Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of findings and advice, June 27, 2024 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 Biologic 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 November 16, 2023. This included highlights on Health Canada leadership changes, updates on COVID-19 and regulatory initiatives, update on the Pediatric Drug Action Plan, proposed Agile Licensing and Precision Regulating 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, who provided A&Is where applicable, 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 House of Commons Standing Committee on Health (HESA) report, Strengthening the Oversight of Breast Implants, and the related government response, an overview of the proposed Clinical Trials Modernization initiative and related SGBA plus integration into this initiative.

3. Session #1: Update on Breast Implants and Government Response

The Medical Devices Directorate (MDD) provided an overview of the HESA report and its recommendations followed by a summary of the government response.

4. Session #2: Update on Breast Implants and Government Response – Committee Discussion

The Committee noted progress over the past year on this topic, including expanded government website information. The Committee acknowledged the limitations of the data available, and discussed an example of successful health data collection from private clinics in a province that may help inform policy for collection of health data from private clinics who perform surgeries with breast implants.

5. Session #3: Clinical Trials Modernization

The Bureau of Policy, Science and International Programs (BPSIP) within the Pharmaceutical Drugs Directorate (PDD) provided an overview of the Clinical Trials (CT) Modernization Initiative, including drivers for change, the proposal to modernize the CT regulatory framework and how this will address CT evolutions, a summary of consultation and feedback, as well as next steps.

6. Session #4: Clinical Trials Modernization – Committee Discussion

The Committee enquired about the scope of consultations, including targeted consultations, and recommended incentivizing industry to align with the increased decentralization of publicly funded women’s health product trials. Further, as a means of increasing CT participation, both in general and to support increased participation of populations traditionally underrepresented in CTs, they recommended increasing education and awareness around clinical trials.  

7. Session #5: Integrating SGBA Plus-Related Components in the Clinical Trials Modernization Initiative

The Centre for Policy, Pediatrics and International Collaboration (CPPIC) at BRDD presented the Branch's approach to integrating SGBA plus-related components in the Clinical Trials Modernization initiative, including providing an overview of the U.S. Food and Drug Administration (FDA) Diversity Plan requirements and components.

8. Session #6: Integrating SGBA Plus-Related Components in the Clinical Trials Modernization Initiative – Committee Discussion

The Committee outlined the challenges of intersectional analyses (e.g., looking at effects based on sex and race or ethnicity). Members also discussed additional demographic data that may be important to collect through clinical trials (e.g., gender, geographic ancestry, genetic diversity, income).  Issues and recommendations related to increasing the participation of groups traditionally underrepresented in clinical trials was discussed. Additionally, barriers to recruitment of clinical trial participants were noted (e.g., disinformation and mistrust in the health care system).

9. Session #7: Review of SAC-HPW Recommendations

CPPIC presented the SAC-HPW Recommendations table, highlighting progress made in specific areas.

10. Session #8: Secretariat update

The Secretariat provided updates to members regarding the posting of agendas/summary of meetings, upcoming plans to review the committee’s terms of reference and mechanisms to obtain topics for the next SAC-HPW meeting.  

11. Summary of Recommendations and Adjournment of Meeting

The Chair provided an overview of the discussion, 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