Notice to stakeholders: Requests to the Special Access Program (SAP) involving psychedelic-assisted psychotherapy

February 27, 2023
Our file number: 23-100122-763

Purpose

Health Canada recognizes the growing interest in the use of psychedelic-assisted psychotherapy and the possible psychological and physical risks to patients associated with this type of therapy. This notice outlines the information that health care practitioners need to know when applying for access to psychedelic drugs through Health Canada's Special Access Program (SAP) for the purposes of psychedelic-assisted psychotherapy.

Background

The information in this notice is relevant to all SAP requests involving drugs for psychedelic-assisted psychotherapy. Currently, the psychedelic drugs most frequently being used in psychedelic-assisted psychotherapy are psilocybin (one of the active ingredients found in "magic mushrooms") and MDMA ("ecstasy"). Psychedelic drugs produce an altered state of consciousness that can last for hours and may affect the emotional state of patients. For this reason, the setting in which the drug is administered can play an important role in reducing the psychological risk associated with administering the drug. Thus, the environment should be psychologically safe during the acute drug effects.

Psychedelic drugs are subject to the Food and Drugs Act (FDA) and its regulations, and most are also controlled under the Controlled Drugs and Substances Act (CDSA). Legally, to conduct activities with psychedelic controlled substances in Canada, health care practitioners need appropriate authorizations from Health Canada under both the FDA and the CDSA. Regulatory amendments to the Food and Drug Regulations (FDR) made it possible for health care practitioners to request access to restricted drugs through the SAP as of January 2022. Psilocybin and MDMA are both classified as restricted drugs.

The decision to authorize a drug through the SAP, whether it is a psychedelic drug or any other class of drug, is based on sufficient evidence to support the requested use, including the drug information available to the SAP at the time of the request, as well as evidence of how it would benefit the patient based on their clinical history. The SAP reviews requests on a case-by-case basis and, if authorized, the sale of the drug is considered exempt from the FDR. An authorization from the SAP is not a broad statement or opinion that the drug is safe, efficacious or of high quality, rather, that the sale is justifiable in the context of a medical emergency. Furthermore, the SAP is not intended to:

promote or encourage the early use of drugs
conduct research
bypass the clinical trial or drug review process

Any drug requested through the SAP, including psychedelic drugs, should be available in a dosage form and, except for rare circumstances, should meet Good Manufacturing Practices (GMP). GMP ensures that products are consistently produced and controlled according to high quality standards.

Process for making an SAP request

Under the FDR, the SAP may authorize the manufacturer of a drug to sell the drug to a health care practitioner if the following conditions are met:

the health care practitioner is licensed to prescribe drugs in the province or territory where they practice
conventional treatments have failed, are unsuitable or unavailable to treat their patients suffering from serious or life-threatening conditions
there is sufficient evidence to support the use, safety and efficacy of the drug for the patient's specific condition

For new or repeat requests, health care practitioners must complete and submit a patient-specific SAP form (Form A) including:

the name of the drug
the quantity of the drug required
the name of the drug manufacturer
identify what treatments have been considered or tried and describe how they have either failed, are unsuitable for the patient or are unavailable on the market
information in respect of the use, safety and efficacy of the drug for the specific condition the patient is suffering from
the name and the civic address of the practitioner to whom the drug is to be shipped
any other information Health Canada may request to help determine whether to issue the letter of authorization

Health care practitioners filing a request must also comply with all regulations and requirements of their regulatory bodies at the provincial or territorial level that apply to their request to the SAP.

In deciding whether to issue a letter of authorization, the SAP considers whether conventional treatments for the condition of the patient have been tried and have failed or have been considered and deemed not appropriate for that patient. The role of Health Canada in the context of the SAP is not to question the practitioner's diagnosis or recommended treatment option.

The SAP will ask manufacturers identified in the request to confirm that they are able and willing to sell the drug to the practitioner for that indication. If the manufacturer of the restricted drug is located in Canada:

they must be a licensed dealer under the CDSA and
the restricted drug must be listed on their licence

If the drug is coming from outside of Canada, the restricted drug must be imported by a licensed dealer who has:

the restricted drug listed on their licence and
obtained an import permit from Health Canada

If the SAP authorizes a request, it issues the manufacturer a letter of authorization, which permits them to legally sell the specified quantity of the drug to the requesting health care practitioner for a patient.

Health care practitioners who want to continue to treat their patient with the drug must complete section E of the patient-specific SAP request form (Form A) on the outcome of the drug use prior to requesting more. Health care practitioners must describe the patient's response to the drug relative to the initial treatment goals when submitting subsequent requests.

Health care practitioners are to use the SAP follow-up form (Form C) for reporting when a drug was requested for a patient only once and won't be requested again.

Health care practitioners are also required to account to Health Canada, upon request, for all quantities of the drug received.

Adverse drug reactions

After the SAP authorizes a drug, health care practitioners are required to report any adverse drug reactions (ADRs) to Health Canada. Health care practitioners must report:

fatal or life threatening reactions within 7 days
serious and unexpected reactions within 15 days of becoming aware of the information

Health care practitioners must report ADRs using the Council for International Organizations of Medical Sciences (CIOMS) forms and send them through Canada Vigilance. Additionally, the practitioner is required to provide a completed SAP follow-up form (Form C) that describes the outcome experienced by the patient using the drug to the manufacturer of the drug and to the SAP.

SAP authorizations and CDSA exemptions

If a restricted drug is authorized for sale through the SAP, parties (for example, practitioners, nurses, pharmacists, etc.) need an exemption under subsection 56(1) of the CDSA to legally conduct activities (for example, possession, transportation, etc.) with the restricted drug.

Health Canada has issued a class exemption to cover some types of potential SAP authorizations for psilocybin and MDMA, thereby avoiding the need for individual exemptions. The class exemption doesn't guarantee that a request will be authorized through the SAP as all requests are assessed on a case-by-case basis. If an SAP authorization for a restricted drug is granted and it's covered by the class exemption, anyone conducting activities related to the authorization must adhere to the terms and conditions set out in the class exemption (for example, record keeping and security). Please note that the class exemption doesn't allow patients to possess or transport restricted drugs. The drugs must be used in the presence of the practitioner or the health care professional to whom the practitioner has delegated this activity. If a SAP authorization for a restricted drug isn't covered by the class exemption, parties will require an individual exemption.

For more information on the process for submitting a request to the SAP and the practitioner's reporting requirements, please consult the guidance document: Special Access Program for drugs: Guidance document for industry and practitioners.

Contact us

Special Access Program
Health Canada
Telephone: 613-941-2108
Fax: 613-941-3194
E-mail: sapd-pasm@hc-sc.gc.ca

Page details

Date modified:: 2023-02-27

Language selection

Search