Canada’s Federal Health Minister Compassionately Grants 3 Patient’s ‘Section 56 Exemptions’ for Psilocybin Mushrooms to treat their Depression and Anxiety

Victoria BC, December 14th, 2021 

3 Canadians, who have been struggling with mental health conditions including depression, anxiety, and PTSD have just been approved by the new Federal Minister of Health, Jean-Yves Duclos, to legally undergo psilocybin therapy as a treatment option. These individuals have been waiting up to 283 days for a reply, and are now 3 of 47 patients, supported by TheraPsil, who have been approved through section 56 exemptions to legally undergo psilocybin therapy. 

TheraPsil, a BC-based non-profit coalition that advocates for legal, compassionate access to psilocybin therapy for Canadians in medical need, supports patients with their applications to seek ministerial approval, and has been advocating for compassionate access, and regulatory change, since 2019. The first 4 patient exemptions for compassionate access to psilocybin therapy in Canada were granted on August 4th, 2020, after patients waited 106 days. 

Robert Foxman, 60 from Montreal, was ecstatic that after waiting for his Section 56 exemption since March 2021, he received an email from Health Canada on Monday, December 6th, 2021, confirming that his exemption had finally been granted. His wish for the New Year is that all applicants who have continued to wait for their long-overdue Section 56 exemptions are approved as soon as possible.

Another patient who was approved on December 6th, Nathan Kruljac, who waited 270 days, had pursued legal court proceedings in order to solicit a response from the Minister of Health regarding his exemption application. Several more patients are expected to file Mandamus Applications in regards to their urgent need for compassionate access to psilocybin therapy.

Nathan had this to say:

“​​It’s about time. I don’t mean that in the “I’m exasperated” sort of way. I mean that as a frame of reference. I have been in agony for 15 years. This decision by the Minister to acknowledge my trauma and pain and allow me compassionate access to psilocybin may be the turning point in my life; it may not. The choice is mine and shouldn’t fall to a decision made by an administrative department of our government. The Minister has accepted that my 15 years of experience and suffering was enough and I hope that it will open doors to help other people with their trauma and give them time.”

These 3 exemption approvals represent a massive paradigm shift in the criteria that Federal Minister of Health, Jean-Yves Duclos is using to determine patient approvals. Since his appointment as Health Minister, Mr. Duclos has only approved patients for psilocybin therapy who are in palliative care or who have been diagnosed with a terminal illness. 

TheraPsil’s CEO, patient-rights advocate, Spencer Hawkswell had this to say:

“This is a major breakthrough. Today we are thankful for Minister Jean-Yves Duclos’ and Minister Dr. Carolyn Bennett’s compassionate response to patients in medical need of psilocybin therapy. We hope that the Minister(s) will continue to approve the countless remaining exemptions from patients with cluster headaches, PTSD, and substance use disorders who equally deserve access. Some of these patients have also waited over 220 days – a perfect example of why medical regulations for psilocybin, which we have written and proposed, as opposed to ad-hoc section 56 exemptions, are so crucial moving forward”.  

Since February 2021, Health Canada began directing patients applying for exemptions to apply for clinical trials instead, of which there are very few. In addition to increasing advocacy for compassionate access and fighting for regulatory change, TheraPsil responded by launching its first-ever research collaboration, a quantitative observational research study aiming to understand the impact of psilocybin-assisted psychotherapy on Canadian patients with end-of-life distress who have received a section 56 exemption. This is the first known scientific study of its kind aiming to provide “real-world” data on this emerging treatment option, in Canada.  However, because this study is only available to patients with exemptions, the ability to collect data relies on the Minister continuing to approve exemptions.

In addition to the need for continued patient exemptions, TheraPsil stresses the need for healthcare professional exemptions to also be approved. Healthcare professional exemptions are essential so that therapists can complete their training in this unique modality and meet the increasing demand of patients being approved for this treatment option, and in anticipation of the future demand, post-medical legalization. In December 2020, Minister Hajdu approved 19 healthcare professionals section 56 exemptions for experiential training purposes. Those exemptions have since expired. Now, over 120 additional healthcare professionals enrolled in Therapsil’s psilocybin-therapy training program have applied for and are awaiting the same exemption approval as their peers did. 

“TheraPsil’s Experiential Module, where a trainee guides another trainee through a 5-gram therapeutic psilocybin journey and then is guided through this same experience for themselves, is crucial for these Healthcare Professionals to complete before being able to best treat a patient. Being able to hold space safely and effectively requires Healthcare Professionals to have their own first-hand experience with psilocybin and right now there are only 5 practitioners in Canada who have been able to undergo legal psilocybin therapy in the context of our training program. By not having this experiential component patients’ safety and treatment efficacy can potentially be put at risk. Please Honourable Minister Duclos, we ask that you grant Healthcare Professionals enrolled in our training programs their exemptions so they can complete training and treat approved patients in urgent need of their care.” – Yasmeen Sadain, TheraPsil’s Director of Training and Operations  

TheraPsil looks forward to continuing to support patient applications, and to working with the Health Minister, Jean-Yves Duclos, Minister Dr. Carolyn Bennett, and Health Canada to approve exemptions for patients in medical need, and Health Care Practitioners so they may use psilocybin for professional training in psilocybin-assisted psychotherapy in preparation to treat patients. 

Canadians are encouraged to learn more and advocate for the medical legalization of psilocybin therapy in Canada, here

Patients interested in applying for section 56 exemptions are invited to confidentially contact TheraPsil, here.

Media Contact:         

Holly Bennett, Director of Communications, holly @ therapsil.ca

All other inquiries:   

Spencer Hawkswell, Executive Director, spencer @ therapsil.ca

 

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