Health Canada is responsible for maintaining and promoting the health of people living in Canada by regulating and communicating risk information on diverse products such as pharmaceuticals, vaccines, medical devices and natural health and pest control products (Government of Canada, 2014a). The organization's governance structure and legal framework supports the various programs and activities at the national/federal level.

The COVID-19 pandemic provides an excellent example of the government's responsibilities for addressing health risks at the federal, provincial/territorial, and local levels (Government of Canada, 2022c). Under the Food and Drugs Act, Health Canada, federally, held responsibility for evaluating, approving, and communicating risk-related information on the messenger RNA vaccines. Health Canada also worked alongside portfolio partners in the Public Health Agency of Canada (PHAC), who were responsible for implementing public health measures while working in collaboration with the provinces and territories (Government of Canada, 2022a,b).

Health Canada has an overarching, health risk decision-making framework (Health Canada, 2000), a strategic risk communications framework (Health Canada, 2006), and a range of tailored, program area-specific documents on risk decision-making (Health Canada, 2000, 2012; Government of Canada, 2013a,b; Health Canada's Consumer Product Safety Program, 2015; Bureau of Microbial Hazards, 2017; Pest Management Regulatory Agency, 2021). A Primer on Scientific Risk Assessment at Health Canada (Saner, 2010) provides additional perspectives on established risk assessment processes while publications on next generation risk assessments (Bhuller et al., 2021; Stucki et al., 2022) show Health Canada's commitment toward more modern approaches to evaluating risks.

Health Canada's health risk decision-making framework defines risk communication as: “Any exchange of information concerning the existence, nature, form, severity or acceptability of health or environmental risks” (Health Canada, 2000). This overarching decision-making framework is also integrated in Health Canada/PHAC's Strategic Risk Communications Framework and Handbook, which provides guiding principles, a seven-step process, and a detailed handbook for communicating risks (Health Canada, 2006).

Health Canada communicates risks through product-specific information, such as labels, inserts, and monographs, as well as messages provided using other platforms (e.g., social media). For each communication, the message is tailored for the audience (Council of Canadian Academies, 2015; Lee and Lee, 2022). This presents one of the greatest challenges in communicating risks as audiences can be extremely broad and heterogeneous. Consequently, the communication modalities need to be diverse and flexible so that they can go from two-way to more complex approaches involving “multi-way” communication. This requires accommodating a varying degree of knowledge, perceptions, attitudes, and behavior of all parties involved (Balog-Way et al., 2020). Further, the ethical (respect) and instrumental (reciprocity) imperatives for effective science communication, and the importance of recognizing the audience's reaction, can also improve clarity and delivery of a message (Moore, 2022).

Some of the Canadian regulations include requirements for communicating risks to help people make informed decisions. For example, Division 5 of the Food and Drug Regulations describes the requirements for human clinical trials. Section C.05.010 of these regulations provides requirements for communicating risks and anticipated benefits arising from participating in a clinical trial. A published guidance document further expands and clarifies the intent of these regulations (Health Canada, 2022a). The challenge is that policies and guidance documents can make the presentation and language more technical. Further, as enforcement activities are typically focused on the regulated industry, certain risk communication products, such as product labels, are also legally enforceable. Therefore, risk communication, in these instances, is intentionally more rigid, when compared to other types of messages.

Complex health and environmental issues, such as the opioid crisis (Belzak and Halverson, 2018), require collaborative efforts and governance from all sectors of society and levels of government. Systems thinking, defined as “… seeing how things are connected to each other within some notion of a whole entity” (Peters, 2014), provides a holistic strategy for decision-makers to consider multiple perspectives necessary for addressing these types of wicked problems.

Using a systems thinking lens, Figure 1 shows how Health Canada's risk management decision-making process is integrated through various steps (visualized as circles) which are further positioned inside a broader system of elements (visualized as slices and bubbles with text). The significance of systems thinking is the ability to recognize the complexity, intersections, and interactions of the overall system and how an impact in one area can affect another or the entire decision-making process. Further, systems thinking and tools to mobilize additional knowledge, such as causal loop diagrams (Haynes et al., 2020), provide insights which could assist in optimizing the strategy for addressing the risk issue. For example, an international decision to ban a particular product could trigger the first step of the risk management process (i.e., identify the issue and its content) at the national level. Once the process starts, a systems thinking approach could help determine the strategy for communicating the risks. For complex issues this includes considering a Pan-Canadian approach and collaboration at all levels of Government (i.e., Federal, Provincial/Territorial, and Local). A systems thinking lens also provides an opportunity to adapt the message based on an understanding of the science behind human behavior and attributes such as risk perception and tolerance (Krewski et al., 2006; Council of Canadian Academies, 2015; Kelly and Barker, 2016).

Health Canada (2000) has historically relied on this type of broad thinking and collaborative approach and the federal government's decision to re-label certain over-the-counter cough and cold products to no longer permit the use of certain products in children under 6 years of age provides one example. To aid in communicating this decision, Health Canada collaborated with various sectors of society, including the public. Further, each sector also discussed their role in delivering the message once the revised labels were in the marketplace (Health Canada, 2008, 2023; Shefrin and Goldman, 2009). More recent examples include the federal approach toward addressing antimicrobial resistance (Government of Canada, 2014b; Public Health Agency of Canada, 2015, 2017), incorporating new approach methodologies into risk assessment (Bhuller et al., 2021; Bury et al., 2021; Clippinger et al., 2022; Gilmour et al., 2022; Stucki et al., 2022; Van Der Zalm et al., 2022), and the management of the COVID-19 pandemic (Government of Canada, 2022a,b,c).

