Record of Proceedings for the Science Advisory Committee for Health Products Containing Cannabis (SAC-HPCC) Subcommittee on Animal Health: July 27, 2021

July 27, 2021, 2:00-4:15 pm Eastern Time

Welcome and opening remarks

The Committee Co-Chair, Dr. Paula Brown, welcomed members of the Subcommittee on Animal Health, Health Canada participants from the Policy, Planning and International Affairs Directorate (PPIAD) and Veterinary Drugs Directorate (VDD).

The Secretariat sought member updates to Conflict of Interest (COI) declarations ahead of the meeting and, as an additional reminder, the Co-Chair invited members to provide any new declarations of affiliations and interests to the external COI advisor. No new declarations were received.

The Co-Chair sought approval of the Record of Proceedings (RoPs) from the Subcommittee’s January 19, 2021 meeting, as well as the agenda for the present meeting. These documents were approved by members with no objections.

How to capture the subcommittee’s cumulative discussions

The goal of this agenda item was to determine how to best capture the Subcommittee’s cumulative discussions and decisions to facilitate the development of the Committee’s report.

The Subcommittee reviewed the Committee mandate objectives included in the SAC-HPCC Terms of Reference. Members noted the need to consider:

• different species separately (companion animals, horses and other food-producing animals);
• dose ranges in animals;
• differences in the availability of evidence relating to delta-9-Tetrahydrocannabinol (THC) versus cannabidiol (CBD), as well as evidence relating to food-producing versus companion animals
• product labelling; and
• mechanisms that could support evidence gathering in clinical practice.

Presentation on key factors used by Health Canada in veterinary product evaluation

Members received a presentation on the key factors used in a veterinary new drug evaluation from VDD.  The presentation included an overview of how certain factors are assessed including:

• The prescription status and indication of a product;

• Drug product ingredients and dosage form and how they may contribute to the safety and efficacy profile;
• Target Animal Safety based on history of use, target animal studies, safety under the proposed conditions of use and adverse events;
• Pharmacology including pharmacokinetic and pharmacodynamics studies that may help inform the dose, frequency of administration and the duration of use; and
• Efficacy based on the outcome measurements from pivotal studies that support the label indication.

Following the presentation, members discussed the need to consider data requirements and labelling, as well as available evidence and gaps.

Continuation of discussion

Further discussion continued on ingredients and indications. There was general agreement to focus on CBD and ensure a clear definition. There was also agreement to categorize evidence by species.

Members discussed the benefit of having proper guidance for veterinarians to assess the safety and efficacy of a product based on the data available, which would allow them to engage with the clients and care of their animals appropriately, considering the possible drug interactions and other safety concerns.

Members also posed questions about how product monographs are developed and used to support the authorization of other products (e.g., antiseptic teat solutions monograph).  

Discussion of the forward agenda and work plan for the Subcommittee

The Co-Chair indicated that the Canadian Food Inspection Agency (CFIA) will be invited to the next Subcommittee meeting for a discussion on the safety of cannabis in food-producing animals and food safety.

Members agreed to focus their work initially on cannabis for use in companion animals.

To support upcoming discussions, the Co-Chair committed to coordinate with the Secretariat to provide members with additional information about product monographs.

Closing remarks

The Co-Chair thanked everyone for participation and helpful discussion in this meeting. The meeting was adjourned.