Terms Of Reference: Therapeutic Products Programme Expert Advisory Committee On Xenograft Regulation

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Contact: Director's General Office

The Expert Advisory Committee on Xenograft Regulation provides the Therapeutic Products Programme with timely advice on medical, scientific, ethical and communication issues related to the regulation of xenografts. The Committee provides collective health professional and related expertise to assist the Therapeutic Products Programme in making appropriate risk management decisions after initial assessments of risk and benefit have been conducted by the Programme. The decision-making responsibility remains with the Therapeutic Products Programme. Occasionally members may be requested to serve on appeal panels and to provide advice to the Programme through other mechanisms convened by the Therapeutic Products Programme. Committee members may also be consulted by other sections of Health Canada.

1. Mandate

To provide Health Canada with timely advice on current and emerging issues concerning:

1. Emerging Issues
   1. scientific and medical advice on risk to third parties as well as risk to recipients such as: the potential for transmission of infectious diseases as a consequence of xenotransplantation; advice on xenozoonosis and whether concomitant practices such as immunosuppression might inadvertently enhance the potential for xenozoonotic transmission; tests used to identify xenozoonotic agents; and, pathobiology of potential infectious agents retroviruses and prions;
   2. other emerging scientific issues related to the safety and efficacy of xenografts such as chemical and biological analytical and testing methods, the use of xenografts and the necessary regulatory research,
   3. use and care of animals intended for Xenotransplantation and,
   4. responses during real or perceived crisis or emergency situations;
2. Clinical Trial Proposals
   1. scientific, medical, ethical and other methodological advice on clinical trial protocols related to Investigational New Drug submissions and Investigational Testing Application for Medical Devices including but not limited to:
   2. minimum requirements for pre-clinical evidence of safety and efficacy to recipients of xenografts, immediate family members, and the general public;
   3. production of animals used for xenografts;
   4. use and care of animals intended for xenografts;
3. Regulatory Issues (Pre and Post Approval)
   1. policy development;
   2. development or assessment of regulations, standards and guidance documents for the practice of xenografts and their safe use;
   3. current and future approval requirements including but not limited to inspections and licensing;
   4. post approval requirements including but not limited to post-approval registry and monitoring methodologies;
   5. possible international harmonization of standards and policy with potential for harmonization as in bullet ii & iii above;
   6. Ethical and policy issues pertaining to xenografts.

2. Reporting Structure

The Committee reports to the Director General, Therapeutic Products Programme. The Programme will be represented by the Director General, or designate, who acts as the Executive Secretary to the Committee . The Therapeutic Products Programme provides support to the Committee, as appropriate.

3. Membership / Participation / Qualifications

1. Types of Members - The Committee will have both Core and Ad Hoc members, selected for their medical/scientific expertise or knowledge pertinent to the mandate of the Committee. Core Members will be permanent members for the duration of their terms. Ad Hoc Members will be invited to serve for a specific topic or group of topics for a defined term. The Committee will also have two members who represent the community at large.
2. Size of the Committee - The number of Core Members will not exceed twelve.
3. Selection of Members -The Chairperson will be selected by the Director General of the Therapeutic Products Programme. The Director General , in consultation with the chair will select individuals to serve on the committee. Ad Hoc Members will also be selected by the Director General in consultation with Chair. Potential Core and Ad Hoc members will be identified through consultation with health professional and scientific societies; academia; and government agencies. Health Canada employees may not serve as members.
4. The membership of the Committee as a whole will reflect an appropriate blend of gender, regional, ethnic and language representation, covering several areas of expertise such as:
   • Medical/Scientific Expertise (Core Members):
     • Infectious Diseases - human retrovirology
     • Infectious Diseases - animal retrovirology
     • Transplant Immunology
     • Clinical Transplantation - solid organ
     • Clinical Transplantation - Tissue cellular
     • Veterinary Medicine and Animal care
     • Public Health
     • Epidemiology
   • Ethics
   • Knowledge of emerging issues and/or community needs/concerns:
     • Two Lay people representing the public at large
   • Other expertise (Ad Hoc Members):
     • Genetic Engineering
     • Transmissible Spongiform Encephalopathy (TSE)
     • Animal care/Welfare
     • Tissue Bank - Records
     • Risk Communication
     • Animal Ethics and Legal/Policy Ethics
       
5. Secretariat and Programme Support - Therapeutic Products Programme staff will provide secretariat support to the Committee. At the call of the Chair, Programme staff will provide information to the Committee.

4. Proposed Tenure/life Cycle

1. Term - Terms of assignment will be for a period of 4 years. A member's term may be extended for an additional term to a maximum of eight years.
2. Forfeiture of Membership-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.
3. Withdrawal from -An individual may withdraw from service on the Committee at any time upon written notification to the Executive Secretary. Membership may be terminated at any time upon written notification from the Executive Secretary.

