Scientific Advisory Committee on Oncology Therapies
Terms of Reference
The Scientific Advisory Committee (SAC) on Oncology Therapies (OT) provides Health Canada with timely scientific, technical, and medical advice related to the regulation of oncology therapies. Involvement of the scientific, medical and consumer communities in the regulatory review process is expected to enhance transparency and provide opportunity for proactive external guidance, thus facilitating the drug review process. The SAC-OT provides Health Canada with advice and recommendations, but the decision-making responsibility remains with Health Canada.
These Terms of Reference for the SAC-OT were accepted on October 15, 2009.
The SAC-OT will provide the Health Canada with ongoing and timely scientific, technical, medical and clinical advice on the evaluation of safety, efficacy, and effectiveness of drugs used for the treatment of cancer as well as policy issues.
Issues for committee consideration could include:
- the development of "standards of evidence" for risk and benefit decision-making for oncology therapies;
- the development of clinical and non-clinical guidance to facilitate the assessment of new drugs used in oncology;
- the appropriate use of concomitant medications for the treatment or modulation of side-effects of oncology therapies;
- the definition and appropriateness of surrogate markers used as endpoints and of other endpoints in clinical trials carried out in patients with cancer;
- the requirements and issues related to clinical trials for oncology therapies;
- identifying new trends or technologies associated with treatments used in oncology;
- issues arising directly from the sponsors' New Drug Submissions for drugs used in oncology;
- issues arising from post-market surveillance activities;
- the labeling, product monographs, package inserts and warnings;
- advice on the suitability of submissions for priority review;
- information required for Notice of Compliance with Conditions (NOC/C); and
- risk communication.
The SAC-OT explores options and provides recommendations for resolution of the issue(s).
2.0 Repoting Structure
The SAC-OT reports to the Director General (DG) of the Therapeutic Products Directorate (TPD), or designate, who acts as the Executive Secretary to the Committee. Secretariat support is also provided by the TPD.
3.1 Selection of Members
Members of the SAC-OT are recruited through open and targeted nomination processes. Potential members are identified through consultation with a broad array of sources such as the Chair and members already on the SAC-OT; Health Canada employees; health professional and scientific societies; academia; government and non-government agencies and/or the public. In order to preserve the independence of both the advisory body and the federal government as decision-maker, Health Canada employees may not serve as members of the SAC-OT.
This process is designed to ensure requisite expertise and experience, and a variety of perspectives, promoting diversity and inclusiveness.
The Executive Secretary selects and appoints a Chair from among the existing core members or nominees whereas other members are selected by the Executive Secretary in consultation with the Chair.
Membership of the SAC-OT as a whole will reflect an appropriate blend of gender and regional representation, covering various areas of expertise, knowledge, and perspectives including health professionals, scientists, academia, and lay representation. Members should include, but are not limited to areas such as:
- clinical trial design
- clinical medicine
- consumer interests
- patient groups
3.2 Types of Members
The SAC-OT has two types of members, core, and ad hoc members. Core members are permanent members who are invited to all meetings for the duration of their terms. The Chair or the Executive Secretary may invite ad hoc members to attend particular meetings or join the SAC-OT for a defined period. Ad hoc members follow the same rules and procedures as core members, and provide advice and recommendations on a particular topic or agenda item. The SAC-OT may also have members from the community to provide user perspective relevant to the work of the committee.
Members are appointed by the Executive Secretary for a two-year term which may be extended for an additional 2 or 4 year term up to a maximum of 6 years. The Secretariat will review membership on a regular basis in consultation with the Chair, and will make recommendations to the Executive Secretary. The Secretariat will endeavour to ensure that appointments of members are scheduled to allow for continuity and systematic rotation of membership.
3.4 Size of the Committee
The SAC-OT has at least 10 core members and it should not exceed 15. Membership may be periodically adjusted to ensure the appropriate representation of expertise and experience.
3.5 Security Clearance
All members are required to undergo a security clearance to the level of "reliability status". Sometimes, but not often, this may entail taking a member's fingerprints should the Royal Canadian Mounted Police require them. A security clearance is valid for ten years.
