e-4334 (Health)

Health Canada recognizes the importance of Canadians having access to the treatments they need, as well as the growing interest in psychedelic-assisted psychotherapy, including with psilocybin. At this time, with the exception of ketamine, there are no authorized therapeutic products containing psychedelic drugs in Canada or elsewhere.

There is ongoing research evaluating the potential therapeutic benefit of the use of psilocybin in the treatment of various mental health and substance use disorders, such as treatment-resistant depression and end-of-life anxiety and distress. Based on preliminary results from clinical trials, there is early evidence that psilocybin, in combination with psychotherapy, may have potential therapeutic benefit; however, as with all drugs, there is the possibility of potential psychological and physical risks that may occur in certain persons exposed to psilocybin.

Health Canada recognizes there are times when access to unauthorized drugs, such as psilocybin, may be appropriate, and encourages patients to discuss potential treatment options with their health care provider.

Clinical research is essential to understanding the effects of any drug, including psilocybin, in a therapeutic context, as well as for the development of drug products that are safe and effective. Of note, the number of authorized clinical trials with psilocybin has increased significantly in recent years. To date, Health Canada has authorized the sale of psilocybin for use in 25 Canadian clinical trials. Through the Canadian Institutes of Health Research, the Government of Canada has provided funding of almost $3 million to fund three new clinical trials evaluating psilocybin-assisted psychotherapy in Canada. In January 2022, regulatory changes came into effect that made it possible for health care practitioners to request access, on behalf of their patients, to restricted drugs like psilocybin through Health Canada’s Special Access Program (SAP). The SAP permits health care practitioners to request access to unauthorized drugs for the treatment of serious or life-threatening conditions in instances where conventional therapies have failed, are unsuitable or unavailable.

Clinical trials remain the most appropriate way to advance research about products with a possible medical benefit and bring it toward market authorization. Both clinical trials and the SAP 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 in accordance with national and international, ethical, medical, and scientific standards.

There are no safeguards and requirements in place for a section 56 (s.56) exemption under the CDSA to help protect the health and safety of patients, to help ensure the quality of the drug, and to provide for administration and oversight by a qualified professional. Therefore, access to psychedelics through clinical trials or the SAP should generally be pursued instead of an individual s.56 exemption, unless it can be demonstrated that access to a psychedelic drug is not possible or suitable through these existing regulatory legal routes.

Medical assistance in dying (MAID) remains a complex and deeply personal issue for many Canadians. The Government of Canada is committed to ensuring that the practice of MAID balances laws that give autonomy and freedom of choice for Canadians, a system that provides strong safeguards that protect those who may be vulnerable, and a process that guarantees compassionate and diligent consideration of every request for MAID.