On June 23, 2015, Health Canada's Health Products and Food Branch (HPFB) held a half-day engagement session with a number of its key stakeholders. The primary purpose of the session was to initiate a two-way dialogue between the Branch and its stakeholders on the current challenges and opportunities for continued and improved engagement as the Branch seeks to update and renew its Strategic Plan for the coming years.
Approximately 60 stakeholders attended the event, representing a broad and diverse range of associations who currently have relationships with HPFB, including health product manufacturers, food industry representatives, health care professionals, consumer advocacy groups and patient group representatives.
Opening remarks were provided by Paul Glover, Health Canada's Associate Deputy Minister, and HPFB's Assistant Deputy Minister, Anil Arora. These presentations set the stage for the afternoon by providing meeting participants with an overview of the Department's regulatory landscape and priorities, highlighting HPFB's recent accomplishments, and providing an overview of where the Branch is heading over the next several years.
Through facilitated table conversations, stakeholders were invited to share their thoughts on several topics of interest to the Branch in the context of the development of a new strategic plan, including:
Attendees were then asked to consider “walking a mile in HPFB's shoes” and provide their diverse sectors' perspectives on where the Branch's primary efforts should focus in the coming months and years.
The challenges currently facing Health Canada are shared by other government organizations and stakeholders alike, and include globalization, rapid product innovation and new technologies, evolving science and the ongoing need to meet Canadian's expectations of rapid access to the latest information about health and safety to help them make informed decisions. In order to address these challenges, the Department will continue to prioritize its regulatory modernization agenda, its commitment to enhancing transparency and openness, as well as its commitment to strengthening partnerships and collaborations.
While HPFB has a distinct role to play as the “regulator”, this role is nevertheless interdependent with that of the Branch's stakeholders given that the protection of the health and safety of Canadians is a shared responsibility. While the Branch has made significant progress on a number of key initiatives over the past year (e.g. Vanessa's Law, the Drug and Health Product Register, Thalidomide Victim's Compensation Package, Food Safety, Ebola response, etc.) it continues to look forward to the next objectives it must meet as it embarks on the development of its next 3-year strategic plan. HPFB's key priorities fit within the overarching Departmental objectives and the HPFB Stakeholder Engagement Session represented an opportunity for stakeholders to provide input into these priorities, and provide insights and feedback to the Branch as it moves forward.
Table conversations throughout the session were animated and frank. This session provided a unique opportunity for stakeholders to engage with senior managers from across the various Branch programs, as well as with stakeholder representatives from other sectors, enriching the many conversations that took place. While participants acknowledged the challenges the Branch is facing, they also provided a number of concrete and creative recommendations to the Branch to begin addressing many of these. Throughout the afternoon, a number of key themes emerged:
A key driver influencing the environment in which health products and foods are regulated is the continual emergence of new science, new medicines and new technologies which may not currently fit existing regulatory frameworks. Companies are seeking market access for new products at a rapid pace, and the pace of product innovation, the pace of new technology development and the level of complexity of new products will only continue to increase into the future.
Attendees encouraged HPFB to adapt its current regulatory processes to ensure that they are sufficiently nimble and flexible to meet the needs of Canadians into the future – to the point even of rethinking the Branch's mandate to include facilitation of market access and innovation, in addition to its current strong health protection focus.
Specific recommendations to the Branch included:
Establishing the level of oversight for a given product to be commensurate with the associated level of risk – in many cases, voluntary standards and consumer education have been very effective in managing risks to Canadians, without the need to resort to regulations;
Aligning regulatory requirements and risk mitigation approaches for health products and foods to the extent possible with those of international like-minded regulators – from a global perspective, the Canadian market is very small, and unique regulatory requirements can deter manufacturers from pursuing registration in Canada, potentially limiting Canadians' access to beneficial products;
Seeking stakeholder input earlier in the regulatory process – this can ultimately facilitate the development of policies, guidelines and regulations that are reflective of stakeholders' and government's mutual goal to bring safe and effective health products and foods to the Canadian market in a timely and efficient manner by bringing diverse perspectives to light at the outset of the process (e.g. at the policy development stage).
It was noted during the session that Health Canada (and HPFB) have a strong and trusted brand, and that efforts should be made to promote and maintain this brand. While participants recognized and acknowledged the fiscal challenges to the Department and the Branch, the question of whether HPFB has enough resources, as well as the right resources remains.
Session attendees encouraged the Branch to adjust its resources to the ever-changing regulatory environment and to endeavour to stay “ahead of the game” to ensure that Canada can be competitive in the global marketplace.
Specific recommendations to the Branch included:
Conducting a comprehensive and robust SWOT analysis to identify the Branch's current strengths, weaknesses, opportunities and threats, in order to determine where best to invest its resources – it was highlighted that the Branch cannot be “all things to all people”, and must focus on what it must do, and on what it does best;
Ensuring that resources are available to address new, emerging or currently under-resourced areas, including: i) collection, analysis and interpretation of “big data”; ii) communication to, and education of, consumers in a way that is useful to them and empowers them to make informed decisions related to their health care – including an understanding of the behavioural science and psychology related to decision-making; and iii) post-market surveillance activities.
