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Published Mar 12, 23
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Health Canada has approved the following prescription medications containing cannabis: Sativex (Nabiximols), which contains tetrahydrocannabinol (THC) and cannabidiol (CBD), is an approved treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis; Marinol, contains synthetic THC only, and was approved to treat loss of appetite in AIDS patients and nausea from chemotherapy.

A full list of drugs authorized for sale in Canada is available on Health Canada's Drug Product Database. Health Canada's 2019 "Consultation on a potential market for health products containing cannabis" heard strong interest from Canadians and stakeholders in cannabis health products, including an interest in products containing CBD that could be bought and used without needing a physician or nurse practitioner to prescribe or oversee their use (much like widely available over-the-counter products).

The report summarizing the feedback received from those consultations is available here. During the consultations, Health Canada made a commitment to seek external scientific and clinical advice from independent experts, and subsequently created the committee, with nine members to look at the evidence that exists with respect to the potential therapeutic benefits of cannabis for human use.

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Member biographies summarizing their expertise are available on the committee webpage. Because discussions and recommendations were to reflect independent, professional opinions and expertise, committee members were all volunteers. However, the work was supported by a secretariat of Health Canada staff, who also attended meetings to provide technical support and answer administrative questions that might arise.

The committee's Terms of Reference stated that the mandate was "to support the development of appropriate safety, efficacy, and quality standards for health products containing cannabis, including the conditions under which these products would be suitable to be used without practitioner oversight." The committee was established to provide advice to support Health Canada's decision-making and was encouraged to reach a consensus in providing advice whenever possible.

Where there was disagreement, members were asked to ensure their opinions were noted and clarified. To ensure the integrity of the committee's advice, Health Canada and an external conflict of interest advisor assessed nominee applications for any potential risk of conflict of interest as part of the selection process. Once members were selected, the committee established a process for managing any potential risk of conflicts of interest.

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Health Canada and an external conflict of interest advisor, assessed members' affiliations and interests, as they applied to agenda items for discussion. If a potential risk was determined by the external conflict of interest advisor, then the member's participation would need to be restricted. All declarations were assessed in consultation with an external conflict of interest advisor and there were no declarations received that restricted any member's participation.

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The cannabis plant contains hundreds of chemical substances; more than 100 of them are known as cannabinoids which affect how cells in the brain and body behave and communicate with each other. Cannabinoids derived from the cannabis plant can sometimes be referred to as phytocannabinoids. THC, one of the commonly known cannabinoids, is responsible for causing the "high" or intoxication.

Although CBD is not intoxicating, it can have effects on the brain and the nervous system. When the Cannabis Act came into force, all phytocannabinoids were listed on Health Canada's Prescription Drug List, which means any health product containing cannabis or cannabinoids that makes a health claim requires a prescription.

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The committee made this decision as more research and evidence is available about the safety and potential therapeutic uses of CBD than for other minor cannabinoids, and because CBD was identified of interest during Health Canada's 2019 public consultation. There was also full consensus among members that any cannabinoid which causes intoxication and poses a risk of addiction, such as THC, would not be suitable for self-care in a non-prescription health product.

Any cannabinoids other than CBD must be only those naturally found in cannabis and together equal no more than two per cent of the total cannabinoid content of the preparation. THC content must not be more than one per cent of the total cannabinoid content. This definition included purified CBD, CBD isolate, CBD-rich cannabis extracts and synthetic CBD ((-) enantiomer only, meaning the form of CBD produced naturally in the cannabis plant) which meet these criteria.

The goal was to establish a single definition that would provide a baseline from which measures and comparisons could be made to support committee deliberations. Committee review of information and advice provided is targeted for the healthy adult population, whom the committee defines as individuals over the age of majority (i.