Canada´s New Regulatory Approach for Cannabis Products

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

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).

Current regulatory framework for cannabis in Canada

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 for non-medical and medical purposes; and
• Prescription drugs containing cannabis.

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.

Proposed new regulatory approach for CHPs

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?).

Health claims under the new approach

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:

• General health claims would not be permitted (i.e., claims with low therapeutic value). These include claims related to general health maintenance, support and promotion.
• Specific health claims would need to be supported by scientific evidence. CHPs would not be authorized based on evidence of traditional use only.
• Cannabis must be listed as an active ingredient and could not be included without a direct link to the health claim. Evidence would need to sufficiently demonstrate the association of the ingredient (i.e., specific phytocannabinoid) with 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.

Retail & Packaging / Labelling Requirements

According to the proposal,

• Provincially & territorially authorized retailers would be able to sell CHPs,
• Federally licensed sellers of cannabis for medical purposes would be able to sell CHPs for use by humans or in animals without a  prescription,
• The Packaging and Labelling would support informed consumer choice and safe & effective use. The information would be based on a pre-market review.

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.