Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): June 17, 2021
List of acronyms
- Health Canada Directorates and Branches
- AADM: Associate Assistant Deputy Minister
- HPFB: Health Products and Food Branch
- PPIAD: Policy, Planning and International Affairs Directorate, HPFB
- TPD: Therapeutic Products Directorate, HPFB
- CSCB: Controlled Substances and Cannabis Branch
- VDD: Veterinary Drugs Directorate, HPFB
June 17, 2021, 12:00pm-2:15pm Eastern Time
Welcome and introductory remarks
The Executive Secretary of the Committee and the Acting Associate Assistant Deputy Minister (AADM) of the Health Products and Food Branch (HPFB) welcomed members to the meeting.
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 interest. The external conflict of interest (COI) advisor confirmed no changes to members' COI assessments.
The AADM of HPFB reviewed key elements of the Committee's Terms of Reference. Members were reminded that the focus of the Committee is on providing evidence-based advice and guidance related to the potential non-prescription use of health products containing cannabis recognizing the already established prescription-based pathways in place through which Canadians can access prescription drugs containing cannabis and cannabis for medical purposes. The AADM also reviewed the Committee's forward plan, including key deliverables.
Members noted that, although the pathway to access cannabis for medical purposes is out of the scope of the Committee's work, advances in research regarding the safety, efficacy and quality of cannabis may help inform the future of that pathway.
Following this opening discussion, the Executive Secretary of the Committee officially confirmed the resignation of one of the Committee's members, Dr. Jean-François Boivin. A follow up discussion focused on the measures in place for the management of conflict of interest in the exercise of the functions of the members on this committee.
The Executive Secretary of the Committee re-confirmed members' commitment to serve on the Committee and all members confirmed their continued interest and commitment.
The objective of presentations at this meeting were to support Committee deliberations regarding the priorities of the research and medical community.
Proposed amendments to the Cannabis Regulations to regulate non-therapeutic cannabis research
Presenter: Controlled Substances and Cannabis Branch (CSCB), Health Canada
Health Canada presented an overview of the proposed regulatory amendments to facilitate non-therapeutic cannabis research with human participants. This presentation included an overview of:
- The legal framework for cannabis
- Current requirements under the Food and Drug Regulations and the Cannabis Regulations for research with cannabis
- The need for non-therapeutic cannabis research
- Related issues and challenges
- Proposed regulatory amendments
Following the presentation, Committee members highlighted the challenges associated with the current quality requirements that must be met by cannabis products used in all cannabis research involving humans. Committee members also noted practical challenges in generating the product-specific pre-clinical data that must be included in the Investigator's Brochure, a requirement for human cannabis research activities through the Food and Drug Regulations. Questions on how therapeutic and non-therapeutic cannabis research would be defined and categorized were also raised.
Health Canada indicated that work is ongoing to develop supportive definitions within the related proposed regulatory amendments to the Cannabis Regulations.
Clinical trials involving cannabis
Presenter: Therapeutic Products Directorate (TPD), HPFB, Health Canada
Health Canada presented considerations for clinical trials involving cannabis. This presentation included:
- Details on current requirements for conducting clinical research with cannabis
- The importance and need for clinical research with cannabis
- Current challenges associated with this research
- The revised risk-based approach for clinical trials with cannabis
An overview of the current requirements for veterinary drug trials under the Food and Drug Regulations were also provided by the Veterinary Drugs Directorate to the Committee.
Following the presentation, Committee members further discussed some of the challenges of conducting research with cannabis, including product availability and quality requirements, as well as the current product-specific pre-clinical data requirements.
Members also briefly discussed considerations related to veterinary health, including potential residue limits and evidence available for establishing such limits in food producing animals.
Defining CBD-containing products on which to focus initial evidence review efforts
Presenter: Dr. Paula Brown, Co-Chair, SAC-HPCC
The Committee Co-Chair described the importance of clearly defining the scope of products to consider in the Committee's initial efforts, particularly given the complexity of the cannabis plant and the flexibility in the Committee's mandate. The Co-Chairs presented a draft definition of CBD-containing products which could be used to focus the Committee's initial evidence review.
Members agreed that initial efforts of the Committee would focus on CBD-rich preparations, including purified CBD, CBD isolates, CBD-rich cannabis extracts and synthetic CBD, which meet certain criteria. The importance of distinguishing between these different categories during Committee discussions was raised, as each of these product types will have its own specific considerations.
Members noted the lack of details on certain study materials in publications and reports and the importance of this consideration while reviewing data moving forward.
Presenter: Dr. Richard Huntsman, Co-Chair, SAC-HPCC
The Committee Co-Chairs thanked members for their active participation. Co-Chairs advised members that the Secretariat would be sharing materials for upcoming meetings and adjourned the meeting.
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