3.6 Affiliations and Interests
As a condition of appointment, potential members of the SAC-OT 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 (TPD) any circumstances that may place, or be seen to place the member in a real, apparent, or potential conflict of interest.
In keeping with the Privacy Act, this completed Affiliations and Interests Declaration Form is considered confidential. The TPD will not make public any information in the form without the member's permission. However, as a condition of membership, members will allow the TPD to publish on Health Canada's website a "Summary of Expertise, Experience, and Affiliations and Interests", which will be based on the completed Declaration Form. Members will be asked to review the content of the Summary for accuracy before its release.
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 Committee may affect the conflict of interest situation of a member. Declarations will be assessed by the TPD prior to appointment and on an ongoing basis as updates occur.
At the beginning of each meeting, the Executive Secretary or 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 Committee.
Members are expected to conduct themselves in an appropriate manner, that is [i.e.], the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization.
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. Documents leaving Health Canada, including electronic and word processing records must be securely stored at all times and must be returned to Health Canada or permanently deleted on request.
3.7 Indemnification and Legal Assistance
All members serve on the SAC-OT on a volunteer basis. In keeping with the Treasury Board's "Policy on Indemnification of and Legal Assistance for Crown Servants" and "Volunteer Policy", 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 SAC-OT and serving as volunteers.
3.8 Travel and Expenses
Members are reimbursed for expenses incurred during their work on the SAC-OT such as travel and accommodation, according to the Treasury Board's "Travel Directive and Hospitality Policy".
3.9 Resignation from the Committee
An individual may withdraw from service on the SAC-OT at any time upon 14 days written notice to the Secretariat. The letter should state the effective date of resignation.
3.10 Reasons for termination
Core members who are absent from three consecutive meetings of the SAC-OT 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. Generally, a member's failure to act according to the Terms of Reference may give cause for termination. In this event, the Executive Secretary will advise the member in writing, stating the reason for the termination and the effective date.
4.0 Roles and Responsibilities
Members of the SAC-OT have a responsibility to Health Canada and by extension to Canadians, to offer their independent and objective advice. Other responsibilities include:
- being available and prepared to participate in meetings (and public forums, if necessary);
- participating in any discussions surrounding the preparation of meeting reports, if necessary;
- notifying the Secretariat and the Chair of any changes in the status of their affiliations and interests in relevance to the mandate; and
- making a verbal statement of affiliations and interests at the beginning of each meeting when asked by the Executive Secretary or the Chair.
In addition to all the responsibilities of a member, the Chair is responsible for the following:
- providing input to and consulting with the Executive Secretary on the selection of members;
- consulting with the Executive Secretary to determine whether to limit the participation of a member in a meeting, depending on the nature of the person's affiliations or interests;
- overseeing and chairing meetings, and facilitating discussion among members in answering the TPD's questions;
- ensuring that all members agree with, or note their disagreement with, the advice in the report to the TPD.
The Office of Science of the TPD acts as the Secretariat of the SAC-OT. The Secretariat liaises between members and the Health Canada, and acts as a resource for members. It also provides leadership and strategic advice in the management of the SAC-OT and works closely with the Chair. In addition, the Secretariat:
- coordinates membership processes such as the affiliations and interests declarations and security clearances, and maintains an up to date membership list;
- coordinates the preparation of meeting agendas, prepares background information packages for the SAC-OT and marks it according to the level to which it is protected under the "Government Security Policy", and drafts the record of proceedings for membership and the Chair's approval;
- maintains any information about the SAC-OT, its mandate, or work that may be posted on Health Canada's website;
- helps to prepare the member designated as media spokesperson, as appropriate;
- coordinates requests for travel reimbursement;
- monitors and evaluates the efficiency and effectiveness of the SAC-OT; and
- carries out additional duties as appropriate in support of the SAC-OT.
4.4 Executive Secretary
The Executive Secretary is the Director General (TPD) who represents Health Canada and makes decisions about the SAC-OT and its advice. The Executive Secretary provides leadership and strategic advice in the management of the SAC-OT and works closely with the Chair and Secretariat.
