Health Canada Announces Intent to Revise Special Access Program

Health Canada announced on December 11th 2020 that it has intention to revise the Special Access Program (SAP) to allow for the safe use of MDMA (methylenedioxymethamphetamine) and psilocybin-assisted psychotherapy helping to address the huge treatment gaps that exist for a range of mental illnesses and substance use disorders.

Health Canada’s notice of intent regarding the SAP will be open for public consultation and comments for the next 60 days. If successful, this new access will positively affect the lives of the many Canadians experiencing mental health conditions who have not responded to existing therapies. This intended change aligns with global ethical guidelines supporting early patient access to promising treatments in a safe and controlled setting.

The Health Canada SAP was designed to allow Canadians access to new, potentially life-saving medications before they are formally approved for routine use in health care.

Historically, psychedelic medications have been ineligible for Special Access Program applications. The proposed regulatory change will enable Canadian patients to apply for psychedelic therapies in a similar process to how other investigational medications are accessed prior to formal drug approval.

A substantial body of research, including the completion of a growing number of randomized clinical trials, has demonstrated that psychedelic-assisted psychotherapies using psilocybin and MDMA appear to be highly effective approaches for the treatment of a host of potentially life-threatening mental health conditions, including: treatment-resistant depression; posttraumatic stress disorder (PTSD); substance use disorders; and severe anxiety associated with terminal diagnoses.

In addition to allowing continuing access for research participants after a clinical trial is complete, the SAP enables physicians to apply for access on behalf of qualifying Canadians who were not research participants.