Record of proceedings for the Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC): November 30 & December 2, 2020
- Session 1 - November 30, 2020, 2:30-5:00pm Eastern time
- Session 2 - December 2, 2020, 2:45pm-5:00pm Eastern time
List of acronyms
Health Canada Directorates and Branches
- CSCB: Controlled Substances and Cannabis Branch, Health Canada
- NNHPD: Natural and Non-Prescription Health Products Directorate, Health Products and Food Branch, Health Canada
- PPIAD: Policy Planning and International Affairs Directorate, Health Products and Food Branch, Health Canada
- VDD: Veterinary Drugs Directorate, Health Products and Food Branch, Health Canada
Other organizations and Committees
- CIHR: Canadian Institutes of Health Research
- ECDD: Expert Committee on Drug Dependence (advisory body to the World Health Organization)
- NASEM: National Academies of Sciences, Engineering, and Medicine
- WHO: World Health Organization
Products and Compounds
- CBD: Cannabidiol
- NHP: Natural health product
- THC: Tetrahydrocannabinol
- VHP: Veterinary health product
Session 1 - November 30, 2020, 2:30-5:00pm Eastern time
Welcome and introductory remarks
The Executive Secretary of the Committee, the Director General of the Policy Planning and International Affairs Directorate (PPIAD), welcomed members and indicated that there would be a number of presentations on the current state of the evidence throughout the afternoon, from Health Canada colleagues as well as from national and international experts.
Following the introductory remarks, the Committee Co-Chairs welcomed members to the meeting and provided an overview of the meeting agenda; the first session would include a series of presentations on evidence, whereas the second session would focus on working discussions and planning the Committee's work.
The Secretariat sought member updates to declarations ahead of the meeting and one update was received which had no impact on their participation. After the first presentation, as an additional reminder, the Co-Chairs invited members to provide any new declarations of interest. There were none received that restricted members' participation.
Health Canada overview of evidence for cannabis use in humans
Presenter: PPIAD, Health Products and Food Branch, Health Canada
An overview of various types of evidence relevant to the Committee's mandate was presented to Committee members. An accompanying Excel document was provided to members, which listed this information. The presentation included an overview of:
- The purpose of this evidence gathering exercise, which was to provide a landscape view of the published works related to the Committee's mandate in order to support the Committee's subsequent discussions.
- A description of the types of evidence compiled
- Literature search results of secondary publications related to the safety, efficacy and quality standards of cannabis, particularly when used for health-related purposes.
- Other related publications (for example, product monographs for approved cannabis-based drugs, reports related to the safety of cannabis or cannabinoids prepared by other International drug regulators)
- Adverse reaction information from the publically-available Canada Vigilance Adverse Reaction Online Database
- Information on clinical trials that is available through publically available data sources
- Advantages and limitations of certain data types, such as their scope and quality considerations.
Following the presentation, the discussion focused on some of the types of evidence outlined in the presentation. For example, some members had questions regarding the status of various cannabis related clinical trials that are captured in Health Canada's online clinical trials database. The scope of the literature search presented was also discussed, including the level to which publications in the social sciences were captured. Finally, Committee members provided suggestions on how the literature search results could be categorized in order to best support the work of the Committee.
Canadian Institutes of Health Research (CIHR) Integrated Cannabis Research Strategy
Presenter: Dr. Samuel Weiss, Scientific Director of the CIHR Institute of Neurosciences, Mental Health and Addictions
The Committee members received a presentation on CIHR's Integrated Cannabis Research Strategy. This presentation included an overview of:
- CIHR's Integrated Cannabis Research Strategy, which was developed to support the advancement and translation of scientific knowledge on cannabis in Canada.
- Emerging evidence on the health effects of cannabis use, including evidence related to use during pregnancy, in youth populations and when driving.
- Research in progress on the health effects of cannabis use.
Following the presentation, the discussion focused on challenges currently faced by Canadian researchers looking to undertake clinical trials involving cannabis. These challenges included product quality requirements, obtaining reliable sources of clinical grade product and the pre-clinical trial data requirements for specific products. Some Committee members also emphasized the importance of collaboration between researchers and industry. Health Canada staff confirmed that work is underway to address some of the points discussed and that they may be discussed further at a future committee meeting.
