Expert Advisory Committee on Cells, Tissues and Organs

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Contact: Director's General Office

Terms of Reference

I. Purpose:

The Expert Advisory Committee on Cells, Tissues and Organs provides the Biologics and Genetic Therapies Directorate (the Directorate) with timely advice on issues under federal responsibility for regulating the safety, quality and efficacy of cells, tissues, and organs, as therapeutic products intended for transplantation.

II. Mandate:

To provide Health Canada with ongoing and timely medical, scientific, ethical, and communications advice on current and emerging issues concerning:

• standards and procedures for safe handling of cells, tissues, and organs intended for transplantation, including prospects for international harmonization,
• infectious disease risks from transplantation,
• clinical practice developments in Canada and internationally,

Without limiting the foregoing, the Committee will carry out its mandate by advising on the following, as requested:

1. Emerging scientific issues related to safety, quality, and efficacy concerning the cells, tissues and organs regulatory framework;
2. The need for the development/amendment of regulations, guidelines and standards for the collection, manufacture, storage and disposal of cells, tissues, and organs intended for transplantation, and regenerative medicine;
3. Medical, pharmacological, toxicological, ethical and clinical issues which may impact on the regulation of cells, tissues and organs and clinical issues;
4. Emerging cells, tissues and organs policy issues;
5. International harmonization of standards and procedures as in 1- 4 above;
6. Advice concerning cells, tissues and organs during real or perceived crises or emergency situations.

In all cases, decision-making responsibility remains with Health Canada.

III. Reporting Structure

The Committee reports to the Director General, Biologics and Genetic Therapies Directorate. The Directorate will be represented by the Director General or designate.

IV. Membership/Participation/Qualifications

Types of Members

The Committee may have both Core and Ad Hoc members selected for their medical/scientific expertise or knowledge pertinent to the mandate of the Committee. The Committee will also have at least two Core members who represent the community at large. One Core member of the Committee will also serve as a Core member of the Expert Advisory Committee on Blood Regulation (EAC-BR) at the invitation of the Director General in consultation with the Chairs of EAC-CTO and EAC-BR.

Role of Member Types

The Chair and Core members may be permanent members for the duration of their term while Ad Hoc members are invited to serve for a shorter, limited period of time to address a specific topic or group of topics. Ad Hoc members may not have the same voting rights as Core members.

Size of the Committee

The number of Core Committee members will not exceed fifteen. Quorum will consist of one more than half of the number of Core members appointed at the time of the meeting. In order to remain effective and efficient, the number of committee participants (Core, Ad Hoc and Liaison) at any given meeting should not exceed 15 members.

Selection of Members

The Chairperson, Core and Ad Hoc members will be appointed by the Director General. Potential Core and Ad Hoc members may be identified through consultation with health professional and scientific societies; academia; and government agencies. Individuals will be recommended by the Secretariat, in consultation with the Chair, to the Director General to serve on the Committee. Health Canada staff may not serve as members.

The membership of the Committee as a whole will reflect an appropriate blend of gender, regional, ethnic and language representation, covering the following areas of expertise, such as:

• cell specialist,
• tissue specialist,
• organ specialist,
• infectious disease (virology, microbiology),
• public health (epidemiology),
• regenerative medicine,
• basic and applied sciences,
• cell biology,
• immunology,
• biotechnology,
• bio-ethics,
• community representation,
• clinical medicine (transplantation)
• critical care
• donor coordination
• tissue banking

Secretariat and Directorate Support

Biologics and Genetic Therapies Directorate staff will provide Secretariat support to the Committee.

V. Tenure

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. Membership terms should be staggered. An extension of assignment is possible at the discretion of the Director General, Biologics and Genetic Therapies Directorate, on the recommendation of the Chair.

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.

Withdrawal from Committee

An individual may withdraw from service on the Committee at any time upon written notification to the Chair and the Director General, Biologics and Genetic Therapies Directorate. Membership may also be terminated for cause at any time on written notice from the Director General. Written notification of termination will be provided to the member by the Director General or designate.

VI. Security Clearance, Conduct and Conflict of Interest

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

Members must ensure that documents received from Health Canada are 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 Committee members will be required to submit conflict of interest declarations to disclose to the Directorate 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 by the Department.

VII. Indemnification and Legal Assistance

The status of all members of EAC-CTO will be that of volunteers, and as a volunteer, you are eligible for the same protection available to Health Canada employees when faced with comparable risks.

It is the policy of Health Canada to completely indemnify departmental appointees against personal civil liability, incurred by reason of any act or omission within the scope of the member's activity and to make no claim against that committee member based upon such personal liability, if the member acted honestly and without malice. You are referred to the Treasury Board Policy on 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, shall inform the Director General.

