Scientific Advisory Committee on Mental Health Disorders: Terms of reference

On this page

• Preface
• Mandate
• Reporting structure
• Membership
• Affiliations and interests
• Security clearance
• Indemnification
• Roles and responsibilities
• Management and administration

Preface

The Scientific Advisory Committee on Mental Health Disorders (SAC-MHD) is a key resource for Health Canada. The committee delivers timely scientific and clinical advice related to the diagnosis and treatment of various mental health disorders.

The inclusion of experts on the committee with clinical expertise in these areas, along with representation from across the Canadian medical landscape increases transparency. It also provides Health Canada with an opportunity to receive informed external guidance. Their advice further contributes to the evidence base that supports the regulatory drug review process.

Mandate

SAC-MHD provides expert advice on current Canadian standards for assessing and treating a broad range of mental health disorders, such as:

• mood disorders
• anxiety disorders
• substance and addiction disorders
• trauma- and stressor-related disorders

This collaborative effort helps ensure that Health Canada remains well-informed about emerging developments and best practices in psychiatry care.

SAC-MHD will deliberate on a range of topics, such as:

• emerging issues on the safety, efficacy, effectiveness and clinical applications of a range of interventions used to treat mental health disorders
• insights into standard-of-care, treatments and conventional therapies used in current psychiatric practice

The SAC-MHD is not a decision-making body. Its role is to provide advice and recommendations as one of several sources of evidence and expertise used by Health Canada in its decision-making processes.

Reporting structure

Health Canada advisory bodies operate under the Health Canada Policy on External Advisory Bodies. All elements of the policy apply to SAC-MHD unless these terms of reference state otherwise.

SAC-MHD reports to the director general (DG) of Health Canada’s Pharmaceutical Drugs Directorate (PDD). The directorate is represented by the DG, or designate, who acts as the executive secretary to the committee. The PDD also provides secretariat support.

Health Canada Policy on External Advisory Bodies

Membership

Members of SAC-MHD are recruited through open and targeted nomination processes. Potential members are identified in consultation with a variety of sources, including:

• academia
• Health Canada employees
• health professional and scientific societies
• the committee chair and current members
• government and non-government agencies

Equity, diversity and inclusion are key considerations in the member selection. Members are also appointed based on their expertise, knowledge and perspectives in psychiatry. Members include clinicians and scientists both in and outside of academia and may include members of the public. Additional considerations include:

• availability
• personal suitability
• professional standing
• affiliations and interests

Members are selected and appointed by Health Canada following a review of the above considerations.

SAC-MHD may include both core and ad hoc members who are chosen for their scientific, medical and technical expertise and knowledge.

Core members sit on the committee for the duration of their terms. There must be at least 5 core members. Membership may be adjusted from time to time to ensure the appropriate representation of expertise and experience.

Ad hoc members are invited by the chair to serve for a specific topic or group of topics.

SAC-MHD may also invite:

• experts to address specific topics of discussion
• members of the public to share unique perspectives

Employees of the Government of Canada cannot serve as chair or committee members, nor participate in preparing the committee’s advice to Health Canada (except in limited circumstances). This helps preserve the independence of the federal government as a decision-maker.

Selection of the chair

The executive secretary selects and appoints the chair from among the core members or non‑members. After consulting the chair, the executive secretary appoints a vice-chair from among the committee members, as needed, for a specific term.

The vice-chair may chair meetings and/or assume other responsibilities of the chair, either at the chair’s request or during the chair’s absence.

Tenure

Members are appointed for 6 months with the possibility of extension based on availability and willingness to continue. The secretariat reviews membership regularly, in consultation with the chair, and provides recommendations to Health Canada. Appointments are scheduled to maintain continuity and support the planned rotation of members.

SAC-MHD is expected to complete its initial mandate within 6 months. After this period, Health Canada may either:

• conclude the committee’s work or
• expand the committee’s role to support broader topics related to mental health disorder

Members interested in continued engagement may be invited to contribute beyond the original scope, at Health Canada’s discretion.

Resignation process

A member may resign from serving on SAC-MHD at any time by providing 14 days’ written notice to the executive secretary, with a copy to the chair. The notice should include the effective date of resignation.

End of appointment

Health Canada may end a member’s appointment for cause. The executive secretary will provide written notice to the member, including the reason for termination and the effective date.

