Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of findings and advice, November 16, 2023 virtual meeting

Context

The Scientific Advisory Committee on Health Products for Women (SAC-HPW)'s mandate 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 and drugs. The Committee will examine 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.

1. Welcome and Opening Remarks

The Director General of Health Canada's Biological and Radiopharmaceutical Drugs Directorate (BRDD) opened the meeting by acknowledging the traditional and unceded territory of the Algonquin Anishinaabeg People, on which the meeting was hosted. The Director General provided updates on Health Canada's recent activities since the previous meeting held in November 22, 2022. This included highlights on Health Canada leadership changes, updates on COVID-19 and regulatory initiatives, and on the departmental Sex and Gender-Based Analyses Plus (SGBA Plus) Action Plan.

2. Chair's Address, Introduction of Members, Review of Affiliations and Interests (A&I), Review of Agenda

The Chair welcomed members, discussed the proposed approach to meetings and the agenda. The Chair thanked members for their commitment and reminded the Committee of its mandate and scope, encouraging members to focus recommendations accordingly. The issues under consideration at this meeting included an update on the Health Products and Food Branch (Branch)-level SGBA Plus Action Plan, discussions on the Branch's disaggregated data strategy and proposed approach for the global harmonization of clinical trial demographic data.

3. Session #1: Piloting New Direction with SAC-HPW

BRDD provided updates to members regarding ongoing process improvements and discussed the new approach to the planning and format of future SAC-HPW meetings.

4. Session #1: Piloting New Direction with SAC-HPW Discussion

The Committee noted areas for improvement and indicated support for more frequent and shorter meetings. The Committee suggested that written updates between meetings would be beneficial. In addition, preference for agenda items to be focused on areas where the Committee's impact would be most targeted was stated.

5. Session #2: Overview of Health Products and Food Branch (HPFB)'s SGBA Plus Action Plan

The Centre of Policy, Pediatrics and International Collaboration (CPPIC) at BRDD provided an update to the Committee on the implementation of the Branch's SGBA Plus Action Plan, early priorities, recent successes and next steps. An overview of key priorities for 2023/24 and 2024/25, including updates related to the disaggregated data strategy, development of guidance documents and HPFB SGBA training were provided.

6. Session #2: Overview of HPFB's SGBA Plus Action Plan Discussion

The Committee made suggestions that materials should attempt to adequately define Equity, Diversity and Inclusion (EDI) categories, and SGBA Plus factors, so as to avoid conflating the two concepts.

7. Session #3: Disaggregated Data Strategy (HPFB's SGBA Plus Action Plan)

CPPIC presented the Branch's approach to disaggregated data as part of the SGBA Plus Action Plan. This included an overview of proposed regulatory amendments that would require sponsors of certain types of drug submissions to submit disaggregated clinical trial data, as well as preliminary data collected to date and a discussion on the next steps required for policy implementation.

8. Session #3: Disaggregated Data Strategy (HPFB's SGBA Plus Action Plan) Discussion

The Committee welcomed the progress on Health Canada's collection of disaggregated data and sought clarifications on some of the data presented. The Committee inquired about future steps for publishing this data and commented that regular updates on the data would be appreciated.

9. Session #4: Global Harmonization of Clinical Trial Demographic Data

CPPIC presented on global harmonization of clinical trial demographic data and sought the Committee's insights and feedback on data categories and terminology. The presentation provided an overview of the international landscape in relation to demographic data considerations, current demographic data categories used (sex, age, and race/ethnicity) and welcomed feedback on other categories for consideration (e.g. gender, socioeconomic status etc.).

10. Session #4: Global Harmonization of Clinical Trial Demographic Data Discussion

The Committee provided suggestions on data categories presented (e.g. sex, age, race/ethnicity) and outlined other considerations for global harmonization (e.g. gender, socioeconomic status). The Committee highlighted potential challenges with harmonization in certain areas, such as standardization of racial/ethnic categories in a globally meaningful context, as well as considerations for appropriate biological or social variables as the basis for certain data categories. Additional recommendations were provided on terminology, and the Committee noted other areas for further deliberation.

11. Secretariat update

The Chair of the Secretariat provided updates to members regarding ongoing process improvements and indicated that an agenda would be shared for the next meeting in the near future.

12. Summary of Recommendations and Adjournment of Meeting

The Chair provided an overview of recommendations tabled by the Committee, thanked the committee for their participation and adjourned the meeting.

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