Working with Psychedelics in Canada: A Regulatory Perspective

Working with Psychedelics in Canada: A Regulatory Perspective

September 14, 2020 By

Although it may seem that research with psychedelic substances is a new phenomenon, interest in this burgeoning field began over 60 years ago. In 1938, a Swiss chemist named Albert Hofmann discovered the psychedelic drug lysergic acid diethylamide (LSD) while working at Sandoz Laboratories after having graduated from the University of Zurich. Upon being hired by Sandoz, Hofmann was assigned to a program responsible for the development of processes that could be used to synthesize compounds produced by medicinal plants. While working on the stimulant properties of ergot derivatives (a group of fungi of the genus Claviceps), he came across LSD-25, the 25th derivative that had been tested. No progress was made in regards to this discovery until 1943 when Hofmann returned to his earlier therapeutic research on the compound after a five-year hiatus.

After having ingested the drug accidentally (and of his own accord numerous times thereafter), Hofmann spent years investigating the drug’s hallucinogenic effects and concluded that it would one day be beneficial in the treatment of schizophrenics and other psychiatric patients. As a result, Sandoz began sending doses of LSD and another psychedelic, psilocybin, to clinics and universities across the world. Research into the use of psychedelics took off and lead to breakthroughs in understanding the brain’s neurochemistry and how therapists may be able to effectively treat mental illness. Unfortunately, regardless of the breakthroughs and promising results from treatment with psychedelics in combination with therapy, LSD was soon after made illegal in most parts of the world effectively derailing any further advancements in psychedelic research.

Fast forward to 2015 where the authors in an article published in the Canadian Medical Association Journal titled “Psychedelic medicine: a re-emerging therapeutic paradigm” concluded that the re-emerging paradigm of psychedelic medicine may open clinical and therapeutic doors long closed (Tupper et al., 2015). Based on current events, it appears that the authors were correct in their findings. Earlier this year, the “first psychedelic-enhanced psychotherapy centre in Canada” opened their doors in Toronto. In June, Numinus Wellness Inc. received approval from Health Canada to amend their existing licence under the Controlled Drugs and Substances Act to allow their researchers to conduct research to standardize the extraction of psilocybin from mushrooms. Most recently, in August of this year, four terminally ill cancer patients were granted a legal exemption to access psychedelic substances as part of their treatment. With so much promise and momentum behind research involving psychedelics, the big question is, what steps need to be taken in order to work with psychedelics in Canada? The answer to that question can be found below.

As you may already be aware, psychedelic substances are regulated by the Controlled Drugs and Substances Act (CDSA) in Canada. This law came into force in 1996 and established eight Schedules of controlled substances and two Classes of precursors. Although the CDSA prohibits activities related to controlled substances and precursor chemicals, there exists an exemption in the Act that would permit a business or research organization to work with any of the substances listed on these aforementioned Schedules. Subsection 56(1) of the CDSA allows the Minister of Health to exempt any person(s), substances, precursor, or class from the application of all or any provisions of the Act if the Minister deems that the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. Depending on the work being conducted, an applicant would either need to apply for an exemption to use a controlled substance for scientific purposes or for clinical studies. Along with an exemption to work with these substances, a business or research organization would also be required to hold a Controlled Drugs and Substances Licence or Dealer’s Licence for short.

In addition to this licence, the company or research organization would also be required to meet the requirements set forth under Part J of the Food and Drug Regulations (FDR) which describes the circumstances and requirements in which persons (including businesses) can conduct the regulated activities mentioned above in regards to restricted drugs for clinical trial or research purposes.

As mentioned above, in order to legally possess and work with any of the substances listed in the Schedules mentioned above, companies and research organizations are required to hold a Dealer’s Licence. This licence would authorize a company or research organization to lawfully possess these controlled substances and conduct activities such as production, packaging, sale, sending, transport and delivery. In order to obtain this licence, an Application for a Controlled Drugs and Substances Dealer’s Licence is to be submitted to the Office of Controlled Substances (the OCS). The OCS is responsible for managing these applications in accordance with the CDSA along with the following regulations:

  • Narcotic Control Regulations (NCR);
  • Benzodiazepines and Other Targeted Substances Regulations (BOTSR);
  • Part G of the Food and Drug Regulations (FDR); and,
  • Part J of the FDR.

Once the application has been submitted, it undergoes an intake process where it is screened to ensure its completeness. Once it has successfully passed the intake process, it proceeds to the review process. During the review process, the information submitted undergoes a rigorous review to verify the content of the information that has been provided, including all security-related information that has been provided. Once the review has concluded, the OCS will initiate the inspection process (if applicable) to ensure that the facility meets the security measures set forth in the requisite Security Directive. A decision on the licence will only be made once the review and security inspection (if applicable) has been completed. The application will either be approved or refused.

For more information, please contact dicentra Cannabis and Psychedelics Consulting today for a quote.