Doctors can use the new legal pathway to request access to psychedelics, such as psilocybin and MDMA, on behalf of their patients.
An amendment to federal food and drugs regulations will increase the way patients can access psychedelic therapies with restricted drugs, including MDMA and psilocybin, Benzinga reports.
This ground breaking decision by Canadian regulators will ease access to psychedelic compounds to allow for medical use under certain circumstances. The government made the move based on emerging scientific evidence showing the therapeutic potential of some restricted drugs, notably psychedelics.
Health Canada’s new legal pathway for access to restricted compounds is the Special Access Program.
What is the Special Access Program?
Under the amendment to the current regulations, Health Canada will allow physicians to request access to restricted drugs on behalf of patients through the Special Access Program (SAP).
Kathleen Marriner, Media Relations Officer of Health Canada’s Communications and Public Affairs Branch, explains that healthcare practitioners will be able to request access to drugs that have shown promise in clinical trials, or are approved in other countries.
SAP is intended to streamline access to special therapies for patients with serious or life-threatening conditions, in cases where other treatments are unsuitable, ineffective or unavailable.
Requests will be considered on a case-by-case basis, considering the evidence available on the use, safety and efficacy of the drug for the patient’s condition. Requests will usually only be granted when positive results of Phase II or Phase III clinical trials are readily available.
Health Canada’s announcement of the program acknowledged the emerging body of evidence highlighting the therapeutic potential of psychedelic compounds like MDMA and psilocybin.
Officials note that this regulatory change is not designed for large-scale authorization for access to restricted drugs. This is reflected by the distinction that patients will not be permitted to request access on their own behalf.
Marriner states that the SAP is available 365 days a year, and that Health Canada aims to contact the requester within 1 working day of receipt.
So what has changed?
Until this amendment to Canadian federal food and drug regulations, patients were only able to access psilocybin treatment in a legal context in two ways.
Firstly, through participation in a clinical trial researching the substance, although vacancies are limited and only exist in specific locations and time periods.
The only other means to access psilocybin was by acquiring a section 56 exemption. Essentially, this process allowed patients to personally seek access to restricted drugs via the Health Minister. However, written authorization from the Health Minister has benefited only 4 dozen patients since August 2020, and generally exemptions were granted more than 100 days after application.
The implementation of this new legal avenue to access psychedelic medicines reflects growing interests in improving access to psilocybin and MDMA for Canadian patients. Although this does not signal specific intent to decriminalise or legalise these restricted substances, it could catalyze the process of creating more sustainable approaches to these medicines.
In 1999, section 56 exemptions allowed Canadians to request access to medical cannabis. An overflow of exemption requests was one of the driving forces behind the legalisation of cannabis for medical purposes in 2001, followed by the full legalisation of adult-use cannabis in 2018.
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