What is Health Canada’s Special Access Program?

January 24, 2022

Posted By: Morgan Kervitsky

Health Canada's Special Access Program (SAP) enables drugs that are not marketed in Canada to be requested by practitioners for the treatment, diagnosis, or prevention of serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

Psilocybin and MDMA now included in Health Canada’s Special Access Program (SAP)

Health Canada recently added psilocybin and MDMA to the list of approved substances healthcare professionals can request for “emergency treatment.

The SAP revisions offer an avenue for medical professionals to access psilocybin and MDMA for treatment, and it signals Health Canada’s increased acceptance of the growing body of research around psychedelic-assisted therapy for many mental health disorders, including PTSD, depression, anxiety, and addiction.

Before Health Canada’s changes to the SAP, healthcare providers could make requests to Health Canada for access to psychedelic medicines through the Section 56 exemptions to the Controlled Drugs and Substances Act (CDSA). However, these requests typically have been more limited and granted for medical purposes such as end-of-life palliative care or for research purposes such as clinical trials.

Frequently Asked Questions:

Who can apply for the Special Access Program?

Only healthcare professionals can request and prescribe psilocybin and MDMA for their patients. Health Canada’s SAP program is designed for the treatment, diagnosis, or prevention of serious or life-threatening conditions, and for whom conventional treatments have failed, are unsuitable or are not available in Canada.

For access to SAP, a healthcare professional is considered someone who:

  • is entitled, under the laws of a province or territory, to treat patients with an unapproved prescription drug
  • practices in that province or territory
  • has prescribing privileges in the respective province

What qualifies a patient for SAP?

Physicians are allowed to request drugs through the SAP for patients for the treatment, diagnosis, or prevention of serious or life-threatening conditions who have not seen success with conventional therapies or where those therapies are not suitable for the patient or not available in Canada. Many mental health conditions are difficult to treat with conventional therapies, and the SAP now potentially offers new options for patients.

I’m a healthcare professional. How do I apply to Health Canada’s Special Access program for my patients?

For more information on applying to Health Canada’s SAP, please visit this page here.

I’m a patient. How do I receive access to this therapy?

If you are interested in learning more about these treatments, please consult your doctor.

Mydecine’s Expertise

With a number of clinical trials beginning this year, Mydecine collaborates with top research organizations and medical facilities to develop and study psychedelic compounds as part of psychedelic-assisted psychotherapy programs. Our partners include John Hopkins University, Leiden University (Netherlands), University of Alberta, Imperial College (London) and other top institutions around the world.

Mydecine currently produces cGMP certified pharmaceutical grade psilocybin and MDMA with coverage under a Health Canada Schedule 1 Drugs and Substances Dealer’s License in Alberta.

In addition to safe products, we offer the expertise of a global team of scientists, physicians and advisors who guide practitioners in the responsible and successful use of these compounds. Mydecine provides healthcare experts with the resources and proper training to successfully integrate psychedelic therapies into existing medical practices under Canada’s new regulations.

Learn more about Mydecine’s Special Access Support and Supply Program.

MEDICAL DISCALIMER: THIS ANNOUNCEMENT DOES NOT CONTAIN MEDICAL ADVICE. The content appearing in this announcement is intended to provide information to the reader. Mydecine Innovations Group, Inc. is not providing or offering medical or psychological advice or services. The information contained herein should not be considered complete. It is not a substitute for professional medical advice, diagnosis, or treatment. Nothing herein should be used without consultation and advice from medical or other health care professionals. The information contained herein is general in nature. It does not cover all possible uses, actions, precautions, or interactions of the medical treatments discussed. The content is not intended as medical advice .Mydecine Innovations Group, Inc. specifically disclaims all responsibility for any liability loss or risk, personal or otherwise, that may, does or will result from the direct or indirect use and application of any of the content in this announcement or any website where this announcement appears.  In no event will Mydecine Innovations Group, Inc., its subsidiaries, agents, or employees be liable for any damages, including but not limited to incidental or consequential damages, personal injury, wrongful death, lost profits or business interruption resulting from any information contained herein.