ARCHIVED – Terms of Reference - Paediatric Expert Advisory Committee
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Preface
The Paediatric Expert Advisory CommitteeFootnote 1 provides a forum for the collaborative exchange of information, ideas and opinions, between external experts and senior Health Canada officials. The Committee is to support Health Canada's role in providing authoritative information tailored to the paediatric population, pregnant and nursing women on the benefits and risks of health products as well as food safety, and in the promotion of health nutrition information.
For this purpose, the paediatric population is defined as infants, children and adolescents from zero to 18 years of age. The Committee will also include a focus on pregnant and nursing women, i.e., maternal health, to the extent that children may be affected by unique exposures to health products and food in-utero and through breast milk.
1.0 Mandate
To provide Health Canada's Health Products and Food Branch with broad strategic advice on how to strengthen the availability, use and sharing of information specific to the paediatric population, pregnant and nursing women on the benefits and risks of health products, food safety and promoting health nutrition information.
The Committee's role is advisory. Health Canada retains decision-making authority in all cases.
1.1 Scope of Committee Advice
The focus of this Committee is pre-to post-market considerations about health products and food in keeping with its mandate. The examination includes: pharmaceuticals; biologics including vaccines, genetic and biotechnological products; medical devices; natural health products; and food, nutrients, additives, contaminants and healthy eating.
The Committee will constitute an integral part of external expert advice to the Health Products and Food Branch on, but not limited to, the following four theme areas:
- The status of authoritative information in Canada specific to the paediatric population, pregnant and nursing women on the benefits and risks of health products and food, including identifying priority areas and recommended approaches;
- How to facilitate increased enrolment of the paediatric population, pregnant and nursing women in safe and ethical clinical studies including clinical trials, and then encourage the submission of this data to the Health Products and Food Branch;
- Providing advice on the leveraging of key domestic and international partnerships to support HPFB's paediatric and maternal health efforts, and
- Strengthening the vigilance of health products and food safety for these populations including improving awareness of post-market surveillance activities, in particular, the reporting of adverse reactions.
2.0 Governance
The Committee adheres to HPFB's Guidance on Advisory Bodies which establishes best practices and standards for managing advisory bodies.
The Committee will provide its advice to the Assistant Deputy Minister (ADM) of HPFB in the form of an annual report. The ADM will select a designate to act as the Executive Secretary to the Committee. The Executive Secretary will be the Office of Science and Risk Management's Branch Science Advisor in the HPFB.
3.0 Membership
The Committee is to consist of 12-15 individuals, including the Chair and Vice-Chair.
The ADM of HPFB, in consultation with the Chair, appoints members following a public open and transparent nomination and selection process for a three-year term. Membership is to be reviewed on a regular basis by the Chair and Executive Secretary. The ADM of HPFB may consider extension(s) to an individual's term to a maximum total period of six consecutive years.
Membership of the Committee as a whole is to include, but not be limited to, the following areas of expertise: paediatric medicine, family medicine/community care, paediatric specialty care, maternal health care, nutrition/diet, food science, paediatric patient safety, parents/consumers, children's health organizations and hospitals. There may also be representation from public health, nursing, epidemiology, immunology, bio-medical ethics, toxicology, complementary and alternative medicine, research, decision-making, clinical pharmacology, pharmacy practice, and the voluntary sector.
In order to preserve the independence of both the advisor and the decision-maker, Health Canada staff will not serve as members of the Committee.
3.1 Membership Considerations
The membership of the Committee is to reflect an appropriate blend of expertise, knowledge and experience as well as a balance of representation from different sectors including healthcare professionals, patients, consumers, academia and industry.
In considering whom to recruit to the Committee, the HPFB may consult with Health Canada staff; other government organizations; external organizations, associations, or experts; the Chair and members already on the Committee; consult with HPFB staff; and/or ask the public for suggestions. The final selection of members rests with Health Canada alone. In appointing Committee members, the HPFB is committed to diversity and inclusiveness. For example, it may select members from specific population groups or geographic locations, when appropriate.
As required, specialized subcommittees and/or panels may be established by HPFB to provide substantive issue-specific and/or product-specific technical / scientific advice on paediatrics or maternal health. When such a need arises, HPFB will examine its current Advisory Committees and Panels memberships including the Committee's to determine if members drawn from these existing bodies could form the new specialized committee or panel. Through this modular approach, HPFB seeks to make the best use of its established relations with informed experts, while ensuring that diversity of perspectives is also maintained.
3.2 Transparency
Transparency will be adhered to through posting on Health Canada's Website Committee information such as the agendas, names, biographical information, and affiliations and interests of members. The HPFB will also release publicly an annual report documenting the advice of the Committee, how the advice was considered in its decision-making process and any resulting impacts on decisions taken.
