From: TheraPsil, Victoria, BC
Via Email: email@example.com
To: Honourable Minister of Health Jean-Yves Duclos
Minister of Health, MP for Québec Quebec, and Dr. Carolyn Bennett Minister of Mental Health and Addictions, MP Toronto—St. Paul’s, Ontario
House of Commons Ottawa, Ontario KIA OA6
Re: Proposed Regulations for Medical Access to Psilocybin
Dear Honourable Ministers,
Congratulations on your new appointments as Minister of Health and Minister of Mental Health and Addictions. These positions are a great honor and come with great responsibility. I wish you both the best over your term.
On behalf of our members across Canada and the elected Board, I also want to take this opportunity to acknowledge that it has been 15 months since the decision to approve the compassionate use of psilocybin for medical purposes. 15 months ago, thanks to the compassion and courage of the Hon. Patty Hajdu, Canada became one of the first countries in the world to facilitate legal medical access to psilocybin therapy for citizens with a palliative diagnosis.
On November 1st, 2021, 2 more patients received section 56 exemptions. We trusted that you would hear the voices of sick and dying Canadians, and act with compassion to respond. Thank you for not letting us down.
Your decision to continue to grant section 56 exemptions continues to positively impact the quality of life and death for dozens of Canadians and their closest family members. We hope that you may have enough trust in our approach to also continue to authorize exemptions for non-palliative patients, those suffering from cancer-related anxiety, depression, substance use disorders, cluster headaches, etc. who have applied for exemptions to access to psilocybin and who have been waiting over 230 days for your compassionate response.
A limited number of Canadians with cancer and others also suffering from depression and addiction are now able to legally use and possess psilocybin mushrooms for psilocybin-assisted psychotherapy, along with 19 medical professionals who are eager to consider recommending this treatment to appropriate patients.
We hope this continues and that all patients are treated equally and with compassion.
With all this progress over the past year, the obvious question is – what’s next? The reality is the world is watching Canada, and looking for us to set the bar on compassion, innovation, and patient-centered care in this rapidly emerging field. Together, we now have an opportunity to lead again.
Thanks to you and Patty Hajdu, the courage of these patients and their health professionals, over 55 Canadians have been granted personal subsection 56(1) However, while 55 applications have been granted, hundreds of other eligible Canadians have been waiting months for compassionate authorization to possess psilocybin through subsection 56(1) of the CDSA.
Regulated access is not only important but also urgent because Canadians are already using psilocybin for therapeutic purposes. In most cases, these Canadians are accessing and possessing psilocybin in contravention of the CDSA. In all cases, these Canadians, even holders of subsection 56(1) exemptions, are accessing psilocybin from an illicit source.
A regulated system will provide for greater safety in quality-controlled psilocybin material used in clearly labeled psilocybin products. A regulated system will also place the discretion on access where it belongs – with the patient’s health care provider, rather than with the Minister of Health, who we cannot guarantee will always have the same compassion as you. A regulated system will increase predictability in access to key therapeutic options for certain mental health and other conditions.
Please, Honourable Ministers, we ask you to act and lead what is next. We ask you to compassionately support the Canadians who are using psilocybin and those seeking exemptions. Section 56 is not a solution, so we have proposed draft regulations. Draft regulations that match the above description can be accomplished in a cost-effective and well-tested manner by applying the enclosed Access to Psilocybin for Medical Purposes Regulations (the “APMPR”). The APMPR is consistent with the Food and Drugs Act (the “FDA”) and the Food and Drug Regulations (the “FDR”) through the enclosed amendments to the FDR and the enclosed Psilocybin Exemption Regulations (the “PER”). Please also see the enclosed overview.
The system created by the APMPR and the PER can be administered in a cost-effective and responsible manner consistent with Canada’s obligations under United Nations drug control conventions.
We hope you will review these regulations that our team of patients, doctors, therapists, lawyers, and citizens have worked on and that we may meet with you personally to discuss what is next. We respectfully request a meeting with you sometime in the 2 weeks to discuss given the urgency of medical access.
Thank you again, Honorable Ministers.
Spencer Hawkswell, CEO, and The TheraPsil team