Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks - August 1, 2000

Previous       Table of Contents            Next

1. Introduction

Risk: A measure of both the harm to human health that results from being exposed to a hazardous agent, together with the likelihood that the harm will occur.

1.1 Why Revise the Decision Making Framework?

A Decision Making Framework has two primary functions. First, it is a quality assurance tool which formalizes decision making as a consistent process with identifiable steps. Secondly it helps to identify the important principles and organizational values of decision making. In 1993, Health Canada published a formal risk determination framework, which defined and described the risk assessment and risk management process in a structured way [Health Canada, 1993]. Since that time, decision makers have been faced with a number of important challenges including: rapidly advancing health related technologies; changes in government organization, roles and responsibilities; and a rapidly expanding, diverse information and knowledge base.

Over the last decade, government decision making has come under increasingly critical scrutiny. In particular, the Krever Commission of Inquiry on the Blood System in Canada (1997) provided a detailed criticism of decision making as it related to the management of Canada's blood supply. In the summer of 1997, Health Canada launched a fundamental review of its health protection operations in response to these criticisms and to the new challenges in health risk management. This initiative ( Health Protection Branch Transition) was designed to help Health Canada and its partners better manage risks to the health of Canadians into the next century [Health Canada, 1998].

Recommendations for improved decision making based on the national public health consultations held by HPB Transition and from various Health Canada working groups focused on several major themes, including:

The Examination of Health Risks Within a Broad Perspective
Traditional risk assessments typically focus on the results of biological, chemical, and physical studies involving the health effects resulting from exposure to a single agent. In recent years, there has been a growing recognition that a number of factors or determinants can affect health, and these determinants together with their interactions, can influence the level of risk for specific populations. There has also been a growing recognition that risks need to be viewed in their public health context to ensure that the most important risks are addressed and that key risks are not ignored because an issue has been defined too narrowly. Taking both of these things into account can lead to more complete and meaningful risk assessments, and to the development of risk management strategies that are more effective and that have fewer unintended adverse impacts.

Collaboration, Partnership and Team Work
To avoid duplication of services and to be cost-effective, governments at all levels are developing partnerships. Canada-wide health protection systems, non-governmental organizations and university research communities are capable of doing some of the work that is now being done within Health Canada. While some level of scientific and other ollaborations have always existed, the nature of these collaborations and the extent to which they are undertaken, must increase in order to ensure that an appropriately broad range of information and expertise are taken into account when identifying, assessing, and managing health risks.

Effective Risk Communication
The growing complexity of risk assessment and risk management, the increasing interest and demand of the public for more information, and the number of recent controversies related to the handling of specific risk issues (e.g. contamination of the blood supply; whether to permit use of recombinant bovine somatotrophin (rBST) in Canada), all contribute to the need for Health Canada to provide interested and affected parties with timely, relevant information, in a format that is useful to them. The public is no longer satisfied with merely being presented with the results of risk management decisions after the fact.

Public Engagement and Stakeholder Participation
In recent years, members of the public have become more interested in being involved in decisions that affect them, especially when it comes to their health. The reluctance of many individuals to rely on government to singularly make risk management decisions, requires that mechanisms be put into place to provide greater opportunities, not only for the exchange of information, but where possible, for participation in the risk management decision-making process.

Transparency
The growing complexity of risk assessment and risk management, and public expectation for information, make it critical that the risk management decision-making process be clear and understandable, in terms of the steps involved, the basis for decisions (including uncertainties, assumptions, and their impacts), and the roles, responsibilities, and accountabilities of participants.

Accountability
In recent years, there has been an increasing public demand for governments to demonstrate accountability for their actions, and to ensure the wise use of limited resources. This requires increased to attention to priority-setting, and to selecting and implementing effective risk management strategies.

Flexibility and Ability to Adapt to New Situations in the Management of Health Risks
The need to deal with new health risks, new discoveries and technologies, a broad range of information and perspectives, and the greater involvement of multiple participants (including different levels of government), all must be factored into risk management decision-making. The current environment requires that a wider range of risk management options be considered, where possible, so that an optimal approach can be selected (i.e. one which is effective, has minimal negative impacts, and can be carried out at a reasonable cost).

The emergence of these challenges has had an enormous impact on public health and the work of health protection. Health Canada has recognized the need to modernize the health protection system, including its approach to risk management decision-making, to deal effectively with such challenges. Much progress has been made over the past several years; however there is currently no formalized, consistent approach, being applied across the spectrum of health protection issues. There is clearly a need to make further progress in this area.

