Section 56 Exemptions
Psychedelics are categorized as Schedule 3 drugs under The Controlled Drugs and Substance Act of Canada. Around the world, ground-breaking research has been conducted on psychedelic medicines and it’s potential medical upside on patients’ mental health challenges such as depression, anxiety, and end-of-life distress. Although research continues to evolve and gain a more defined understanding of the potentially life-changing effects of psilocybin, under paragraph (J) of Food and Drug regulations of the CDSA, most psychedelic drugs are prohibited. Nevertheless, via the Health Minister certain exemptions can be made to access psychedelic drugs to improve the quality of life for individuals experiencing mental health disorders.
56 (1) The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.[1]
Research from John Hopkins University[2] has shown psilocybin has significantly helped people with addictions to smoking, alcohol, and cocaine. With our program we would like to help patients with addiction problems, suffering from ADHD, OCD, PTSD, or any trauma to get access to psilocybin and other psychedelic drugs.
Moreover, studies from John Hopkins have articulated “Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial”[3] With qualified candidates, Rejuva will look to help patients get access to psychedelic treatments while using the data to validate to Health Canada that psychedelic-assisted treatments could be the future of treating a myriad of mental health conditions.
Under Section 56 of CDSA, exemption 56(1) has become the preferred route to get legal psychedelic-assisted treatments in Canada. We are currently helping eligible candidates submit application with the hope of receiving exemption for psychedelic-assisted treatments. If you do like to start your application please fill out our initial intake form and we will contact you upon a thorough review.
Special Access Program
The Special access program considers requests for access to non-marketed drugs from practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or unavailable. In 2013, Health Canada passed an amendment that excludes access to psychedelics i.e., psilocybin. However, there is hope for Health Canada to make changes to these regulations:
“Health Canada is proposing to reverse the remaining regulatory changes made in 2013, which would remove the current prohibition on access to restricted drugs through the SAP.”[4]
If these changes are to be granted, it will give health care professionals greater access to treat patients using psychedelics for mental health conditions in a much shorter timeframe than the long cumbersome process currently in place. Currently, there are multiple countries that have legalized psychedelic drugs to treat major mental health conditions while funding research to further global scientific understanding. At Rejuva, we believe amending access regulations is key to both patient treatment and furthering research on this potential life-changing medicine. As with any regulatory medical changes reputable publications and researchers hope to present an irrefutable mountain of evidence to catalyze change both for the short and long term.
To qualify for our SAP program, please note you must meet the following requirements:
- Must be over the age of 19
- Patients with resistant history for depression and anxiety medication(s)
- Patients suffering from ADHD or OCD
- Patients suffering from PTSD
- Developmental or early-life trauma
- Individuals looking for easing of anxiety and depression for end of life care
- Individuals dealing with addiction
Unfortunately, patients that have been diagnosed with schizophrenia, borderline personality disorder, or bipolar disorder; or have uncontrolled medical conditions will not be suitable applicants.
Rejuva Alternative Medicine Research Centre is assisting qualified patients to access legal psychedelic treatments by facilitating applications for exemption under section 56(1) of the CDSA.
[1] Legislative Services Branch, “Consolidated Federal Laws of Canada, Controlled Drugs and Substances Act,” Controlled Drugs and Substances Act, April 30, 2021, https://laws-lois.justice.gc.ca/eng/acts/c-38.8/page-12.html#:~:text=56%20(1)%20The%20Minister%20may,the%20opinion%20of%20the%20Minister.
[2] Johnson, Matthew W, Albert Garcia-Romeu, and Roland R Griffiths. “Long-Term Follow-up of Psilocybin-Facilitated Smoking Cessation.” The American journal of drug and alcohol abuse. U.S. National Library of Medicine, January 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641975/.
[3] Roland R Griffiths et al., “Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients with Life-Threatening Cancer: A Randomized Double-Blind Trial,” Journal of psychopharmacology (Oxford, England) (SAGE Publications, December 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367557/.
[4] Canada, Health. “Government of Canada.” Canada.ca. / Gouvernement du Canada, December 30, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html.
Branch, Legislative Services. “Consolidated Federal Laws of Canada, Controlled Drugs and Substances Act.” Controlled Drugs and Substances Act, April 30, 2021. https://laws-lois.justice.gc.ca/eng/acts/c-38.8/page-12.html#:~:text=56%20(1)%20The%20Minister%20may,the%20opinion%20of%20the%20Minister.
Johnson, Matthew W, Albert Garcia-Romeu, and Roland R Griffiths. “Long-Term Follow-up of Psilocybin-Facilitated Smoking Cessation.” The American journal of drug and alcohol abuse. U.S. National Library of Medicine, January 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5641975/.
Griffiths, Roland R, Matthew W Johnson, Michael A Carducci, Annie Umbricht, William A Richards, Brian D Richards, Mary P Cosimano, and Margaret A Klinedinst. “Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients with Life-Threatening Cancer: A Randomized Double-Blind Trial.” Journal of psychopharmacology (Oxford, England). SAGE Publications, December 2016. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5367557/.
Canada, Health. “Government of Canada.” Canada.ca. / Gouvernement du Canada, December 30, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html.