Terms of Reference of the Expert Advisory Committee on Information for Physicians on Marihuana for Medical Purposes (EAC-IPMM)

The Expert Advisory Committee on Information for Physicians on Marihuana for Medical Purposes (EAC-IPMM) provides Health Canada (HC) with scientific/medical advice related to the 2010 version of the document published by Health Canada entitled "Information for Health Care Professionals- Marihuana" and its amended versions. Involvement of the scientific and medical communities in specific questions and issues related to this document is expected to enhance transparency and provide an opportunity for external input, thus improving the quality of the information that is provided to physicians by Health Canada regarding marihuana for medical purposes.

Date Terms of Reference endorsed: January 26, 2012

1.0 Mandate

The Controlled Substances and Tobacco Directorate (CSTD) has identified the need for an Expert Advisory Committee (EAC-IPMM) to provide advice and recommendations to Health Canada on the current information on marihuana for medical purposes and any additional information/ education materials that might be of help so that physicians can be better informed of the current science on marihuana for medical purposes and thus better support their discussions with patients.

Health Canada has the responsibility and sole authority to make decisions with respect to the mandate of this advisory body.

2.0 Reporting Structure / Governance

Health Canada advisory bodies operate under the Health Canada Policy on External Advisory Bodies. All elements of the policy apply to the EAC-IPMM unless these Terms of Reference specifically state otherwise. Section references in this template are to the policy.

Health Canada is represented by the Director General (DG) of the Controlled Substances and Tobacco Directorate (CSTD), who is the Executive Secretary to the EAC-IPMM.

The EAC-IPMM reports to the Executive Secretary and the Office of Research and Surveillance in the CSTD (ORS) will provide Secretariat support as required.

3.0 Membership Nomination Process

Members of the EAC-IPMM are recruited through a targeted nomination process. The goal of the nomination process, as detailed below, is to ensure that, together, advisory body members have a range of knowledge, expertise, and experience and reflect a variety of perspectives. Health Canada promotes diversity and inclusiveness in advisory body membership.

The Chair and advisory body members are appointed by the Executive Secretary. They are appointed at pleasure, and appointments may be ended without cause or consultation.

3.1 Membership Considerations

3.1.1 Size of the Committee

The Committee will consist of 9 core members and one (1) Chair (permanent for the duration of their term).

3.1.2 Types of Members

The Committee is composed of core members selected for their medical/scientific expertise or knowledge pertinent to issues posed to the Committee but may also include ad hoc members, if required. Core members are permanent members for the duration of their terms. Ad hoc members may be invited on an "as-needed" basis to provide input on a specific topic.

3.1.3 Selection of Members

The Executive Secretary, based on input provided by the Secretariat, selects and appoints a Chair from among the nominees. The Secretariat will recommend potential core members for confirmation by the Executive Secretary. In order to preserve the independence of both the advisory body and the federal government as decision-maker, Federal government employees will not serve as members of the EAC-IPMM.

The mandate of the EAC-IPMM defines its membership. The membership of the Committee as a whole should cover various areas of medical and scientific expertise related to cannabis and cannabinoids including but not limited to areas such as: pain, oncology, neuromuscular diseases, psychopathology (mood disorders, anxiety disorders), cannabinoid pharmacology, and clinical or pharmacy practice.

At the discretion of the Executive Secretary and with the approval of the Chair, ad hoc members may be invited to attend meetings or to join the advisory body for a defined period to provide input on a topic or agenda item. An ad hoc member must follow the same rules and procedures as a core member.

The Chair and the Executive Secretary may grant observer status, for all or part of the Committee's deliberations to selected individuals, including Health Canada employees that would benefit from the deliberations of the Committee.

3.2 Affiliations and Interests

As a condition of appointment, potential members of the EAC-IPMM are required to complete and return the "Affiliations and Interests Declaration Form." This form is used to disclose to the Secretariat any circumstances that may place, or be seen to place the member in a real, apparent, or potential conflict of interest.

