On June 19, 2019, Health Canada launched a consultation on the potential market for cannabis health products that would not require practitioner oversight. The purpose of the consultation is to seek feedback from Canadians and industry on the kinds of products they would be interested in purchasing, manufacturing or selling, if such products were to be legally available in Canada. The government is also aware that some Canadians are interested in potential therapeutic uses of cannabis for minor ailments for human use (e.g., sleeplessness, pain relief for sore muscles) and for animals (e.g., pain relief).
The Cannabis Act and its regulations provide Canadians with strictly regulated access to cannabis products (e.g., dried cannabis, fresh cannabis, cannabis oil). Under this framework, the production, distribution, and sale of cannabis by federal licence holders is subject to strict quality and security controls to protect public health and safety. When the Cannabis Act came into force in October 2018, the following categories of products were permitted:
- Cannabis products for non-medical and medical purposes; and
- Prescription drugs containing cannabis
These cannabis products, whether sold for medical or non-medical purposes, cannot be sold with labels or marketed in a manner that provides information about health benefits of the product, appropriate dosing, or other information about their use as a treatment for health conditions.
What that means is that under the current framework established by the Cannabis Act and Food and Drugs Act, there is no legal way to sell a health product with cannabis (i.e. a drug that contains cannabis and makes a health claim) without the oversight of a practitioner (e.g., a doctor or a veterinarian). Furthermore, the Cannabis Regulations only authorize drugs containing cannabis to be sold with a prescription to individuals, or for animals, under the care of a practitioner.
Following the consultation, Health Canada intends to gather external scientific advice on the appropriate evidence standards required to demonstrate safety and efficacy. The information gathered through this process will inform next steps on the development of a regulatory pathway for cannabis health products, leading to draft regulations for consultation in the future.
Any new pathway to market for cannabis health products must ensure the strict controls put in place under the Cannabis Act to protect youth, displace the illegal market and restrict promotion of cannabis. This pathway would also need to leverage Health Canada’s established evidence-based system for controlling access to safe, effective and quality products that make health claims alleging to maintain and improve Canadians’ health.
If you are interested in reading the consultation paper and participating, please use the following link. Alternatively, the consultation document alone is also available for viewing. The consultation will be open for comments until September 3rd, 2019.
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