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Terms of Reference – Science Advisory Committee on Health Products Containing Cannabis: November 2, 2020

Preface

The Cannabis Act and its regulations provide Canadians with strictly regulated access to cannabis products. When the Cannabis Act came into force in October 2018, two types of cannabis products were permitted on the market:

As part of the development of the Cannabis Regulations in 2018, Health Canada committed to holding consultations regarding a potential approach for non-prescription health products containing cannabis. This consultation was launched on June 19, 2019 and closed on September 3, 2019.

The purpose of this consultation was to seek feedback from Canadians, as well as the cannabis and health products industries, regarding the kinds of products they would be interested in manufacturing, selling or purchasing, should a legal pathway to market for these products be established. As part of this consultation, the Department made a commitment to seek external scientific advice regarding the appropriate evidence standards for non-prescription health products containing cannabis.

Health Canada is establishing the Science Advisory Committee on Health Products Containing Cannabis (the Committee) to support the Department’s consideration of potential safety, efficacy, and quality standards for health products containing cannabis, including under which conditions these products would be suitable to be used without practitioner oversight (e.g., dose and indication). The Committee will provide Health Canada with scientific advice and recommendations, but the decision-making responsibility remains with Health Canada. Health Canada will determine the need for further consultations on potential policy and regulatory issues (e.g., protecting young persons, packaging and labelling requirements or retail environment) based on the Committee’s scientific recommendations.

The Committee will ensure consistency with the principles set out in the Health Canada – Public Health Agency Scientific Integrity Policy and all associated guidelines. The Committee will also be subject to clear and transparent conflict of interest procedures as outlined in these Terms of Reference.

These Terms of Reference were accepted on November 2, 2020.

1.0 Mandate

To provide Health Canada with independent scientific and clinical advice to support the development of appropriate safety, efficacy, and quality standards for health products containing cannabis, including the conditions under which these products would be suitable to be used without practitioner oversight (e.g. dose and indication). The Committee will review available evidence regarding the use of cannabis and health products containing cannabis, address specific scientific questions, review current and emerging scientific and clinical issues, and provide evidence-based advice to help inform a potential regulatory path forward.

The focus will be on providing evidence-based advice and guidance on scientific and clinical issues related to health products containing cannabis intended for human use and without practitioner oversight. A sub-committee will also be formed to specifically address issues related to health products containing cannabis intended for animal use.

Issues for the Committee to consider could include:

  1. The state and level of evidence regarding the safety, efficacy and quality of cannabis, including specific phytocannabinoids such as THC or CBD, when used for therapeutic purposes. This includes advice regarding any factors, specific to cannabis, that Health Canada should consider when reviewing the benefits, harms and uncertainties of therapeutic cannabis use. Relevant information includes the current regulatory framework for health products, the safety profile of existing non-prescription products and natural health products, and all available pre-clinical and clinical evidence such as the scientific literature, real-world evidence, evidence related to currently approved health products containing cannabis and data received directly through a submission or application to Health Canada;
  2. Information that should be considered during Health Canada’s review of whether a product is suitable to be used without practitioner oversight, and advice on how to address any gaps in that information;
  3. Any factors, specific to cannabis, that should be considered when determining evidence-based dosage thresholds and conditions of use for specific phytocannabinoids, such as THC or CBD, when used without practitioner oversight; and,
  4. Information regarding the priorities of the research and medical community with respect to potential therapeutic uses of specific phytocannabinoids, such as THC or CBD.

2.0 Reporting structure

The Committee reports to the Associate Assistant Deputy Minister of HPFB (AADM). The Director General (DG) of the Policy Planning and International Affairs Directorate (PPIAD) will serve as the Executive Secretary to the Committee, and secretariat services will be provided by PPIAD. The AADM may delegate specific duties to other DGs within HPFB as appropriate.

To promote strong linkages between the work of the Committee and Health Canada policies and programs, the Committee will collaborate with the Therapeutic Products Directorate, the Natural and Non-prescription Health Products Directorate, the Veterinary Drugs Directorate, the HPFB Senior Medical Advisor, and senior officials from the Controlled Substances and Cannabis Branch as required.

3.0 Membership

3.1 Selection of members

Members of the Committee will be recruited through an open nomination process. In addition, potential members may also be identified through consultation with a broad range of sources, such as: health professional and scientific societies; academia; the provinces and territories; and/or the public. Health Canada and other federal officials may not serve as members of the Committee; however, the Department will leverage the expertise available across the Government of Canada. This process is designed to ensure requisite expertise and experience and a variety of perspectives, promoting diversity and inclusiveness.

