Over the course of the past two years, TheraPsil has assisted over 130 patients, but it calls the country’s current limitations a “cruel approach” on the part of Health Canada. The organization has attempted to set up a formal meeting with parliament members, but so far has been denied, so it’s taking the conversation straight to the capital to protest between Nov. 28-30.

Spencer Hawkswell CEO of TheraPsil, believes that patients need to have legal access to psilocybin or psilocin. “There is ample evidence of both the safety and efficacy of psilocybin in the treatment of various mental health conditions,” said Hawkswell in a press release. “The previous Minister recognized this and started approving exemptions. Unfortunately, this Minister has stopped and refused to consider reasonable regulations to ensure vulnerable Canadians don’t have to go to Court to access treatment that can improve their quality of life and death.”

Current Schedule III Substances under the Controlled Drugs and Substances Act are psilocybin and pilocin. The Special Access Program is an exception that allows patients to legally access the drug. 

TheraPsil uses Thomas Hartle as an example to show the challenges patients are facing. Hartle was diagnosed with breast cancer in 2016. Hartle was one of the first to receive approval from former Health Minister Patty Hajdu to use psilocybin to treat “end-of-life anxiety” in 2020, which was valid for one year. The treatments worked well and Hartle reapplied to continue access in October 2021. However, Jean-Yves Duclos, the current Health Minister, denied him.

“We hope to meet with the Minister to find out why he and his officials are being so cruel to us,” said Hartle in a press statement. “Instead of a compassionate response, Health Canada is referring dying and vulnerable patients to a special access program that results in lots of red tape but no access for most. Many, like me have gone over a year without a response to their urgent requests.”

TheraPsil plans to arrange interviews with media over the next few hours in order to bring attention both for the medicinal benefits and for better access. “Mental health is a non-partisan issue,” said palliative care physician Dr. Valorie Masuda. “Reasonable treatment options should be available to Canadians who have the right to MAiD [Medical Assistance in Dying]. It is cruel to withhold medicine from vulnerable patients, especially when those medicines have worked for them.”

TheraPsil sent an open letter to social workers and medical professionals earlier in the month, asking for regulations on psilocybin. “We believe that our patients have a right to Medical Psilocybin and this open letter is to demand this right on their behalf. We need a compassionate and immediate response and solution to the Section 56 applications for psilocybin access and seek your response to our proposed request for ‘Access to Psilocybin for Medical Purposes Regulations,’” the letter stated.

Meanwhile in Canada, Apex Labs received a “no objection” letter from Health Canada, which effectively greenlit the first North American study on psilocybin as a treatment for military veterans who suffer from conditions such as depression and post-traumatic stress disorder. “Veterans are already self-medicating with micro-doses of unregulated psilocybin products without knowing the potency and safety of the product they are consuming,” said Apex Labs CEO Tyler Powell. “Our goal is to expand access to pharmaceutical grade drug products through regulated systems, providing transparency and support for patients in need.”

In a new study, The New England Journal of MedicineThe benefits of psilocybin were also demonstrated in a double-blind clinical trial on Nov. 3. “In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects,” the researchers wrote. These adverse effects include headaches, nausea and dizziness as well as suicidal thoughts.