Question Period Note: Access to drugs, including psychedelic drugs, through health canada's special access program

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• On January 5, Health Canada reversed regulatory changes made in 2013 that prohibited access to restricted drugs through Health Canada’s Special Access Program (SAP). These new amended regulations allow health care practitioners to request access to restricted drugs, such as psilocybin (the active ingredient of magic mushrooms) and MDMA (Ecstasy), for emergency treatment of patients with serious or life-threatening conditions.
• Psilocybin advocacy groups and the psychedelic investment sector are leveraging the regulatory changes to promote psilocybin as a therapeutic treatment for a broad range of mental health and substance use conditions. There is a high volume of media coverage from national, industry and psychedelic-oriented media outlets and much of it focuses on patient access to restricted psychedelic drugs for therapeutic purposes.
• Health Canada recognizes the importance of Canadians having access to the treatments they need. That is why we have a robust regulatory system that includes a rigorous, science-based review process that ensures the safety, efficacy and quality of drugs marketed in Canada.
• For exceptional cases, Health Canada's Special Access Program (SAP) offers practitioners the opportunity to gain access to drugs that are not approved for sale in Canada
• The SAP considers requests from practitioners treating patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable or unavailable, and where there is sufficient evidence to support the use of that drug for the patient’s condition.
• Although the SAP has been instrumental in saving Canadian lives, clinical trials remain the best method to access experimental therapies. Trials are designed to protect patients and to advance knowledge about experimental products with a possible medical benefit.

IF PRESSED ON ACCESS TO PSYCHEDELICS VIA SAP …
• Health Canada is committed to providing health care practitioners with ways to support patients with serious or life-threatening conditions.
• To this end, on January 5, 2022, we updated the SAP regulations to allow practitioners to request access to restricted drugs, such as psilocybin and MDMA, on behalf of patients with serious or life-threatening conditions, where other therapies have failed, are unsuitable, or are not available in Canada, and where there is sufficient evidence to support the use of that drug for the patient’s condition.
• In addition, the drug manufacturer must also agree to provide their drug for the proposed purpose and may impose conditions. The SAP cannot compel a manufacturer to provide a drug.
• This regulatory change is not intended to promote or encourage the use of restricted drugs, or to circumvent the well-established clinical trial or drug review and approval processes.
• Several physicians have already accessed psilocybin for the treatment of patients with serious medical conditions.

Through Health Canada’s Special Access Program (SAP), health care professionals may request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable and where there is sufficient evidence to support the use, safety and efficacy of the drug for the patient’s specific condition.

A SAP authorization allows a manufacturer to sell a drug that has not been authorized for sale in Canada. Requests through the Special Access Program must provide sufficient evidence to support the use of the drug for the patient’s condition. Manufacturers who provide drugs through the Special Access Program are requested to confirm that their product is manufactured according to Good Manufacturing Practices, to ensure that patients are administered a known dosage of the drug and with known composition (i.e. ingredients) from a dealer licensed under the Controlled Drugs and Substances Act.

However, the manufacturer must be willing to provide the product for the proposed use. They can also impose conditions. There have been occasions when manufacturers have refused to provide the product via SAP for a variety of reasons, including financial considerations, limited supply and potential negative impacts on their marketing application if not used appropriately, resulting in poor outcomes.

Only regulated health care practitioners who are authorized to treat patients with prescription drugs may file requests on behalf of their patients through the Special Access Program

Drugs considered for release under SAP include pharmaceutical, biologic and radiopharmaceutical products.

Regulatory Amendment for Restricted Drugs

On January 5, 2022, Health Canada published final regulations in the Canada Gazette, Part II that reversed regulatory changes made in 2013 to the Food and Drug Regulations (FDR) that prohibited access to restricted drugs through SAP. The regulatory changes came into force immediately.

These new amended regulations allow health care practitioners to request access to restricted drugs, such as psilocybin and MDMA, for emergency treatment of patients with serious or life-threatening conditions. Health Canada has published on Canada.ca a Controlled Drugs and Substances Act (section 56) class exemption, which will enable health care practitioners and certain other professionals to conduct activities with MDMA and psilocybin that have been authorized for sale through the SAP.

Psilocybin advocacy groups and the psychedelic investment sector are leveraging the regulatory changes to promote psilocybin as a therapeutic treatment for a broad range of mental health and substance use conditions. Some stakeholders see the regulatory change as a business opportunity to provide wide access through the SAP. As a result, significant efforts have been invested in educating stakeholders on the role of the SAP through information on Canada.ca, numerous meetings, and correspondence. There remains a high volume of media coverage from national, industry and psychedelic-oriented media outlets and much of it focuses on patient access to restricted psychedelic drugs for therapeutic purposes.

Clinical trials remain the best method to advance our knowledge about products with a possible medical benefit, but have not undergone the rigorous, science-based review process to be approved as marketed drugs. A clinical trial protects participants by providing a framework so that potential treatments are administered in accordance with national and international ethical, medical and scientific standards. These trials can also help to build the evidence related to the safety and efficacy of drugs.

As of November 4, 2022, Health Canada has authorized, though SAP, the use of psilocybin for 50 patients. Health Canada has also approved 16 clinical trials involving use of psilocybin, 13 of them since the beginning of 2022.
Cost
Patients receiving access to drugs through the SAP are responsible to pay for the drug, or may have the cost covered by their own private health insurance plans. In some cases, public drug plans cover the cost or the manufacturer provides the drug through the SAP at no cost.

• Health Canada’s Special Access Program (SAP) provides health care professionals with the ability to request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access is only considered when conventional therapies have failed, are unsuitable or are unavailable and when there is sufficient evidence to support the use of that drug for the patient’s condition.
• The SAP is designed for exceptional circumstances and not intended to circumvent clinical trial testing or drug review processes.
• Clinical trials remain the best method to protect patients and advance our knowledge about products with a possible medical benefit that have not undergone the rigorous, science-based review process to be approved as marketed drugs. Clinical trials can be conducted for as few as a single patient or for a larger group.