Dave Hodes
On January 5, Health Canada added amendments to the Special Access Program (SAP) that now allow physicians to request patient access to psychedelic treatments, including MDMA, psilocybin, LSD, and DMT.
The Health Canada regulations state that drugs that have not been approved for sale in Canada can generally be requested through Health Canada’s SAP in instances where conventional therapies have failed, are unsuitable, or unavailable.
Regulatory amendments made to Part C of the Food and Drug Regulations in 2013 restricted drugs (such as psychedelics) became the only category of controlled substances that could not be requested through the SAP.
Restricted drugs generally do not have approved medical uses. Since the regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance, with some now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials, according to Health Canada.
As a result of the 2013 regulatory amendments, under the Food and Drugs Act, clinical trials became the only mechanism by which the sale of a restricted drug could be authorized for the treatment of patients.
That mechanism has changed as of the new amendments on January 5.
The reaction to this historic move came quickly in both Canada and the U.S. Joel Shacker, CEO of Core One Labs, a psychedelics research and technology company based in Vancouver, British Columbia, summarized a lot of the sentiment. “Core One applauds Health Canada’s serious approach to mental health reform and feels a brighter future is in near sight for many Canadians. Well done, Canada!”
Just a week after the announcements of the amendments, Denver-based Mydecine Innovations Group, a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced they would be launching the Special Access Support and Supply Program (SASSP) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy.
Another readout on the SAP amendments move came from Origin Therapeutic Holdings in Vancouver, British Columbia, soon to be a publicly-traded venture capital incubator fund for the psychedelics industry, now with investments in early-stage biotech space with a psychedelics focus in wellness retreat space and psychedelic-assisted therapy space. “I think it’s definitely a step forward and kind of a sign of legitimacy for the psychedelics industry,” Alexander Somjen, CEO and director of Origin Therapeutics, told Green Market Report. “If you’re a biotech startup in the psychedelic space, this potentially means more and easier availability and less red tape for being able to obtain psilocybin or MDMA to treat patients that are facing life-threatening mental illness for which no existing conventional treatment has been effective. So I think it just makes everybody’s lives in the ecosystem a little bit easier.”
The amendments move by Canada Health as published in the Canada Gazette comes at a time when companies are investing more in research and development and has helped prompt a renewed interest in psychedelics therapy development. “I was on a call with a chief science officer of one of our investing companies who told me that taking psilocybin in a supervised setting for an acute mental illness is similar to hitting the ctrl-alt-delete function on a computer,” Somjen said. “And I thought that was really interesting because it’s true that more and more psychedelics are being shown to really boost the neuroplasticity of the human brain and help people see the world differently.”
Somjen said that the biotech-related companies in the psychedelics space are “going to continue to be the bellwethers,” ie, the leading indicators of future trends. “It’s going to be interesting to see over the course of this year if any of these (startup) companies can actually get to the point where they can commercialize a psychedelic-based pharmaceutical treatment,” Somjen said. “I think ultimately, there’s a lot of exciting deal flow we’re seeing in the startup space. So I think more and more of these companies will be in a position to go public later in the year.”
The lead-up to the amendments this year under SAP demonstrates the Canadian government’s growing interest in offering help for mental health treatment. There’s a sense of urgency in the country—5 million Canadians were treated for mental illness in 2009, the last year statistics were published. The total cost from mental health problems and illnesses to the Canadian economy is conservatively estimated to be at least $50 billion per year.
The amendments process began on December 12, 2020, when Health Canada published a Notice of Intent in the Canada Gazette signaling Health Canada’s intent to amend the Food and Drug Regulations and the Narcotic Control Regulations to restore potential access to restricted drugs through the SAP.
This was significant. Past regulatory amendments made in 2013 did not allow restricted drugs to be requested through the SAP except for clinical trials. But before those 2013 amendments were made, Health Canada cited the fact that MDMA and psilocybin had been granted “breakthrough therapy” by the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression.
So clearly, even as far back as 2013, Health Canada officials were watching and wondering if they should make a move to do more for treating mental illness in the country. Yet, no practitioner requested access to a restricted psychedelic through SAP in 2013.
The publication of that notice of intent for Health Canada in December began a 60-day comment period. The Health Department received written feedback from 392 respondents. The vast majority of the responses were submitted by individual members of the public, while 25 responses were submitted on behalf of organizations, including psychedelic research or advocacy groups, industry (i.e. current or prospective licensed dealers and/or manufacturers), clinician groups, medical clinics, and others.
Some respondents self-identified as health care professionals (e.g. physicians, clinical counselors, registered nurses), frontline workers (e.g. social workers), or researchers/scientists. Physicians and therapists often expressed interest in expanding their treatment options to include psychedelic restricted drugs.
Approximately 22 percent of respondents described having an experience with a mental health disorder or other health conditions and had a personal interest in seeking treatment with a psychedelic restricted drug.
