Regulators with Health Canada announced official changes to the country’s Special Access Program (SAP), which will allow physicians the ability to request access to restricted drugs such as psychedelics for people with serious or life-threatening medical conditions.
“There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin that have been granted “breakthrough therapy” designation by the United States Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively,” Health Canada said in a published statement in the Canada Gazette.
The announcement also stated that each request would be reviewed on a case-by-case basis since the SAP is for emergencies only.
Psychedelics and other restricted drugs were previously not available through the SAP. The announcement from Health Canada also stated that the changes are not intended to create access for these drugs on a large scale or demonstrate an intent toward legalization or decriminalization of these restricted drugs.
Officials with Health Canada made the changes based on new research regarding the therapeutic effects of psychedelics.
“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,” officials stated in the announcement.
As health officials in Canada ease restrictions on psychedelics for medical purposes, United States officials are also making it easier to study these substances. The announcement could be the first step in making child-resistant containers filled with psilocybin pills more accessible to adults.
The US Drug Enforcement Agency (DEA) posted a notice requesting an increased production of psychedelics for research and clinical trials.
Researchers from universities in Canada and the US published a study stating that psychedelics may help alleviate psychological stress derived from systematic racism.
A few CEOs from different clinics expressed their support for the amendments from Health Canada.
“Health Canada’s recent decision is a ringing endorsement of MDMA and psilocybin’s therapeutic potential,” Greg Rovner, CEO of Healy, said in an email interview with High Times. Healy is a telemedicine platform for patients seeking alternative medicinal treatment and psychedelic clinics.
“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.”