Health Canada will appoint core and ad hoc members from among the nominees, following a review by a selection committee. The selection committee will be composed of Government of Canada staff with expertise in science and may include: representatives from the Office of the Chief Science Advisor to Health Canada, the Directors General from the Natural Non-prescription Health Products Directorate; Therapeutic Products Directorate; Veterinary Drugs Directorate; and the Policy Planning and International Affairs Directorate; the HPFB Senior Medical Advisor; and, senior officials from the Controlled Substances and Cannabis Branch. An external conflict of interest expert will advise the selection committee (refer to section 3.6 for further information).

Two Co-Chairs will be appointed by Health Canada from among the core members. To preserve the independence of the federal government as a decision maker, a federal employee can neither chair nor be a member of an advisory body and cannot participate in the formulation of an advisory body’s advice to Health Canada.

3.2 Types of members

In striking this committee, Health Canada is seeking membership from experts with a wide range of knowledge and experience. In addition, Health Canada is seeking representation of Canadians with lived experience as a patient who uses cannabis for medical purposes or health products containing cannabis.

Scientific experts must have a university degree with specialization in one of the following fields of study:

Except for members selected to represent their experience as a patient, preference will be given to individuals with a doctorate, juris doctor, or medical or veterinary medicine degree, and to candidates with relevant publications in peer-reviewed journals. Health Canada will also consider members’ expertise working with at-risk populations, such as pregnant or breastfeeding women, children, or other sub-populations.

Patient representatives will be selected based on their first-hand personal experience using cannabis or health products containing cannabis, as well as any experience working in similar committee structures.

3.3 Tenure

Members will be appointed by Health Canada for a minimum term of one year, which may be extended for additional terms based on Health Canada’s needs and the members’ availability and willingness to continue their membership.

Core members will be permanent members for the duration of their terms and ad hoc members will be invited to serve on working groups for a specific topic or group of topics. The Secretariat will review membership on a regular basis in consultation with the Co-Chairs, and will provide advice to the AADM HPFB. The Secretariat will endeavour to ensure that appointments of members are scheduled to allow for continuity.

3.4 Size of the Committee

The Committee will have a total of 8 to 12 core members. Membership may be periodically adjusted to ensure the appropriate representation of expertise and experience. The number of members in ad hoc working groups may vary, depending on the topic and the range of expertise required.

3.5 Security clearance

All members are required to undergo a security clearance to the level of “reliability status”. This will entail taking a member’s fingerprints. A security clearance is valid for ten years.

3.6 Affiliations and interests

As a condition of appointment, potential members of the Committee are required to complete and return the Affiliations and Interests Declaration Form for Advisory Body Members. This form is used to disclose to the Secretariat (PPIAD) any circumstances that may place, or be seen to place the member in a real, apparent, or potential conflict of interest. Health Canada prefers nominees who do not currently have, and have not had for the past two years, direct or indirect affiliations and interests with cannabis or health products industries, including financial, intellectual and other relevant interests.

Nominees will be screened for potential conflict of interest by the selection committee. Potential conflicts of interest will be determined based on an assessment of a nominee’s declaration of interests and affiliations and curriculum vitae. The selection committee will also seek advice from an external conflict of interest expert in cases of uncertainty.

The conflict of interest expert will attend relevant selection committee meeting(s) to answer questions or concerns from the selection committee; and provide specific advice on how to deal with identified conflicts of interest (real or perceived) on a case-by-case basis during the Committee membership selection process and for the duration of the Committee. Given the importance of this role, a rigorous selection process will be followed to select the conflict of interest advisor.

In keeping with the Privacy Act, this completed Affiliations and Interests Declaration Form is considered confidential. Health Canada will not make public any information in the form without the member’s permission. However, as a condition of membership, members will allow the Secretariat to publish on Health Canada’s website a Summary of Expertise, Experience, and Affiliations and Interests, which will be based on the completed Declaration Form. Members will be asked to review the content of the Summary for accuracy before its release.

It is incumbent upon the member to update his/her declaration in writing, should his/her personal situation change or where the matters before the Committee may affect the conflict of interest situation of a member. Declarations will be assessed by the Secretariat prior to appointment and on an ongoing basis as updates occur.

