Question Period Note: Psychedelics

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• While the therapeutic use of psychedelics like MDMA and psilocybin [sai·luh·sai·bn] have shown promise in clinical trials, further research is needed. At this time, with the exception of ketamine, no psychedelic drugs have been approved in Canada or elsewhere.
• Clinical trials are the most appropriate and effective way to advance research with unauthorized drugs while protecting the health and safety of participants.
• The number of authorized clinical trials with psilocybin has increased significantly over the past year – a trend our government is hoping will continue.

IF PRESSED ON THE GOVERNMENT OF ALBERTA’S ANNOUCEMENT TO REGULATE THE USE OF PSYCHEDELIC DRUGS
• Health Canada is responsible for authorizing drugs; provinces and territories are responsible for regulating the practice of medicine and delivery of health services within their jurisdiction.
• Ketamine is currently the only psychedelic drug in Canada approved for therapeutic use.
• Alberta has announced that its new regulations are intended to provide additional safeguards and oversight for how psychedelic health services are delivered in their province.
• Health Canada will closely follow the implementation of these new regulations.
IF PRESSED ON PSILOCYBIN EXEMPTION REQUESTS FOR HEALTHCARE PROFESSIONALS
• The use of psilocybin is being studied in clinical trials by researchers in Canada and internationally, but there are no approved therapeutic products containing psilocybin in Canada or elsewhere.
• Clinical trials are the most appropriate mechanism for health care professionals who wish to use psilocybin to improve their knowledge of psychedelic-assisted psychotherapy.

If PRESSED ON PATIENT PROTECTION IN CLINICAL TRIALS
• It is important that Canadians have access to safe clinical trials.
• Health Canada’s role includes a rigorous, science-based review of all clinical trial applications in Canada, and subsequent inspection activities to help ensure compliance.
• Research Ethics Boards help to ensure the protection of participants, while provincial regulatory colleges ensure quality care is provided by their members.
• When clinical trials include psychedelics, additional safeguards are implemented to protect participants.

IF PRESSED ON THERAPSIL AND ONGOING LITIGATION
• Health Canada has met with TheraPsil a number of times and has heard their request for increased compassionate access to psilocybin.
• Health Canada cannot comment further on matters related to the litigation regarding access to psilocybin.
• Health Canada will continue to meet with TheraPsil as required.

USE OF PSYCHEDELICS FOR THERAPEUTIC PURPOSES

Interest in the potential therapeutic use of psychedelics – particularly MDMA and psilocybin – for the treatment of various mental health and substance use disorders is on the rise. Psychedelics are typically being studied in combination with psychotherapy (i.e., psychedelic-assisted psychotherapy).

Most psychedelics (also known as hallucinogens) are controlled as “restricted drugs” under the Controlled Drugs and Substances Act (CDSA). Restricted drugs do not currently have approved therapeutic uses and can only be used for research or scientific purposes, including in authorized clinical trials. With the exception of ketamine, no psychedelic drugs have been approved for sale in Canada or elsewhere. Psilocybin and MDMA have received “breakthrough-therapy” designation from the United States Food and Drug Administration in an effort to help bring these drugs to market more quickly.

Advocates continue to push Health Canada to increase access to psychedelic drugs, especially psilocybin (“magic mushrooms”), for therapeutic purposes. Some stakeholders are advocating for the creation of a separate medical access pathway for psilocybin, similar to cannabis. In addition, some stakeholders and Indigenous partners are requesting access to psilocybin for traditional, spiritual, and/or ceremonial uses.

LEGAL ACCESS PATHWAYS

There are times when access to unauthorized drugs may be appropriate. In some circumstances, with the support of a regulated health care practitioner, it may be possible for individuals to legally access psilocybin through one of three pathways: 1) through participation in an approved clinical trial; 2) through the Special Access Program; and 3) through a subsection 56(1) exemption under the CDSA.

Clinical trials and Health Canada’s Special Access Program are existing regulatory options through which a legal source of psychedelic restricted drugs may be accessed. Both clinical trials and the Special Access Program have safeguards and requirements in place to protect the health and safety of patients, help ensure the quality of the drug, and provide for administration and oversight by a qualified professional. These pathways should generally be pursued instead of an individual exemption under the CDSA, unless it can be demonstrated that access is not possible or suitable through these existing legal routes. The Special Access Program and individual exemptions from the CDSA are not mechanisms to encourage the early use of unauthorized drugs, nor are they meant to be used as a means of circumventing clinical development or the established drug review and approval process.