3.3 Affiliations and Interests
To be considered for appointment, potential members of the Committee will complete the Affiliations and Interests Declaration Form for Advisory Body Members. In keeping with the Privacy Act, a completed Affiliations and Interests Declaration Form is considered confidential. The HPFB will not make public any information in the form without the member's permission. However, as a condition of membership, Committee members will allow the Branch to publish on its Web site a Summary of Expertise, Experience, and Affiliations and Interests, which will be based on the complete 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 their declaration in writing, should their personal situation change. Declarations will be reviewed by the Department prior to appointment and on an ongoing basis if updates occur. The management of affiliations and interest, including conflicts of interest, will adhere to the requirements of HPFB's Guidance on the Management of Advisory Bodies.
Committee 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.
3.4 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 must sign a confidentiality agreement before participating in an advisory body, as a member, invited guest, observer, or resource person. The agreement prohibits the disclosure of any protected information received through participation in the Committee, including information received orally or in writing. The HPFB will mark information according to the level to which it is protected under the Government Security Policy.
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.
3.5 Security Clearance
As a condition of appointment, all members must undergo a security clearance to the "enhanced reliability status" level.
3.6 Indemnification
All members serve on the Committee on a volunteer basis. In keeping with Treasury Board's Policy on Indemnification of and Legal Assistance for Crown Servants, 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.
3.7 Travel and Expenses
Members will be reimbursed for expenses incurred during their work on the Committee, such as travel and accommodation, according to Treasury Board's Travel Directive and Hospitality Policy.
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 advice to the HPFB. Committee members are appointed as individuals on the basis of their individual expertise, and they are not to represent their firms, organizations or associations. They serve as knowledgeable individuals in their own right and in the best interests of all Canadians, aiming to promote health product vigilance, while recognizing the roles and responsibilities of consumers, industry and health professionals in achieving optimal health product therapy.
Specific responsibilities include:
- being available and prepared to participate in meetings;
- being available and prepared to attend a public input activity related to the Committee's mandate, if necessary;
- considering information that is relevant to the Committee's mandate, this may include information that the Branch has received from the public during a public input process, for instance, through meetings, interviews, public forums, or in writing;
- participating in discussions before the Committee prepares its report to the HPFB;
- notifying a Branch official and the Chair of any changes in the status of their affiliations and interests relevant to the Committee mandate;
- making a verbal statement of affiliations and interests at the beginning of a meeting, or if asked by the Branch or the Chair.
As qualified experts, members - based on their expertise and declared affiliations and interests - may be asked to participate in a Committee's sub-committee, to represent the Committee's viewpoint at other HPFB advisory body meetings, or to participate in branch initiatives as an external advisor.
As well, in the event expert advice and public input is sought on a specific issue with respect to a specific product or class of products, matters which are not within the mandate of the PEAC, select members may be asked to join a one-time expert committee which would be supplemented with additional scientific expertise.
4.2 Responsibilities of the Chair and Co-Chair
The Chair and Co-Chair are officially appointed by the ADM of HPFB. In addition to all the responsibilities of a Committee member, the Chair is responsible for the following:
- overseeing and chairing meetings;
- consulting with the Executive Secretary to determine how public input will be sought and deciding if all, or part of, a meeting should be held in private, in consultation with and subject to particular requests from the Branch;
- providing input to the Executive Secretary on the selection of members;
- consulting with the Executive Secretary to end the appointment of a member;
- consulting with the Executive Secretary to determine whether to limit the participation of a member in a meeting, depending on the nature of the person's affiliations or interests;
- coordinating the work of the Committee;
- facilitating discussion among members in answering the Branch's questions before preparing advice or recommendations for the Branch;
- ensuring that all members agree with, or note their disagreement with, the advice in the report to the Branch;
- preparing and delivering the report to the Branch; and
- supporting, in any other way, the PEAC's mandate.
If the Chair is unavailable, the Co-chair assumes the role of Chair.
4.3 Responsibilities of the Executive Secretary
The Executive Secretary is the designated Federal Official who provides leadership and strategic advice in the management of the Committee and works closely with the Chair and Secretariat. In particular, the Executive Secretary is responsible for preparing and delivering the Committee's advice to the Assistant Deputy Minister of HPFB in the form of an annual report. The Executive Secretary will make recommendations on this advice.
The Executive Secretary reports back to Committee at the beginning of each meeting on next steps and, if applicable, the impact of the advice received.
4.4 Responsibilities of the Secretariat
The Secretariat, i.e., the Office of Paediatric Initiatives is within the Office of Science and Risk Management under the leadership of HPFB's Branch Science Advisor. The Secretariat acts as a liaison between Committee members and the Branch, as a resource for members, and works closely with the Chair. In addition, the Secretariat:
- coordinates preparation of the meeting agendas, records-of-decision including issue summaries and reports, and maintains any information about the Committee, its mandate, or work that may be posted on the Health Canada Web site;
- coordinates the processes for the Affiliations and Interests Declaration Forms, Confidentiality Agreements, Security Clearances, and others as necessary for members;
- coordinates preparation of information for the Committee and marks it according to the level to which it is protected under the Government Security Policy;
- maintains a list of forward agenda items and nominees;
- coordinates requests for travel reimbursement;
- helps to prepare the Committee member designated as media spokesperson, if appropriate;
- monitors and evaluates the efficiency and effectiveness of the Committee; and
- carries out additional duties as appropriate in support of the Committee.