VIII. Reimbursement

Members will be compensated for travel expenses according to federal government policy.

IX. Management and Administration

EACs are initiated by Health Canada to act as independent sources of information and expertise, to bring leading-edge knowledge to bear on issues identified by the Department and to provide advice as requested.

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

The committee is supported by a Working Group (WG), composed of members from selected BGTD Centres, and Directorates of Health Canada, as well as the Public Health Agency of Canada and the Assisted Human Reproduction Implementation Office. The Working Group functions to identify and prioritize potential issues for review, discussion and recommendation by the Expert Advisory Committee. For issues initiated by Health Canada, the Working Group ensures that the Committee receives a fair and balanced information package and provides the Committee with current policy interpretations and operational processes to facilitate decision making.

To bring forward potential agenda items, members must complete an EAC-CTO Issue Sheet, with supporting documentation [including reference to the Mandate and relevance to the program] and submit it to the Secretariat. The Director General, in conjunction with the Chair of EAC-CTO will determine if an issue is within the mandate of the Committee. Approved items will be actioned through the Working Group EAC-CTO, to be presented as agenda items at future meetings of the Committee. The status of a request will be reported to the Committee at the next Meeting.

Meetings will be held in the National Capital Region, or by teleconference if the need arises. Meetings 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 request of the Committee and with the approval of the Chair and the Director General, interested parties or concerned members of the public, government regulated bodies or stakeholders may be invited as guests to make presentations to the Committee in writing or in person. The Director General may, in consultation with the Chair, grant observer status, for all or part of the Committee deliberations, to selected individuals including Directorate staff who would benefit from the deliberations of the Committee. For issues of public interest, where a broader consultation would add value to the decision making process, a meeting or partial meeting may be opened to the public. The determination of whether or not an issue is appropriate for broader public consultation and the type of consultation, would be taken by the Director General and the Chair of EAC-CTO. Input from the Working Group which supports EAC-CTO would be sought. Types of public consultation may include dialogue, publication in Canada Gazette Part I, focus groups, mailouts for feedback, public meetings/town halls, roundtables, surveys/polls, technical consultations, web postings for feedback, workshops and working groups (including working committees).

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 of tools, meeting attendance will be by invitation only. At the request of the Committee, a portion of any meeting can be held in camera. A summary of such discussions will be provided by the Chair to the Secretariat. 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 and should be referred to the Biologics and Genetic Therapies Directorate.

The Committee's advice, rendered to the Director General, Biologics and Genetic Therapies Directorate, is 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. In cases where there is a real divergence of opinion, the Committee will document the different opinions and the number of members supporting each opinion recorded.

A Record of Meeting will be prepared as soon as possible after each meeting by the Secretariat. These will be certified for accuracy by the Chair. Records of Meetings will be kept to the minimum of detail required to summarize effectively the proceedings and to reflect the committee's recommendations and advice.

There will be no attribution. The Secretariat will be responsible for the distribution of the Record of Meeting. The Record of Meeting will be posted to the Biologics and Genetic Therapies Directorate website after the removal of confidential and personal information consistent with the provisions of the Access to Information Act. The Biologics and Genetic Therapies Directorate will review the Committee annually to ensure that the Committee continues to meet on-going needs. The Directorate retains the prerogative to disband the Committee following such review.

These Terms of Reference will be subject to review within a two year period by the Department.

Updated March 26, 2007

Appendix 1

Scope of the Human Cells, Tissues and Organ Regulations

The Regulations apply only to organs and minimally manipulated cells and tissues.

"minimally manipulated" means, in respect of

1. a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; and
2. cells and nonstructural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility.

The Regulations do not apply to any of the following therapeutic products:

1. cells, tissues and organs that are for non-homologous use;
2. cells, tissues and organs that are for autologous use;
3. tissues and cells that, except for lymphohematopoietic cells that are derived from bone marrow, peripheral blood or cord blood, have a systemic effect and depend on their metabolic activity for their primary function;
4. cells, tissues and organs that are used in investigational testing involving human subjects under Part 3 of the Medical Devices Regulations or clinical trials under Division 5 of Part C of the Food and Drug Regulations;
5. Class IV medical devices that are regulated under the Medical Devices Regulations;
6. blood components, blood products and whole blood, except for cord blood for use in lymphohematopoietic cell transplantation;
7. cells and tissues that are regulated under the Assisted Human Reproduction Act or any of its regulations; and
8. semen that is regulated under the Processing and Distribution of Semen for Assisted Conception Regulations.