Canadian Animal Health Products Regulatory Advisory Committee (CAHPRAC) - Terms of Reference
Public input from the use of advisory bodies is a key source of advice that the Canadian Food Inspection Agency's (CFIA) Policy and Programs Branch and Health Canada's Health Products and Food Branch (HPFB) uses in their regulatory decision-making.
Involvement of the Canadian Animal Health Products Regulatory Advisory Committee (CAHPRAC) in the work of both CFIA and the Veterinary Drugs Directorate (VDD) is an integral part of quality regulatory decision-making that reflects our commitment to a more open, transparent, and accountable advisory body process by ensuring that the perspectives of regulated parties and other stakeholders impacted by the decision making process are appropriately considered.
The Terms of Reference (ToR) of the Canadian Animal Health Products Regulatory Advisory Committee is governed by the Health Canada Policy on External Advisory Bodies.
The Canadian Animal Health Products Regulatory Advisory Committee provides strategic policy advice, from the perspective of regulated parties and stakeholders, on matters relating to animal feed and the implementation of recommendations from the International Federation for Animal Health (IFAH) Benchmarking Report as it relates to veterinary drugs and veterinary biologics with the goal of improving efficiency, capacity, responsiveness, cost effectiveness and timely availability of products.
The purpose of the advisory committee is to provide stakeholder input into the Canadian regulatory system for animal health products (veterinary biologics, veterinary drugs) and animal feed, from the perspective of regulated parties and stakeholders who are directly or indirectly impacted by regulatory system.
For matters pertaining to the CFIA, the decision-making responsibilities ultimately rest within the CFIA in accordance with its regulatory mandate under the Health of Animals Act and Regulations and the Feeds Act and Regulations.
For matters pertaining to the VDD, the decision-making responsibilities and accountability remain with the Health Products and Food Branch in accordance with its regulatory mandate under the Food and Drugs Act and Regulations.
3.0 Reporting Structure/Governance
The Canadian Animal Health Products Regulatory Advisory Committee provides updates on progress to the VDD Stakeholder Advisory Committee and reports to the Health Products and Food Branch of Health Canada and the Policy and Programs Branch of the Canadian Food Inspection Agency. The responsibilities of Executive Secretary are shared by Health Canada and the CFIA, as represented by the Director General of Health Canada's VDD and the Executive Director of the Animal Health Directorate, CFIA.
The mandate of the Canadian Animal Health Products Regulatory Advisory Committee determines its membership. The advisory body will have a minimum of two (2) core members who represent the perspectives of a) the animal health products industry, b) veterinarians, c) livestock producer groups, and d) consumers (including individual pet owners, and the general public); and will not exceed 12 appointed members. Membership may be periodically adjusted to ensure the full representation of expertise and experience. Members of the advisory body should include, but is not limited to, the following sectors:
- Animal health products industry (manufacturers and importers)
- Livestock producers and pet owners
- Animal feed industry
4.1 Appointment of Members
Members of the advisory body will be recruited through a targeted nomination process involving members from the VDD Stakeholder Advisory Committee. The process will ensure requisite expertise and experience, a variety of perspectives, and to promote diversity, and inclusiveness related to the mandate of the Canadian Animal Health Products Regulatory Advisory Committee.
Members of the Canadian Animal Health Products Regulatory Advisory Committee are appointed by the Executive Secretaries. In considering whom to appoint, the CFIA and VDD will follow the appointment considerations listed in the Health Canada Policy on External Advisory Bodies, Chapter 2: Membership, 2.0 - 2.12.
In order to support their ability to provide well-informed advice, the Canadian Animal Health Products Advisory Committee members may receive and discuss at meetings information from Health Canada and the CFIA that is confidential in nature. Every person must sign a confidentiality agreement before participating in the Canadian Animal Health Products Advisory Committee as a member, invited guest, observer, or resource person. The agreement prohibits the disclosure of any confidential information received through participation in the committee, including information received orally or in writing. The Branch 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.
