How to Get Started?
Are you here to learn about how TheraPsil may help you or a loved one gain access to legal psilocybin-assisted psychotherapy?
We recommend you begin first by visiting our FAQ page here.
Our FAQs page will provide you the information you need to have a clear understanding of TheraPsil, Psilocybin-Assisted Psychotherapy and how we may be able to help you.
Accessing Psilocybin-Assisted Therapy in Canada - Current Pathways:
The Special Access Program (SAP)
As of Jan 5th 2022, Health Canada is requesting all patients who are in need of medical access to psilocybin, for a serious or life-threatening illness, to first either access a Clinical Trial and/or attempt access via the Special Access Program (SAP).
- A Special Access Program (SAP) request must be made by a patient's prescribing healthcare professional on a patient’s behalf.
- A response regarding an SAP request expected within 1-2 days of submission.
- If granted access to psilocybin through the SAP, the patient’s designated health care practitioners would be provided a GMP synthesized psilocybin product.
- Administration of the psilocybin is via a patient's prescriber or other qualified healthcare professional assigned to administer the psilocybin.
- Currently, whole psilocybin containing mushrooms cannot be accessed legally through the SAP request process.
If you would like your prescriber to submit an SAP request on your behalf, direct your prescriber to visit our Support Your Patient page here.
To learn more about what we know about the Special Access Program so far, click here.
If your SAP request is approved, please contact TheraPsil at email@example.com so you may be connected to therapy teams trained in psilocybin-assisted psychotherapy who can assist your doctor in administering the psilocybin and ensuring you are supported through the treatment program, which includes preparation and integration sessions.
A Clinical Trial
- Health Canada indicates that clinical trials are their preferred method of patients gaining access to psilocybin
- Through successfully entering a clinical trial, patients have the opportunity to contribute to research and gain access to synthetic psilocybin in controlled clinical setting
- Accessing a clinical trial is dependent on clinical trial timeline and recruitment; Patients must meet eligibility criteria, which is often quite strict.
Visit clinicaltrials.gov to see if there are any clinical trials with psilocybin that you may be eligible for.
A Section 56 Exemption
Since August 2020, TheraPsil has supported 58 patients in successfully accessing legal psilocybin-assisted psychotherapy. As of Jan 5th 2022, Health Canada accepting section 56 applications if “it can be demonstrated that access to psilocybin was not possible through existing legal routes” (i.e through a clinical trial or through the SAP).
- If a patient’s prescriber has submitted an SAP request and it has been denied OR a patient’s prescriber has reviewed the SAP material and determined that SAP is not a suitable route for the patient, and the patient has no access to clinical trials, a Section 56 Exemption Application can be made by a patient with the written support of their prescribing healthcare practitioner.
- A response time from Health Canada regarding a Section 56 Exemption application is unknown as response times have and varied greatly in the past, however TheraPsil is committed to advocating for Health Canada to respond to all applications in a reasonable time frame.
- If granted access to psilocybin through a Section 56 Exemption the patient themselves can legally possess and inge93312st psilocybin containing mushrooms in conjunction with psychotherapy to treat their distress.
- Section 56 exemptions are usually granted for a duration of 12 months with no limit on the number of treatments to occur.
Do I qualify to submit a section 56 exemption?
- My prescriber has already submitted an SAP request on my behalf and it has been denied OR I have reviewed the SAP material with my prescriber and we have determined that SAP is not suitable for me.
- There are no clinical trials in which I can access.
- I meet TheraPsil’s below eligibility requirements for support.
As of January 2020, TheraPsil supports Canadians who meet the following criteria:
- You are a resident of Canada,
- You have existential distress as a result of a past or present terminal or life-threatening diagnosis,
- As a result of your past or current diagnosis you experience psychological distress (anxiety/depression/demoralization/ hopelessness),
- Your emotional distress has not successfully responded to other treatments,
- You are interested in trying psilocybin-assisted therapy,
- You have a prescribing health care practitioner who will support you in applying for legal access to psilocybin-assisted therapy OR will complete a referral to a TheraPsil Medical Associate.
Although we hope to eventually provide support in accessing psilocybin-assisted psychotherapy to all Canadians in medical need, we have decided to currently limit our treatment scope to end-of-life and illness-related distress, as this treatment has the most rigorous scientific evidence demonstrating therapeutic efficacy and safety. We also limit ourselves to helping only those facing end-of-life and illness-related distress at this time as we are a small non-profit with limited capacity. We must ensure we only expand our services in accordance with our means and ability to provide safe and equitable care and ensure a high standard of support is provided to each patient.
If all 3 points above are true, click the button below to fill out a secure form and join our waitlist for assistance in applying for a section 56 exemption.
Please check your spam folder for our emails!
Please note: TheraPsil has an extensive patient waitlist. As a small non-profit with limited staff, we may not be able to process requests immediately. We hope to be able to respond to your request within 7-14 business days. Once your request is processed, you will receive an email from us informing you if we can hee or if you have been added to our waitlist. We appreciate your patience and understanding as we do our best to support as many patients as we can. TheraPsil’s team cannot guarantee the success of any request to Health Canada for legal access to psilocybin in conjunction with psychotherapy.
Help Canada move closer towards medical legalization of psilocybin and psilocybin therapy through regulatory change
We recognize that the current legal pathways to access psilocybin-assisted psychotherapy (the Special Access Program, Section 56 exemptions or enrolling in a clinical trial), while useful to open the door for access and help some individuals, are not an ideal way for patients to access healthcare. As such, TheraPsil continues to advocate for regulatory change so that all Canadians in medical need can access regulated medical psilocybin and psilocybin-assisted psychotherapy through direct consultation with their healthcare provider, rather than the government, like most other medical treatment options.
If you do not qualify now or have been added to our wait list, we encourage you to advocate for regulatory change with us so that ALL Canadians in medical need can soon have access to this treatment option. Learn more here.
If you or a loved one could benefit from psilocybin therapy, please contact your Member of Parliament using our advocacy tool, to let them know compassionate access to psilocybin therapy is an issue that deserves immediate attention. Your voice matters and will help make change.
For a comprehensive breakdown of the difference between accessing psilocybin through the Special Access Program, Section 56, and our Proposed Regulations:
Please Note: We are committed to completely legal behavior in our advocacy of psilocybin for medical purposes. Recommending the therapeutic use of a psychedelic substance, providing psychedelic psychotherapy, or referring an individual to a therapist for psychedelic therapy is currently illegal, as these actions can open us to the criminal charge of aiding and abetting the possession of a controlled substance.