Recent Developments In The Canadian Psychedelics Industry

• Published date: 17 February 2025
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: McMillan LLP
• Author: Ms Leila Rafi, Sasa Jarvis, Kiira Kaarid (Summer Student), Veronica Russo and Gary Preteau

Introduction

The psychedelics industry in Canada continues to shift, and the outcomes of certain developments remain unclear. During times of unpredictability, understanding the landscape, and potential future development, is crucial for industry participants and stakeholders. In this bulletin, we provide an update on the key advancements and trends in the Canadian psychedelics space since our last annual review of 2022.

Accessing Psychedelics

Psychedelics are classified as controlled substances under the federal Controlled Drugs and Substances Act (the "CDSA"). In effect, this designation means that most activities involving psychedelics are prohibited with certain exceptions. As noted in our prior bulletins, there are currently three avenues for individuals to access psychedelics in Canada - an exemption under section 56 of the CDSA, the Special Access Program ("SAP") and clinical trials.

Section 56 Exemptions

Section 56 of the CDSA permits the Minister of Mental Health and Addictions and Associate Minister of Health (the "Minister") to grant discretionary exemptions for access to controlled drugs and substances, on a class or individual basis, if such exemptions would serve a medical, scientific, or other public interest purpose ("Section 56 Exemption").¹

On January 31, 2023, the first province-wide Section 56 Exemption took effect in British Columbia, permitting adults to possess prescribed amounts of opioids, methamphetamine, cocaine, and MDMA, without facing criminal charges.² Concerns arose in the province around the use of illicit drug use in public spaces, resulting in the B.C. government twice amending its Section 56 Exemption to limit its application in public spaces, among other limitations.³ As of May 7, 2024, B.C.'s Section 56 Exemption only applies in private residences, shelters, and designated health care clinics and possession of opioids, methamphetamine, cocaine, and MDMA is once again prohibited in most public spaces.⁴

Shortly thereafter, on May 17, 2024, the City of Toronto's request for a Section 56 Exemption to decriminalize possession of all drugs listed in the CDSA was rejected. The Minister found that the proposal, initially submitted on January 4, 2022, did not adequately protect public health or maintain public safety.⁵ Concerns included the feasibility for law enforcement to implement the plan, protection of youth, and the lack of support from key players like the Ontario provincial government.⁶

A significant portion of individual applications for Section 56 Exemptions have similarly been denied. In November 2024, it was reported that since 2020, 643 patients and healthcare practitioners have applied to access psychedelics through a Section 56...