4.3 Transparency of membership
The Government of Canada will be transparent about the membership of the Canadian Animal Health Products Regulatory Advisory Committee. As a condition of appointment, advisory body members will allow the publishing on Departmental Web sites a Summary of Expertise, Experience, and Affiliations and Interests. The Summary is prepared based in part on the Affiliations and Interests Declaration Form for Advisory Body Members completed by each member. Before the summary is published, advisory body members will be asked to review the content of the Summary for accuracy, and consent to its publication.
4.4 Verbal declarations
In addition to requiring advisory body members to publish the Summary, members will also be asked to make a verbal statement of their relevant affiliations and interests at the beginning of a meeting.
5.0 Roles and Responsibilities
Roles and responsibilities of members, the Chair, the Executive Secretary, and the advisory body secretariat, including the commitment to confidentiality, of the Canadian Animal Health Products Regulatory Advisory Committee are guided by Chapter 4: Roles and Responsibilities, 4.1 - 4.17 of the Health Canada Policy on External Advisory Bodies.
The roles and responsibilities of non-members such as invited guests, observers and contracted experts for specific purposes are guided by Chapter 5: Non-Members: Presenters, Invited Guests, and Observers, 5.0 - 5.9 of the Health Canada Policy on External Advisory Bodies.
5.1 Federal Employee Participation
Federal employees from both Health Canada and CFIA may be asked to provide information or observe advisory body deliberations.
5.2 Affiliations and Interests
Chapter 3: Affiliations and Interests, 3.1 - 3.9, of the Health Canada Policy on External Advisory Bodies, in relation to managing affiliations and interests of advisory body members, will be respected by members of the committee. Potential members of the advisory body must complete and return the Affiliations and Interests Declaration Form for Advisory Body Members to the Secretariat by the deadline specified to be considered for appointment.
In keeping with the Privacy Act, a completed Affiliations and Interests Declaration Form for Advisory Body Members is confidential. Advisory body members are responsible for notifying the Secretariat and Chair if there are any changes in their affiliations and interests.
Members are expected to conduct themselves in an appropriate manner; the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.
The specific questions and issues for advisory body discussions will be determined by the Executive Secretaries in consultation with the Chair and with input from the members.
6.2 Meeting notice and invitations
Meetings will be held at the call of the Secretariat in collaboration with the Chair. Invitations to attend a meeting are sent out by the Secretariat of the advisory body. Meeting attendance is by invitation only.
6.3 Frequency, type, and location of meetings
The Canadian Animal Health Products Regulatory Advisory Committee will meet on an as needed basis in the National Capital Region. Additional meetings and/or teleconferences may be called at the discretion of the Executive Secretary in consultation with the Chair.
For all meetings, members should make every effort to ensure that a secure line is used for teleconferences and that no person who has not been approved by the Chair and Secretariat can listen to the proceedings.
Upon the completion of the mandate, the Executive Secretaries will review the IFAH report in consultation with their respective organizations and make a decision with regards to the dissolution of the committee.
The advisory body will not provide advice resulting from a meeting unless a quorum of half of the members plus one is present.
Advisory body members will be expected to demonstrate fairness and a commitment to in-depth examination of matters under review. Discussion during meetings is to be frank and free-flowing. All members of the advisory body have equal status during discussion.
The advisory body is encouraged to reach consensus in providing advice, whenever possible. Lack of consensus may indicate uncertainty regarding the available information. In such cases, the advisory body shall make a recommendation with respect to further study of the issue and/or a proposal for resolution. In cases where there is a real divergence of opinions that can not be resolved, the different opinions will be documented, and the number of members supporting each opinion recorded.
Minutes of the meetings will be a shared responsibility of both the CFIA and VDD. Prepared minutes will be circulated to members for review and final approval by the Chair and Executive Secretary. Minutes will be kept to the minimum detail required to summarize effectively the proceedings and to reflect the advice offered. There will be no attribution of comments unless specifically requested by a member. The CFIA and VDD will be responsible for the distribution of the minutes to members of the Canadian Animal Health Products Regulatory Advisory Committee. The minutes will be posted to the Branch website after approval by the Chair and Executive Secretary.