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 CSTD to publish on Health Canada's website and in print 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 the meeting, the Executive Secretary or the Chair will ask members to make a verbal statement of their affiliations and interests. The level of participation of a member with potential or actual conflict is determined by the Chair in consultation with the Secretariat.

Members are expected to conduct themselves in an appropriate manner. They may not use their position on an advisory body for their private gain or for the gain of any other person, company, or organization.

3.3 Confidentiality

To support their ability to provide well-informed advice, EAC-IPMM members may receive confidential information. Everyone must sign a Confidentiality Agreement before participating in the EAC-IPMM as a member, ad hoc member, presenter, or observer.

The Confidentiality Agreement prohibits the disclosure of any confidential information received through participation in the advisory body, including information received orally or in writing, through email correspondence, telephone calls, print materials, meeting discussions, etc.

The Secretariat will mark information according to the level to which it is protected under the  Policy on Government Security.

The Chair will ensure that everyone participating in the meeting, telephone discussion, email exchange, or in another form of communication has received clear instructions on the confidentiality of the proceedings.

3.4 Security Clearance

All members are required to attain an enhanced security clearance. The Secretariat provides the required forms to candidates for appointment.

3.5 Legal Assistance and Indemnification

All members serve on the EAC-IPMM on a volunteer basis.

Health Canada undertakes to provide its volunteer advisory body members with protection against civil liability provided the volunteer member acts in good faith, within the scope of their volunteer duties; and does not act against the interests of the Crown.

Members act collectively as an advisor to Health Canada with respect to the mandate of their advisory body but they are not final decision-makers. The Department has the ultimate responsibility and accountability for any decision resulting from the advice received from an external advisory body.

3.6 Travel and Expenses

Members are reimbursed for travel and accommodation expenses incurred during their work on the EAC-IPMM, according to the Treasury Board's  "Directive on the Management of Expenditures on Travel, Hospitality and Conferences".

3.7 Tenure

Members are appointed by the Executive Secretary for a one year term. The appointment will be from December 19, 2011 to December 18, 2012.

3.8 Resignation Process

It is preferable for a member to provide 14 days' notice of the intent to resign. The resignation letter must be in writing and be addressed to the Executive Secretary and to the Chair. The letter should state the effective date of the resignation.

3.9 Reasons for Termination

Health Canada may end a member's appointment by writing to the member stating the reasons the appointment is being concluded and the effective date. Appointments may end for a variety of reasons: the member's term is complete; the mandate of the advisory body has been completed; the advisory body's mandate has changed, thus requiring a different membership, etc. An appointment may also be ended for cause when, for example, a member fails to act according to the Terms of Reference, breaks the Confidentiality Agreement, or misses a meeting without satisfactory reason.

4.0 Roles and Responsibilities

4.1 Members

Members of the EAC-IPMM have a responsibility to Health Canada, and by extension to Canadians, to offer their independent and objective advice in reference to the mandate of the EAC-IPMM. To do so, they must consider all input received that is related to the mandate of the advisory body.

The members of the EAC-IPMM will have a number of expected deliverables which can be broken down into those to be performed prior, during and after the meeting of the EAC.

Prior to the face-to-face meeting of the EAC:

• Review and provide comments on the meeting agenda and the EAC's Terms of Reference (attached) or any documents sent prior to the meeting.
• Review and provide comments on the peer-reviewed version of the document published in 2010 by Health Canada (HC) entitled "Information for Health Care Professionals- Marihuana" (attached);
• Bring up any other issues in this document that may be conflicting, unclear or require discussion and/or clarification;

During the meeting:

• Discuss and reach a consensus on the specific issues that have been highlighted by HC as being unclear and requiring debate or clarification;
• Provide recommendations to HC on the final content of the "Information for Health Care Professionals-Marihuana" document;
• Provide recommendations on any possible additional information/ education materials needed by physicians (besides the revised "Information for Health Care Professionals- Marihuana" document to be produced by HC). This item may be addressed at a second, subsequent meeting (TBD).