1.2 Developing a Revised Approach

Through HPB Transition, Health Canada is developing a decision-making framework, consisting of three components (issue identification, risk assessment, and risk management), and a number of documents that provide guidance in dealing with related considerations.

What's in a Name?

There is no standardized terminology when it comes to dealing with health risks. Various agencies and organizations use different terms to refer to the same process, and in some cases, the same terms to refer to different processes. This can present a problem in instances where these groups need to exchange information, collaborate, or ensure that legislated requirements or international agreements are adhered to.

For example, the term "risk analysis" is used in the area of food safety, by the Codex Alimentarius Commission, Health Canada's Food Programme, and the Canadian Food Inspection Agency, the term "risk determination" is used in the 1993 Health Canada Framework, and the term "risk management" is used by the Canadian Standards Association, U.S. Presidential/Congressional Commission on Risk Assessment and Risk Management, U.S. Environmental Protection Agency, International Standards Association, and Health Canada's Therapeutic Products Programme.

Use of the term the general term decision-making framework is intended to avoid the difficulty of trying to reconcile terminology differences that exist, while recognizing that Health Canada needs to take the perspectives of various health protection agencies into account.

The revised approach:

• Maintains a focus on health and safety.
  
  
• Broadens the base of information used for decision-making.
  
  
• Supports an evidence-based approach.
  
  
• Provides clarity in terms of the process followed, information used, and decisions made.
  
  
• Provides sufficient flexibility to address a range of risk issues and situations.
  
  
• Strengthens the Department's ability to evaluate risk management strategies.
  
  
• Clarifies the roles, responsibilities, and accountabilities of participants.
  
  
• Provides greater opportunities for the involvement of interested and affected parties.
  
  
• Provides the basis for a systematic, comprehensive, coordinated Branch, and Department-wide approach.
  
  
• Serves as a tool at the center of a broader framework for policy development.

Consistency: A Key Advantage of the Revised Approach

Although the Department has had an "official" approach for assessing and managing health risks since 1993, the approach has been implemented to varying degrees across and even within various Branch programs. While programs have done well in meeting their own needs and dealing with many risk issues, there has been no coordinated effort to train individuals in applying a common approach, or to ensure that the approach is applied in a consistent and comprehensive manner. This is especially a concern for risk issues that cut across program areas (e.g. a chemical contaminant in air, water, and food), and has sometimes resulted in different risk assessment and management approaches being used, difficulties in
information exchange and understanding, and difficulties in developing consistent Branch risk management policies.

The development of a revised approach for risk management decision-making (including the framework, its underlying principles, and associated guidance documents) together with a coordinated implementation effort across and within various programs, will provide the Branch with a common, consistent, and comprehensive means of dealing with risk issues. Working together can increase efficiency, effectiveness, and consistency of decisions, reduce duplication of effort, identify gaps in science and policy, and help to ensure that resources are used effectively.

1.3 Underlying Principles

A number of principles underlie the risk management decision-making process, and provide a general basis for decisions made and actions taken. A key difference between the revised approach and that embodied in the 1993 framework, is the formalization of a number of such principles, and the more consistent integration of these principles into the steps of the decision-making process.

The principles described below reflect Health Canada's current risk management decision-making philosophy. The principles respond to the changes in our operating environment, noted earlier, as well as other values that have been emphasized both in internal and external consultations. Some of the principles are based on ideas from other sources [European Commission, 1998; Hrudey, 1998; Light and Hrudey, 1998; Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997 a, b; Hattis, 1996; National Research Council, 1996]. The principles are inter-related and must be applied in a cohesive fashion.

In practice, many of these principles have been evolving over the last several years, as Health Canada has strived to continuously improve the policy development and decision-making process. Further some principles have already been applied when dealing with certain health protection issues. Defining these principles in an explicit way, as a key element of the revised approach, can help to ensure a common understanding among individuals who participate in, are interested in, or affected by, the risk management decision-making process, and that the principles are implemented in a more consistent manner across all health protection programs.

While every attempt should be made to apply the various principles below to specific risk issues and situations, it should be noted that their application may be limited in certain instances due to legislative or other requirements or restrictions.

Underlying Principles

• Maintaining and Improving Health is the Primary Objective
  
  
• Involve Interested and Affected Parties
  
  
• Communicate in an Effective Way
  
  
• Use a Broad Perspective
  
  
• Use a Collaborative and Integrated Approach
  
  
• Make Effective Use of Sound Science Advice
  
  
• Use a "Precautionary" Approach
  
  
• Tailor the Process to the Issue and its Context
  
  
• Clearly Define Roles, Responsibilities, and Accountabilities
  
  
• Strive to Make the Process Transparent

Maintaining and Improving Health is the Primary Objective.
Give health and safety precedence in making risk management decisions, over economic and other considerations. Balance Health Canada's mandate to protect the health and safety of Canadians, with the right of individuals to make personal choices. Where these two interests are at odds, decisions must always favour the former over the latter.

