Medical use of psilocibyn in Canada could grow, but consumer sale unlikely

A court case could force the Canadian government to process requests to use psilocybin for psychotherapeutic treatment more quickly. But the sale of any sort of psilocybin product to the general public remains a long way off.

Nathan Kruljac, a 40-year-old man from British Columbia, is taking the Canadian government to court in order to force it into rendering a decision on his application for a legal exemption to allow him to include psilocybin as part of his therapy for anxiety, depression and post-traumatic stress syndrome.

Kruljac was diagnosed with cancer when he was 25. While he survived the potentially fatal disease, it left him with “debilitating end of life distress,” Ottawa lawyer Nicholas Pope wrote in Kruljac’s application.

“The applicant has attempted all conventional treatments for his psychological distress, including psychiatry, counselling, group therapy, cognitive behavioural therapy, targeted group therapy, introspective writing and private journaling. None have brought him freedom from his suffering,” Pope said.

The case could set the stage for a larger court challenge that would consider the general legality of psilocybin for psychotherapeutic treatment in Canada. However, full regulation of psilocybin is not currently part of Canada’s plans, according to a spokesperson for Health Canada.

While clinical trials have been approved, Health Canada has no plans to change the regulations governing psilocybin over the next two years, said spokesperson Charlaine Sleiman.

“At this time, Health Canada has no plans to develop new regulations for psilocybin or psilocin, the two controlled substances that can be found in ‘magic mushrooms’,” she specified.

 

Clinical trials over legal exemptions

 

Health minister Patty Hajdu has granted several dozen exemptions to the legal ban on psilocybin in Canada since August 2020 to allow it to be used in treatment, but Kruljac has heard nothing from the government since he applied for an exemption on 11th March.

“Most decisions have come out between one and a hundred-ish days,” Pope told CBD-Intel, adding that Kruljac is suffering. “This is now at 150 days.”

Pope said Kruljac would prefer to settle the question out of court, “but at this point something had to be done to actually get a response from the minister”.

“Taking this long to render a decision constitutes implied refusal.”

Health Canada has not yet filed its response to Kruljac’s court application. Sleiman said the government would prefer patients to access psilocybin through clinical trials, rather than granting legal exemptions.

“Clinical trials are the most appropriate pathway to access products with a possible medical benefit that are experimental and have not yet undergone the rigorous, science-based review process to be approved as marketed drugs,” she added.

“Clinical trials represent the best option for patients, as they protect the best interests of the patients and ensure that the substances are administered in accordance with national and international ethical, medical and scientific standards.”

To date, Health Canada has approved two clinical trials of psilocybin, she said. Compass Pathfinder started a clinical trial of psilocybin in March 2019 to help patients with treatment-resistant depression. The Brain and Cognition Discovery Foundation received the green light from Health Canada in July for a study on using psilocybin for depression, but Health Canada lists the start of its trial as “pending”.

 

Many resorting to ‘underground’ psilocybin use

 

However, a non-profit group that tries to help patients access psilocybin told CBD-Intel that this was a mealy-mouthed response. Spencer Hawkswell, CEO of non-profit group TheraPsil – which is also funding Kruljac’s court case – said that his group has told Health Canada multiple times that it was putting people in danger as the trials have long since reached maximum numbers. By not granting legal exemptions, the agency was forcing people to experiment on their own in potentially unsafe conditions.

“It’s frustrating because we have made it very clear that those clinical trials are full,” said Hawkswell.

He added that his group noticed the government had started slowing down its processing of psilocybin exemptions around February or March and started directing patients towards clinical trials, and that TheraPsil had been in communication with Health Canada numerous times since then. It had even drafted 165 pages of proposed new regulations for psilocybin based on the existing regulations for medical cannabis and sent them to Health Canada a few days ago.

Patients are now resorting to using psilocybin underground, and this could be unsafe for them, he said. It is now hoped that Kruljac’s case will lead to a judicial review of the government’s actions and whether they have respected Canada’s Charter of Rights.

“I really do hope that the government acts in the best interest of patients and in a way that is consistent with our constitution, but if necessary, how far will we take this? All the way.”

 

What This Means: Sympathy for Kruljac’s plight aside, the main takeaway from the case from a business perspective is that any thought of a product using mushroom psychedelics as the active ingredient is a very, very long way away from being allowed to go on general sale in Canada.

The hopes of companies like Silo Wellness, which wants to follow up the recent release of its Bob Marley branded range of functional non-psychedelic mushroom products in the Canadian market with ones containing psychedelic active ingredients looks to be very small at this point in time. Or very far away.

It looks like, for the foreseeable future, Silo and other companies banking on relaxation of laws governing psychedelics will have to look to other markets for any upcoming product launches.

 Elizabeth Thompson CBD-Intel contributing writer

Photo: Wikimedia Commons

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