Proposed Approach to the Regulation of Health Products Containing Cannabis not Requiring Practitioner Oversight

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Kalpna Mistry

Kalpna Mistry

During the November 2017 public consultation to solicit input on regulations under the Cannabis Act, it was determined that further consideration was necessary in order to determine an appropriate regulatory approach for health products containing cannabis without requiring the oversight of a medicinal practitioner.

Under current regulatory framework already established by the Cannabis Act and Food and Drugs Act, there is no legal way to sell a health product with cannabis without it requiring the oversight of a medical practitioner.

However, many Canadians are becoming more interested in the potential for therapeutic uses of cannabis for minor ailments they suffer through such as sleeplessness or pain relief for sore muscles. Because of this, there are many Cannabis products with unauthorized health claims that are emerging on to the cannabis market illegally to meet the demand not yet covered by regulatory framework. One of the main examples is cannabidiol or CBD products that claim to provide relief from muscle aches, joint pain, and inflammation.

In response, Health Canada commenced an on-line consultation in order to seek input from Canadians and other interested stakeholders such as the cannabis and health products industries. This 75-day comment period was focused the types of cannabis products they would be interested in manufacturing, selling, or purchasing that would not require any practitioner oversight. This consultation provided key insights to allow Health Canada to better understand the types of product formats and corresponding health claims that would be of interest to Canadians within the cannabis retail environment.

The summary report for the June 2019 online consultation was published by Health Canada on September 25, 2020 with key stakeholders being notified of its publication. Please utilize the following link if you wish to view this summary report https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/summary-report-consultation-potential-market-health-products-cannabis.html

Following the end of this consultation at the beginning of September in 2019, Health Canada committed to seek external advice on appropriate evidence standards for any non-prescription health products that contain cannabis. This commitment led to establishing a Science Advisory Committee on Health Products Containing Cannabis.

The Scientific Advisory Committee

In order to continue the development of the Cannabis Regulations and as committed to during the 2019 on-line consultation, Health Canada began forming the Scientific Advisory Committee. Members of this committee include experts with a wide range of knowledge and experience including representation of Canadians with lived experiences as patients who use health products containing cannabis or cannabis for medical purposes.

The Scientific Advisory Committee will provide independent scientific and clinical advice in order to support Health Canada’s consideration of appropriate safety, efficacy, and quality standards for health products containing cannabis. Additionally, this advice will include any conditions under which the proposed products would be suitable for usage without the need for any practitioner oversight with details such as dosage and indication. A sub-committee will also be formed in order to specifically address any issues related to health products containing cannabis that are intended for animal use.

This committee has been given term that lasts one year, with an option in place to renew based on Health Canada’s needs at that time.

Issues for the Committee to consider could include:

  1. The state and level of evidence regarding the safety, efficacy, and quality of cannabis, including specific Phyto cannabinoids such as THC or CBD, when used for therapeutic purposes. This includes advice regarding any factors, specific to cannabis, that Health Canada should consider when reviewing the benefits, harms, and uncertainties of therapeutic cannabis use. Relevant information includes the current regulatory framework for health products, the safety profile of existing non-prescription products and natural health products, and all available pre-clinical and clinical evidence such as the scientific literature, real-world evidence, evidence related to currently approved health products containing cannabis and data received directly through a submission or application to Health Canada.
  2. Information that should be considered during Health Canada’s review of whether a product is suitable to be used without practitioner oversight, and advice on how to address any gaps in that information.
  3. Any factors, that are specific to cannabis, that should be considered when determining evidence-based dosage thresholds and conditions of use for specific Phyto cannabinoids, such as THC or CBD, when used without practitioner oversight; and,
  4. Information regarding the priorities of the research and medical community with respect to potential therapeutic uses of specific Phyto cannabinoids, such as THC or CBD.

Potential Regulatory Approach

Health Canada has now announced that they plan to continue their review and consideration of both the results obtained from the 2019 on-line consultation and the advice sought from the Science Advisory Committee in order to determine appropriate evidence standards for these types of proposed products. This will further help to allow Canadians to make informed choices to maintain and improve their health and to assist the development of potential regulatory approaches.

Any decision being made regarding access to non-prescription health products containing cannabis will be based on evidence with the key objective for any potential regulatory approach being to ensure public health and safety requirements of the Food and Drugs Act and the Cannabis Act are met.

All regulatory proposals are expected to follow the regular consultation procedure. This includes the publication of draft regulations in Canada Gazette, Part 1.

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Resources

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/regulation-cannabis-products-health-claim.html

https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis.html

https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis/document.html

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