Scientific Advisory Committee on Health Products for Women - Draft Terms of Reference

The Scientific Advisory Committee on Health Products for Women (SAC-HPW) provides Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs.  The Committee will examine issues across the product life cycle, from development to real-world use, with a focus on patient perspectives and experiences.  The Committee will provide an opportunity for independent, external advice to inform the drug and device regulatory process.  The Committee provides Health Canada with advice and recommendations, but the decision-making responsibility remains with Health Canada.

These Terms of Reference of the SAC-HPW were accepted on May 17, 2019.

1. Mandate

To provide Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs. The Committee will examine issues across the product life cycle, from development to real-world use, with a focus on patient perspectives and experiences. This includes providing advice to help inform the regulatory review process, addressing specific questions on women’s health related to the evidence used to support the safety, efficacy and quality of drugs and medical devices, addressing questions on current and emerging issues (pre- and post-market) and identifying areas where clarification is needed with regard to policy, processes guidance and applicable regulatory requirements.

Issues for committee consideration could include:

• health products specific to women e.g., contraceptives and contraceptive devices, breast implants, transvaginal meshes, etc.
• representation of women in clinical trials and investigational testing, and sex as a biological variable in drug/device development
• evidence/data to support sex and gender-based analysis, including other considerations such as those related to Indigenous women’s health, in medical device applications and drug submissions and other social determinants of health or health factors and how they may interact
• challenges/gaps in sex and/or gender-related factors including sex and/or gender-based and differences in safety profiles for drugs and devices
• Enhanced communication and engagement with interested parties (consumers, patients, industry, healthcare professionals, etc.) of sex and/or gender-related factors for drugs and devices
• pharmacovigilance strategies that identify sex and/or gender-related factors in health product performance, and/or
• seek advice/recommendations on specific questions

The Committee explores topics identified by Health Canada and/or recommended by Committee members, identifies options and provides advice/recommendations for resolution of the issue(s).

2. Reporting Structure

The SAC-HPW reports to the Health Canada Management Committee which includes:

• the Director General (DG) of the Therapeutic Products Directorate (TPD)
• the DG of the Biologics and Genetic Therapies Directorate (BGTD)
• the DG of the Marketed Health Products Directorate (MHPD), and
• the DG of the Medical Devices and Clinical Compliance Directorate in the Regulatory Operations and Enforcement Branch (ROEB)

This Management Committee works in consultation with the Health Products and Food Branch (HPFB) Senior Medical Advisor.

Secretariat support is provided by the TPD.

3. Membership

3.1 Selection of Members

Members of the proposed SAC-HPW will be recruited through an open nomination process. In addition, potential members may also be identified through consultation with a broad range of sources, such as: health professional and scientific societies; industry; academia; government and non-government departments and agencies; and/or the public. Health Canada and other federal officials may not serve as members of the SAC-HPW; however, the Department will leverage the expertise available across the Government of Canada (such as in the Canadian Institutes of Health Research (CIHR), the Public Health Agency of Canada and Indigenous Services Canada) as subject-matter experts on gender and women’s health.  This process is designed to ensure requisite expertise and experience and a variety of perspectives, promoting diversity and inclusiveness.

The Management Committee will appoint core and ad hoc members from among the nominees, following a review by a Health Canada selection committee composed of staff from the various relevant Directorates, Branches and partners including CIHR. A Chair will be selected by the Management Committee from among the core members. The Management Committee, after consulting the Chair, may appoint, for a specific term, a Vice-Chair from among the members of the Committee.

3.2 Types of Members

Membership of the SAC-HPW will reflect an appropriate balance of gender and regional representation covering various areas of expertise, knowledge, and perspectives, including patient groups; health professionals such as pharmacists, physicians and nurse practitioners; scientists; experts from industry, academia, and/or public policy.  Areas of expertise could include:

• women’s health research including research ethics
• first-hand personal experience as, for example, a health professional, patient, or caregiver
• clinical trial or investigational testing involving women
• sex and gender-based analysis (particularly for drug or device development)
• medical devices (including devices unique to women such as breast implants, contraceptive devices)
• drugs  (pharmaceuticals, biologics, gene therapies) including regarding sex-based differences for safety and/or efficacy
• post-market real world issues with drugs and devices related to women’s health;
• Indigenous women’s health issues, and/or
• other relevant expertise

3.3 Tenure

Members are appointed by the Management Committee for a two-year term, which may be extended for additional terms based on the members’ availability and willingness to continue their membership. Core members will be permanent members for the duration of their terms and ad hoc members will be invited to serve for a specific topic or group of topics. The Secretariat will review membership on a regular basis in consultation with the Chair, and will make recommendations to the Management Committee. 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-HPW has at least 7 core members and is not to exceed 12 core members total. 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-HPW 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 Web site 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 representative for the Management Committee 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 and the representative for the Management Committee.

Members are expected to conduct themselves in an appropriate manner, 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 and guest speakers serve on the SAC-HPW on a voluntary basis. In keeping with the Treasury Board’s “Policy on Legal Assistance and Indemnification” 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-HPW and serving as volunteers.

3.8 Travel and Expenses

Members and guest speakers are reimbursed for expenses incurred during their work on the SAC-HPW 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-HPW 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-HPW 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 Management Committee will advise the member in writing, stating the reason for the termination and the effective date.

3.11 Official Languages

In keeping with the federal Official Languages Act, SAC-HPW members have the right to receive documents and participate in discussions in the official language of their choice.

4. Roles and Responsibilities

4.1 Members

Members of the SAC-HPW 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  relevant to the mandate, and
• making a verbal statement of affiliations and interests at the beginning of each meeting when asked by the representative for the Management Committee or the Chair

4.2 Presenters and Observers

Presenters and observers may not participate in discussions at the SAC-HPW meeting unless the Chair specifically invites them to do so. Only committee members may participate in the formulation of advice or recommendations to Health Canada.

