Scientific Advisory Committee on Health Products for Women (SAC-HPW): Summary of Findings and Advice February 23rd, 2021 Virtual Meeting via Zoom

Context

The Medical Devices Action Plan (MDAP)^{Footnote 1} was launched in December 2018 to communicate on Health Canada’s strategies to strengthen the regulatory framework for medical devices. One of the key commitments in the MDAP is to expand scientific expertise that will help inform regulatory decision-making practices and policies. As part of this commitment, Health Canada has established a new external Scientific Advisory Committee on Health Products for Women (SAC-HPW). The mandate of the 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 and drugs.

The SAC-HPW is made up of 9 core members with a variety of expertise, knowledge, and perspectives, including patient groups; health professionals such as pharmacists, physicians and nurse practitioners; scientists; academia, and policy.

The inaugural SAC-HPW meeting was May 16-17 2019 and a second teleconference meeting was held on November 28, 2019. This latest meeting was a videoconference meeting on February 23^rd, 2021. The objectives of this meeting were to:

1. Provide overview of how Health Canada integrated SGBA+ concepts in the review of COVID-19 vaccines
2. Respond to a committee’s inquiry about the use of SGBA+ in vaccine prioritization and roll-out
3. Inform and seek feedback on post-market activities and safety review of breast implants
4. Seek feedback on a reflection paper Health Canada could submit to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Overall summary of advice

1. In approving the subsequent vaccines, Health Canada should request sex-disaggregated and gender-related data on safety and side effects and incorporate these considerations in the evaluation of the vaccines.
2. A retrospective case study should be developed to investigate how breast implants were regulated and to identify the gaps that led to the current situation.
3. A roadmap of actionable items should be developed by the Medical Devices Directorate, to better target the efforts of the committee. This roadmap should clearly delineate Health Canada’s realm of responsibility and opportunities for action.
4. More information should be available to consumers about medical devices and include a wide array of evidence (e.g., update the Health Canada breast implant website content to include a more exhaustive list of symptoms and relevant links to connect users with important evidence and information).
5. In developing a reflection paper for the ICH, both sex and gender science and/or SGBA+ and/or equity diversity and inclusion (EDI) should be in the content title explicitly. The use of sex and gender science should be a main focus of the reflections.

The committee also had suggestions that fell outside of the scope of health products for women as regulated by Health Canada:

1. Regarding the vaccine prioritization scheme, the committee recommended the use of sex/gender disaggregated data and a social determinants of health lens (e.g., gender, occupation, neighbourhood deprivation indices) to determine and adjust prioritization. When the Public Health Agency of Canada and local Public Health Agencies evaluate the efficacy of a single dose, they should include considerations of sex, gender, and other relevant factors. Data on transgender and gender diverse individuals should be acquired. A framework for research using real-world evidence should be developed, to enable the use of disaggregated federal/provincial/territorial data on adverse events.
2. Regarding breast implants, research funding should be made available to improve the evidence around implants-related adverse reactions.
3. Medical education should be improved across a range of specialties to inform physicians (generalists and specialists) of the considerations specific to devices used by females and women.
4. Health Canada should consider the development of a fund for expenses related to health products-related injuries and advocacy.
5. Revisit possibilities surrounding the development of a registry to track the use (effectiveness, safety) of high-risk devices.

Summary of discussions

1. Welcome and Opening remarks

The Chief Medical Advisor opened the meeting, re-introduced her role as Chief Medical Advisor for Health Canada and Senior Medical Advisor for the Health Products and Food Branch, and welcomed all SAP-HPW members and Health Canada employees while acknowledging everyone’s flexibility to meet virtually. She then provided an overview of Health Canada’s response to COVID-19 as well as the ministerial commitments to integrating SGBA+ in policies.

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

The Chair thanked Dr. Sharma and welcomed SAC-HPW members and speakers. She acknowledged how fatiguing it is to meet continuously on Zoom and thanked participants for their flexibility. She provided an overview of the agenda, encouraged members to participate in the ongoing efforts to identify an Indigenous representative for the committee, and opened the floor for the introduction and affiliations & interests disclosures of the committee members, guest speakers, and Health Canada Management committee members present.

3. Health Canada Presentation – Actions in Response to SAC-HPW Comments and Past Recommendations

The Director General outlined eight previous recommendations from the committee and the responses that were ongoing or had been completed to date. This was followed by a discussion with the committee to clarify the responses and provide additional input.

4. Session #1: SGBA+ Considerations in the Development / Review of Health Canada Authorized COVID-19 Vaccines

The presenter provided an overview of the SGBA+ considerations that were involved in the review of the two SARS-CoV-2 vaccine submissions that had received Health Canada approval at that point in time. In both cases, sex and other considerations had been collected and submitted to Health Canada. For example, the pivotal trials achieved 50/50 representation from males and females, around 17% of participants were non-white, between 21% and 26% of participants were 65 years of age or older, and between 20% and 46% of participants had co-morbidities that increased their risk of severe COVID-19 infection. One pivotal trial included more than 80% of participants from at-risk occupation groups (e.g., healthcare, retail). Neither submission provided information regarding pregnant women, offspring exposed to the vaccine in utero or through breastmilk, people under 16 years old, nor the impact of other social determinants of health. Both sponsors have undertaken follow-up safety studies involving pregnant women and children, and the results will be reported to Health Canada.