At the beginning of each meeting, the Co-Chairs will ask members to make a verbal statement of their relevant affiliations and interests. The level of participation of a member in conflict is determined by the Co-Chairs in consultation with the other members of the Committee and the AADM HPFB.

Members are expected to conduct themselves in an appropriate manner, i.e., the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.

3.7 Confidentiality

In order to support their ability to provide well-informed advice, committee members may receive and discuss at meetings information from Health Canada that is confidential in nature. Every person will sign a confidentiality agreement before participating in the committee as a member, invited guest, observer, or resource person. The agreement prohibits the disclosure of any confidential information by any means (including social media) received through participation in the committee, including information received orally or in writing.

All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Committee. Members must not discuss this information with persons not on the Committee, or divulge information obtained from the work of the Committee, including presentations made to it, until such a time this information has been officially released for public distribution. Documents leaving Health Canada, including electronic records must be securely stored at all times and must be returned to Health Canada or permanently deleted upon request.

The Secretariat will mark information according to the level to which it is protected under the Policy on Government Security. The Committee Co-Chairs will ensure that everyone participating in the meeting, telephone discussion, e-mail exchange or in another form of communication has received clear instructions on the confidentiality of the proceedings.

3.8 Indemnification and legal assistance

All members and guest speakers serve on the Committee on a voluntary basis. In keeping with the Treasury Board’s Policy on Legal Assistance and Indemnification members are eligible for the same protection against personal civil liability as federal employees when faced with comparable risks while acting within the mandate of the Committee and serving as volunteers.

3.9 Travel and expenses

Members and guest speakers will not be compensated for their participation on the Committee. They will be reimbursed for expenses incurred during their work on the Committee such as travel and accommodation, according to the Treasury Board’s Directive on Travel, Hospitality, Conference and Event Expenditures .

3.10 Resignation from the Committee

An individual may withdraw from service on the Committee at any time upon 14 days written notice to the Secretariat. The letter should state the effective date of resignation.

3.11 Reason for termination

Core members who are absent from three consecutive meetings of the Committee will forfeit membership in the Committee. Ad hoc members who do not attend in response to two consecutive invitations will forfeit membership in the Committee. Generally, a member’s failure to act according to the Terms of Reference may give cause for termination. In this event, the AADM HPFB will advise the member in writing, stating the reason for the termination and the effective date.

3.12 Official languages

In keeping with the Official Languages Act, the Committee members have the right to receive documents and participate in discussions in the official language of their choice.

4.0 Roles and responsibilities

4.1 Responsibilities of members

Members of the Committee have a responsibility to Health Canada and by extension to Canadians, to offer their independent and objective scientific advice. Other responsibilities include:

4.2 Responsibilities of presenters and observers

Presenters and observers may not participate in discussions at the Committee meeting unless the Co-Chairs specifically invites them to do so and must disclose any conflict of interest or affiliations at the beginning of their presentation. Only Committee members may participate in the formulation of advice to Health Canada.

4.3 Responsibilities of Co-Chairs

In addition to all the responsibilities of a member, the Co-Chairs will be responsible for the following:

4.4 Responsibilities of the Secretariat

The Policy Planning and International Affairs Directorate acts as the Secretariat for the Committee. The Secretariat liaises between members and Health Canada, and acts as a resource for members. It also provides leadership and strategic advice in the management of the Committee and works closely with the Co-Chairs. In addition, the Secretariat:

4.5 Support to the Secretariat

Health Canada employees may assist the Secretariat with meeting logistics, document preparation, and other tasks.

4.6 Responsibilities of Federal subject-matter experts

Medical, scientific, technical and program, policy, and other subject-matter experts, including Health Canada officials, support the work of the Committee in a variety of ways, including:

4.7 Responsibilities of the Associate Assistant Deputy Minister (AADM) of the Health Products and Food Branch (HPFB)

The HPFB AADM maintains the discretion to act on the advice of the Committee according to HPFB policy priorities. The HPFB AADM provides leadership and strategic advice in the management of the Committee and works closely with the Co-Chairs and Secretariat. The HPFB AADM reviews the Committee final report and ensures that the Committee is delivering on its mandate. The HPFB AADM may attend meetings as and when required.

4.8 Media and communications

All members are expected to protect and maintain as confidential any privileged information divulged during the work of the Committee. Discussion of the Committee work with the media or at conferences or other external events should only be done when authorization is given by the HPFB AADM.

