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Canada Regulators Ease Access to Psychedelic Drugs

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 GazetteOfficial 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. The program did not previously allow access to restricted drugs, including psychedelics.

Special Access Program allows health professionals to apply for permission to administer unapproved therapies to patients suffering from serious, life-threatening or terminal medical conditions. It is available only for cases in which conventional therapies are ineffective, unsuitable or unavailable in Canada. The program does not allow patients to apply for treatment on their behalf.

Psychedelic Research Continues

The potential for therapeutic effects of psychedelics such as MDMA, psilocybin and ketamine have been demonstrated, especially in the treatment of serious mental illnesses like anxiety, depression and addiction. Published in the journal JAMA PsychiatryPsilocybin therapy-assisted psychotherapy proved to be a rapid-acting, effective and quick treatment of a 24 person group with major depressive disorder. A separate 2016 study found that patients with terminal cancer experienced significant and lasting decreases in anxiety and depression after psilocybin therapy. 

“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. A clinical trial is the first option. This only allows patients to be accepted on a very limited basis. They are also not widely available. Patients could also gain access to restricted drugs by personally requesting a special exemption to regulations from Canada’s Health Minister.

Easy 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.

John Huber, a medical forensic psychologist and chief executive officer of Tripsitter Clinic (a publicly-traded provider of ketamine therapy and telemedicine) praised the Canadian government’s efforts to promote and recognize the positive effects of psychedelic therapies.

“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 Chronic News. “We hope Canada’s success pushes the U.S. government to follow a similar pathway while awaiting FDA approval for MDMA and psilocybin.”

Heally CEO Greg Rovner said that the Canadian regulators’ decision to make psychedelics more accessible should encourage new research.

“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.”