Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of findings and advice, November 22nd, 2022 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 as well as 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 Chief Medical Advisor opened the meeting by acknowledging the traditional and unceded territory of the Algonquin Anishnaabeg People, on which the meeting was hosted. Highlights were provided on Health Canada's recent regulatory activities since the previous meeting and on the departmental Sex and Gender-Based Analyses Plus Action Plan (SGBA Plus).

2. Chair's address, introduction of members, review of Affiliations and Interests (A&I), review of agenda

The Chair reminded the committee of its mandate and scope and encouraged members to focus their recommendations accordingly.  The Chair expressed positive remarks on the progress made by the committee and how many of its recommendations have considered or implemented by Health Canada.  The issues tabled for discussion during this meeting included: updates from past recommendations; an overview of Risk Management Plans (RMP) in Canada and managing the risk of teratogenicity; monitoring the safety of COVID-19 vaccines in women; and an update on the Branch’s SGBA Plus Action Plan.  In additional, the Committee expressed their support to have representatives from Canada’s health technology assessment organizations, CADTH and INESSS, to participate as observers on SAC-HPW to provide expertise in the Digital Technology and Artificial Intelligence realms.

3. Session #1: Updates and Discussion on past SAC-HPW recommendations to HPFB

The Director of CPPIC-BRDD provided an overview on previous SAC-HPW recommendations, which have since been consolidated and organized by priority. The new template for listing recommendations by Committee includes linkages to those recommendations that have been considered or implemented in Health Canada decision-making over time.  Noting the growing list of recommendations, the importance of prioritization was acknowledged by the Committee, and this remains a pending/forward action item.

Regarding recommendations related to HPFB’s SGBA Plus Action Plan, the Chair noted that SGBA Plus is subsumed by Equity, Diversity and Inclusion (EDI) and reminded Health Canada that the role of the Committee is focussed on Sex and Gender.

4. Session #2a: Overview of Risk Management Plans (RMPs) in Canada – Managing the Risk of Teratogenicity

The Marketed Health Products Directorate provided an overview on the use of RMPs by Health Canada and discussed Health Canada’s approaches to managing the risk of teratogenicity with certain drug products, and challenges associated with implementing effective risk mitigation measures.  The MHPD sought the Committee’s feedback on the tools and interventions used to mitigate risks.

5. Session #2b: Risk Management Plans- Discussion

The Committee commented that pharmacovigilance systems and Adverse Drug Reaction (ADR) Reporting (e.g. follow-up on birth outcomes in exposure during pregnancy) are often incomplete and there is a need to gather additional evidence in pregnant women.  The MHPD noted that targeted ADR follow-up forms are sometimes used which goes beyond routine Pharmacovigilance.  In the post-market space, evidence-based risk management entails pharmacovigilance activities that may also include data that is reviewed from later phase clinical trials, observational studies, and/or follow-ups with patient groups.  The Committee highlighted the challenges posed by not having clinical trial data from pregnant women.

The Committee commented that it considered the use of some risk mitigation measures to be inappropriate as they can impede equitable access to medications by pregnant people.  Moreover, concerns were raised over some measures that women of childbearing potential are required to take to prevent pregnancy, in order to access some medicines.  The importance of clearly communicating risks and obtaining informed consent were stated.

6. Session #3: Monitoring the safety of COVID-19 vaccines in women

The Marketed Health Products Directorate presented on Health Canada’s approach to the monitoring of the safety of authorized COVID-19 vaccines in women, with a focus on menstrual changes, risk of pregnancy complications, and the effects on breastfeeding. The committee was asked to provide feedback and recommendations on these topics.

7. Session 2b: COVID-19 Vaccines in Women - Discussion

Interest was expressed in learning more about manufacturers’ indemnification against liability of COVID-19 vaccines in other jurisdictions and the potential impacts on the uptake of vaccines in Canada.  The MHPD noted that manufacturers have a legal requirement to undertake pharmacovigilance activities.  The Chief Medical Advisor added that the Public Health Agency of Canada (PHAC) has a Vaccine Injury Support Program to assess and provide compensation to people who have been injured as a result of receiving an authorized vaccine.

The Committee shared its concern that early in the pandemic, pregnant and women of child-bearing potential were excluded from clinical trials.  The members further shared that, in addition to studying the effects of drugs and vaccines effects on women’s reproductive systems, the impacts on male fertility should also be considered, noting that male fertility effects were observed with some COVID-19 vaccines.

8. Session #4: The Health Canada SGBA Plus Action Plan: Update

The Biologic and Radiopharmaceutical Drugs Directorate provided an update to the Committee on the implementation of the Branch’s SGBA Plus Action Plan, including policy and regulatory updates that have taken place and that are planned regarding the collection, analysis and reporting of disaggregated data in drug submissions.

9. Session #4B: SGBA Plus Action Plan Update - Discussion

The Committee made recommendations for guidance development that would address the identity factors of sex and gender, so as to not conflate the two concepts which is often done, and for the collection and analysis of such clinical trial data accordingly.

10. 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 coming months.

11. 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: policy.bureau.enquiries@hc-sc.gc.ca