On January 5, 2022, the Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program), SOR/2021-271 (the "Amending Regulations"), came into force, which enacted certain amendments to the Food and Drug Regulations ("FDR") and the Narcotic Control Regulations ("NCR"). Most notably, the Amending Regulations have revived Canada's "Special Access Program" as it relates to "restricted drugs" (including various controlled substances commonly regarded as 'psychedelics') and restore the ability of healthcare practitioners to request access to restricted drugs from Health Canada on behalf of patients with serious or life-threatening conditions in instances where other therapies have failed, are unsuitable, or are not available in Canada.. The Amending Regulations represent one of the most significant steps towards regulating and facilitating access to restricted drugs for medical purposes to date.
Undoing the Past
In instances where conventional therapies have failed, are unsuitable, or unavailable, Canada's Special Access Program allows practitioners to access new, potentially life-saving substances, including those regulated under the federal Controlled Drugs and Substances Act ("CDSA"), for their patients before they are formally approved for routine use in Canadian healthcare. As the Special Access Program exists for emergency access, requests are granted to individuals on a case-by-case basis where scientific evidence supports the potential safe and therapeutic effects of a substance.
In 2013, certain amendments made to the NCR and Parts C and J of the FDR excluded restricted drugs from the scope of controlled substances that could be legally accessed through the Special Access Program. Part J of the FDR defines "restricted drugs" as including certain controlled substances listed on the schedule to Part J of the FDR, including various psychedelics such as psilocybin (and psilocin), 3,4-methylenedioxymethamphetamine (MDMA), N,N-Dimethyltryptamine (DMT), and Lysergic acid diethylamide (LSD). As a result of their exclusion from the applicability of the Special Access Program, the only mechanisms by which the sale and importation of a restricted drug could be authorized for patient treatment were approved clinical trials and exemptions from the applicability of the CDSA issued under subsection 56(1) of the CDSA ("Section 56 Exemptions").1
Since the implementation of the prohibitive regulatory amendments in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has advanced considerably. Most notably, certain Phase II and Phase III clinical trials have indicated that restricted drugs such as psilocybin and MDMA demonstrate potential therapeutic efficacy for use as treatment of mental health ailments such as post-traumatic stress disorder and depression.
Additionally, over the last several years, Canada's capital markets have seen an influx of companies that operate in the psychedelics industry, including operators of medical clinics, clinical research organizations, and stakeholders otherwise focused on the research and development or psychedelics-based therapy and treatment.
In response to the emerging scientific evidence and, possibly, the evolution of the nascent psychedelics industry, the Amending Regulations have repealed the provisions in the NCR and FDR that previously prohibited the ability of physicians, pharmacists and their patients to achieve access to restricted drugs through the Special Access Program. On behalf of their patients with serious or life-threatening conditions, healthcare practitioners will now again be able to request restricted drugs through the Special Access Program in instances where other therapies have failed, are unsuitable, or are not available in Canada.
While the Amending Regulations are not intended to create large-scale access to restricted drugs, they represent:
- an express acknowledgement by the federal government of the potential therapeutic benefits of using psychedelics to treat various symptoms and ailments, especially those related to mental health;
- the receptiveness of the federal government to empirical evidence of restricted drugs' therapeutic benefits; and
- a significant step by the federal government towards regulating and facilitating access to restricted drugs for medical purposes.
The Amending Regulations enrich the existing mechanisms (i.e., clinical trials and Section 56 Exemptions) by introducing another, possibly more efficient and reliable, avenue through which patients with life-threatening conditions may access restricted drugs and psychedelics-based therapies. Indeed, while personal Section 56 Exemptions (rather than class Section 56 Exemptions) continue to be utilized successfully by healthcare professionals such as TheraPsil to support patients with life-threatening conditions, these exemptions involve lengthy wait times and an arduous legal process not designed for patient care, and are granted on individual bases for narrow prescribed purposes. This is contrasted to the Special Access Program that exists for emergency patient access and responds to requests within 48 hours. Similarly, clinical trials do not guarantee continued patient access to a substance after the trial in question has ended. In combining the Amending Regulations with these already existing mechanisms, access to therapies reliant on restricted drugs has become more accessible.
1. One exception is the allowance for access to diacetylmorphine (i.e. heroin) under the Special Access Program, which was a specific carve-out enacted in 2016.
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