Members who receive communications from the media should inform the Secretariat on a timely basis. In the case of media requests, the HPFB AADM will coordinate a response in consultation with the Co-Chairs and Health Canada Media Relations and will appoint a member to be the media spokesperson when circumstances warrant this.

5.0 Management and administration

5.1 Transparency

Health Canada is committed to ensuring transparency as an operating principle by:

5.2 Meeting agendas

The agenda and specific questions and issues for the Committee discussions will be determined by the HPFB AADM in consultation with the Co-Chairs and the Secretariat.

5.3 Meeting notices and invitations

All meetings are held at the call of the HPFB AADM in consultation with the Co-Chairs. Meeting attendance is by invitation only. Notices are sent by the Secretariat. Members receive the agenda, briefing material and presentations, in advance of the meeting.

5.4 Frequency, type and location of meetings

Core Committee meetings in the National Capital Region, or teleconferences, will be held a minimum of three times. Additional meetings and/or teleconferences may be held on an as needed basis at the discretion of the HPFB AADM in consultation with the Co-Chairs and Secretariat.

A meeting cannot be held unless quorum is achieved. Quorum is determined to be at least one-half the number of existing core members, one of which must be a Co-Chair.

For all teleconferences, members should ensure that any person who has not been approved by the Co-Chairs and Secretariat not listen to the proceedings.

5.5 Deliberations and records of proceedings

Deliberations during meetings may be held in camera upon confirmation by members in order to foster open, frank, and free-flowing discussion and in these cases are not electronically recorded. All members have equal status during discussion, and are expected to demonstrate fairness and a commitment to in-depth examination of matters under review. Only topics that fit within the mandate of the Committee will be discussed.

At the discretion of the HPFB AADM and with the approval of the Co-Chairs, specific experts or stakeholders may be invited to make presentations to the Committee in writing or in person.

The Co-Chairs and the HPFB AADM may grant observer status, for all, or part of, the Committee deliberations to selected individuals who would benefit from the deliberations of the Committee.

Members provide advice to Health Canada captured in Records of Proceedings (RoPs). The Committee is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the RoP will reflect the diversity of opinions and/or lack of consensus. The reasons for a lack of consensus, if any, must be clearly identified and substantiated. In such cases, the Committee shall provide advice with respect to further study of the issue and a proposal for resolution. In cases where there is a real divergence of opinion, the different opinions will be documented, and the number of members supporting each opinion recorded.

A draft RoP is prepared by the Secretariat and circulated to members for review, and final approval by the Co-Chairs and the HPFB AADM. As a condition of membership, members shall agree to the audio recording of the meeting only for the purpose of drafting the RoP to be published on Health Canada’s website and allow public access to an outline of presentations made during committee meetings. This agreement shall be confirmed verbally at the start of every meeting. Of note, as outlined in the first paragraph of this section, deliberations during meetings may be held in camera, and thus not electronically recorded. Invited guest speakers will be given the opportunity to review the draft RoP to ensure that their views are properly captured. The final RoP will summarize the proceedings to reflect the advice offered. The Secretariat is responsible for the distribution of the RoP.

When issues are of a general nature, the agenda and the record of proceedings will be posted on Health Canada’s website in both official languages. In the event that topics discussed are considered confidential (e.g. issues discussed regarding a particular drug submission or application), the meeting documents will become part of the official Health Canada file. In the event that the Co-Chairs and the HPFB AADM believe that the Committee would benefit from broader stakeholder input, a portion of the meeting could become public.

5.6 Final report

The Secretariat in consultation with the Co-Chairs and the members will draft the Committee’s final report following the completion of required meetings, which will address the work done by the Committee. As directed by the HPFB AADM, the report will outline key results and advice on the mandate laid out in these terms of reference.

5.7 Review

The Secretariat will review the Committee at the end of the year, and will work with the HPFB AADM and the Co-Chairs to review the mandate, activities, Terms of Reference, and relevance of the Committee to determine whether it has met its objectives and continues to meet the needs of Health Canada. The HPFB AADM retains the prerogative to disband the body, or extend it if there are areas that could benefit from the Committee’s advice and support. Advice regarding possible improvements will be considered on an ongoing basis.

6.0 References

The Health Products and Food Branch’s Health Canada Policy on External Advisory Bodies (2011) governs the Terms of Reference, and the management and administration of the Committee.

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