Some of the challenges of taking a systems thinking approach include the time, resources (both human and financial), and governance structure required to establish and maintain the collaborative space (Trochim et al., 2006; Boswell et al., 2021). Another challenge is effectively communicating risks within an organization when collaborating with diverse programs. Consequently, while developing strategies for communicating risks externally, sufficient time is also required to ensure a mutual, internal understanding.

While systems thinking is not required for all health and environmental risk issues, applying a systems thinking lens can help guide complex issues (Peters, 2014; Gates, 2016). Further, for global public health risks, systems thinking can provide mechanisms for incorporating agile approaches to knowledge mobilization by developing concepts through experimentation (Haynes et al., 2020). For example, improving the communication of risk within an internal and interdisciplinary team using several rounds of the (broken) telephone game. For those unfamiliar with this game, each person whispers a message to their immediate neighbor; at the end of the line, the last person says the message aloud to the room. In this example, members of an interdisciplinary team relay the risk communication message with a goal for making the outcoming response less technical. This type of exercise helps guide a team's understanding of choosing practical and easily understandable words and language for use in communicating risks.

Experts in risk communication have published key attributes, principles, and characteristics that can generate and strengthen messages (Health Canada, 2006; Lundgren and McMakin, 2013; Council of Canadian Academies, 2015; Aven, 2020; Covello, 2022; Friedman and Rogers, 2023; Peters, 2023). Another tool is a memory aid known as: BroadCAST-3Cs which brings together several of these risk communication attributes.² “Broad” is a reminder that regulatory risk communication, by necessity, is often for a large and heterogeneous population (Goerlandt et al., 2020). “CAST” stands for core, the underlying reason for the risk communication, audience, spokesperson, and the importance for providing the risk communication message in a timely manner. The “3Cs” is a mnemonic for conveying information that reflects the risk context, must be clear (sometimes written as clarity), and concise. Risk communicators, therefore, should adjust messages to meet the 3Cs of each target audience thereby informing them in a useful and meaningful way.

When identifying the core of a health or environmental risk issue, it is important to develop this concept from a principle-based mindset and not a position-based one (e.g., risk sciences vs. policy). Further, if the core principle is promoting health and safety, each member of an interdisciplinary team may approach a risk issue from a unique perspective, but what unites them is the core principle. It is also important to recognize that the technical leads for an issue may not be the spokesperson responsible for relaying the information to the public. Similarly, the audience can also change from internal staff to external stakeholders, partners, and publics. As a result, the spokesperson must adjust the messaging according to the audience while delivering the message in a timely manner, and models, such as “IDEA,” can also provide useful insights for this process (Sellnow and Sellnow, 2019).

Given the technical nature surrounding risk sciences, assessment, and management, there sometimes is a misconception that the plain language principles clear and concise are not applicable to risk communication. There are also expectations that any communication with the public must be at a certain grade level, which is not the case. Plain language principles can be applied to all types of communication. Updates to the international standards (ISO Standards, 2023) and national guidance documents (Government of Canada, 2020) aim to provide additional guidance in this regard (plain language expert, personal communication, June 17, 2021).

During the COVID-19 pandemic, governments at all levels had to manage uncertainty, misinformation, and advances in science. Health Canada continued to update and communicate regulatory advice using various platforms. Further, providing independent, regulatory, and timely input aligned with recommendations on how to maintain public trust and confidence during a global crisis (Mihelj et al., 2022). Health Canada officials also successfully used this approach to address the changing environment by providing clear communication for the safe use of diverse products, such as ultraviolet radiation-emitting devices (Health Canada, 2022b).

With advancements in technology, access to information and opinions is easier than ever before. Users acquire risk information from traditional sources, such as radio, articles, and television, and more recent forms of social media and artificial intelligence technologies. This imposes an additional burden to release effective regulatory risk communication in a timely manner, especially when dealing with uncertainty and misinformation (Howell and Brossard, 2021).

Regulatory risk communication must also address the concerns of the audience by understanding their position, behavior, and level of receptivity. This is no small feat to deliver on the multitude of platforms currently in use. Consequently, checking the “pulse” on how the audience received the information is also important in confirming that the message was delivered in the right context and by the appropriate spokesperson. Further, risk communicators must also ensure that audiences can access and use credible and trustworthy sources, a responsibility that extends to all public servants as they can inform individuals in their respective sphere of influence.

In 2015, the Council of Canadian Academies published Health Product Risk Communication: Is the Message Getting Through? These experts described the regulatory context for health product-related risk communication, documented existing best practices and tools, and recommended methods to evaluate the extent of reach to the target audience and impact of the conveyed message (Council of Canadian Academies, 2015). Additional recommendations included the importance of performance measurements using theory- and paradigm-based evaluations, such as realism (Pawson and Tilley, 2004; Pawson et al., 2005; Blamey and Mackenzie, 2016; Breuer et al., 2016; Pawson, 2017; Treasury Board of Canada Secretariat, 2021, n.d.).

There are several barriers in undertaking evaluations and here we identify three key barriers to robustly evaluating risk communication: resource constraints (time, human, and funding), complex performance measurement indicators, and limited expertise. Federal resources are typically devoted to core activities and projects. Developing an underlying theory for evaluation and measurement can be time consuming and complex. Consequently, it may be difficult to find teams with appropriate expertise. However, these barriers should not prevent authorities from dedicating time to, at least, discuss and reflect on lessons learned. This is especially important for initiatives without a formal evaluation component.