Government of Alberta’s Regulatory Amendments Related to Psychedelics

On October 5, 2022, the Alberta Government announced amendments to the Mental Health Services Protection Regulation that will come into force on January 16, 2023. These Regulations set out new requirements for the use of psychedelic drugs in the treatment of psychiatric disorders in Alberta. While some stakeholders initially interpreted this announcement to mean that psychedelic drugs would be more broadly accessible in Alberta, Alberta has since clarified that its Regulations are intended to increase oversight of psychedelic-assisted therapy in the province to ensure its safe and effective use.

Charter Challenge

In August 2022, seven patients and one health care practitioner filed a Charter challenge against the Government of Canada regarding access to psilocybin. They assert that the current avenues of accessing psilocybin are insufficient and a violation of Section 7 of the Canadian Charter of Rights and Freedoms, which guarantees the right to life, liberty, and security of the person. While it is too early to predict how this case will progress, Charter challenges can take years to work their way through the courts.

Legal Challenge for Exemption Requests from Health Care Professionals

On July 11, 2022, a group of Applicants filed an application that challenges decisions made by the Minister on June 9, 2022, refusing their applications for exemptions under ss. 56(1) of the CDSA to possess, transport, consume and destroy psilocybin to be used as part of an experiential training module (psilocybin-assisted psychotherapy).

The constitutionality of the CDSA is not challenged in this matter. As with the Charter challenge, this matter is still in its very early stages.

Clinical trials

Health Canada has authorized several clinical trials with psilocybin and MDMA since 2018 (most of the psilocybin clinical trials have been authorized within the past year). These include clinical trials to assess the efficacy of psilocybin in patients with depression or treatment-resistant depression, post-traumatic stress disorder, alcohol use disorder; the safety of low doses of psilocybin; and the safety of psilocybin for health care providers enrolled in a psychedelic training program. In Spring 2022, the Canadian Institutes of Health Research launched a funding opportunity that will provide up to $3 million to support clinical trials to assess the therapeutic efficacy and safety of psilocybin-assisted psychotherapy for the treatment of substance use and mental health disorders.

Safety Requirements for Clinical Trials

To date, Health Canada has received two complaints related to the conduct in clinical trials investigating MDMA-assisted therapy and one complaint related to ketamine-assisted therapy as treatment for certain mental health conditions. In these cases, Health Canada quickly took appropriate compliance and enforcement actions to investigate allegations of non-compliance with the FDA and its associated regulations.

Current Status (ROEB input)
In June 2022, Health Canada conducted two MDMA clinical trial inspections The MDMA clinical trial in Montreal, sponsored by MAPS, received a compliant rating. The MDMA clinical trial in Toronto, sponsored by the Remedy Institute, received a non-compliant rating (NC) and a notice of immediate suspension. The Department has received and reviewed the corrective actions from Remedy and deemed the sponsor’s response satisfactory. The clinical trial authorization was reinstated on September 23, 2022.

In July 2022, Health Canada participated in a joint inspection with the U.S. Food and Drug Administration (FDA), of MAPS in San Jose, California (headquarters). There were no major findings identified by Health Canada and the FDA after conducting a full sponsor inspection.

Ketamine Clinical Trials (ROEB input)

Health Canada has authorized a number of clinical trials involving the use of ketamine for the treatment of mental health disorders. In October 2021, a complaint was received alleging issues with the general oversight of the ketamine clinical trial sponsored by the University of Ottawa - Institute of Mental Health research.

Current status (ROEB input)

Starting in February 2022, Health Canada conducted inspections at the three sites of the clinical trial sponsored by the University of Ottawa - Institute of Mental Health Research. One trial site received a compliant rating. The other two sites each received a non-compliant rating. One of these two sites has since submitted a satisfactory response of corrective actions and the Department has informed them that they can proceed with their trial at this site. Health Canada is currently reviewing the corrective actions for the second site.

Special Access Program (SAP)

On January 5, 2022, regulatory amendments came into force which allow health care practitioners, on behalf of patients with serious or life-threatening conditions, to request access to restricted drugs through the SAP when other therapies have failed, are unsuitable, or are unavailable in Canada.

Individual subsection 56(1) exemptions

Many factors are considered when reviewing and making a decision on a request for a subsection 56(1) exemption to use psilocybin in relation to a medical condition. These factors may include but are not limited to (as per Health Canada web page):

• The availability of clinical trials or other regulatory pathways, such as the Special Access Program, to request access to the substance;
• The medical condition for which the psilocybin is requested to be used;
• The existing scientific evidence to support the use of psilocybin for the treatment of the condition;
• Whether other conventional therapies have been considered;
• Whether the use of the substances is supported by a health care practitioner;
• Public health and public safety objectives of the CDSA;
• Other federal, provincial, and/or municipal laws or regulations that may apply to the proposed activity; and
• Risks, including risk of diversion.

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