Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): March 3, 2021

List of acronyms

• Health Canada Directorates and Branches
  • TPD: Therapeutic Products Directorate
  • PPIAD: Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada
• Others
  • PDL: Prescription Drug List

March 3, 2021, 2:30-5:00pm Eastern Time

Welcome and introductory remarks

The Committee Co-Chairs, Dr. Paula Brown and Dr. Richard Huntsman, welcomed members to the meeting. The Co-Chairs then sought approval of the meeting agenda as well as the Record of Proceedings for the November 30 and December 2, 2020 Committee meetings. These documents were approved with no objections.

The Secretariat sought member updates to declarations ahead of the meeting and, as an additional reminder, the Co-Chairs invited members to provide any new declarations of interest. There were none received that restricted members' participation.

The Co-Chair, Dr. Paula Brown, provided an update on the Subcommittee on Animal Health, which held its first meeting on January 19, 2021. An overview of that meeting was provided, including a summary of the presentation to the Subcommittee on the current state of evidence for use in animals. Committee members also received an overview of the outcome of the Subcommittee's initial planning discussion; it is anticipated that the Subcommittee will hold a few more meetings in parallel to those of the full Committee, with a goal of generating animal-specific advice that could be integrated into the broader advice of the full Committee.

Presentations

Overview of SAC-HPCC forward agenda

Presenter: Dr. Richard Huntsman, Co-Chair, SAC-HPCC

The Co-Chair provided members with an overview of the proposed forward agenda and framework developed to guide the Committee's work over the coming months. The presentation included an overview of;

• The Committee's mandate objectives
• The proposed approach to address mandate objectives
  • A series of meetings throughout the next year, with each meeting designed to inform one or two of the mandate objectives
  • Meetings in the spring are anticipated to focus on safety and efficacy, whereas meetings in the summer and fall will consider other aspects of the Committee's mandate
• The proposed work plan to support upcoming meeting discussions
• Upcoming meeting logistics

Following the presentation, there was some discussion on the strong ties between safety and efficacy. There was mention that initial safety-related considerations could focus on healthy populations and then the scope could broadened, especially as particular indications are considered. Members also discussed the importance of considering drug-drug interactions in their safety-related discussions.

Committee members discussed the limited scientific evidence available on the efficacy of cannabis and phytocannabinoids for certain indications. Members also raised that previous reviews may effectively support their initial evidence review efforts, and that consideration of primary literature may be particularly important when assessing indication-specific efficacy.

Overview of targeted questions related to Prescription Drug List (PDL) principles

Presenter: Therapeutic Products Directorate (TPD), Health Products and Food Branch, Health Canada

Health Canada presented proposed targeted questions to support the Committee in identifying where evidence regarding safety, efficacy and dosing data is sufficiently robust, and where uncertainties remain.

This presentation included an overview of:

• The PDL principles
  • The three broad principles for determining prescription status
  • The drug assessment process
• The PDL and phytocannabinoids
  • The prescription status of health products containing phytocannabinoids
  • Cannabis-based drugs authorized by Health Canada
• The PDL amendment process and associated evidence requirements
• Questions developed to support the Committee's review of the evidence, including general and product-specific questions

Following the presentation, the discussion focused on the scope of cannabis and cannabis-derived compounds to consider in the Committee's initial evidence review efforts. There was mention that there may be different considerations and risks associated with different types of compounds. The importance of accurate and consistent use of associated terminology was also raised.

Related discussions included mention of the various compounds found in cannabis, including terpenes, as well as considerations on how detailed the Committee should make its recommendations.

Additional discussion points among the Committee members included the process for PDL amendments, and the parties involved in submitting related data and information. The importance of considering public health impacts was also mentioned, as well as safety at both the population and individual levels.

Overview of revised evidence list

Presenter: Policy Planning and International Affairs Directorate (PPIAD), Health Products and Food Branch, Health Canada

A revised evidence list was presented to Committee members. The presentation included an overview of:

• The purpose of the document, which was to provide members with a short list of key publications that could be used as a starting point to support their initial evidence review and forward planning efforts
  • This list also compliments the more extensive evidence compilation presented to the Committee at its November 30, 2020 meeting
• A description of the types of evidence included
  • Reports prepared by national and international organizations
  • Product monographs and prescribing information for cannabis and cannabinoid-based drugs
  • Other related publications

Following the presentation, Committee members provided feedback on the publications captured within the list and highlighted additional articles that may be helpful to include. Members were invited to share those resources with the Committee Secretariat, which will update the list accordingly.

Discussion period

Committee members discussed and provided feedback to the Secretariat and Co-Chairs on the proposed forward agenda, targeted questions, and revised evidence list.

One of the main points raised by members was the cost of certain cannabis products and the related impacts and barriers, particularly for higher doses. Members also discussed the findings of studies that investigated how specific patient groups currently access cannabis products for medical purposes. The importance of product quality was another point of discussion.

Members briefly discussed the prescription drug space, as well as the associated challenges that industry may face. This included mention of the current range of products available in the legal non-medical cannabis market.

Members then discussed the proposed forward agenda, and the need to incorporate opportunities for discussion of other associated considerations, such as public health factors. Members reiterated the importance of determining the scope of cannabis and cannabis-derived compounds that would be considered while reviewing available evidence and the need to build evidence-based recommendations. To support the development of recommendations, members discussed considerations of approaches to achieve formal consensus.

Closing remarks

The Committee Co-Chairs thanked members for their active participation. They informed members that they will work with the Secretariat to update the Committee's forward agenda and evidence list based on the day's discussions. Co-Chairs advised members that the Secretariat would be sharing materials for upcoming meetings with them in the coming weeks and adjourned the meeting.