Summary of findings and advice: Scientific Advisory Committee on Health Products for Women (SAC-HPW) October 27th, 2021 virtual meeting via Zoom

Context

The mandate of the Scientific Advisory Committee on Health Products for Women (SAC-HPW) is 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 as well as drugs. The Committee examines issues across the health product life cycle, from development to real-world use, with a focus on patient perspectives and experiences.

The SAC-HPW is made up of 9 core members with a variety of expertise, knowledge, and perspectives, including: patient representatives; health professionals; academics with scientific and policy expertise.

The objectives of the videoconference committee meeting that occurred on October 27^th, 2021 were to:

1. Discuss the progress of the Medical Devices Directorate’s proactive risk assessment strategy
2. Hear the activities and priorities of the US-FDA Office of Women’s Health
3. Discuss the progress on the Health Products and Food Branch (HPFB) Sex and Gender-based Analysis Plus (SGBA Plus) Action Plan

Summary of Discussions

1. Welcome and opening remarks

The Chief Medical Advisor opened the meeting by acknowledging that the meeting was hosted on traditional, unceded Algonquin Anishinaabe territory. She provided a brief update on departmental priorities and progress since the last meeting, such as the COVID-19 response, creation of Health Canada’s SGBA Plus integration network, improvement of gender equality in the safety and efficacy management of health products, as well as on the appointment of two new ministers for the Health portfolio.

2. Chair’s address, introduction of members, review of affiliations and interests (A&I), review of agenda

The Chair officially welcomed the members, gave an overview of the documents that were sent ahead of the meeting, and reminded the committee of its mandate and scope and encouraged members to focus their recommendations accordingly.

3. Session #1: Actions in response to past SAC-HPW recommendations to the Medical Devices Directorate (MDD)

The Director General of MDD provided an overview of recent progress made on past recommendations. He solicited clarifications from the committee regarding one of the recommendations, to better understand the intent of the committee. Discussion with the committee clarified its intent and proposed additional parameters to improve the recommendations and their follow-up in the future.

4. Session #2: Actions in response to past SAC-HPW recommendations to drug directorates

The presenter explained how recommendations from the June meeting would be addressed by the Branch’s Sex- and Gender-Based Analysis (SGBA) Plus Action Plan being developed. She identified a few recommendations requiring clarification from the committee, which led to discussions.

5. Session #3: Update on medical devices foresight exercise

The presenter provided an overview of the Medical Devices Directorate’s new foresight exercise, which the members commented on over the summer. The presentation focused on the triage tool that was created to prioritize devices that should undergo risk assessment where devices of concern are identified through trusted partner networks. The committee discussed the use of the tool in the context of Foresight.

6. Session #4: Overview of US-FDA Office of Women’s Health

The presenter provided an overview of the various activities and priorities of the United States Food and Drug Administration (FDA)’s Office of Women’s Health. She clarified that her office is not involved in health product review and approval, but rather, oversees the FDA’s objective of advancing women’s health across the FDA’s portfolios. Their three-pronged approach is based on science, education, and engagement. For example, they recently published a roadmap of women’s health research, which identifies seven priority areas. This roadmap will guide the orientation of her office for the next few years.

7. Session #5: Revisiting the HPFB SGBA Plus Action Plan

The presenter reminded the committee of the presentation she provided at the June 2021 meeting, during which she had detailed the development process of the Action Plan. She then focused on the description of the three overarching goals of the Action Plan, to explain them in more detail and to support committee feedback. The ensuing conversation identified ways to clarify the plan and make it more concrete.

8. Session #6: Effectiveness of risk communications related to high-risk medical devices

The Marketed Health Products Directorate proposed a plan to convene a panel of health professionals specializing in medical devices for women. Feedback was sought from the committee regarding the topics, panelists, and the types of risk communications products that would be relevant to discuss.

9. Secretariat updates

The Secretariat provided updates to members regarding the satisfaction survey that ran in August 2021 and informed the committee of logistical updates for 2022 meetings.

10. Summary of recommendations and adjournment of meeting

The Chair, with the help of committee members, summarised the recommendations that had received committee support during the meeting, thanked members for their participation, and adjourned the meeting.

Overall summary of advice

1. That the cumulative table of recommendations be brought forward at each meeting and that respective Directors-General provide responses to key recommendations in their purview.
2. That Health Canada consider the development of a cross-branch evergreen public roadmap document on women’s health products, with forward looking goals derived from the recommendations.
3. That the Foresight Project consider using a matrix approach to help identify prioritization principles, and leverage the existing dynamic triage tool to integrate SGBA Plus principles and practices.
4. That the SGBA Plus Action Plan include measures on outcomes and accountability in performance measures and audits in learning and applying SGBA Plus, across Health Canada.
5. That a focus on understanding, measuring, and applying gender to regulatory processes for drugs and devices be developed.
6. That Health Canada generate multi or bilateral support for a dedicated International Council for Harmonization (ICH) guidance on SGBA Plus, including a review of sex and gender measurement tools.
7. That an upcoming meeting item focus on health care providers’ role(s) in regulatory activities, including risk communications and adverse event reporting and mechanisms to engage.
8. That Health Canada sponsor a Best Brains Exchange with CIHR to support the development of women’s health registries and regulatory changes that might strengthen the approach to harm reduction for women.

The Record of Proceedings is available upon request, (please note that confidential information will be redacted). Please submit your request to: policy.bureau.enquiries@hc-sc.gc.ca