Additional discussion points among the Committee members included the level of funding currently allocated to cannabis research, compared to the revenue cannabis sales are generating. All agreed on the importance of continued research in this field.
National Academies of Sciences, Engineering, and Medicine (NASEM) report on the Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017)
Presenter: Dr. Ziva Cooper, Director, University of California, Los Angeles (UCLA) Cannabis Research Initiative; Associate Professor, Psychiatry and Biobehavioral Science, UCLA Semel Institute for Neuroscience and Human Behaviour
Committee members received a presentation on the NASEM report published in 2017 on the Health Effects of Cannabis and Cannabinoids. This presentation included an overview of the:
- NASEM Report background, including the scope of the work and the evidence gathering process.
- Evidence supporting therapeutic effects of cannabis, including conditions for which conclusive, moderate, limited and insufficient evidence was identified.
- Adverse effects of cannabis
- Barriers to research
Following the presentation, there was discussion on the types of products American consumers are interested in (e.g. those with topical or transdermal delivery systems), and the level of evidence currently available for those product types. There was also discussion on the types of cannabis products approved for research in the United States and some of the related challenges faced by researchers, such as, navigating state and federal laws, and obtaining products with the necessary quality requirements.
Adverse Reactions associated with Cannabis Products Reported to Health Canada
Presenter: Office of Cannabis Science and Surveillance, Controlled Substances and Cannabis Branch (CSCB), Health Canada
Members received a presentation on adverse reactions (ARs) associated with cannabis products from the Office of Cannabis Science & Surveillance at Health Canada. This presentation summarized the results of adverse reaction data with cannabis products reported to Health Canada's Canada Vigilance database during the first full year following the coming into force of the Cannabis Act (October 17, 2018 to December 31, 2019). Aggregate data analysis, including key observations, as well as a summary of assessments of serious and medically important cases (causality assessment, case series) and emerging safety signals were all captured.
This presentation included an overview of:
- Background and purpose of the report
- Scope of data considered and methodology
- Next steps, including continued routine monitoring of all adverse reactions associated with cannabis products.
Following the presentation, Committee members discussed the availability of data pre-legalization. There were also questions regarding the ability to look at the adverse reaction data collected by product type, such as those with cannabidiol (CBD). The presenter confirmed that these types of analyses are ongoing, and are possible due to the nature of the dataset. In particular, legal products are identified which supports the ability to determine product composition. A conversation on the level of reporting captured also took place, as well as a description of other types of related data sources available (e.g. hospitalization records, etc.).
World Health Organization's Expert Committee on Drug Dependence (ECDD)
Presenter: Dr. Bruna Brands, Senior Science Advisor, Office of Drug Science and Surveillance, CSCB, Health Canada; Professor, Department of Pharmacology and Toxicology, University of Toronto; Member of the ECDD, World Health Organization
The Committee received a presentation on the ECDD recommendations on cannabis and cannabis-related substances. The presentation included an overview of:
- The role and composition of the World Health Organization's ECDD
- ECDD's review process for psychoactive substances
- The rationale for ECDD's review of cannabis and cannabis-related products
- ECDD's recommendations on scheduling of cannabis and cannabis-related products
Discussion following the presentation touched on the potential impacts of the ECDD recommendations, and how the maximum percentage of tetrahydrocannabinol (THC) included in the ECDD's recommendation for CBD preparations was determined.
The Committee's Executive Secretary and the Co-Chairs thanked presenters and members for their participation, and expressed their anticipation for the second part of the meeting, to occur later that week.
Session 2 - December 2, 2020, 2:45-5:00pm Eastern time
Welcome and introductory remarks
The Co-Chairs welcomed members and invited them to provide any new declarations of interest. There were none that restricted committee members' participation.
The Committee's Executive Secretary introduced the agenda for the day's meeting.
Discussion of product examples for animal use
Presenter: Veterinary Drugs Directorate (VDD), Health Products and Food Branch, Health Canada
The Committee received a presentation on examples of products for use in animals. The presentation included an overview of:
- What is currently allowed
- Examples of hemp Veterinary Health Products (VHPs)
- Observations from the VHP program
- What is being heard from Canadians, based on the 2019 consultation on potential market for health products containing cannabis that would not require practitioner oversight as well as on VDD's ongoing engagement and correspondence with regulated parties and other stakeholders.
