Terms of Reference: Expert Advisory Panel on the use of Avastin in Metastatic Breast Cancer (EAP-AmBC) - Health Canada

The Biologics and Genetic Therapies Directorate's (BGTD) Expert Advisory Panel on the Use of AVASTIN™ in Metastatic Breast Cancer (EAP-AmBC) is being established to provide advice to BGTD on the benefit-risk analysis of AVASTIN™ for the treatment of patients with metastatic HER2-negative breast cancer, and the value of continuing to make AVASTIN™ in combination with paclitaxel available as an option for patients with metastatic breast cancer (mBC).

Using information provided by the BGTD and information presented on the day of the Panel meeting by BGTD and the product sponsor, the Panel will address the questions presented in a distributed issue summary. The Panel provides BGTD with advice and recommendations, but the decision-making responsibility remains with Health Canada.

1.0 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 at the Panel meeting;
• participating in the discussions and reaching conclusions based on the specific questions presented in the distributed issue sheet.

The Panel will provide responses to the issues or questions raised by BGTD in the form of a report within the timelines agreed upon in these Terms of Reference.

2.0 Reporting structure

The Panel reports to the Director General of the Biologics and Genetic Therapies Directorate, who acts as the Executive Secretary to the Panel. The BGTD will provide secretariat support to the Panel, as appropriate.

3.0 Membership

3.1 Selection of members

Members of the Panel are selected for their scientific/medical/technical expertise and knowledge. Individuals will be recommended by the secretariat to the Director General to serve on the committee/panel. The Director General selects and appoints a Chair and panel members from among the nominees. In order to preserve the independence of both the expert advisory panel and the federal government as decision-maker, Health Canada employees may not serve as members of the Panel.

Membership of the Panel as a whole covers areas of expertise and knowledge such as:

• Medical Oncology, specialization in breast cancer
• Patient representation

3.2 Size of the panel

The Panel will consist of an appropriate number of members, not to exceed 8, including the Chair, to ensure the appropriate representation of expertise and experience.

3.3 Security clearance

All members are required to undergo a security clearance to the level of "reliability status". A security clearance is valid for ten years.

3.4 Affiliations and interest

As a condition of appointment, potential members of the Panel are required to complete and return the "Affiliations and Interests Declaration Form for Advisory Body Members". This form is used to disclose to the Secretariat any circumstances that may place, or be seen to place the member in a real, apparent, or potential conflict of interest.

It is incumbent upon the member to update his/her declaration in writing, should his/her personal situation change or where the matters before the Panel may affect the conflict of interest situation of a member. Declarations will be assessed by the BGTD prior to appointment and on an ongoing basis as updates occur.

At the beginning of the meeting, the Chair will ask members to make a verbal statement of their relevant affiliations and interests. The level of participation of a member in conflict is determined by the Chair in consultation with the other members of the Panel.

Members are expected to conduct themselves in an appropriate manner, that is, the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.

3.5 Confidentiality

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.

In the case of media requests, the Executive Secretary will coordinate a response in consultation with the Chair and Health Canada Media Relations and will appoint a member to be the media spokesperson when circumstances warrant this.

3.6 Indemnification

All members serve on the Panel on a volunteer basis. Health Canada undertakes to provide its volunteer members with protection against civil liability provided the volunteer member acted in good faith, within the scope of their volunteer duties, and did not act against the interests of the Crown.

3.7 Travel expenses

Members will be reimbursed for expenses incurred during their work on the Panel, such as travel and accommodation, if applicable, according to the Treasury Board's Travel Directive and Directive on the Management of Expenditures on Travel, Hospitality and Conferences.

4.0 Proposed duration of panel

The Panel will be convened for a finite term until the final report of the recommendations of the Panel has been provided to the Biologics and Genetic Therapies Directorate. The Panel meeting will be of half day duration and will occur via a teleconference in the Spring of 2011. The Panel will be dissolved once the Panel report, with recommendations, has been completed. An individual may withdraw from service on the Panel at any time upon written notification to the Director General.

5.0 Management and administration

The specific questions and issues for Panel discussion will be developed by the BGTD. The agenda will also 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 ten calendar days in advance of the panel meeting.

Presentations will be made to the Panel by the Biologics and Genetic Therapies Directorate and the drug sponsor, Hoffman La-Roche.

Discussions during the meetings shall be open, frank, and free-flowing. All members of the Panel shall have equal status during the discussions. In order to foster open and frank discussions 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 to specific comments made. 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 a response to questions with recommendations to the Director General of the BGTD, and will be reached by consensus. Lack of consensus may indicate uncertainty with the information presented. In such cases, the Panel shall 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 different opinions will be documented, and the number of members supporting each opinion recorded.

The Panel will strive to answer the questions during the in camera session. If the Panel's report is not finalized during 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 calendar days of the date of the meeting.

The Health Products and Food Branch's 2007 "Guidance on Advisory Bodies" governs the Terms of Reference and the management and administration of this Expert Advisory Panel.