Health Canada’s New SAP Rules: A Q&A With Numinus’ Payton Nyquvest

PN: Due to the previous stigma towards psychedelic medicines, these drugs could not be approved via the Health Canada Special Access Programme which is the mechanism that allows for patient access to investigational or currently unapproved treatments when other treatments have been ineffective. So, in effect, there was not a mechanism for patients in need to access psychedelic medicines.  This was not ethical, and Health Canada knew this. It was an old decision based on dated sentiment, not evidence and the current government should be congratulated on making this change.

We know that many available mental health treatments do not benefit enough patients and untoward side effects are common.  The SAP amendment will now allow physicians to request patient access to psychedelic treatments, such as MDMA- and psilocybin-assisted therapy, for serious conditions on a case-by-case basis when other treatments have been ineffective. This change has the potential to positively affect the lives of people experiencing serious mental health conditions when available therapies have failed, are unsuitable or are unavailable in Canada. A large and growing body of research has demonstrated the benefit of psychedelic-assisted therapy in treating many conditions and through the recently announced changes to Health Canada’s SAP, we hope more people will have access to therapies not yet approved in Canada.

PN: Consistent with the Notice of Intent that was published in Canada Gazette, Part I, regulatory amendments were made on December 17, 2021, to restore the possibility for practitioners who are allowed to prescribe drugs to request access to restricted drugs through Health Canada’s Special Access Program (SAP). Prior to this, psychedelic medicines could not be requested via SAP and there was no other mechanism to facilitate patient access in a legal and timely way.

Practitioners can, on behalf of patients with serious or life-threatening conditions, can now request access to psychedelic medicines through the SAP when other therapies have failed, are unsuitable, or are unavailable in Canada and when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient.

The SAP does not have a wait list, as it is meant for emergency access. Practitioners can, on behalf of patients with serious or life-threatening conditions, request access to restricted drugs through the SAP when other therapies have failed, are unsuitable, or are unavailable in Canada and when there is sufficient data to support the safety and efficacy of the drug for the specific condition of the patient.  The timeline for a response from the SAP program is 1-2 days.

Patients cannot apply to the SAP directly, and only licensed healthcare practitioners who are authorized under the laws of a province or territory to treat patients with a prescription drug may file requests through the SAP.

PN: The evidence to support LSD, psilocybin and MDMA assisted psychotherapy goes back decades and studies show that these treatments can be very safe.  For instance, a study comparing MDMA-assisted psychotherapy to the use of antidepressants for PTSD demonstrated MDMA was safer.  We similarly know that when offered in a safe environment by trained staff, psilocybin and LSD are also very safe.  Health regulators want to see medications approved through research.  Psychedelics are unique since LSD, MDMA and psilocybin were once widely used in clinical contexts prior to being made illegal.  For instance, MDMA is believed to have been used in over 150,000 therapy sessions prior to being made illegal.  LSD was once widely used in the treatment of alcohol use disorder. So, psychedelics were uniquely precluded for use through the SAP and, similarly, are uniquely different than traditional pharmaceutical drugs since they have been around for a long time.

The SAP is also not perfectly fit for certain psychedelics. For example, in the case of Psilocybin, it is a naturally occurring substance that is more akin to a traditional medicine than a pharmaceutical drug, so a traditional pharma type approach is not entirely appropriate. Here, given what we know about Psilocybin and its longstanding safety record in both traditional/sacred medicine contexts as well as recreational use, further progress should focus on a medical access regime that is less cumbersome and more fit for purpose than the Special Access Program.  

What we do know is this is a crucial step that recognizes the research and benefits of psychedelic-assisted therapy. And while full regulated medical access may not be part of this announcement, with no limit to SAP requests, we hope this can start to provide lasting change for the many people in Canada in need.  

PN: Health Canada should be congratulated for making this change. What it means is that they are acknowledging that psychedelics can be used as medicine and validates the rigorous studies that have shown that certain psychedelics can be very safe and useful when used clinically for the treatment of certain mental disorders.

The SAP program really leaves patient safety with the physician or prescriber requesting the medication and if a patient has a serious medical illness without other treatment options, we feel Health Canada has an ethical obligation to allow for patient access. We expect Health Canada agrees. This change to the SAP was made specifically for this reason.  Legalization is another matter.

PN: Numinus will be working closely with Health Canada to understand the regulatory change and, where appropriate, support appropriate SAP requests. We are currently operating clinics with appropriately established psychedelic-assisted psychotherapy infrastructure and trained therapists and physicians to support patients with special access requests. We are closely following updates from Health Canada on the SAP amendment and will follow their guidance and regulations consistent with the updated SAP Guidance document. We are well positioned to support our affiliated physicians and clients with SAP requests.

PN: Canada has the potential to be a world leader as this program has the ability to allow organizations to get tremendous experience with certain psychedelics for patients with serious health conditions where other treatments have not been successful. There will be some great experience developed in Canada and, hopefully, new opportunities for people who are struggling.

PN: While we ultimately expect to see psychedelics fully researched and understood so that they can be part of the mainstream mental wellness system, the SAP announcement is a huge stride that does provide a vehicle for persons in Canada that would otherwise not have access.  This is a very concrete step in the right direction, and we expect increased evidence and interest going forward.

PN: MDMA is farthest along in the traditional drug development process with a Phase 3 trial completed by MAPS and a second Phase 3 trial well underway.

Psilocybin is different in that it is a naturally occurring substances that has been used for hundreds of years in a traditional/sacred medicine context.  We believe there should be an access mechanism that is not the traditional drug development model though observably there are groups pursuing approvals for synthetic psilocybin.

It will be interesting to see how the drug approval process for MDMA unfolds with, hopefully, psilocybin leading the way or close behind once health policy makers are full versed current evidence and safety data.

PN: We expect that MDMA, and psilocybin-assisted psychotherapy will be part of the mainstream mental wellness system. Other psychedelics may also have come online by that time.  The evidence around effectiveness and safety are growing continuously.