Therapsil sues Canadian government over access to psilocybin

Thomas Hartle, a terminal cancer patient, is the lead plaintiff in a lawsuit against Health Canada to allow medical access to psilocybin. Partnered with Hartle is the nonprofit Therapsil, along with seven other patients and a medical professional. The complaint filed indicates that access to psilocybin is a constitutional right.

Led by an attorney specializing in cannabis and psychedelics Paul Levin argues that current avenues of legal access to psilocybin violate section 7 of the Canadian Charter of Rights and Freedoms. Canada’s first medical cannabis framework was created with the same Charter challenge in 2001 with the landmark R vs. Parker Case.

The lawsuit is the culmination of lengthy negotiations between the founder of Therapsil Dr. Bruce Tobin and Health Canada. Tobin began researching access to psilocybin for terminally ill patients in 2017 after reading research from Johns Hopkins, with limited success.

However, in the current landslide of positive psychedelic press and research, the legal case for psilocybin access has an increasingly solid foundation.

Psilocybin legal in Canada

Previously, Canadians seeking access to psilocybin had to either enroll in a clinical trial or use Section 56, which allows exemption from the drug laws with the authorization of the federal Minister of Health.

Section 56 helped about 60 Canadians and gave Thomas Hartle access to the first legal psilocybin therapy in Canada in 2020. While this represents progress, Section 56 and available clinical trials are only open to a limited number of people in need.

Earlier this year, Canada created a third way by modifying the “Special Access Program” to allow access to psilocybin. The SAP was originally created for cancer drugs not available in Canada.

However, despite small gestures in a praise-promoting direction, Therapsil says 150 patients received no response from Health Canada regarding their requests. As a result, the organization’s waiting list grew to more than 800 people ask for help accessing psilocybin.

This led Spencer Hawkswell, CEO of Therapsil, to criticize SAP as “the slow access program” and clarified that:

“It seems obvious that Canadians should have a medical right to psilocybin after what happened with cannabis. Also, patients who are fighting this fight may not have enough time to see its resolution. It is essential that ministers work with these patients, fighting this case would be a stain on Canada’s so-called “patient-centred” healthcare system.

Hawkswell expressed frustration that some health ministers have disagreed with granting exemptions and that the current framework is ill-equipped for psychedelics. The current framework was created to access drugs not available in Canada, but psychedelics are not just another drug. And Therapsil is not advocating for decriminalization but for medical psilocybin, where the compound is used as part of a psychedelic-assisted therapy protocol.

In a therapeutic setting, medical psilocybin should be administered by experienced medical professionals, ideally trained themselves in the use of psilocybin. Therapsil previously helped therapists train by sending each other 5-gram trips, but Health Canada has also been inconsistent with granting exemptions for training psychedelic therapists. The filed complaint will also address this issue if accepted.

Access to psilocybin for medical purposes

A previous attempt by Therapsil to remedy the situation was the submission of a 165-page document dubbed the Regulations on Access to Psilocybin for Medical Purposes or APMPR. The proposed regulations for legal and medical access to psilocybin follow previous cannabis legislation established in 2016 – the Access to Cannabis for Medical Purposes or ACMPR.

Therapsil first submitted the document in 2021, but Health Canada was slow to act. However, Hawkswell told Microdose he was optimistic:

“I believe that the Honorable Ministers of Health will accept the ACMPR and adopt this regulation or regulation exactly like this. Instead of reinventing the wheel, our team did the administratively simple thing and modeled these robust regulations from our current medical cannabis regulations.

If approved, the APMPR regulations would allow individuals and companies to cultivate or synthesize psilocybin following approved best production practices. Like previous cannabis regulations, processing natural psilocybin into products and selling medical psilocybin to other licensees would be permitted. Requirements for permitted amounts, packaging, and concentrations of psilocybin are also included.

The Radio-Canada reported that Therapsil is not the only organization to ask Health Canada for a regulatory framework. The Multidisciplinary Association for Psychedelic Studies (MAPS) and the Canadian Psychedelic Association (CPA) also have proposals for Health Canada. Health Canada has not issued any statement on its intentions for the future. However, the psychedelic conversation reaching the ears and desks of Canadian regulators is giving rise to optimism.

One would hope that an honest review of existing psychedelic research, legal businesses being created, and compassion for people like Thomas Hartle would inspire policy that would allow Canadians medical access to psilocybin.

To note: Therapsil is currently running a fundraising campaign for the case and, at the time of writing, has yet to reach its $100,000 goal. You can donate dollars and cryptos here.