Partnering with others to maximize resources and expertise – many participants noted the need for HPFB to focus on doing the work that only HPFB can do, and to collaborate with governments, industry, health care professionals, the public health community and other stakeholders to do the rest.
Participants noted that, in the current environment and context, HPFB can no longer continue to try and be everything for everybody, and must start to move away from the perception that only the Branch can be responsible for certain aspects of health product and food regulation. There is a genuine and immediate need for the Branch to strengthen existing partnerships, and to consider establishing new ones, in order for it to continue to deliver effectively on its mandate.
It is recognized that in the current complex, global environment, no single regulator can work in isolation – to be successful, the Branch will need to partner with others not only in Canada, but also around the world.
Specific recommendations to the Branch included:
Strengthening and redefining existing partnerships with industry – stakeholders are keen to expand their relationship with HPFB to include more than just the “regulator-regulated party” dynamic and contribute to, and build upon partnerships that already exist. These partnerships can allow a more effective contribution to the pursuit of common objectives and can assist HPFB in better serving Canadians
Building new and stronger partnerships with “non-traditional” stakeholders, including consumers, patients, health care professionals and the academic sector – these sectors are often at the forefront of detection for emerging issues and trends and can play a strong advisory role to the Branch with respect to upcoming areas of challenge to be addressed.
Strengthening and establishing partnerships with domestic and international regulatory partners – HPFB should not continually be looking to “re-invent the wheel” with respect to regulating health products and foods, and should look to leveraging our partners' expertise in certain areas to address gaps and challenges within the Canadian context.
While acknowledging that the current meeting was a positive indication that HPFB is committed to building and improving its methods of stakeholder engagement, it was noted that additional focus to engaging with Branch stakeholders early, and in a consistent manner was necessary. While perspectives on the appropriate level of engagement varied between participants, the need for enhanced and proactive communication by the Branch of upcoming opportunities for consultation, feedback and input was echoed by all groups.
Stakeholders spoke of the existing bi-lateral engagement processes across specific product lines as a model for success, and encouraged the Branch to consider adopting similar, predictable means of engaging across programs and issues to ensure meaningful engagement with all stakeholders. A common thread within this theme was that early and meaningful engagement allows stakeholders to become ambassadors for HPFB.
Specific recommendations provided to the Branch included:
Engaging stakeholders at the early stages of decision-making and policy development - there is an overall feeling that late-stage consultations reinforce the perception that seeking stakeholder views is simply an afterthought. This tends to result in stakeholders having to assume a reactive position, rather than being proactive contributors to Branch programs and processes;
Elevating the level of engagement with stakeholders to topics that impact HPFB's strategic direction - while stakeholders are accustomed to being engaged in the development of program-specific directions, they are also eager to provide input to more over-arching principles impacting the Branch, including the establishment of strategic priorities and broader policy direction.
Better planning for engagement and predictable follow-through are needed. In many cases, stakeholders have limited resources to devote to consultation processes, and knowing where and when their input will be sought in advance allows them to ensure that resources are made available as needed. It is equally important that the Branch follow-through on how it has used stakeholders' feedback in its decision-making processes.
The HPFB would like to thank all participants for their candid, frank and constructive input to the Stakeholder Engagement Session. The input and feedback received is critically important to the Branch, and the HPFB management team intends to use the ideas and input received during this session to create a “baseline” from which we will strive to improve the Branch's engagement with all stakeholders.
The “macro” level engagement initiated at this session – which cuts across all of HPFB's product lines – will continue, and will complement the ongoing engagement processes already underway on specific product areas and issues. The Branch commits to taking the messages heard from this session and translating them into substantive and concrete actions.
A total of 32 session participants provided feedback to HPFB via a web-based survey on the June 23 Stakeholder Engagement Session.
While some respondents provided comments related to event logistics, overall feedback on the session content was positive, with approximately two-thirds of respondents indicating that they were satisfied or very satisfied with the session, and 94% recommending that similar sessions be planned in the future. All respondents felt that the discussion topics were relevant to highly relevant to their organizations and many indicated that the diversity of stakeholders present provided a unique opportunity for those impacted by the Branch and its activities to discuss common issues. The high level of engagement from HPFB senior management was also noted and appreciated. In addition, respondents shared a number of concrete ideas about how to ensure that future sessions continue to be effective and provide value to participants and Branch representatives alike.
The Branch wishes to extend its sincere thanks to all those participants that took the time to provide their feedback through the survey and questionnaire. The survey results have been shared with HPFB's senior management team, and the feedback received, as well as the ideas provided for future sessions, will be considered in the planning of future bi-lateral, sector-specific and/or Branch stakeholder engagement events.