Appointments may end for cause for any one of the following reasons:

• member has failed to act according to the committee’s terms of reference
• member has failed to comply with their obligations under the confidentiality agreement
• a change in the member’s affiliations and interests results in a direct financial interest that prevents participation
• core members have missed 3 consecutive meetings
• ad hoc members have not replied to 2 consecutive invitations without informing the secretariat of the reason
• member has acted in a way that jeopardizes the integrity of the committee

Other reasons that could lead to the end of an appointment include:

• member resigns
• member’s term is complete
• committee’s mandate is complete
• member becomes a federal government employee
• member’s knowledge, experience or expertise is no longer relevant as committee’s mandate has changed
• Health Canada and collaborating government departments, agencies or organizations rescind the committee’s mandate and terms of reference

Affiliations and interests

Potential SAC-MHD members must complete and return the Affiliations and Interests Declaration Form for Advisory Body Members. This form discloses any circumstances that may place, or be seen to place, the member in a real, apparent or potential conflict of interest.

This form will be protected in accordance with the Privacy Act, except that as a condition of membership the PDD may publish online a brief biography and summary of his or her affiliations and interests. The summary is based on the completed form. Members review and approve their summary for accuracy before it’s published.

Members are responsible for updating their declaration in writing when their personal situation changes or matters before the committee present a conflict of interest. The PDD assesses all declarations before appointments are made and on an ongoing basis as updates occur.

At the start of each meeting, the chair asks members to verbally state their relevant affiliations and interests. The chair determines the level of participation of a member in conflict, in consultation with the other committee members.

Members must conduct themselves appropriately. They must not use their positions for private gain or to benefit any other person, company or organization.

Security clearance

Members must undergo a security clearance to the level of “reliability status”. This may involve the RCMP taking their fingerprints. A security clearance is valid for 10 years.

Indemnification

All members and invited guest speakers serve on SAC-MHD as volunteers. Health Canada commits to providing its volunteer committee members with protection against civil liability arising from their actions as members. This protection applies if the members act in good faith, within the scope of their volunteer duties, do not act against the interests of the Crown and have no other protection.

In order for an eligible member to receive protection against civil liability, including for legal costs of defending an action as well as any award of damages against them, volunteer members must:

• inform Health Canada promptly of any claim, action, suit or proceeding brought against them and
• obtain Health Canada’s consent, in advance, to the legal counsel selected to represent them and any associated costs

Health Canada may, at its own expense and discretion, participate in the conduct of the defence of any such claim, action, suit or proceeding, and any negotiations for the settlement of the same.

Health Canada will indemnify the member for payment of any settlement, provided the member has obtained Health Canada’s consent to the settlement.

Members act collectively as advisors to Health Canada on the committee’s mandate, but they are not final decision-makers. Health Canada retains ultimate responsibility and accountability for any decisions that take into account advice received from an external advisory body.

Roles and responsibilities

Members

Members of SAC-MHD have a responsibility to Health Canada and by extension to people in Canada to offer their independent and objective advice.

They must also:

• be available and prepared to participate in meetings, including virtual meetings (for example, teleconferences, email exchanges, videoconferences) and public forums, if necessary
• take part in any discussions about the committee’s recommendations, advice or report to Health Canada
• notify the secretariat and the chair of any changes in the status of their affiliations and interests related to the mandate
• make a verbal statement of affiliations and interests at the beginning of each meeting when asked by the chair
• consider all the input received related to the mandate when preparing recommendations, advice or report
• inform the secretariat of any media inquiries about SAC-MHD

Commitment to confidentiality

Members must commit to confidentiality and ensure they do not disclose any sensitive or confidential information received as part of their involvement in the committee. They must not discuss this information with individuals who are not part of the committee. This includes any content arising from its work, including presentations, until the information has been officially released by Health Canada for public distribution.

Documents leaving Health Canada, including electronic and word processing records, must be securely stored. They must be returned to Health Canada or permanently deleted upon request.

Before participating in SAC-MHD, members sign a confidentiality agreement. This confidentiality agreement comes into effect on the date that it is signed by the last of the parties. The confidentiality agreement remains in effect until the member is notified in writing on behalf of Health Canada by the executive secretary named in paragraph 9 that this agreement is terminated in whole or in part.

