In a groundbreaking decision, the Canadian government is changing the way patients can access psychedelic therapies with restricted drugs, including MDMA and psilocybin.
Through an amendment to federal regulations, Health Canada is now allowing physicians to request access to restricted drugs on behalf of patients through the Special Access Program.
This program is meant to streamline access to special treatments for patients with serious or life-threatening conditions in instances where other therapies have failed or are unsuitable.
While the official communication made sure to note that “this regulatory change will not result in large-scale authorization for access to restricted drugs,” the event can be seen as an official acknowledgement of MDMA and psilocybin’s therapeutic potential and eventually lead to further decriminalization measures.
The Amendment
In the Wednesday edition of the Canada Gazette, the Canadian government published an amendment to the Food and Drug Regulations that now allows restricted drugs to be requested through Health Canada’s Special Access Program, which include psilocybin and MDMA, among others.
The Special Access Program (SAP) allows healthcare practitioners to access drugs that have shown promise in clinical trials, or are approved in other countries, explained Kathleen Marriner, Media Relations Officer of the Communications and Public Affairs Branch of Health Canada.
This means that practitioners will, on behalf of patients with serious or life-threatening conditions, be able to request otherwise restricted drugs through the SAP in instances where other therapies have failed, are unsuitable or are not available in Canada.
“There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin,” noted the Canadian Government’s official communication.
The Gazette acknowledged that, since restricted drugs were banned from the SAP, the science pertaining to the efficacy and safety of some of them has continued to advance, with several now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials.
What Is The Special Access Program And How Does It Work?
Health Canada’s Special Access Program was created to allow healthcare practitioners to access drugs that have shown promise in clinical trials, or are approved in other countries, for patients with serious or life-threatening conditions where conventional treatments have failed, are unsuitable or are not available in Canada.
“Each request is assessed on a case-by-case basis, taking into consideration the level of evidence available on the use, safety and efficacy of the drug for the patient’s specific condition,” Marriner explained in an email.
“Requests to the Special Access Program are normally only considered when positive results of Phase II or Phase III clinical trials…
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