All media requests related to the advisory body statements or activities should be directed to the Chair. The Chair, in consultation with the Secretariat, will coordinate a response depending on whether the request is related to the mandate and work of the Canadian Animal Health Products Regulatory Advisory Committee or the respective organizations. Discussion of the work of the advisory body with the media or at conferences should be done only when authorization is given by the Secretariat, in consultation with the Chair.
The Secretariat and Chair will, by mutual agreement, appoint a member of the advisory body to be the media spokesperson. The Secretariat works with Government of Canada communications staff to formally prepare the advisory body member who has been appointed as the media spokesperson.
6.8 Indemnification and Legal Assistance
In keeping with the Treasury Board's Policy on Legal Assistance and Indemnification and its Volunteer Policy advisory body 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 advisory body and serving as volunteers.
A member who becomes aware of a possible claim or proceeding as a result of any alleged act or omission within the scope of the member's activities must inform the Secretariat.
In keeping with current Treasury Board policies on indemnification, which precludes payment and requires members to serve as volunteers, members will not be paid for their time on the advisory body. However, non-industry members may be reimbursed for expenses incurred during their work on an advisory body, such as travel and accommodation, according to the Treasury Board's Directive on the Management of Expenditures on Travel, Hospitality and Conferences.
6.10 Security Clearance
All advisory body members are required to undergo a security clearance to the level of "reliability status". Sometimes this may entail taking a member's fingerprints should the RCMP require them. A security clearance is valid for 10 years. The Secretariat supplies the paperwork to members.
Individuals may be invited to attend individual meetings on an ad hoc basis, to provide specific information or perspectives, and participate in 'public' discussions of specific agenda items.
Canadian Animal Health Products Regulatory Advisory Committee members are appointed by the Executive Secretary for a three-year term. Membership and tenure will be reviewed by Chair and the Secretariat, who will make recommendations to the Executive Secretaries. The Secretariat will endeavor to ensure communication regarding the time mandate and tenure of this committee with the VDD Stakeholder Advisory Committee and members of the Canadian Animal Health Products Regulatory Advisory Committee. The continuation of this Committee will be assessed periodically by the Chair and the Executive Secretaries. Procedures for resignation and termination will be guided by Chapter 2.0: Membership, 2.10 - 2.12 of the Health Canada Policy on External Advisory Bodies.
6.12 Advisory Body Report
The Canadian Animal Health Products Regulatory Advisory Committee will provide advice (report), with reasons for the advice it provides, in the form of minutes, or a record of proceedings, or a formal report. The (report) is intended to summarize the key discussion points and to reflect the advice given. The (report) is prepared by the Secretariat and verified for completeness and accuracy by the Chair. Following this review, and within one month following the meeting, the Chair will distribute the record of proceedings to members for comments.
The Canadian Animal Health Products Regulatory Advisory Committee will finalize and submit its report in writing to the Executive Secretary. The report will include the advisory body's advice and the reasons for the advice. It will indicate whether the advice is shared by all members and identify any points of disagreement. The report will also indicate when a member's participation has been limited as a result of his/her affiliations or interests. The Health Product and Food Branch will make the report public on its Web site.
6.13 Review of the Advisory Body
The Secretariat can make minor amendments to these Terms of Reference, in consultation with the Chair, subject to informing the members at the next meeting. It is the intent that the Executive Secretaries disband the advisory body following the completion of the committee's mandate.
The mandate and Terms of Reference for the Canadian Animal Health Products Regulatory Advisory Committee will be discussed at the first meeting, and will be reviewed and amended on an annual basis. Amendments to the mandate or terms of reference must be approved by Health Canada and CFIA. Any changes to the mandate or Terms of Reference will be made following consultation with advisory committee members, with input from other stakeholders if appropriate.
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