The implications and nuances are still to be analyzed and understood, but this morning a BIG announcement was made by Health Canada. In short, Health Canada's Special Access Program (SAP) has been the only mechanism available in Canada for seeking s.56 exemptions to the Controlled Substances Act (for example, starting in August 2020, Therapsil led the charge with applications for the use of psilocybin for end of life anxiety and treatment resistant depression). However, this was a very cumbersome process, and the need for these treatments (and the relative safety and effectiveness of psychedelic therapies) very quickly outpaced the SAP mechanism and outdated regulations around 'illegal' drugs, and psychedelic substances in particular.
As you may remember over the past 18 months or so, there have been a couple of public consultation processes on this question, and thanks to the hard work of many people raising their voice, lending their expertise and advocating for change, there have been some intriguing amendments made to the SAP, which seem to open up access to psychedelics in Canada for licensed professionals for research and limited/narrow prescriptive uses. The email and links to the amendment are below:
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Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) The purpose of this email is to inform you that on January 5, 2022, the following regulatory amendments were published in the Canada Gazette, Part II, and came into force immediately: · Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) These regulatory amendments restore the possibility for practitioners who are allowed to prescribe drugs to request access to restricted drugs through Health Canada’s Special Access Program (SAP). With the regulations now amended, practitioners who are allowed to prescribe drugs can, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP when other therapies have failed, are unsuitable, or are not available in Canada, and when there is
sufficient data to support the safety and efficacy of the drug for the specific condition of the patient. All SAP requests will continue to be assessed on a case-by-case basis and there is no guarantee that access to restricted drugs will be granted through the SAP. Please note that the SAP is for emergency treatment only; there is no waitlist. Patients cannot apply to the SAP directly. The regulatory amendments are not intended to promote or encourage the early use of unapproved drugs, or to circumvent the well-established clinical trial or drug review and approval processes. Clinical trials are the best way to advance research into unapproved drugs. The regulatory amendments also removed cocaine from the definition of “restricted drug” so that all cocaine products are regulated as narcotics under the Narcotic Control Regulations, thereby removing complexity for stakeholders applying to conduct or conducting activities with cocaine. ________________________
This is an important amendment to the current legal and regulatory landscape in Canada, and a HUGE milestone for the psychedelic community!
To be clear however: this DOES NOT mean that psychedelics are legal, and the general public are still not legally allowed to possess or use psychedelic substances. So please stay prudent and safe.
But what this does mean is that the research and therapeutic landscape has the potential to shift a LOT in the coming months and years, and depending on how these amendments are enforced and expanded, Canada is potentially poised to contribute robustly to the evolution and development of psychedelic studies and practice globally.
This is a BIG deal! There is still lots to be done to continue to advocate for the legalization and freedom for a wide range of psychedelic use-- including personal and religious/ spiritual/ ritual-- but this is a big step for Canada and for the psychedelic community. We will see how this all plays out in a practical way as the coming weeks and months unfold, but for now, let's celebrate the win!!
Image from Creative Commons: "psychedelic-boom" by burningmax is licensed under CC BY-NC-SA 2.0