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Health Canada, the country’s health department, said drug regulations would be changed due to new research into the therapeutic benefits of psychedelics.
“There is new scientific evidence to support the potential therapeutic use of some restricted drugs, particularly psychedelic restricted drugs like MDMA and psilocybin,” noted Health Canada in the Canada Gazette, an official government publication.
In accordance with the federal food and drug regulation change, physicians can request access to restricted drugs on behalf of their patients through Health Canada’s Special Access Program. Previously, restricted drugs, including psychedelics, were not available through the program.
The Special Access Program enables healthcare professionals to apply for permission to use unapproved treatments for patients with serious or life-threatening medical conditions. The program applies only in cases where conventional therapies have failed, are unsuitable, or are not available in Canada. Patients are not permitted to apply for access to treatment through the program on their own behalf.
Psychedelic research continues
Research on psychedelics including psilocybin, MDMA, and ketamine has shown the drugs to have potential therapeutic benefits, particularly for severe mental illnesses such as depression, addiction, and anxiety. A study published in the journal JAMA psychiatry in 2020 found psilocybin-assisted psychotherapy to be a fast-acting and effective treatment for a group of 24 participants with major depression. A separate study published in 2016 found that treatment with psilocybin resulted in significant and sustained decreases in depression and anxiety in patients with life-threatening cancer.
“Given the growing scientific interest in certain restricted drugs, it is expected that Health Canada will at some point encounter a situation where scientific evidence supports the therapeutic use of a restricted drug under the special access program,” regulators wrote in the announcement dated Nov. “The regulatory changes are therefore expected to benefit patients with severe or life-threatening illnesses who may be granted access to restricted drugs through the Special Access Program when other therapies have failed, are unsuitable, or are not available in Canada.”
Ahead of Wednesday’s announcement, patients could gain access to psychedelic drugs in two legal ways. The first method would be to take part in a clinical study that only admits patients to a limited extent and is not available nationwide. Patients could also gain access to restricted medication by personally requesting an exemption from the regulations with the Canadian Minister of Health.
Facilitating patient access
Regulators noted in the announcement that “the regulatory changes will not create large-scale access to restricted medicines and signal no intention to decriminalize or legalize restricted medicines. The Special Access Program is only intended for emergency treatment. ”But the move is intended to facilitate access to psychedelic medication for patients with exceptional needs.
Dr. John Huber, a clinical forensic psychologist and CEO of Tripsitter Clinic, a publicly traded provider of telemedicine for ketamine therapy listed on the Canadian Securities Exchange, applauded the Canadian government for advancing and recognizing the benefits of psychedelic therapy.
“This landmark decision will expand access to MDMA and psilocybin therapy and help save the lives of people with life-threatening mental illnesses,” Huber wrote in an email Highest times. “We hope Canada’s success will lead the US government to embark on a similar path while awaiting FDA approval for MDMA and psilocybin.”
Greg Rovner, CEO of Heally, a telemedicine platform for psychedelic clinics and patients seeking alternative medical treatment, said the decision by Canadian regulators to ease access to psychedelics should spur new research on the drugs.
“Health Canada’s latest decision is a clear confirmation of the therapeutic potential of MDMA and psilocybin,” Rovner wrote in an email. “It recognizes the growing body of research into the benefits of psychedelics and broadens access to psychedelics for patients with serious and life-threatening illnesses. We hope for further studies on the safety and effectiveness of psychedelics that will drive further regulatory reforms. “