Health Canada, the nation’s health department, said that drug regulations were being amended based on new research into the therapeutic benefits of psychedelics.
“There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin,” Health Canada noted in the Canada Gazette, an official government publication.
Under the amendment to federal food and drug regulations, physicians will be able to 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 permits health care professionals to request 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 not available in Canada. Patients are not permitted to request access to treatment through the program on their own behalf.
Psychedelic Research Continues
Research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. A study published in the journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was a quick-acting and effective treatment for a group of 24 participants with major depressive disorder. Separate research published in 2016 determined that psilocybin treatment produced substantial 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 would eventually encounter a situation where scientific evidence supports the therapeutic use of a restricted drug within the context of the Special Access Program,” regulators wrote in the January 5 announcement. “The regulatory amendments are therefore expected to benefit patients with serious or life-threatening conditions who may be granted access to restricted drugs through the Special Access Program in instances when other therapies have failed, are unsuitable, or are unavailable in Canada.”
Before Wednesday’s announcement, patients could gain access to psychedelic drugs through two legal avenues. The first method would be to participate in a clinical trial, which only accepts patients on a limited basis and are not available nationwide. Patients could also gain access to restricted drugs by personally requesting a special exemption to regulations from Canada’s Health Minister.
Easing Access for Patients
Regulators noted in the announcement that “the regulatory amendments will not create large scale access to restricted drugs and they do not signal an intent towards the decriminalization or legalization of restricted drugs. The Special Access Program is for emergency treatment only.” But the move should make it easier for patients with an exceptional need to access psychedelic drugs.
Dr. John Huber, a clinical forensic psychologist and the CEO of Tripsitter Clinic, a publicly-traded ketamine therapy telemedicine provider that is listed on the Canadian Securities Exchange, applauded the Canadian government for continuing to advance and acknowledge the benefits of psychedelic therapy.
“This breakthrough decision will expand access to MDMA and psilocybin therapy and help save the lives of those with life-threatening mental health conditions,” Huber wrote in an email to High Times. “We hope Canada’s success pushes the U.S. government to follow a similar pathway while awaiting FDA approval for MDMA and psilocybin.”
Greg Rovner, CEO of Heally, a telemedicine platform for psychedelic clinics and patients looking for alternative medicine treatment, said the decision by Canadian regulators to ease access to psychedelics should spur new research into the drugs.
“Health Canada’s recent decision is a ringing endorsement of MDMA and psilocybin’s therapeutic potential,” Rovner wrote in an email. “It recognizes the growing body of research into the benefits of psychedelics and expands access to psychedelics for patients in serious and life-threatening conditions. We hope to see more studies on the safety and efficacy of psychedelics that will spur further regulatory reform.”