Chair

In addition to their responsibilities as a committee member, the chair:

• provides input to and consults with the executive secretary on the selection of members if required
• consults with the executive secretary to determine whether to limit the participation of a member in a meeting based on their affiliations or interests
• oversees and chairs meetings, and facilitates discussion among members in answering the PDD’s questions
• clarifies the meeting’s purpose and anticipated outcomes at the start of the meeting
• invites members to make a presentation at a meeting, when relevant and appropriate

The chair also:

• identifies when information and discussions should be treated as confidential and clarifies member expectations regarding this information
• asks members to state their relevant affiliations and interests at the start of the meeting
• ensures that members agree with, or note their disagreement with, the advice in the report to the PDD
• delivers the committee’s advice to Health Canada and ensures the preparation of the meeting records or report
• acts as the designated media spokesperson for the committee
• helps the advisory body fulfill its mandate

At the request of the chair or when the chair is absent, the vice-chair will chair the meeting and take on the chair’s other tasks, as required.

Secretariat

The PDD’s Office of Clinical Trials is the secretariat for SAC-MHD.

In general, the secretariat:

• works closely with the chair
• acts as a resource for members
• liaises between members and Health Canada
• provides leadership and strategic advice on how the committee is managed

The secretariat also:

• coordinates membership processes, such as affiliations and interests declarations and security clearances, and maintains a current membership list
  • may restrict participation in a meeting due to the nature of the person’s affiliations or interests
• prepares meeting agendas and background information packages, marks the packages in accordance with the government’s security policy and drafts the record of proceedings for membership and chair approval
• maintains information about SAC-MHD, its mandate or work that may be posted online
• helps to prepare the chair, who serves as the designated media spokesperson, as appropriate
• coordinates requests for travel reimbursement
• discusses whether broader input is needed at a meeting, decides whether all or part of a meeting should be held in private and considers who should be an observer to all or part of a meeting
• liaises with Health Canada, including seeking input from subject-matter experts
• undertakes any tasks that the executive secretary delegates to it

As well, the secretariat:

• reports to the executive secretary on the committee’s activities
• monitors and evaluates the efficiency and effectiveness of SAC-MHD
• determines when the committee’s mandate has been fulfilled
• carries out additional duties as appropriate in support of SAC-MHD

Support to the secretariat

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

Health Canada’s subject-matter experts

Health Canada’s medical, scientific, technical and program, policy and other subject-matter experts support the work of a committee in several ways. For example, they:

• provide information about government policies and programs
• deliver presentations or answer questions at committee meetings
• prepare background documents such as research summaries and regulatory process overviews

Executive secretary

The executive secretary is the director general of the PDD. The executive secretary represents Health Canada and makes decisions about SAC-MHD and how the advice provided by the committee will be used.

The executive secretary provides leadership and strategic advice on how SAC-MHD is managed and works closely with the chair and secretariat. The executive secretary attends the introductory portion of the meeting, may depart after that and does not take part in committee deliberations.

Media and communications

Discussion of SAC-MHD work with the media or at conferences or other external events should only be done when authorization is provided by the Executive Secretary.

In the case of media requests or inquiries, the Executive Secretary, will coordinate a response in consultation with the Chair and the Health Canada Media Relations unit and will facilitate with the SAC-MHD Chair as spokesperson in accordance with the Policy on Communications and Federal Identity.

Read the Policy on Communications and Federal Identity.

Social media

The secretariat must review and approve all social media content about the committee’s work when the content is developed by a committee member.

Management and administration

Transparency

Transparency is a key operating principle.

One element of transparency involves establishing regular meeting schedules, where possible, for advisory bodies such as SAC-MHD.

Health Canada also posts information related to committee members online.

Learn more about SAC-MHD members:

• membership
• terms of reference
• members’ biographies
• members’ expertise, experience, and affiliations and interests

SAC-MHD balances transparency in its operations with the need to protect confidential and proprietary information related to regulatory submissions.

As set out in the Access to Information Act, Canadian citizens and permanent residents may access information in federal government records, subject to certain specific and limited exceptions. The act enhances the accountability and transparency of federal institutions to promote an open and democratic society. Transparency enables public debate on the conduct of those institutions.

