Question Period Note: Psychedelics

• There is significant interest in the potential use of psychedelics, particularly psilocybin (“magic mushrooms”) and MDMA, for the treatment of a variety of serious mental health conditions including major depressive disorder, treatment-resistant depression, and post-traumatic stress disorder. At present, there are no drugs containing psilocybin approved for sale in Canada or internationally. Patients, practitioners and researchers are asking Health Canada to consider increasing access to psychedelics so they can explore their potential use as therapeutic products.

KEY MESSAGES
• We are deeply concerned about the burden of mental illness on Canadians, their families, and their communities.
• While psychedelics like MDMA and psilocybin [sai·luh·sai·bn] have shown promise in clinical trials for the treatment of some illnesses, further research is still needed.
• The Government of Canada encourages researchers to undertake clinical trials on the therapeutic uses of these drugs to help build the evidence base and protect the best interests of patients and individuals.
IF PRESSED ON SECTION 56(1) EXEMPTIONS FOR PSILOCYBIN …
• Currently, the best way for patients to access psilocybin is through participation in a clinical trial. Clinical trials ensure that substances are administered in accordance with national and international ethical, medical and scientific standards.
• By exception, patients can seek an exemption under section 56 of the Controlled Drugs and Substances Act to access psilocybin.
• Health Canada continues to process requests for subsection 56(1) exemptions and prioritizes the review of exemption requests from terminally ill patients to treat end-of-life distress.
• Each request for an exemption is carefully reviewed on a case-by-case basis, taking into account all relevant considerations, including evidence of potential benefits and risks or harms to Canadians.
• In the case of psilocybin, Health Canada’s review includes consideration of the individual’s medical condition, whether conventional therapies and other regulatory pathways have been considered, and the scientific evidence available to support the request.
IF PRESSED ON ONGOING LEGAL CHALLENGE (MANDAMUS APPLICATION) …
• Thank you for the question. I will not provide any comments given the pending litigation.
IF PRESSED ON ACCESS TO A “SECURE SUPPLY” OF PSILOCYBIN AND TO ISSUE EXEMPTIONS FOR HEALTH CARE PROFESSIONALS …
• Health Canada has not evaluated the efficacy and safety of psilocybin, nor has it approved its sale for therapeutic use under the Food and Drug Regulations.
• By exception, patients can seek an exemption under section 56 of the Controlled Drugs and Substances Act to access psilocybin. An exemption is not the same as a drug authorization under the Food and Drugs Act. Exemptions are considered on a case-by-case basis, taking into account all relevant considerations, including evidence of potential benefits and risks or harms to Canadians.
• The Department continues to process requests for exemptions, while prioritizing requests from patients who are terminally ill.

Use of psychedelics for therapeutic purposes in Canada

Canadians are increasingly seeking novel approaches for the treatment of mental health issues. As such, interest in the potential therapeutic use of psychedelics for the treatment of mental health disorders is on the rise.

Psilocybin is one of the active ingredients in magic mushrooms, while MDMA is a synthetic compound made in laboratories. There are many different kinds of psychedelics including LSD (acid), DMT (ayahuasca), mescaline (peyote), etc. Many psychedelics are being studied as an adjunct therapy alongside conventional psychotherapeutic techniques in clinical settings. This is also known as psychedelic-assisted psychotherapy.

Most psychedelics (also known as hallucinogens) are controlled as “restricted drugs” under the Controlled Drugs and Substances Act (CDSA). Restricted drugs generally have no approved medical uses and can only be used for research or scientific purposes, including in authorized clinical trials. No products containing psilocybin have been approved in the US, Canada, or internationally.

The United States Food and Drug Administration (FDA) has designated psilocybin as a “breakthrough-therapy” for the treatment of treatment-resistant depression/Major Depressive Disorder. Similarly, MDMA has received “breakthrough-therapy” designation for the treatment of PTSD by the FDA. A “breakthrough-therapy” designation is a process designed to fast track the drug review and approval process for drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may be a substantial improvement over existing therapeutic options for a particular medical condition.

Access to psilocybin

Psychedelics are subject to legal controls under the Food and Drugs Act and the CDSA. This means that access to psilocybin and other psychedelic restricted drugs must be authorized by Health Canada. At this time, there are two possible options for individuals to access restricted drugs, namely through participation in an approved clinical trial or through a subsection 56(1) exemption under the CDSA.

As for clinical trials, Health Canada has approved three with psilocybin since 2018. This includes two phase 2 trials looking at the efficacy of psilocybin in patients with treatment-resistant depression and one phase 1 trial in healthy volunteers that is assessing the safety of low-dose psilocybin.

As for exemptions, Health Canada continues to receive a high volume of requests pertaining to psilocybin, and, more recently, MDMA. Health Canada continues to prioritize and grant exemptions to terminally ill patients seeking access to psilocybin for the treatment of end-of-life distress.

Health Canada has proposed regulatory amendments that would create a third pathway to access restricted drugs. Should the regulatory amendments be made, practitioners will, on behalf of patients with serious or life-threatening conditions, be able to request restricted drugs (including psilocybin and MDMA) through the Special Access Program in instances where other therapies have failed, are unsuitable, or are not available in Canada. All applications would be considered on a case-by-case basis, taking into consideration the evidence pertaining to the safety and efficacy of the drug, as well as the particular needs of the patient.

Legal Challenges

On July 26, 2021, an application for a writ of mandamus was filed with the Federal Court of Canada regarding an outstanding psilocybin exemption request under the CDSA. The exemption application itself was submitted on March 11, 2021. The exemption request is for use of psilocybin mushrooms by a non-terminal patient who is in remission from follicular non-Hodgkin’s lymphoma. The patient requested access to psilocybin mushrooms to treat distress (i.e. anxiety, depression, PTSD) associated with fear of cancer recurrence.

On December 6, 2021, an exemption was issued to this patient.

KEY FACTS
• In Canada, psychedelic-assisted psychotherapy is being tested in clinical trials to treat patients with selected mental health disorders.
• Health Canada has authorized three clinical trials with psilocybin and we are encouraging further research in this area.
• Health Canada has also granted exemptions under subsection 56(1) of the Controlled Drugs and Substances Act to patients with serious or life threatening illnesses, when conventional treatments have failed, to allow them to possess psilocybin while undergoing psychotherapy as well as to a small number health care practitioners for professional training purposes.
• Health Canada is developing a regulatory proposal that would allow practitioners to apply to the Special Access Program to access restricted drugs, such as psilocybin, for emergency treatment of their patients.