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Jul 5, 2019
Health Canada Proposes New Regulatory Pathway for “Cannabis Health Products”
On June 19, 2019, Health Canada released a document titled Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight (the “Consultation Paper”). The document canvasses Health Canada’s plans to create a new regulatory pathway for Cannabis Health Products (“CHPs”) in the context of seeking public and industry input on this proposed new branch of Canada’s cannabis regulatory regime.
What is a CHP?
Health Canada proposes to define CHPs as drugs containing cannabis that make health claims regarding treatment of “minor ailments.” A “drug containing cannabis” is just a cannabis product that is marketed with a therapeutic claim. To paraphrase the Cannabis Regulations, this is a claim that the cannabis product prevents or treats a disease or abnormal state, or modifies an organic function in human beings.
The proposed CHP regime would capture drugs containing any cannabinoid, or other ingredient that currently comprises cannabis pursuant to Schedule 1 of the Cannabis Act. Accordingly, it appears that the much desired de-scheduling of cannabidiol (CBD) is not yet on the table for the federal government.
It is useful to note that by definition, a “drug containing cannabis” and “cannabis products” for medical purposes differ (in the Cannabis Regulations) only because the former can be marketed with a(n explicit) therapeutic claim, and the latter cannot.
Where will CHPs be sold?
Currently, under the Cannabis Act and the Food and Drugs Act (“FDA”), any drug containing cannabis can only be sold to consumers with health practitioner oversight pursuant to a doctor’s prescription – just like any other prescription pharmaceutical drug (e.g. through a pharmacy). Cannabis products for medical purposes, on the other hand, can be sold only by holders of a federal Cannabis Act licence for medical sale to consumers who have provided the required medical document (akin to a prescription).
Under the proposed new framework, CHPs would be available to consumers through the same retail channels as recreational cannabis products (i.e., provincially-authorized retailers) and also from holders of a federal licence for medical sale – but without the requirement for a medical document.
This will be welcome news to medical sale licence holders who otherwise would be facing the creation of a new class of health-oriented cannabis products that they could not sell. This element of the proposed CHP regime may also encourage new federal medical sale licence applications by retail chains (e.g. pharmacies and health stores), some of whom may have been reticent to join a medical cannabis retail market focused on selling smokeables.
Federal medical sale licence-holders and provincially-authorized retailers selling CHPs would be subject to the same restrictions that apply to the current sale of medical or recreational cannabis products, including restrictions on promotions that may be appealing to young persons, etc.
Health Canada indicates that young persons would be protected from unrestricted use of CHPs by the imposition of a requirement that CHPs only be accessed through a responsible adult. The obvious implication is that minors will not be permitted to purchase CHPs, but it may be that the government will seek to impose additional statutory responsibilities on adults who purchase CHPs for ultimate use by children under their care. Such responsibilities could include, for example, a duty to act responsibly and in the child’s best interests before facilitating the use of a CHP by a minor.
It will be disappointing to some, but not surprising, that CHPs are not proposed to be sold alongside licensed Natural Health Products in any retail location. Such open retail channels are an unlikely prospect for any product containing THC and, accordingly, also for CBD-only products until the regulatory regime differentiates between the two.
Who will manufacture CHPs?
The Consultation Paper does not specify what Health Canada-issued licences would have to be held by CHP manufacturers. Given that Health Canada intends to rely on the FDA framework for health claims and other requirements, it seems likely that CHPs would, like other drugs containing cannabis, be manufactured only by holders of a Cannabis Drug Licence (issued under the Cannabis Act) and a Drug Establishment Licence (issued under the FDA).
CHP manufacturers would not be able to make general health claims (e.g. related to general health maintenance or promotion) and any specific claims would need to be backed by scientific evidence. Like other drugs containing cannabis, CHPs would be subject to a pre-market review by Health Canada to determine whether health claims made and the safety, efficacy and quality of the product are supported by scientific evidence. CHP packaging/labelling would also undergo a pre-market review and would have to include dosing information, directions for product use, listing of ingredients and any warnings of potential side effects.
Though arguably a welcome baby step in the right direction, this Cannabis Health Product initiative will feel like more of the same to most Canadians and other cannabis industry stakeholders, as it does not differentiate between THC and non-psychoactive cannabinoids like CBD. Instructions on how to provide feedback to Health Canada on the Consultation Paper (before consultation closes on September 3) can be found here.
For further information, please contact Jeremy Burke or another member of the Aird & Berlis Cannabis Group.