The Secretariat receives support from a branch-wide Paediatric Working Group with includes representation from the Public Health Agency of Canada and the Strategic Policy Branch of Health Canada.
4.5 Media
Discussion of Committee work with the media or at conferences or other external events should only be done when authorization is given by the Executive Secretary. The Executive Secretary, in consultation with the Chair, will appoint a member of the PEAC to be the media spokesperson when circumstances warrant this.
All media requests related to the Committee's statements or activities will be directed to Health Canada, Media Relations who will coordinate responses with the Executive Secretary and designated media spokesperson.
5.0 Management and Administration
5.1 Frequency of Meetings
The Committee meets two times per year. Additional meetings may be held at the request of the Chair or the Secretariat, in consultation with the Executive Secretary. These or any additional meetings may be undertaken using in-person, web-based or other communication vehicles.
5.2 Meeting Agendas
The Committee members and the HPFB working group are canvassed for agenda items at least eight weeks in advance of regularly scheduled meetings. The agenda is then developed by the Chair, in collaboration with the Executive Secretary. The agenda, along with supporting meeting materials, are provided to Committee members a minimum of two weeks prior to the meeting.
5.3 Committee deliberations and reports
Advice from the Committee is in the form of recommendations. The Committee is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the meeting record will reflect the diversity of opinions. The Committee would not provide recommendations unless a quorum is present. The quorum for the Committee is determined to be one half of the members plus one.
Reports will be published after the Committee has approved the content. Reports posted online will be available in both official languages and will comply with Treasury Board's Common Look and Feel Guidelines, Health Canada's Guidelines for Presentation of Reports and Publications, and Health Canada's Guidelines for Presentation of Public Involvement Activities and Consultations. The contents of the report will be non-attributable - there will be no references to individual Committee members or member of the public.
5.4 Invited guests
The HPFB, 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. However, an invited guest may not participate in the formulation of advice or recommendations to the Branch. Invited guests will be required to sign a confidentiality agreement if confidential information is to be disclosed at the meeting
5.5 Observers
The HPFB, or the Chair in consultation with the Executive Secretary, may allow individuals, organizations, or members of the general public to observe a meeting, or parts of a meeting. A limited number of federal employees may be permitted to observe a meeting, to respond to questions and provide information at the call of the Chair and the Executive Secretary.
The HPFB will assess and forward to the Chair for consideration any requests from the public to observe a meeting, or parts of a meeting, that it receives. A response will be provided to the requester by phone or in writing as soon as a decision has been made, and will include the reasons for the decision.
Observers who are not federal employees will be required to sign a confidentiality agreement if confidential information is to be disclosed at the meeting. Federal employee observers will continue to be governed by their Public Service Oath or Solemn Affirmation.
5.6 Process for resignation
Members will provide 14 days' notice of their intent to resign. The resignation notice must be in writing and be addressed to the Executive Secretary and to the Chair. The letter should state the effective date of resignation.
5.7 Reasons for termination
A member's failure to act according to the Committee's terms of reference may give cause for termination. The Executive Secretary will consult with the Chair when the Branch is considering ending the appointment of an advisory body. However, the decision to end the appointment rests solely with Health Canada. When a decision has been made, the Executive Secretary will advise the member in writing, stating the reason for the termination and the effective date.
The Executive Secretary and the Chair will review the Committee's mandate, activities, terms of reference and relevance every two years to ensure that it continues to meet ongoing needs. Recommendations for improvement will be considered on an ongoing basis. The Branch retains the prerogative to dissolve the Committee following such review.
Records-of-decisions including issue summaries are prepared by the Secretariat following each meeting and verified for completeness and accuracy by the Chair and Executive Secretary. Following this review, these records will be distributed to PEAC members for comments six weeks after the meeting. Once approved by all Committee members and the Executive Secretary, the records-of-decisions can be used for information sharing, and be posted publicly to the Departmental website.
Records-of-decisions are to be kept to the minimum detail required to summarize effectively attendance, presenters, documents reviewed, the key discussion points and to reflect advice and/or recommendations given. There shall be no attribution unless specifically requested by a member.
The Committee may recommend suitable topics for specialized subcommittees and panels, commissioned studies, consultations or liaisons with outside organizations to address specific paediatric issues. The Committee may also recommend individuals with appropriate expertise to undertake such activities. In both instances, the ADM's approval is required. One or more members of the Committee will participate in these initiatives and bring preliminary recommendations and/or information, as appropriate, to the full Committee for discussion and subsequent action. All materials prepared for, or on behalf of the Committee, are the property of Health Canada.
Minor amendments to the Terms of Reference (TOR) can be made by the Secretariat, in consultation with the Chair and Executive Secretary, subject to informing the members at the next meeting.
Revised: February 2, 2009
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