5. Security Clearance, Conduct And Conflict Of Interest

All Committee members will be required to undergo a security clearance to the level of "enhanced reliability".

Documents leaving the Therapeutic Products Programme must be securely stored at all times.

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. They must refrain from any conflict of interest and, indeed, its very appearance. In situations where conflict of interest, or the appearance thereof arises in the course of the work of the Committee , the individual involved must declare its existence and disqualify himself/herself from participation in the discussion and/or from further membership on the Committee according to the circumstance or specific situation.

Guidance on conflict of interest will be provided to potential members when discussing the appointment. Before appointment, all potential members will be required to submit conflict of interest declarations to disclose to the Programme any circumstance that may place, or be seen to place, the member in a real, apparent or potential conflict of interest. This information will be updated annually. It will be incumbent upon the member to update his/her disclosure should his or her personal situation change or where the matters before the Committee may affect the conflict of interest situation of a member.

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.

6. Indemnification Of And Legal Assistance

Indemnification and legal considerations for members of external advisory committees as either volunteers, Crown servants, or contractors of the Public Service of Canada is outlined.

Volunteers are individuals who provide services without compensation, or any other thing of value in lieu of compensation, other than reimbursement for expenses actually incurred. Such individuals are protected against the risks to which they are exposed under the Government's Volunteers Policy. The protection provided to volunteers is virtually the same as that provided to servants of the Crown for purposes of indemnification and legal assistance.

Members who receive honoraria, over and beyond travel claims and miscellaneous per diem and meals, are not volunteers. In order to receive legal assistance, non-volunteers must be appointed by the Deputy Minister. The legal coverage for members is retroactive back to the EAC members first participation on the committee. Once appointed, they fall into the category of Crown servants described in Article 7.1 (ii) of the Treasury Board Policy on the Indemnification of and Legal Assistance for Crown Servants. All core and ad hoc members of Expert Advisory Committees within Health Canada will be appointed by the Deputy Minister and thus protected as Crown servants.

Individuals who are engaged under contract are neither volunteers, employees, nor Crown servants, and are afforded no legal assistance. Contractors should obtain proper legal coverage against possible third party claims. Costs associated with such coverage are the responsibility of the contractors.

7. Compensation

Members will be compensated for travel expenses according to federal government policy. Honoraria may be paid to persons outside the Government of Canada for the performance of a service. The per diem rate for honoraria will be set by the Therapeutic Products Programme. Specific contractual arrangements will be made should additional work be offered or assigned to Committee members.

8. Management And Administration

The specific questions and issues for discussion will be determined by the Director General in conjunction with the Chair, with input from Programme staff, members and stakeholders. The agenda will be developed by the Executive Secretary of the Committee in collaboration with the Chair.

Invitations to attend meetings will be issued in writing. Members will receive an agenda, briefing materials and other documentation as far as possible but at least seven days in advance of meetings. Notice of the meeting will be posted on the Therapeutic Product Programme
website three weeks ahead of the meeting.

Meetings will be held in the National Capital Region, or by teleconference if the need arises. Meeting will be held at the call of the Director General in collaboration with the Chair. There will usually be two scheduled meetings each year, with additional meetings if necessary.

At the discretion of the Committee and with the approval of the Chair and the Director General, interested parties or concerned members of the public may be invited to make representations to the Committee in writing or in person. The Director General may, in consultation with the Chair, grant observation status, for all or part of the deliberations, to selected individuals including Programme staff who would benefit from the deliberations of the Committee .

In order to remain effective and efficient, the Committee should not exceed 15 members for any meeting. A quorum will consist of at least one-half the number of existing Core Members.

Discussion during meetings will be open, frank and free-flowing. All members of the Committee will have equal status during discussion. In order to foster open and frank discussion and to permit the use of a variety tools, Committee deliberations will be in camera. Committee members will be 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 will not be discussed. They should be referred to the Therapeutic Products Programme, or the Committee should request a change in its mandate.

Decisions of the Committee are recommendations to the Director General, Therapeutic Products Programme, and are reached by consensus. Lack of consensus may indicate uncertainty of information. In such cases, the committee will make a recommendation with respect to further study of the issue and a proposal for resolution.

Minutes of the meetings will be prepared within five working days after the meeting by the Secretariat. These will be certified for accuracy by the Chair. Minutes will be kept to the minimum detail required to summarize effectively the proceedings and to reflect decisions taken. There will be no attribution. The Secretariat will be responsible for the distribution of the minutes. The minutes will be posted to the Therapeutic Products Programme website after the removal of confidential and personal information consistent with the provisions of the Access to Information Act.

The Therapeutic Products Programme will review the Committee annually to ensure that the Committee continues to meet on-going needs. The Programme retains the prerogative to disband the Committee following such review.