unavailable controlled substances can request a Section 56 exemption from Health Canada. This is for those with conditions like chronic pain or nausea not helped by usual treatments. It’s also for scientific research or law enforcement. To qualify, applicants must show strong proof of need, such as medical records or research plans.
Alberta Psychedelic-Assisted Therapy Requirements
- Apply for and hold a license under the Mental Health Services Protection Act.
- Appoint a psychiatrist as medical director
- Develop and maintain written policies, procedures and records
- Report on service utilization and complaints
- Ensure critical incident reporting and response
- Ensure staff meet qualifications and training requirements
- Prescription by a psychiatrist or physician in consult is required
- Administration must take place at medical facilities/clinic only, except for end-of-life care
- No self-administration and no direct dispensation/sale to a patient
- Rules about monitoring/care when in an altered state apply
- Qualifications to provide psychotherapy are required
- The provider must comply with the other rules in the Standards
ATMA is here to help you through this process whether you want to receive world-class training, facilitate and offer psychedelic therapy sessions, prescribe psychedelics, Special Access Program (SAP) support, find & connect you with an interdisciplinary team and patients, give you access to our clinics, clinic licensing, and more!
Alberta Psychedelic-assisted Therapy Rules and Guidelines
Below is a summary of Alberta’s Regulatory Requirements, Rules and Guidelines for Psychedelic-assisted Therapy (PaT) as of January 16, 2023. Alberta’s regulations emphasize standards of training for all licensed and non-licensed healthcare professionals who wish to participate in the field of psychedelics and this will likely be the case for all provinces as they roll out their regulations. ATMA offers patient, practitioner and clinics a one stop solution to implement Psychedelic-assisted Therapy in which ever province you live in.
Prescribers must ensure all prescriptions provide the following information:
- Direction on the quantity of the drug that may be dispensed or sold at any one time and the intervals of time required between each dispensation or sale
- Information about the dosage and whether the drug is to be used in the context of a psychedelic
Supervisors of psychedelic-assisted therapy must either be regulated health professionals authorized to perform the restricted activity of psychosocial intervention who meet a standard of qualifications or experience and are members of one of the following regulatory colleges:
- Alberta College of Occupational Therapists
- College of Physicians and Surgeons of Alberta
- College of Alberta Psychologists
- College of Registered Nurses of Alberta
- College of Registered Psychiatric Nurses of Alberta
- Alberta College of Social Workers
A medical director who is a psychiatrist must be appointed by the licensed service provider to oversee all clinically related aspects of the licensed services.
Where psychedelic-assisted therapy is being provided:
- Only an authorized regulated health professional can administer a psychedelic drug and it must take place at the facility listed on the license of a licensed service provider, a hospital, or an accredited medical facility. An exception to the location of administration exists for end-of-life patients.
- Authorized regulated health professionals or other approved individuals must monitor, treat and care for the patient while in an altered state of consciousness.
Supervisors as well as everyone working in a licensed facility must have Psychedelic-assisted Therapy Training. Our focus is to support all healthcare professionals and clinics interested in psychedelic-assisted therapy. If you have questions on these regulations and how you can participate, join any of our monthly Live Webinar Information Session where all Q&As are welcome.
