Expert Advisory Panel on Insulin - Terms of Reference

The Biologics and Genetic Therapies Directorate’s (BGTD) Expert Advisory Panel on Insulin (EAP-I) has been established to advise Health Canada on the place of animal and biosynthetic human insulins in the treatment of diabetes.

Using information provided by the BGTD and information presented the day of the Panel Meeting, the Panel will be expected to address the questions presented in the Issue Sheet. The decision-making responsibility remains with the Biologics and Genetic Therapies Directorate.

The Panel is established within the elements noted in the Health Products and Food Branch’s (HPFB) “Guidance on Advisory Bodies” which establishes best practices and standards for managing advisory bodies.

1. Mandate

The Panel will fulfill its mandate by reviewing:

• the documentation provided by the BGTD prior to the Panel meeting.
• listening to the presentations given on the date the panel Meeting is held.
• discussing and arriving at conclusions based on the specific questions presented in the Issue Sheet.

The Panel will respond to the issues or questions presented in the form of a Report within the timelines agreed upon in these Terms of Reference. The Report will take the form of responses to questions by the BGTD in the Issue Sheet.

2. Reporting Structure

The Panel reports to the Director General (DG), Biologics and Genetic Therapies Directorate (BGTD) or designate, who acts as Executive Secretary to the Panel. Biologics and Genetic Therapies Directorate will provide Secretariat support to the Panel, as appropriate.

3. Membership / Participation / Qualifications

The Panel members have been selected for their expertise and knowledge. The Chair is selected by the DG of the BGTD. The Panel will consist of an appropriate number of members, not to exceed 12, including the Chair.

The membership of the Panel as a whole covers areas of expertise and knowledge such as:
endocrinology, pediatric endocrinology, immunology, basic sciences, ethics, patient and community representation.

Members will serve on the one day Panel as knowledgeable individuals in their own right and in the best interests of Canadians.

Health Canada (HC) staff will not serve as members of the Panel, but will provide Secretariat support, respond to questions, and provide information at the call of the Chair.

4. Proposed Duration of Panel

The Panel will be convened for a finite term until the final report of the deliberations of the panel has been provided to Health Canada. The Meeting of the Expert Advisory Panel on Insulin will take place on October 30, 2008 from 8:30 a.m. to 4:00 p.m. EDT in Ottawa. The Panel will be dissolved once the meeting report with conclusions has been completed. An individual may withdraw from service on the Panel at any time upon written notification to the Director General.

5. Security Clearance, Conduct, Affiliations/Conflict of Interest, and Confidentiality

Panel 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.

Panel members must be willing to sign Confidentiality Agreements. All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Panel. Members must not discuss this information with persons not on the Panel, or divulge information obtained from the work of the Panel, including presentations made to it, until such time as this information has been officially released for public distribution.

The HPFB Guidance on Affiliations and Interests has been provided to the Panel. As a condition of serving on the Panel, members will be required to submit to the Executive Secretary declarations of their affiliations or interests. An internal review committee will examine the declarations to judge if any circumstances may place, or may be seen to place the member in a real, potential or perceived conflict of interest. As a condition of appointment, members will allow Health Canada to publish on its website a Summary of Expertise, Experience and Affiliations and Interests. The Summary will be prepared by BGTD and members will be asked to review the content for accuracy before its release. A verbal declaration of affiliations and interests will be made at the panel Meeting.

Members are required to undergo a security clearance to the level of ‘reliability status’, and are expected to ensure that confidential or protected documents are securely stored, at all times, and disposed of properly.

Any questions from media should be forwarded to the Chair who will refer them to Health Canada for a response. If Health Canada determines it is appropriate for a Committee person to speak on a particular issue, a spokesperson could be identified.

6. Indemnification and Legal Assistance

The status of all members will be that of volunteers, and as a volunteer, Panel members 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 panel member based upon such personal liability, if the member acted honestly and without malice. Members are only protected when the advice given lies within the mandate of the Panel. Panel members are referred to the Treasury Board Policy on Volunteers.

7. Compensation

Members will be compensated for travel expenses according to Treasury Board policy.

8. Management and Administration

The specific questions and issues for Panel discussion will be determined by the BGTD. The agenda will be developed by the BGTD.

Prior to the meeting, members will receive an agenda, briefing materials and other documentation as far as possible but at least fourteen days in advance of the panel meeting.

Presentations will be made to the Panel by the Biologics and Genetic Therapies Directorate and the Marketed Health Products Directorate, Health Canada and by the Canadian Diabetes Association and the Insulin Dependant Diabetes Trust or an individual representing the patient perspective.

Discussion during the meetings shall be open, frank, and free-flowing. All members of the Panel shall have equal status during the discussion. In order to foster open and frank discussion and to permit the use of a variety of tools, Panel deliberations will be in camera. Panel members are expected to demonstrate fairness and a commitment to in-depth examination of matters under review. There will be no attribution. Topics that do not fit within the mandate of the Panel are not to be discussed.

Advice from the Panel will be in the form of responses to questions with recommendations to the Director General of the BGTD, and will be reached by consensus. Lack of consensus may indicate uncertainty regarding the available information. In such cases, the Panel shall make a recommendation with respect to further study of the issue and a proposal for resolution.

The Panel will strive to answer the questions during the session. If the report is not finalized at that time, the final response will be prepared by the Chair, in consultation with the Panel, and submitted to the Director General, BGTD within 15 working days of the receipt of the draft response from the Meeting.