After the meeting:

• Provide comments and approve the draft report prepared by the Health Canada Secretariat as well as the final content of the "Information for Health Care Professionals-Marihuana" document;
• Follow up on any action items requested during the meeting and attend teleconferences, if necessary.

The members provide advice and make recommendations to Health Canada on the information and questions as submitted.

Other responsibilities include:

• being available and prepared to participate in advisory body meeting(s), including email exchanges and conference calls, if requested;
• participating in any discussions surrounding the advisory body's recommendations, advice or the preparation of meeting reports, if necessary;
• notifying the Secretariat and the Chair of any changes in the status of their affiliations and interests in relevance to the mandate during the time they are members of the advisory body;
• making a verbal statement of affiliations and interests at the beginning of the meeting when asked by the Chair; and
• directing any media inquiries to the Secretariat and notifying the Secretariat about the inquiry.

4.2 Chair

In addition to all the responsibilities of a member, the Chair is responsible for the following:

• providing input to and consulting with the Secretariat on the selection of members;
• consulting with the Secretariat to determine whether to limit the participation of a member in a meeting, depending on the nature of the person's affiliations or interests;
• consulting with the Executive Secretary to end the appointment of a Committee member;
• overseeing and chairing the Committee meeting;
• facilitating full and frank discussion among Committee members in relation to Health Canada's questions and agenda in fulfillment of the advisory body's mandate, including in formulating its recommendations, advice, or report to Health Canada;
• inviting members to make a presentation at a meeting when relevant and appropriate;
• coordinating the work of the Committee;
• seeking consensus on the advisory body's advice from all advisory body members, and if there is not agreement, ensuring that this diversity of opinion is noted in the final report;
• identifying when information and discussions are considered confidential and clarifying expectations regarding this protected information;
• reviewing and tabling the Committee's report to the Executive Secretary; and
• supporting, in any other way, the fulfillment of the Committee's mandate.

4.3 Secretariat

The Office of Research and Surveillance (ORS) of the CSTD acts as the Secretariat of the EAC-IPMM. The Secretariat is the administrative liaison between advisory body members and Health Canada, is a resource for members, and works closely with the Chair and Executive Secretary. The Secretariat identifies and prioritizes the specific questions and issues for Committee discussion. In addition, the Secretariat:

• coordinates the membership appointment process as well as processes such as the affiliations and interests declarations and security clearances, and maintains an up-to- date membership list;
• coordinates the preparation of the meeting agenda, sends out invitations to Committee members, prepares background information packages for the EAC-IPMM, and drafts the report. The final report summarizing the recommendations of the Committee will be drafted for the review and approval by the membership and the Chair;
• maintains any information about the EAC-IPMM, its mandate, or work that may be posted on Health Canada's web site;
• coordinates requests for travel reimbursement;
• assists the Chair in carrying out the Chair's responsibilities;
• undertakes any tasks delegated to it by the Executive Secretary;
• reports to the Executive Secretary on the activities of the advisory body;
• carries out additional duties as appropriate in support of the EAC-IPMM.

The Secretariat receives guidance and support from a "Working Group" with representation from within the Department (i.e. the Office of Research and Surveillance, the Office of Controlled Substances and the Office of Policy and Strategic Planning of the Controlled Substances and Tobacco Directorate of the Healthy Environments and Consumer Safety Branch as well as the Strategic Communication Directorate of the Public Affairs, Consultation and Communications Branch).

4.4 Executive Secretary

The Executive Secretary is the Director General (CSTD) who represents Health Canada and makes decisions about the EAC-IPMM and its advice. The Executive Secretary provides leadership and strategic advice in the management of the EAC-IPMM and works closely with the Chair and Secretariat.

If applicable, the Executive Secretary, or a delegate, reports back to the advisory body at the beginning of each meeting on next steps and the impact of the advice received.

