20/21 November 2019
Health Canada (HC) proposes a regulatory pathway for a new class of cannabis products referred to as Cannabis Health Products (CHPs). On June 19, 2019, HC started a consultation on potential market for CHPs that would not require practitioner oversight. HC will accept comments until September 3, 2019.
According to HC, there is currently a growing interest in potential therapeutic use of cannabis for minor ailments. In addition, cannabis products with unauthorized health claims are emerging on the market illegally such as cannabidiol (CBD) products. Natural health products and cosmetics currently marketed containing no more than 10 parts per million (ppm) tetrahydrocannabinol (THC) are outside of the scope of this proposal and current oversight of these products would not be affected (e.g. hemp products).
In the current regulatory context, there is no legal way to sell a CHP (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).
Since October 2018, the following two categories of products were permitted:
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, appropriate dosing, or other information about their use as a treatment for health conditions.
Prescription drugs that contain cannabis are subject to a scientific review by HC for safety, efficacy and quality before they can be sold, and are marketed with authorized health claims.
HC proposes to allow CHPs to include any cannabis ingredient or substances extracted from cannabis, as well as other medicinal and non-medicinal ingredients supported by robust scientific evidence. Robust scientific evidence would also be required to demonstrate that the interaction of the different substances would be safe and effective. Therefore HC asks in the current survey if and what "scientific evidence" is currently available that demonstrates the efficacy of cannabis and / or if industries are working on generating any evidence?
However it remains unclear what will be accepted by HC for "scientific evidence" (e.g. published scientific literature? Clinical trial data? Data from non-interventional studies?).
According to HC, the new approach would include restrictions on the types of health claims that would be permitted, along with strict evidence requirements to support the health claim:
In order to ensure the evidence bar for these types of products is appropriate, HC will seek expert advice regarding the level of scientific evidence necessary to show that products could be used safely, and consider how both existing and new scientific studies could be incorporated into the review process.
According to the proposal,
Further to this consultation, HC intends to advance draft regulations for comment. For more information please see the Document: Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight.