APMPR First Draft – Proposed ‘Access to Psilocybin for Medical Purposes Regulations’

Background 

TheraPsil, in consultation with patients, lawyers and regulatory experts have drafted a proposed framework for the legalization of psilocybin for medical and therapeutic purposes. This proposed regulation creates a framework for patients to access medical psilocybin in consultation with a healthcare provider, and access regulated psilocybin products. This framework is based upon the 2016 regulations for medical cannabis in Canada, the Access to Cannabis for Medical Purposes Regulations (ACMPR), and is similarly proposed to be called the ‘APMPR’, or the Access to Psilocybin for Medical Purposes Regulations.

Public Consultation 

TheraPsil invites public consultation and dialogue regarding the first draft of proposed regulations to put forward further recommendations to Health Canada. We hope you will join us in this collaborative process to help Health Canada enact regulations that will make medical psilocybin and psilocybin therapy a safe, effective, equitable, and accessible treatment option in Canada.

Our first round of public consultation closed on September 21st, 2021 at 11:59 pm PST. 

 

Cover Letter to Minister Hajdu 

TheraPsil
Victoria, BC

Via Email: hcminister.ministresc@canada.ca
CC: Patty.Hajdu@parl.gc.ca 

Hon. Patty Hajdu, PC
Minister of Health MP for Thunder Bay
Superior North House of Commons
Ottawa, Ontario
KIA OA6

Re: Proposed Regulations for Medical Access to Psilocybin

Dear Honourable Minister,

I hope you are well and staying safe this summer.  Thank you again for your tireless work during the pandemic to keep all Canadians safe.  We are grateful for your constant efforts.

On behalf of our members across Canada and the elected Board, I also want to take this opportunity to mark the one-year anniversary of your decision to approve the compassionate use of psilocybin for medical purposes.  One year ago this week, thanks to your leadership, Canada became one of the first countries in the world to facilitate this access for citizens with a palliative diagnosis.

While many believed this would never happen and that you would never take a risk like this, we trusted that you would hear the voices of sick and dying Canadians, and act.  Thank you for not letting us down.

Since then, your decision has had a positive impact on the quality of life and death for dozens of Canadians and their closest family members.  We are also honored that you have shown enough trust in our approach that you have taken the next step to also authorize the first exemptions for non-palliative access to psilocybin. A limited number of Canadians with cancer and others suffering from depression and addiction are now able to legally access mushrooms, along with the 19 medical professionals eager to consider recommending this treatment to appropriate patients. 

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, 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 many 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 Minister, 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 are 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”).

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 response from you in the 2 weeks given the urgency of medical access. 

Thank you again Honorable Minister. 

From, 

Spencer Hawkswell, CEO, and The TheraPsil team

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