Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): September 2, 2021

List of acronyms

Health Canada Directorates and Branches

• CSCB: Controlled Substances and Cannabis Branch
• HPFB: Health Products and Food Branch
• NNHPD: Natural and Non-prescription Health Products Directorate, HPFB
• PPIAD: Policy, Planning and International Affairs Directorate, HPFB
• TPD: Therapeutic Products Directorate, HPFB
• VDD: Veterinary Drugs Directorate, HPFB

September 2, 2021, 3:00pm-6:00pm Eastern Time

Welcome and introductory remarks

The Committee Co-Chairs, Dr. Paula Brown and Dr. Richard Huntsman, welcomed members to the meeting. The Committee Secretariat from the Policy, Planning and International Affairs Directorate (PPIAD) and representatives from the Therapeutic Products Directorate (TPD), Veterinary Drugs Directorate (VDD) and Natural and Non-prescription Health Products Directorate (NNHPD) of the Health Products and Food Branch (HPFB) were in attendance, as well as members from the Controlled Substances and Cannabis Branch (CSCB). The external expert writer who will be supporting the Committee with drafting Committee reports was also in attendance.  Representatives from the Australian Therapeutic Goods Administration (TGA) joined the latter part of the meeting as guest presenters.

Prior to the meeting, members provided input to the Secretariat regarding key efficacy considerations related to cannabidiol (CBD), based on their expertise and the available information. The Co-Chairs thanked members for their feedback and outlined that the input provided would help to effectively guide the meeting discussion.

Administrative items

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

The Co-Chairs sought approval of the Record of Proceedings (RoPs) from the Committee’s July 30 meeting, as well as the agenda for the present meeting. Members approved these documents with no objections.

To support the continuation of work pertaining to other phytocannabinoids, Co-Chairs sought member confirmation about their willingness to extend the Committee’s lifespan. Members were supportive of continuing work until spring 2022.

Based on knowledge gaps identified by members in previous meetings, the Co-Chairs confirmed they were working with the Secretariat to engage with select experts recommended by members. Members reiterated the importance of considering external perspectives for particular topics, including key public health and efficacy considerations.

Presentations

The objective of presentations at this meeting were to support Committee deliberations regarding the efficacy of CBD use in humans.

Committee discussion on CBD efficacy

Presenter: Dr. Paula Brown

Dr. Brown led a discussion on indications for which there is evidence that CBD may be effective.

Based on the available information, members discussed the types of indications that would be appropriate for use without a prescription. They also flagged those that would require ongoing practitioner oversight, which would fall outside of the Committee’s mandate.

Members then shared their perspectives and analyses of the various types of evidence available on the efficacy of CBD for various indications. Information considered by members included randomized clinical trials, anecdotal evidence, data from traditional use, epidemiological data and animal studies. Members also discussed considerations of data obtained through surveys and their associated benefits and disadvantages.

Members noted that many studies on CBD efficacy have focused on the treatment of severe neurological disorders, and thus data on other comorbidities, such as sleep, anxiety and pain is limited and complex. Limitations of the data currently available on CBD efficacy were also considered. Members noted variations in dosing schedules and routes of administration, the low quality of many studies (high risk of bias, lack of blinding), the low number of studies available, and the small sample sizes considered in many studies. They also noted that various conditions of use have not been taken into account in current data.

Overall, members agreed that there was currently a lack of high quality data on the efficacy of CBD for a range of indications, and that available robust scientific or clinical data was largely insufficient.

Committee discussion on CBD dosing

Presenter: Dr. Richard Huntsman

Dr. Huntsman guided the next portion of the discussion, which focussed on dosing ranges for CBD.

Members first discussed the possibility of a CBD dosage range that is safe and efficacious across various indications. Members shared that establishing that type of dose would be very challenging, particularly as a wide range of CBD doses have been used in the limited evidence currently available and since indication-specific dosing factors must be considered.

The Committee also raised that dosing ranges used in studies completed to date often do not consider potential drug-drug interactions. They noted that many of the current CBD efficacy studies are focussed on the treatment of severe neurological disorders, therefore dosing data for comorbidities is complex.

Members briefly discussed CBD dose ranges for which no serious adverse reactions were noted and considered studies that looked at the efficacy of CBD within those limits. A number of related studies were mentioned and discussed by members.

Members shared that they would like to continue these conversations during their next meeting, along with a discussion of conditions of sale that could be used to encourage adverse event reporting if health products containing cannabis were to be made available without practitioner oversight.

Presentation from the Australian Therapeutic Goods Administration and Discussion Period

Presenter: Dr. Tony Gill, Senior Medical Adviser of Medicines Regulation, Therapeutic Goods Administration, Australia

The Committee members received a presentation from the Australian Therapeutic Goods Administration (TGA). This presentation included an overview of;

• The goals and role of the TGA
• The drug scheduling framework
• The scheduling process, including key criteria and scheduling factors
• The poison standard for medicinal cannabis
• Recent efforts and decision around the scheduling of CBD

Following the presentation, the Co-Chairs facilitated a discussion period between Committee members and representatives from the TGA. The discussion focussed on safety and efficacy standards, considerations of the evidence for the efficacy of CBD and current labeling requirements for health products.

The Committee Co-Chairs thanked the TGA for their informative presentation.

Wrap up and next steps

Presenter: Co-Chairs

The Committee Co-Chairs reminded members that the next meeting will continue to focus on safety and efficacy considerations related to CBD, including dosing. The Co-Chairs thanked members for their active participation, and adjourned the meeting.