Medical Psilocybin Regulations in Canada

TheraPsil is advocating for medical psilocybin regulations to make access to medical psilocybin, and psilocybin therapy a legal, safe, regulated and accessible treatment option in Canada.

In August 2021, TheraPsil, in consultation with patients, lawyers, and policy experts drafted a proposed framework for medical psilocybin in Canada.

Lay Summary

Our proposed regulation creates a framework for patients to access psilocybin for medical or therapeutic purposes, in consultation with their healthcare provider, and access regulated psilocybin products from a Health Canada approved licensed dealer. 

If a patient’s healthcare provider agrees that medical psilocybin or psilocybin therapy is a reasonable treatment option for said patient, they would write the patient a medical document. 

This patient would then be able to legally access psilocybin products from a licensed producer, or grow their own psilocybin mushrooms, within the terms that have been stipulated within the medical document.

The medical document can be written by either a Physician or Nurse Practitioner and must include the patient's contact information, medical condition and the authorized quantity of psilocybin as well as the period of use. The medical document may also stipulate other details based upon the patient's individual circumstances such as where the psilocybin must be delivered to, (e.g. patients own home, doctor's office, treating therapist's address) and also the nature and terms of consumption of psilocybin, (e.g. with psychotherapy sessions).

If and when a patient receives a medical document for psilocybin, the patient can then either send their medical document to a sales license holder who will send psilocybin product to where the medical document specifies, or the patient can send the medical document to Health Canada who will provide a registration certificate that will allow the patient to order starter materials from a sales license holder, so they may grow their own psilocybin mushrooms.

Why does Canada need medical psilocybin regulations?

To date, 42 Canadians in medical need and 19 Healthcare Professionals, supported by TheraPsil, have received approved section 56 exemptions from the Federal Health Minister, allowing them to legally use, possess, and transport psilocybin in the context of psilocybin therapy. Unfortunately, there are many more Canadians, equally suffering, who have been waiting months for a response.

Section 56 exemptions, where the Minister of Health grants individual exemptions for psilocybin use to patients on a case-by-case basis, while beneficial to open the door to compassionate access over the past year, is not a sustainable model to offer healthcare. When some patients are approved for this treatment option, and others are not, it is clear: section 56 exemptions are arbitrary, discriminatory, and infringe upon patients section 7 and section 15 charter rights.

Furthermore, these exemptions issued to patients and healthcare practitioners to date have not defined an authorized source of psilocybin. As a result, these Canadians do not have access to a well-defined source of quality-controlled psilocybin material with clear labelling for the amounts of psilocin and psilocybin present in the psilocybin material. The lack of a well-defined source of psilocybin in these particular examples illustrates shortcomings of issuing ad hoc authorizations to possess through CDSA exemptions.

To fix this problem Canada urgently needs a change in regulations that would allow medical psilocybin and psilocybin therapy to be accessible through consultation between a patient and their healthcare provider, not through case-by-case exemptions granted by the Federal Minister of Health.

How can we make psilocybin medically available?

We have proposed new regulations for psilocybin: Access to Psilocybin for Medical Purposes Regulations, or ‘APMPR’. 

These regulations would be implemented through regulations under the Controlled Drugs and Substances Act and their delivery into a regulatory framework would be administratively easy for the following reasons:

  1. They follow the medical cannabis blueprint
  2. APMPR is consistent with the Food and Drugs Act (the “FDA”)
  3. APMPR only requires amendments to the Food and Drug Regulations (the “FDR”)
  4. The Psilocybin Exemption Regulations (PER) are already regulations under the CDSA and the FDA and would become an addition to APMPR 
  5. The system created by the APMPR and the PER can be administered in a cost-effective and responsible manner consistent with Canada’s obligations under United Nations drug control conventions. 

A strong feature of these proposed regulations is that they follow the medical cannabis blueprint, in Canada. Psilocybin mushrooms, like cannabis, is a product that has an active ingredient and therefore has to be labeled very clearly. For that ingredient, there must be very clear boundaries around what the product can and cannot have in it. Much like a drug product, psilocybin would be manufactured to certain specifications, however, there would be no therapeutic claim associated with the product. 

The APMPR, the PER, and the amendments to the FDR will create a system that can provide predictable, quality-controlled products to Canadians for therapeutic purposes based on a medical document executed by a healthcare practitioner. 

If this system were to be implemented, then psilocybin products would be manufactured by license holders, who would be manufacturing in accordance with standards. When the products are provided either directly to the patient or to their healthcare provider,  that product would be clear and healthcare providers, as well as the patients, would understand how much psilocybin is being used and what form it's in, (e.g. a dried fruiting body, an edible product, etc).

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