- Consumer Perspectives
- Industry Perspectives
- Health Professional Perspectives
- Illicit market
Following the presentation, there was a discussion on the research culture in the veterinary space. Members highlighted that the veterinary community is interested in undertaking studies in animals with health products containing cannabis, but similar to studies in humans there are challenges such as obtaining reliable sources of product. Members also commented that pharmaceutical market is much smaller in the veterinary space.
A discussion on products of interest also took place. There was mention of an interest in CBD products and the potential benefits of combination products, such as those containing CBD and THC, for certain indications in animals. A member also described the endocannabinoid system in animals, and how this may influence the animal's response to cannabis products.
Some considerations around food-chain implications were raised, as well as related controls currently in place.
Guidelines and rules currently in place within veterinary professional groups in Canada, and some examples of the implications of those measures in practice were also mentioned.
Discussion of product examples for human use (non-prescription)
Presenters: PPIAD, Natural and Non-prescription Health Products Directorate (Health Products and Food Branch) and CSCB, Health Canada
Committee members received a presentation on product examples for human use. The presentation included an overview of:
- The goal and purpose of the presentation, which was to provide the Committee with selected examples of marketed products containing cannabis and their association with health and health claims.
- Cannabis products
- Legal and prohibited representation
- Illegal cannabis products
- Natural health products (NHP)
- NHPs containing permitted Cannabis sativa plant parts being legally marketed with health claims
- Common NHP refusals
Topics raised during the subsequent question and answer period included the responsibilities related to the purchase of illegal products, particularly through online retailers.
Current state of evidence for use in humans
The goal of this agenda item was to provide Committee members time to discuss the current state of evidence.
To guide the discussion, the Committee Co-Chairs first reviewed the Committee's mandate and provided initial scoping considerations.
One of the main points raised by members during the discussion period was that the Committee should make a distinction between products containing only CBD, and those that also contain THC, as there are important differences between the two product types. A suggestion was to consider separate work plans for each.
Members raised questions on current barriers faced by Canadian researchers in terms of undertaking clinical trials involving cannabis and cannabis-based products. It was noted that additional information from Health Canada on clinical trial requirements in this space would be provided to the Committee at a subsequent meeting.
The types of evidence available and that should be considered by the Committee was discussed. This included mention of;
- Anecdotal evidence: Many members suggested that this type of evidence may be particularly informative. Recommendations to track or collect this type of information in a more formalized way were also discussed.
- Observational and cohort studies: Members mentioned that these types of studies may not include study populations that are representative of the Canadian population.
- To support their review of the evidence, members discussed the possibility of grading different types of evidence. In particular, a suggestion was made to start with high grade clinical trial data, for example, and then evaluate and grade other types of available evidence.
- There was also mention of undertaking risk-benefit analyses, which may then help to guide recommendations.
Members discussed how to approach the mandate objectives included in the Committee terms of reference. There was general agreement that the Committee would focus on the state and level of evidence regarding the safety, efficacy and quality of cannabis, including specific phytocannabinoids such as THC and CBD, when used for therapeutic purposes. Following that, members would discuss factors to consider for dosage and conditions of use would be assessed, and then suitability of use without practitioner oversight. Finally, the Committee would address the priorities of the research and medical community.
Some initial considerations raised by members regarding the safety and efficacy of cannabis when used for therapeutic purposes included:
- That patient-level safety will be an important consideration, as well as population-level safety. A member highlighted that it will be key for the Committee to effectively scope their work, and clearly outline what they should and should not consider.
- Members discussed that it may be helpful to first look at existing reports and reviews on safety and efficacy. These sources of information may provide a strong basis for the Committee's work.
- The potential of prioritizing certain indications, such as pain management, was discussed.
Members also mentioned quality-related consideration. For instance, extraction methods and compounds used to isolated specific phytocannabinoids from plant parts.
Members discussed current regulatory frameworks and how safety and efficacy evidence may help to guide related recommendations.
The Executive Secretary of the Committee thanked everyone for a great discussion and mentioned that the Secretariat will work with Co-Chairs to develop a work plan based on the day's discussion.
It was confirmed a subcommittee on veterinary health would be established early in the new year.
The Executive Secretary of the Committee thanked members for their participation and adjourned the meeting.
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