With respect to SAC-MHD, information related to its work may be assessed for public release in the event a request for access to this information is received. Information includes input from members in any form (for example, emails, meeting records, etc.).

Members may consult with the secretariat for additional information on potential implications of the Access to Information Act.

Learn more about the Access to Information Act.

Meeting agendas

The executive secretary consults the chair and the secretariat when establishing a meeting agenda, specific questions and the issues that will be discussed.

Meeting notices and invitations

All meetings are scheduled at the call of the executive secretary, in consultation with the chair. Meeting attendance is by invitation only, with notices sent by the secretariat. Members receive the agenda, briefing material and presentations in advance of the meeting.

Frequency, type and location of meetings

Meetings are held virtually. Extra meetings may be held if needed at the discretion of the executive secretary in consultation with the secretariat.

A meeting cannot be held unless there is a quorum (50% of core members, including the chair or the vice-chair when acting as substitute).

Participation in virtual meetings is restricted to individuals approved by the chair and the secretariat. Only approved individuals may view or listen to the meeting proceedings.

Observers

The secretariat, or the chair in consultation with the executive secretary, may allow individuals, organizations or members of the public to observe all or part of a meeting.

Observers are not allowed to provide input on agenda items or participate in the discussions, unless invited to do so by the chair.

As part of the opening remarks at a committee meeting, the chair will:

• identify, by name and organization, those who are observing all or part of the meeting
• state the requirements and expectations regarding any confidential matters being discussed at the meeting and
• clarify that observers may not participate in the discussions, either by speaking or expressing their support for or disagreement with what is being said, unless invited to do so by the chair
  • those who do not respect these rules may be asked to leave the meeting

Invited presenters

The secretariat, or the chair in consultation with the executive secretary, may invite individuals 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 invites them to do so. They do not help to formulate advice.

Requirement of presenters and observers

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

• confidentiality agreement
• Affiliations and Interests Declaration Form
• Personnel Screening, Consent and Authorization Form

Deliberations and reports

Deliberations during meetings are held in camera to foster open, frank and free-flowing discussion. All members have equal status during the discussion. They are expected to demonstrate fairness and a commitment to in-depth examination of matters under review. Only topics that fit within SAC-MHD’s mandate are discussed.

At the discretion of the executive secretary, and with the approval of the chair, experts or stakeholders may be invited to present to the committee, either in writing or in person.

The chair and executive secretary may grant observer status for all or part of the meeting to selected individuals. This includes Health Canada employees who may benefit from the deliberations.

Members provide advice to Health Canada in the form of recommendations. These recommendations are captured in a record of proceedings (RoP).

SAC-MHD is encouraged to reach a consensus on a recommendation whenever possible. When a consensus is not possible, the RoP reflects diverse opinions. The reasons for a lack of consensus must be clearly identified and substantiated. In such cases, SAC-MHD will make a recommendation with respect to further study of the issue and a proposal for resolution. Where there is a considerable divergence of opinion, the viewpoints are documented and the number of members supporting each opinion is recorded.

The secretariat prepares a draft RoP for members to review. Invited guest speakers are given the opportunity to review the draft RoP to ensure that their views are properly recorded.

The final RoP is approved by the chair and executive secretary, and then distributed by the secretariat.

Agendas, RoPs and SAC-MHD meeting recommendations will be made available upon request. Health Canada may post summaries of recommendations online.

Note: Issues discussed on a particular submission are considered confidential and the meeting documents become part of the Central Registry.

Intellectual property

Health Canada must be able to freely use (for example, publish, reproduce, translate) the work authored by members of SAC-MHD.

Committee members who help to formulate written materials (for example, documents and reports) are required to assign to the Government of Canada any copyrights they own. They must also waive any moral rights they have in those materials.

As such an Assignment of Copyright and Waiver of Moral Rights is to be signed by SAC-MHD members.

Review

When SAC-MHD’s initial mandate ends after 6 months, the secretariat will work with the executive secretary and the chair to review its mandate, activities completed and terms of reference. SAC-MHD’s role may evolve to support broader or other mental health disorder discussions.

During the review process, the directorate (PDD) may seek feedback from the chair, members, participants, observers and others. The PDD retains the right to disband the body following this review.

Recommendations for improvement are considered on an ongoing basis.