4.3 Chair

In addition to all the responsibilities of a member, the Chair is responsible for the following:

• providing input to and consulting with the Management Committee on the selection of members
• consulting with the representative for the Management Committee 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, facilitating discussion among members in answering Health Canada’s questions, and ensuring that the two official languages can be used, and
• ensuring that all members agree with, or note their disagreement with, the advice in the report to the Health Canada Management Committee

4.4 Vice-Chair

At the request of the Chair, or in the case of the Chair’s absence, the Vice-Chair will chair the meeting(s) and take on the Chair’s other tasks, as required.

4.5 Secretariat

The Bureau of Policy, Science and International Programs of the TPD acts as the Secretariat of the SAC-HPW. The Secretariat liaises between members and Health Canada, and acts as a resource for members.  It also provides leadership and strategic advice in the management of the SAC-HPW 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 in consultation with the relevant  Directorates, prepares background information packages for the SAC-HPW 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-HPW, its mandate, or work that may be posted on Health Canada’s Web site
• 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-HPW, and
• carries out additional duties as appropriate in support of the SAC-HPW

4.6 Support to the Secretariat

Health Canada employees may assist the Secretariat with meeting logistics, document preparation, and other tasks.

4.7 Federal Subject-matter Experts

Medical, scientific, technical and program, policy, and other subject-matter experts from the federal government support the work of a committee in a variety of ways, including:

• preparing background documents such as research summaries and regulatory process overviews
• providing information about government policies and programs, and
• making presentations, answering questions or providing factual guidance at a committee meeting

4.8 Management Committee

The Management Committee is comprised of the Director General (DG) of the Therapeutic Product Directorate (TPD), the DG of the Biologics and Genetic Therapies Directorate (BGTD), the DG of the Marketed Health Products Directorate (MHPD), and the DG of the Medical Devices and Clinical Compliance Directorate in the Regulatory Operations and Enforcement Branch (ROEB). The Management Committee works in consultation with the HPFB Senior Medical Advisor and makes decisions about the SAC-HPW and its advice/recommendations. The Management Committee provides leadership and strategic advice in the management of the SAC-HPW and works closely with the Chair and Secretariat. A representative of the Management Committee may attend meetings as and when required.

4.9 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-HPW work with the media or at conferences or other external events should only be done when authorization is given by the Management Committee. Members who receive communications from the media should inform the Secretariat on a timely basis.

In the case of media requests, the Management Committee, 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. Management and Administration

5.1 Transparency

Health Canada is committed to ensuring transparency as an operating principle by:

• ensuring that meeting schedules are predictable, where possible, and
• posting SAC-HPW materials, on Health Canada’s Web site including:
  • Terms of Reference;
  • Membership;
  • Summary of Expertise, Experience, and Affiliations and Interests;
  • Biographies of members;
  • Agendas;
  • Records of Proceedings and/or formal reports and Health Canada’s response;
  • Presentations made to the Committee, and;
  • Written correspondence sent to the SAC-HPW or to the Management Committee;

5.2 Meeting Agendas

The agenda and specific questions and issues for SAC-HPW discussions will be determined by the Management Committee in consultation with the Chair, Committee members and the Secretariat.

5.3 Meeting Notices and Invitations

All meetings are held at the call of the Management Committee 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 two times per year in the National Capital Region. Additional meetings and/or teleconferences may be held on an as needed basis at the discretion of the Management Committee 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 or the Vice-Chair in the Chair’s absence.

For all teleconferences, members should ensure that any person who has not been approved by the Chair and Secretariat may not listen to the proceedings.

The SAC-HPW 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 may be held in camera upon confirmation by members in order to foster open, frank, and free-flowing discussion and in these cases are not electronically recorded. 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-HPW will be discussed.

At the discretion of the Management Committee and with the approval of the Chair, specific experts/stakeholders may be invited to make presentations to the Committee in writing or in person.

The Chair and the Management Committee may grant observer status, for all, or part of, the Committee deliberations to selected individuals, including Health Canada employees, who 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 (RoP). The SAC-HPW 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 and/or lack of consensus. The reasons for a lack of consensus, if any, must be clearly identified and substantiated. In such cases, the SAC-HPW 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 the Management Committee. As a condition of membership, members shall agree to the audio recording of the meeting, to the publication of the RoP on Health Canada’s Web site and allow public access to slide presentations made during committee meetings. This agreement shall be confirmed verbally at the start of every meeting. Invited guest speakers will be given the opportunity to review the draft RoP to ensure that their views are properly captured. The final RoP will summarize the proceedings to reflect the advice offered. 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 Web site in both official languages. Issues discussed on a particular drug submission or medical device licence application, are considered confidential and the meeting documents will become part of the official Health Canada file. In the event that the Chair and the Management Committee believe that the SAC-HPW would benefit from broader stakeholder input, a portion of the meeting could become public.

5.6 Review

The Secretariat will review the SAC-HPW every 2 years, and will work with the Management Committee and the Chair to review the mandate, activities, Terms of Reference, and relevance of the SAC-HPW to ensure that it continues to meet the ongoing needs of Health Canada. The Management Committee in consultation with the HPFB Senior Medical Advisor retains the prerogative to disband the body following such a review. Recommendations for improvement will be considered on an ongoing basis.

6. References

The Health Products and Food Branch’s Health Canada Policy on External Advisory Bodies (2011) governs the Terms of Reference, and the management and administration of the SAC-HPW.

Email: hc.policy.bureau.enquiries.sc@canada.ca
Telephone: 613-948-4623
Fax: 613-941-1812