4.5 Media and Communications
All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Committee. Discussion of SAC-OT work with the media or at conferences or other external events should only be done when authorization is given by the Executive Secretary.
In the case of media requests, the Executive Secretary, will coordinate a response in consultation with the Chair and the Health Canada Media Relations and will appoint a member to be the media spokesperson when circumstances warrant this.
Documents leaving Health Canada, including electronic and work processing records, must be securely stored at all times and must be returned to Health Canada or permanently deleted upon request.
5.0 Management and Administration
Health Canada is committed to ensuring transparency as an operating principle by:
- ensuring that meeting schedules are predictable, where possible; and
- posting SAC-OT materials, with confidential and personal information removed, on Health Canada 's website including:
- Terms of Reference
- Summary of Expertise, Experience, and Affiliations and Interests
- Biographies of members
- Records of Proceedings and/or formal reports and Health Canada's response.
5.2 Meeting agendas
The agenda and specific questions and issues for SAC-OT discussions will be determined by the Executive Secretary in consultation with the Chair and the Secretariat.
5.3 Meeting notices and Invitations
All meetings are held at the call of the Executive Secretary in consultation with the Chair. Meeting attendance is by invitation only. Notices are sent by the Secretariat. Members receive the agenda, briefing material and presentations, in advance of the meeting.
5.4 Frequency, Type, and Location of meetings
Meetings will be held up to three times per year in the National Capital Region. Rarely, additional meetings and/or teleconferences may be held on a needs basis at the discretion of the Executive Secretary in consultation with the Secretariat. A meeting cannot be held unless quorum is achieved. The quorum is determined to be at least one-half the number of existing core members, one of which must be the Chair.
For all teleconferences, members should make every effort to ensure that a secure line is used for the call and that no person who has not been approved by the Chair and Secretariat can listen to the proceedings.
The SAC-OT may be required to hold a meeting, or parts of a meeting, in public to allow the public to observe the discussions and understand the issues under consideration.
5.5 Deliberations and Reports
Deliberations during meetings are held in camera in order to foster open, frank, and free-flowing discussion. All members have equal status during discussion, and are expected to demonstrate fairness and a commitment to in-depth examination of matters under review. Only topics that fit within the mandate of the SAC-OT will be discussed.
At the discretion of the Executive Secretary and with the approval of the Chair, specific stakeholders may be invited to make presentations to the Committee in writing or in person. The Chair and the Executive Secretary may grant observer status, for all or part of the Committee deliberations to selected individuals, including Health Canada employees that would benefit from the deliberations of the Committee.
Members provide advice to Health Canada in the form of recommendations. These recommendations are captured in a record of proceedings. The SAC-OT is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the RoP will reflect the diversity of opinions. The reasons for a lack of consensus, if any, must be clearly identified and substantiated. In such cases, the SAC-OT 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.
A draft RoP is prepared by the Secretariat and circulated to members for review, and final approval by the Chair and Executive Secretary. The final RoP will effectively summarize the proceedings to reflect the advice offered and there will be no attribution, i.e. there will be no references to comments made by individual members or the public. The Secretariat is responsible for the distribution of the RoP.
When issues are of a general nature, the agenda and the record of proceedings will be posted on Health Canada's website in both official languages. Issues discussed on a particular submission are considered confidential and the meeting documents will become part of the Central Registry file. In the event that the Chair and the Executive Secretary believe that the SAC-OT would benefit from broader stakeholder input, a portion of the meeting could become public.
The Secretariat will initiate an evaluation of the SAC-OT every 2 years, and will work with the Executive Secretary and the Chair to review the mandate, activities, Terms of Reference, and relevance of the SAC-OT to ensure that it continues to meet ongoing needs. The TPD retains the prerogative to disband the body following such a review. Recommendations for improvement will be considered on an ongoing basis.
The Health Products and Food Branch's "Guidance on Advisory Bodies", and "Policy on Public Input" govern the Terms of Reference, and the management and administration of the SAC-OT.
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