Medical Psilocybin Regulations in Canada

There are three United Nations treaties that together form the international law framework of the global drug control regime:

• The 1961 United Nations Single Convention on Narcotic Drugs 
• The 1971 Convention on Psychotropic Substances 
• The 1998 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 

The proposal to create an international legal framework governing psychoactive substances was an initiative of the United States that dates back to the start of the 20th century and has gone through iterations stages since then.

The purpose of these treaties was to establish internationally applicable control measures with the aim of ensuring that psychoactive substances are available for medical and scientific purposes while preventing them from being diverted into illegal channels. The treaties also include general provisions on the trafficking and use of psychoactive substances.

The 1961 and 1971 Conventions classify controlled substances in four lists or Schedules, according to their perceived therapeutic value and potential risk of abuse.

The purpose of the 1961 United Nations Single Convention on Narcotic Drugs was to replace the previous international agreements that had been reached and include new provisions that did not appear in the previous treaties and thus create a unified, universal system of drug control. This system is intolerant and prohibitionist concerning the production and supply of narcotic drugs, except for their production and supply for medical and scientific purposes.

The purpose of the 1971 convention was the need for a new treaty and was argued on the basis of a distinction between the 'narcotics' controlled by the 1961 Convention and  'psychotropic substances'.

The 1988 Convention came about in the framework of the political, historical, and sociological context of the 1970s and 1980s in response to the “war on drugs”, leading to the adoption of more repressive measures. This treaty also significantly reinforced the obligation of countries to establish criminal offenses in order to combat all aspects of the illicit production, possession, and trafficking of psychoactive substances.

As a signatory of the United Nation drug conventions, Canada’s drug control policy operates within the international framework on drug policy.

In May 1997, Parliament passed the Controlled Drugs and Substances Act (“CDSA”) to replace both the Narcotic Control Act and parts of the Food and Drugs Act in one consolidated drug control act as was designed to meet Canada’s international obligations.

At the federal level, the implementation of the CDSA was an effort to categorize regulated drugs based on their potential for abuse, as well as the benefits they provide from a medical standpoint. 

The active ingredients in magic mushrooms are chemicals called psilocybin and psilocin. In Canada, both of these substances are classified as “controlled substances” under the Controlled Drugs and Substances Act (CDSA),  meaning that the federal government has categorized them as having a higher-than-average potential for abuse or addiction. 

The CDSA generally prohibits all uses and activities of controlled substances such as sale, production, and possession, etc, unless authorized through, for example, a clinical trial and a licence or an exemption, granted by Health Canada's Office of Controlled Substances. 

The implementation of the CDSA reinforced and expanded Canada’s strictly prohibitionist approach to drug control and the punitive focus of these laws has attracted significant criticism. Firstly, the lack of express criteria that defines scheduling decisions has resulted in the absence of a rational correlation between the potential harms of drugs and the corresponding punishment. Furthermore, the current prohibitionist policy has continued to unnecessarily criminalize drug users which has resulted in the misdirection of resources and undue harm to individual Canadians. In particular, Canada has turned hundreds of thousands of people into criminals for the possession of arbitrarily defined substances. 

No, a medical document is not a prescription. The only similarity is that only physicians and nurse practitioners can issue a medical document to a patient. Prescriptions are for drug products that have a DIN number associated and a therapeutic claim. Psilocybin, like cannabis, is a controlled substance. Much like a drug product, psilocybin would be manufactured to certain specifications, however, there would be no therapeutic claim associated with the product (unlike a drug product or natural health product in Canada.)

Again following the medical cannabis blueprint, is the decision of whether or not a particular individual is well suited to receive psilocybin for therapeutic purposes would be made by their health care practitioner, not by a government official who themselves is not a health care practitioner and is perhaps unfamiliar with that person’s case (other than through an exemption application). This would increase equality and safety by making access predictable.

1. A patient who would like to access psilocybin for a medical purpose must see their physician or a nurse practitioner (NP)
2. The patient’s physician or NP would then assess the patient and their medical reasons and ensure that the patient meets all of the safety criteria necessary to consume psilocybin.
3. IF the physician/NP deems that the patient is suitable for psilocybin, they will then write the patient a medical document. 
4. Under the proposed APMPR regulations, individuals with a medical document signed by a health care practitioner can purchase psilocybin for medical purposes directly from a federally licensed seller. 
5. Individuals may alternatively register with Health Canada who will provide a registration certificate that will allow the patient to order starter materials from a sales license holder.
6. The amount of psilocybin an individual is authorized to possess or produce for medical purposes is determined by their health care practitioner and written into the medical document. This authorized amount determines how much psilocybin the individual may possess in public or, if they register with Health Canada, how much psilocybin they may produce (or designate someone to produce on their behalf) for their own medical purposes.
7. The medical document may also stipulate the terms by which psilocybin is to be used. For example, during psychotherapy sessions.
8. Health care practitioners are expected to make authorization decisions justified by the condition for which their patient is receiving treatment and which are grounded in the available evidence.

No. The basis upon which healthcare practitioners can write medical documents would be regulated at the provincial level by colleges and other healthcare regulators.

Health care practitioners are regulated by provincial/territorial medical regulatory (licensing) authorities. Most provincial and territorial medical regulatory bodies have their own set of standards and guidelines for members, which may include codes of practice related to authorizing psilocybin for medical purposes. As a result, authorization practices and the use of psilocybin for medical purposes may vary among provinces and territories.

Through proposed regulations, we’ve established a supply chain and access. The way that psilocybin is given should be regulated by provinces. Ie, from medical document to patient.

Yes. This will be written and specified by the physician/NP writing the medical document for the patient, but must not exceed 1 year. This is consistent with medical cannabis medical documents.

Yes. There is a recall system, such as, if any issues arise with a product, the license holder is obligated to report this to Health Canada within 24 hours and that product will be recalled.

No. If so, the medical document has to reflect that e.g “use in psychotherapy” and the physician or NP can state they need to be notified each time psilocybin is ordered or have the psilocybin product delivered to the treating therapist.

10mg = 1g psilocybin mushrooms, therefore the average strength of psilocybin mushrooms, the average box will not have more than 1g psilocybin. This is an intuitive way to relate back to the things people use, such as fruiting bodies. This amount is unlikely to be an issue if an individual took more than wanted to. For dosing, it is also a reasonable amount e.g., 20-30mg would equate to a high dose and 5mg tablets could be manufactured for microdosing.