In early August 2020, the Federal Minister of Health granted an exemption under the Controlled Drugs and Substances Act(CDSA) to four terminally ill Canadians to use psilocybin in their end of life care.
Psilocybin is one of the active ingredients/chemicals in “magic mushrooms,” the other is psilocin. Both psilocybin and psilocin are controlled substances under Schedule III of the CDSA. The sale, possession, production, etc. are prohibited unless authorized for clinical trial or research purposes under Part J of the Food and Drug Regulations. Both have been illegal in Canada since 1974. According to Health Canada, there are no approved therapeutic products containing psilocybin in Canada. However, the purified active ingredient, i.e. psilocybin, is being studied in supervised clinical settings for its potential to treat various conditions such as anxiety and depression.
The Minister’s exemption marks the first time a legal exemption has been granted in Canada for patients to access psychedelic substances for treatment. The four individuals suffer from terminal cancer and have experienced anxiety etc. that have not responded to conventional psychotherapy treatments. They applied for an exemption under compassionate grounds under section 56(1) of the CDSA.
Subsection 56(1) of the CDSA allows the Minister of Health to exempt any person or class of persons or any controlled substance or precursor or class thereof from the application of all or any provisions of the Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.
Health Canada’s policy regarding exemptions for scientific purposes (e.g.clinical research) indicates that the applicant must ensure that the controlled substance is an integral part of the protocol and that the use and storage of the controlled substance will not contribute to the diversion or abuse of the substance. It is not clear what the considerations are for individual exemptions, but we expect Health Canada will delineate a policy as the decision is likely to spark more applications.
While we can expect more exemptions in the future, physicians and psychotherapists are reminded of their respective College obligations. Of course, unless there is authorized use of psilocybin (as in these four individual exemptions), health professionals will not be able to prescribe the psychedelic substance. This, however, brings back the discussion surrounding cannabis for medical purposes top of mind.
Medical cannabis is subject to different rules than recreational cannabis. The production and sale of medical cannabis is regulated exclusively by the federal government, while provincial governments are responsible for some of the regulations for recreational cannabis.
The College of Physicians and Surgeons of Ontario (CPSO) has a policy on Cannabis for Medical Purposes that was last updated in January 2019. As with any treatment, physicians are not obligated to prescribe cannabis if they do not believe it is clinically appropriate for the patient. Particular care must be taken if a physician is prescribing cannabis for patients under the age of 25. Unlike more ‘conventional prescriptions,’ the policy advises physicians to require their patients to sign a written treatment agreement that, at minimum, specifies that the patient agrees that they will:
The agreement should also include a clause that specifies that in case of a breach of the agreement, the physician may decide not to continue prescribing cannabis to the patient. For further detail, physicians are encouraged to review the policy on Cannabis for Medical Purposes as well as the CPSO’s Prescribing Drugs policy.Disclaimer: A blog post is never a substitute for legal advice specific to your circumstances, particularly when surrounding circumstances are changing rapidly or novel.
In December 2019, Ontario’s Attorney General introduced Bill 161, the Smarter and Stronger Justice Act (the “Act”), which became law on July 8, 2020. The Act hopes to simplify a complex and outdated justice system by bringing changes to how legal aid services are delivered, how class actions are handled, and how court processes are administered.
Of note, the Act has amended the Judicial Review Procedures Act (JRPA) to establish new rules as to when an application for judicial review may be brought.
Any decisions made on or after July 8, 2020 are now subject to a 30-day limit for bringing an application for judicial review unless another Act provides otherwise. Courts, however, retain powers to extend the time for making an application for judicial review if satisfied that there are apparent grounds for relief and that no prejudice or hardship will be incurred by the delay. Before these amendments, the JRPA did not set out any time limits for bringing an application, but courts had powers to extend the time to bring an application if another Act prescribed the limit.
The Chief Medical Officer of Health for Ontario has issued an updated Directive #2 (dated May 26, 2020) for Regulated Health Professionals in the province.
Pursuant to the updated Directive #2, all deferred non-essential and elective services by health care providers may be gradually restarted – subject to the rest of the requirements set out in the Directive.
The updated Directive #2 does not provide particularly detailed guidance to health professionals on how to proceed, likely because it applies to such a broad spectrum of health care and health professionals. It does, however, provide some principles to assist health care providers in making decisions as we enter this transitional period.