Canada, long regarded a pioneer in drug policy reform, is now trying to move the needle on patient access to psilocybin, the active ingredient in “magic mushrooms.”
The country’s history with early cannabis legalization has placed it at the center of attention in the psychedelics scene, as patients, advocates and healthcare professionals seek to expand access to psychedelics-assisted therapy.
Since 2020, Health Canada has allowed over 50 patients and doctors to legally use psilocybin through special government-granted exemptions. However, pressure is building for alternative solutions that can guarantee access to more people in a more agile way.
How Are Patients In Canada Accessing Psilocybin Treatment Today?
In 2019, TheraPsil was created as a non-profit to help Canadians in medical need access legal, psilocybin-assisted psychotherapy. Today, this is done by helping patients to navigate an application process that can get them government approval to use psilocybin in a therapeutic context.
In August of 2020, the Canadian Minister of Health Patty Hajdu allowed four terminally ill cancer patients to legally use psilocybin as part of a palliative care treatment for end-of-life distress.
The exemption was granted, thanks to subsection 56 of the Controlled Drugs and Substances Act, which allows the minister of health to exempt any person or any controlled substance when “necessary for a medical or scientific purpose or is otherwise in the public interest.”
Later in 2020, 17 healthcare professionals were granted exemptions to possess and use psilocybin to conduct professional psilocybin therapy training. This is considered an important part of the learning process for psilocybin facilitators.
To date, TheraPsil has supported 28 patients and 19 healthcare professionals in receiving section 56 exemptions for psilocybin use.
“We stand on the shoulders of giants here in Canada,” says TheraPsil CEO Spencer Hawkswell.
“We've got similar advocacy that we've done with cannabis and medical assistance in dying. It's all about putting patients first. And we've got a compassionate health minister.”
Is Psilocybin Legalization Coming To Canada Any Time Soon?
In 1999, section 56 exemptions allowed Canadians to first use cannabis legally for medical purposes. An overflow in exemption requests was one of the driving forces behind Canada's decision to legalize cannabis for medical purposes in 2001, which led to the full legalization of adult-use cannabis in 2018.
“The courts said that the section 56 process was unconstitutional and that Health Canada needed to have regulations,” Hawkswell said.
In recent months, industry insiders have voiced optimistic sentiments that psilocybin will soon take the same path. Expectations further rose when Oregon became the first U.S. state to launch a legal psilocybin program in November 2020
Hawkswell summarized these sentiments eloquently.
“I can certainly suspect that at this point in time there are too many exemptions and that they're already seeing that it's going to become unsustainable to have this as a long-term solution,” he voiced.
However, a Health Canada spokesperson told Benzinga that the “development of a medical psilocybin program is not being considered at this time.”
Yet not all hope is lost for Canadian patients, as there are other alternatives that could lead to the opening of psilocybin access in Canada.
“Clinical trials remain the most appropriate pathway to allow access to experimental products, including psilocybin, with a possible medical benefit, that have not yet undergone the rigorous, science-based review process to be authorized as marketed drugs,” said Kathleen Marriner, media relations officer from Health Canada’s communications and public affairs branch.
Full legalization of psilocybin for medical reasons is likely to occur after the compound has gone through all four phases of clinical trials, the same way as any other pharmaceutical would be regulated. In the U.S., this is not expected to occur at least after 2025.
Psilocybin Access Could Expand Soon Nonetheless
While an Oregon-style psilocybin program does not appear to be on Health Canada’s agenda for the near term, the agency is exploring a route that could allow patients to access psilocybin treatment without the need for an exemption from the Health Minister.
Last December, Health Canada opened a public consultation to seek comments on a proposal to amend the Food and Drug Regulations and the Narcotic Control Regulations, that would restore potential access to restricted drugs through Health Canada’s Special Access Program (SAP).
The amendment includes MDMA and psilocybin, among other drugs. If approved, practitioners could request access to restricted drugs on behalf of patients with serious or life-threatening conditions in instances where other therapies have failed or are unsuitable.
According to Health Canada, requests to use a drug under the Special Access Program are normally processed within one working day. In contrast, the initial requests to use psilocybin under section 56 exemptions were granted only after more than 100 days of waiting.
The consultation period has closed and “Health Canada is currently considering the comments received to determine the best path forward,” Marriner said.
Finding A Sustainable, Long-Term Solution
Hawkswell fears that his organization is becoming a bottleneck for patient access to psilocybin, which is why TheraPsil is focused on expanding therapist training in order to offer treatment to more patients.
He referred to section 56 exemptions as “a stopgap solution.”
The organization is supporting advocacy efforts for regulations that allow psilocybin access and training through the public healthcare system.
“I believe it's just as much in the government's interest to create regulations because, at this point in time, these regulations really aren't satisfactory. And not just because they take a long time, but because they're not safe, or not as safe as they could be.”
While the exemptions present an almost unique way for patients to access psilocybin as a scheduled substance, Hawkswell believes the system could be greatly improved.
“The safer thing to do would be to educate doctors and support patients fully instead of haphazardly through these exemptions. So I both like the exemptions now, but also do have to note that there are ways that they can be better,” he concluded.
Photo Credits: Benzinga, Unsplash, Pexels, Guillaume Jaillet and Bence Lengyel
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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