5. Session #2: Role of SGBA+ in COVID-19 Vaccination Roll-out to Priority Groups

The presenter provided an overview of the distribution of responsibilities between Health Canada, PHAC, and provincial health authorities; the inner workings of the National Advisory Committee on Immunization; how SBGA+ considerations were incorporated in their recommendations; and the tools – namely the PROGRESS-Plus framework – used to evaluate and incorporate SBGA+ considerations. During the discussion, the presenter invited interested committee members to reach out to him if they had suggestions on how to improve the use of a SBGA+ lens in the work of the NACI.

6. Session #3: Patient Experiences/Perspectives on Breast Implant Products

The Medical Devices Directorate introduced the two patient representatives who had been recruited in presenting their experience with breast implants.

The first patient representative offered a brief introduction of her personal story with breast implants, focusing on the harms she experienced. She highlighted the need for the Committee and Health Canada to understand how breast implants evolve/degrade in real-time in women’s lives instead of waiting for adverse events to be reported decades later. She highlighted how the information provided to women seeking breast implants appears biased and minimizes risks, often portraying them as “unknown” when in fact this is not accurate. She mentioned that many women with implants turn to online forums to gather information from peers since their health providers are rarely receptive to their concerns. She hypothesized that surgeons and other health providers might lack appropriate training to monitor implants, identify implants-related adverse reactions, and help their clients manage their health. She reiterated her willingness to contribute to Health Canada’s work to improve the safety of breast implants.

The second patient representative shared her own experiences and challenges with breast implants, including her own progression to breast implant associated anaplastic large cell lymphoma (BIA-ALCL). She explained how neither the disease nor its symptoms were recognized as being related to breast implants for a year, which delayed treatment. Based on personal experience and the testimony of many other women with breast implants, she described how health complaints were routinely dismissed or denied as being related to the implants, the reality of the adverse health effects versus the proclaimed safety of the implants combined with lack of appropriate follow-up made women uncertain or reticent about broaching the topic with their healthcare provider. She emphasized that because of the lack of clear guidelines, it is next to impossible to obtain proper follow up (magnetic resonance imaging) even in the private sector. She raised the issue that when considering acquiring breast implants, she saw herself as a consumer and as such had wanted sufficient information to make an informed decision. However, she unwittingly became a patient because of the lack of balanced, unbiased information provided and lack of appropriate maintenance and follow up of her implants. She closed by highlighting how recent independent research is starting to shed additional light on the breast implant-associated harms and that she would be happy to work with Health Canada to continue improving the safety of these devices.

7. Session #4: Post-market Activities on Breast Implants

The presenter gave an overview of the risk assessments that had been undertaken regarding breast implants currently licensed in Canada. She described that historically, textured implant options were available, but now only smooth and micro-textured implants are licensed. Common and known adverse reactions to breast implants include pain, swelling, bleeding, mild to serious infection, and changes in nipple and breast sensation. BIA-ALCL can develop months or years following breast implant procedure. As of May 2019, there were 26 confirmed Canadian cases of BIA-ALCL; however, updated higher numbers will be published in the spring. Health Canada launched a new webpage on breast implants in January 2020 which provides an overview of these devices, their associated risks, Health Canada’s role in regulating them, safety reviews, and links to report problems or concerns. She shared that new regulations to strengthen the post-market surveillance and risk management of medical devices were just published in December 2020, which will enable her team to use additional regulatory tools to improve the safety of devices, including breast implants. A review of newly available data on BIA-ALCL is ongoing, in parallel to a more comprehensive risk assessment of systemic symptoms associated with breast implants, which is expected to be complete in the following summer.

8. Session #5: Potential Proposal of an ICH Reflection Paper / Guidance Document on Equity / Diversity in Drug Development and Post-Market Activities

The presenter described a proposal for Health Canada to champion an international reflection paper on the development of equity and diversity in drug development and post-marketing activities. She described the workings of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is the internationally-recognized committee that works to improve drug development across the world. She also described the process to submit topics for new guidance documents. She presented a reflection paper to advance patient-focused drug development (PFDD) currently opened for comments on the ICH website. She explained how Health Canada could seize this opportunity to propose an additional reflection paper / guidance document under the PFDD umbrella on how to integrate SBGA+/equity, diversity and inclusion concepts in drug development. She sought the committee’s input on this proposal. The committee engaged in discussions and agreed that such a proposal from Health Canada to the international community would be relevant. The committee also raised the importance of putting sex and gender science (instead of equity, diversity and inclusion) at the core of such document, even if this approach goes against international practices, and that the clarification of the concepts of sex and gender could be Canada’s international contribution.

9. Summary of Recommendations and Adjournment of Meeting

The Committee summarized and agreed on their recommendations on each topic. The Chair thanked the members for their patience and input today. The Chair also thanked the speakers for their meaningful contribution and continued collaboration with the committee. The meeting was adjourned and the members proceeded to an in-camera session.

The Record of Proceedings is available upon request. Please submit your request to: hc.policy.bureau.enquiries.sc@canada.ca