The Canadian Government has amended regulation in order to allow patients to access psychedelic medicines such as psilocybin and MDMA.
Canada’s Special Access Program (SAP) will now enable physicians the right to request access to psychedelic-assisted psychotherapy for patients, which will be reviewed on a case-by-case basis.
The Canadian psychedelics industry has welcomed the news as a positive development for patients, noting that it will prevent psychedelic medicines following the path of cannabis – which has ended up with a lack of clinical research – and that it recognises the growing evidence base supporting the efficacy of psychedelics.
Published in the government’s official newspaper, the Canada Gazette, the regulation amendments relate to the Controlled Drugs and Substances Act and the Food and Drugs Act.
The amendments are expected to benefit patients with serious or life-threatening conditions, says the government. Patients will be granted this access when “other therapies have failed, are unsuitable, or are unavailable in Canada.”
The change is a response to requests to remove restrictions on the compounds as evidence has been emerging in recent years regarding the therapeutic potential of psychedelic medicines.
In particular, substances such as psilocybin and MDMA have been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for conditions such as treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD).
Implementation of the amendments was confirmed after a 60-day consultation with healthcare professionals, organisations, researchers, academics, licensed dealers and the general public regarding the government’s intent to restore access to these restricted drugs. It has stated it received written feedback from 392 respondents.
In the publication, the government says: “Overall, nearly all comments were supportive of the proposed regulatory amendments and/or increasing access to psychedelic substances more broadly.
“The Department received very little opposition to the proposal, making up less than 2 per cent of all responses.”
Kelsey Ramsden, CEO of Vancouver-based MINDCURE, which is carrying out a first-of-its-kind study investigating MDMA-assisted psychotherapy for treating female Hypoactive Sexual Desire Disorder (HSDD), commented: “For emergency patients, this news means gaining access to life changing mental health care. This can be truly transformative for both the patient in their ability to live out their last days, as well as for their families and supporting communities.
“For MINDCURE, it confirms that leaders in Federal Health Policy acknowledge the promise of psychedelics. Assuming they will stay strong with implementing the emergency-only approvals, it confirms that we will not be going down the slippery slope of recreational use that cannabis saw, which resulted (for cannabis) in a lack of funding for true drug development and clinical research.
“The balance between keeping clinical trials as the only regulatory route to market with a very small number of emergency access cases will be pivotal. I am confident that emergency-only will be maintained.
“Health Canada is open to psychedelics, and they want to see the clinical research proof come out to support widespread use. This means those of us conducting clinical research programmes are in the best position to be able to develop drugs that will change the paradigm of care in mental health.”
“Reversing the prohibition on accessing restricted drugs does not guarantee that requests for psychedelic restricted medicines will be authorised through the Special Access Programme,” commented Dr Evan Wood, CMO at Vancouver-based Numinus Wellness, which is hosting an extension of the MAPS-sponsored trial exploring MDMA-assisted therapy for PTSD.
“All requests will continue to be assessed on a case-by-case basis, taking into consideration the level of evidence regarding the safety and efficacy for the proposed use, as well as the patient’s condition and their clinical status.
“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.
“Numinus believes this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic-assisted psychotherapy.
“Greater accessibility is something Numinus has stood behind since we started and will continue to support and advocate for.”
Dr Douglas Cook, CMO at Dimensions and chairperson and head of neurosurgery at Queen’s University, Kingston, Ontario, stated: “Patients in urgent and life threatening circumstances who have failed to improve with traditional therapies will have the SAP as an option to access psychedelic therapies that are showing promise in palliative care and in a number of mental health indications.”
Dimensions carries out psychedelic-assisted therapy programmes supported by neuroscientific research.
“The application will be submitted on behalf of the patient by a physician who will summarise the need and justification for treatment. The turn around time is rapid and once approved a patient will be able to source medicine from a licensed dealer. This process is a welcome option to help those in dire need of options for otherwise unresponsive diseases.
“Dimensions firmly believes that psychedelics have the potential to alleviate suffering for a number of mental health and medical indications. We further believe that psychedelic therapy is optimally delivered in a safe, comfortable setting with trained professionals to set intentions of therapy, guide the experience and follow up after.
“To this end, Dimensions is looking forward to the opportunity to host individuals who have obtained psychedelics through the SAP in retreat and ceremony. Our goal will be to provide groups of patients with common diagnoses and intentions in retreat. Furthermore, our medical team will be able to assist patients, in partnership with their primary caregivers, in obtaining SAP approval.
“Dimensions lauds Health Canada for opening the SAP program for psychedelic therapies. This decision recognises the growing evidence base supporting the efficacy of psychedelics in end-of-life care and for several mental health and medical indications.
“Moving forward Dimensions will continue to support rigorous science and strong regulatory oversight in completing clinical trials and preclinical studies to further define the mechanisms, safety and efficacy of psychedelics for various indications.”
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