Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of findings and advice, February 1st, 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. She provided updates on Health Canada's recent activities in response to the COVID-19 pandemic since the previous meeting and on the departmental Sex and Gender-based Analyses Plus Action Plan. She also provided an overview on the measures Health Canada has been to increase safety and adverse event reporting in the post-market space for breast implants.

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 issues under consideration during this meeting included: a discussion on draft Breast Implant Patient Checklist and Medical Device Incident Reporting Templates; an update on the Health Canada and Branch-level SGBA Plus Action Plans; and an overview of a study on applying SGBA+ to the Lifecycle Management of Prescription Drugs, funding by a joint HC-CIHR initiative.

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

The Director General of MDD provided an update on a number of the committee’s past recommendations and discussed recommendations that require additional clarity or revision. He referenced a report on SGBA Plus in Medical Devices that has been finalized and revisions to the BIA-ALCL data blog and communications approach. There was a discussion on a potential registry of health products for women and whether that would fall within Health Canada’s mandate; the DG indicated it would not, but it is an initiative that HC could be interested in supporting.

4. Session #2a: Breast Implant Patient Checklist

The Medical Devices Directorate provided an overview of a draft breast implant patient checklist. Health Canada requires manufacturers of breast implants to develop a risk-related patient checklist, with the expectation that these checklists are discussed between a patient and their health care professional prior to undergoing a breast implant procedure. The committee was asked where Health Canada should post an example checklist. The committee feedback included recommendations specific to the form (e.g. consistent and clear terminology, framing risk in a way that ensures patients understand them, and ensuring the focus is on the implant itself vs. breast implant procedures). Feedback from the committee also suggested that posting the tool on a website or making it an interactive patient tool would be useful.

5. Session #2b: Medical Device Incident Reporting Templates

The Medical Devices Directorate sought the committee’s advice on the collection of SGBA Plus information through Health Canada’s medical device incident report forms. The committee suggested the form should align with the drug adverse reaction form and recommended it collect data on sex and gender, including trans individuals. It was also recommended that the wording of data categories and terminology be examined to ensure alignment with best practices (e.g. change ‘vulnerable population’ to ‘sub-population’).

6. Session #3: The Health Canada SGBA Plus Action Plan: Collaborating to Build on our Success

The Strategic Policy Branch of Health Canada provided an overview of the department-level SGBA Plus Action Plan. It was underscored that Health Canada’s approach focuses on intersectionality and that the goal is to embed SGBA Plus considerations across the organization. The approach aligns with the Health Portfolio’s SGBA Plus policy, which was approved in December, and the larger government priorities. It was communicated that focus is on ensuring accountability, increased knowledge and evidence, as well as capacity and expertise. The Health Products and Food Branch then gave a brief presentation on how the HPFB SGBA Plus action plan aligns with the larger departmental plan. It was communicated that focus will be on improving SGBA Plus data submitted, enhancing the way this data in analysed and increasing the SGBA Plus information publicly available.

7. Session #4: Applying a SGBA+ to the Lifecycle Management of Prescription Drugs

Dr. Lorraine Greaves, Principal Investigator, provided an overview on a report funded via a research policy partnership between the Canadian Institutes of Health Research and Health Canada. The report focused on integrating sex, gender and equity-related data into the lifecycle management of prescription drugs.

8. 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 April meeting in the coming months.

9. 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.

Overall summary of advice

1. The SAC-HPW should be updated and consulted on the content of Health Canada’s SGBA Plus training for staff as it is developed.
2. Future meetings should include time for examining the entire Table of Recommendations.
3. Dr. Anna Gagliardi, author of the CIHR-HC research-policy partnership project on SGBA Plus and the regulation of medical devices, should be invited to present her results and recommendations at a future meeting.
4. Inclusion of mandatory fields for sex, gender identity and information on gendered social determinants of health (income, education, roles) and that “vulnerable populations” be renamed “subpopulations” on medical device incident report forms.
5. The draft Breast Implant checklist should become a user-friendly, plain language, interactive tool for potential consumers and include photographs; psychosocial evidence on motivation, quality of life and experiences post implant for both augmentation/or reconstruction patients; information on the removal (explantation) procedure and its consequences; coverage by private and public insurance and costs; quantification or percentages attached to each risk; and boxed warnings regarding specific risks. It should account for “optimism bias”, present a “most likely scenario” regarding outcome, and explain regulatory history.
6. Health Canada should participate in a CIHR-organized Best Brains Exchange led by Women and Gender Equality (WAGE) to provide input on the logistics and value of setting up a women’s medical device registry for Canada.
7. Health Canada should engage in a leadership role with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) on developing a document on SGBA Plus indicators and processes in drug and device regulation.
8. Health Canada should examine the impact of Canada’s market size on it its regulatory role and processes regarding drugs and devices and discuss at a future SAC-HPW 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