4.5 Media and Communications

All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Committee. Discussion of the EAC-IPMM's work with the media or at conferences or other external events should only be done when authorization is given by the Executive Secretary.

In the case of media requests, the Executive Secretary will coordinate a response in consultation with the Chair and the 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:

• ensuring that meeting schedules are predictable, where possible;
• ensuring an accurate and up-to-date report;
• publishing/posting to the Health Canada website the ToR, membership, member biographies, Summary of Expertise, Experience, and Affiliations and Interests, and the final report (containing the recommendations).

5.2 Meeting Agendas

The agenda and specific questions and issues for EAC-IPMM discussions will be approved by the Executive Secretariat in consultation with the Secretariat and the Chair.

5.3 Meeting Notices and Invitations

The meeting is held at the call of the Executive Secretary or the Secretariat, in consultation with the Chair. Meeting attendance is by invitation only. The notice is sent by the Secretariat. Members will receive an agenda, briefing materials and other documentation as far in advance as possible but at least ten working days prior to the meeting.

5.4 Frequency, Type, and Location of Meetings

The initial meeting will be held in the National Capital Region. An additional meeting and/or teleconference may be held as required at the discretion of the Executive Secretary in consultation with the Secretariat (Secretariat in consultation with the Chair).

For all teleconferences, members should make every effort to ensure that the conversation is private and that a secure telephone line is used for the call. Only members of the Committee or others approved by the Chair and the Secretariat can listen to the deliberations.

5.5 Observers

The Secretariat or the Chair, in consultation with the Executive Secretary, may allow individuals or organizations to observe a meeting or part of a meeting. Observers may not provide input on agenda items or participate in the discussions, unless specifically invited to do so by the Chair (in consultation with the Secretariat).

5.6 Invited Presenters

The Secretariat, or the Chair in consultation with the Executive Secretary, may invite individuals or associations with particular expertise or experience to provide input on a specific topic or agenda item. Invited guests may participate in the discussions if the Chair (in consultation with the Secretariat) specifically invites them to do so, but they do not participate in the formulation of advice.

5.7 Requirements of Presenters and Observers

Health Canada may require an invited presenter or observer to complete the:

• Affiliations and Interests Declaration Form;
• Confidentiality Agreement;
• Personnel Screening, Consent and Authorization Form.

5.8 Deliberations

Deliberations during the meeting are held in camera (i.e. private) in order to foster open, frank and free-flowing discussion. All members of the Committee will have equal status during discussion. Committee members are expected to demonstrate fairness and a commitment to in-depth examination of matters under review.

Topics that do not fit within the mandate of the Committee are not to be discussed.

Committee members are expected to conduct themselves in an appropriate manner, i.e. the use of their position cannot be reasonably construed to be for their private gain or that of any other persons or organization.

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 time as this information has been officially released for public distribution. Documents leaving HC must be securely stored at all times and any confidential information provided must be returned or securely destroyed.

The Committee must have quorum when making recommendations or providing advice to Health Canada. The quorum is defined as half the number of core members plus one (the Chair).

5.9 Recommendations and Final Report

Advice from the Committee is in the form of recommendations to the Executive Secretary. These recommendations are captured in a draft report. The EAC-IPMM is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the report will reflect the diversity of opinions. The reasons for a lack of consensus, if any, must be clearly identified and substantiated. In cases where there is a real divergence of opinion, the Chair will ensure that the different opinions and the number of members supporting each opinion are recorded and will make a recommendation with respect to further study of the issue and a proposal for resolution. The recommendations will have to be evidence-based.

A draft report is prepared and circulated by the Secretariat to members and the Chair for review within 1 month of the conclusion of the meeting, and a final report will be submitted by the Chair to the Executive Secretary. The final report will be posted to the Health Canada website and summarize the EAC-IPMM's recommendations to reflect the advice offered. The report will not contain any attributions, i.e. there will be no references to comments made by individual members.