February 24, 2022
February 24, 2022
Canada’s Special Access Program & Medical Psychedelics in Canada
Recent amendments to the 2013 Special Access Program highlights the opportunity for access to restricted substances. What does the SAP mean for care providers, patients, and psychedelics companies?
Psychedelic Exemptions in Canada
Recent changes to Canada’s Special Access Program (SAP) speeds up the process that allows psychedelic drugs to be used in serious or life-threatening conditions, or where other treatments have failed. While the Canadian Government has claimed that these developments do not “signal an intent towards the decriminalization or legalization of restricted drugs,” such changes indicate an understanding of the effectiveness of these substances in treating illnesses and a greater commitment to their usage.
Previously, authorization to possess psychedelics was only given to those who were exempt under section 56 of Canada’s Controlled Drug and Substances Act (CDSA). This exemption was granted on an individual case basis to health care professionals, permitting them to administer controlled substances (including psychedelics like psilocybin and ayahuasca).
History of Section 56 Exemptions
The first section 56 exemptions for psilocybin were granted on 4 August 2020 for select patients with terminal cancer. Prior to this, exemptions for other psychedelic substances had been made, including for the use of ayahuasca in spiritual rituals. While companies such as TheraPsil were able to assist people to submit section 56 exemption applications for their illnesses, there were concerns that some people who needed treatment were waiting months for a response from the Minister of Health. Last year it was reported that over 150 applications had been received but not answered. For people who are suffering from severe illness, awaiting a response for this long can be a hellish ordeal.
2021 saw section 56 exemptions requested by Canadian governing bodies for psychedelics and hard drugs like heroin and crack cocaine.
In November 2021, British Columbia sought to decriminalize all hard drugs for people over 19, with a separate exemption request for psychedelic drugs expected at a later date. This proposal was intended to help “reduce the risks and harms that are associated with the stigmatization and marginalization of people who use drugs.”
In the same month, the City of Toronto filed for a section 56 exemption, requesting that all drugs be legalized in the area. Should these requests be granted and such trends catch on, the result could mean benefits for society, quality of life, and the economy, as savings from policing and persecuting low-level drug offenses might just be allocated to productive means of treatment (e.g., drug consumption facilities, drug rehabilitation, effective drug education in schools, and needle exchanges, as in the case of the Portuguese decriminalization of drugs).
What SAP Updates Could Mean for Psychedelic Therapy
It’s too early to tell for sure how this law change might pan out for clinicians, patients, and psychedelics companies. However, it’s worth asking: Will this lead to exemptions for other psychedelic drugs being permitted under SAP?
One major plus is that SAP requests will be granted in a more timely fashion than section 56 exemptions. Another is that the process for drug access is clearly laid out by the Canadian Government and easy to understand.
It’s also possible that a greater number of substances will be permitted under SAP. In August 2021, Canadian Health Minister Patty Hajdu allowed psilocybin to be used legally for the first time since it was made illegal in Canada in 1974. The case involved four Canadians who had late-stage cancer and were permitted for psychedelic treatment of their end-of-life-distress.
According to the Canadian Government, possession, production, or sale of psilocybin is prohibited “unless authorized for clinical trial or research purposes.” Section 56 exemptions have enabled access for these causes.
For access via SAP, substances must have a proven track record of both safety and efficacy in treating serious or life-threatening conditions. Healthcare professionals who apply for use of non-marketed drugs in Canada must:
- Inform patients of possible risks and benefits of the drug and its development status
- Report results and adverse reactions to Health Canada
- Record quantities of the drug received
- Support the decision with credible evidence
The SAP may enable the use of various psychedelics for individuals unable to find solutions in traditional treatment.
One significant mental health issue is the opioid epidemic, which shows no sign of slowing as current treatment options fall short. There’s an urgent need to seek alternatives that can play a role in successfully treating addiction and other challenges.
Part of the work involved in MINDCURE’s research is pushing toward the recognized medical value of psychedelic substances including ibogaine and novel molecules. That includes identifying risk factors and developing safe practices and protocols for use in psychotherapy.
Psychedelics Industry Route: Regulations Over Recreation
The SAP plays a small yet important role in moving Canadian policy toward access for those who need psychedelic treatment. It considerably shortens the length of time required to grant permission to use psychedelics in situations where patients have exhausted other available options or are in serious, life-threatening conditions.
While some might believe that the future of psychedelic policy should follow the cannabis industry in legalization for recreational use, many in the psychedelics industry believe that this route may be a step in the wrong direction. Psychedelics are powerful substances, and misuse could result in severe consequences, potentially leading to backlash, as has been seen in the past.
The goal for MINDCURE is to promote the medical knowledge and value of psychedelic substances so that they may be safely and effectively used to support healing.
SAP: A Step in the Right Direction
Last year saw the first instances of psilocybin being granted approval for use under section 56 exemptions. Since then, scores of people have been able to access the drug, helping to reduce suffering from various conditions. While it’s optimistic to assume that trends could continue under SAP to give more patients access to psychedelic treatment, we can still celebrate the win for those patients who are receiving such innovative and effective medicines. While ministers claim the SAP is not a gateway for regulatory changes, shifting public consensus and, especially, psychedelic research, are likely to play a part in developing policies.
We’re working to bring changes to bring options to mental health with slow and steady psychedelic implementation. With a focus on data-backed and research-based practices, MINDCURE will continue our mission to build diversity into the psychedelics used in treatments, contributing to the knowledge bank of psychedelic substances.