Involve Interested and Affected Parties.
Provide adequate opportunities for affected and interested parties to be involved in the risk management decision-making process [Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997 a, b; Canadian Standards Organization, 1997]. This includes the decision as to whether to apply a precautionary approach and which provisional risk management strategy should be implemented.

Involvement means providing individuals and groups with access to relevant information, and with an opportunity to express their views and to influence policy decisions. It does not mean that unelected and unaccountable members of the public or other groups can make decisions for which Health Canada is accountable. The nature and extent of involvement may vary depending on a number of factors including whether there is a need for a quick response (e.g. in an epidemic) and the level of resources available, and may range from active participation, to ensuring that concerns are sufficiently addressed, to the provision of information. Providing opportunities for involvement can build trust, lend credibility to decisions, and provide access to critical information. In order to be effective, the process for involvement must be clear and explicit, and carried out in a systematic way.

Communicate in an Effective Way.
Provide clear, accurate, relevant information to interested and affected parties in a timely manner, using a format that is useful and easily accessible to them [Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997 a, b; Canadian Standards Organization, 1997]. Communication is a two-way process and includes developing an understanding of the needs of interested and affected parties, reacting to concerns and informing, consulting, and educating. An important aspect of effective communication is providing individuals with enough information to allow them to contribute to the decisionmaking process in an informed way. The specific nature and extent of communications varies as does the nature and extent of public involvement.

Health Canada has a responsibility to inform and educate Canadians about risks to their health, and the process that is being used to assess and manage these risks. This includes helping individuals to understand that every choice brings with it some degree of risk and that certain risks are shared by society as a whole. It also includes providing information that allows individuals to make their own decisions on matters which concern their health, particularly when the degree of risk is low and the information is readily accessible. When possible, it also includes providing opportunities for individuals to contribute to the risk management decision-making process by expressing their concerns and perspectives, and by providing knowledge and expertise that can help to shape the process and decisions made.

Effective communication is especially important in cases where there are large discrepancies between perceptions and scientific assessments of risk. Special care must be taken care when communicating with groups whose first language is neither English nor French, to ensure that their concerns are understood and that risk messages are communicated in an understandable manner.

Use a Broad Perspective.
To the extent possible, take into account a variety of information when identifying, assessing, and managing risks, while maintaining a focus on health and safety. A sufficiently broad understanding of the issue and its context are key to focusing risk assessment efforts, identifying risk management goals, selecting efficient and effective strategies, and appropriately allocating resources.

Risk assessment must be sufficiently broad to ensure adequate understanding of the risk and to identify effective risk management options. Where possible, assessments must take into account both data from "scientific" studies, and information on determinants of health (e.g. social, cultural, ethical considerations, economic status), where these determinants are demonstrated to have an effect on the level of risk for specific populations. Where possible and appropriate, assessments must also consider interactions between agents rather than individual agents in isolation.

Risk management decisions must consider a variety of information in order to ensure that the best risk management strategy is selected and that it is implemented in an effective manner. The expected effectiveness of potential risk management options, and legislative, international trade, or other requirements and limitations are obviously key considerations. Taking a broad perspective means also taking into account factors such as risks vs. benefits, potential social, cultural, ethical, political, environmental, legal, economic, and other impacts, and the perspectives of interested and affected parties.

While it is important to strive for a broad perspective, it should be noted that the extent to which this is possible may be limited by existing legislation, which obviously, takes precedence.

Taking a Population Health Approach

Determinants of health is the collective label give to factors and conditions that are thought to have an influence on health. These include things such as income and social status, social support networks, education, employment and working conditions, social and physical environments, personal health practices, and coping skills. Some determinants play a more prominent role than others for given health issues, and interact in complex ways to affect population health.

Taking a population health approach involves focusing on the health of the population as a whole, and of subgroups within the population, by addressing factors that contribute to health and their complex interactions. The approach addresses not only the physiological, psychological and behavioural components of health, but also the entire range of factors that contribute to our physical, mental and social well-being. The overall goal of a population health approach is to maintain and improve the health status of the entire population while reducing inequalities in health status among population sub-groups.

Use a Collaborative and Integrated Approach.
Use a collaborative and integrated approach for identifying issues, and assessing and managing risks. The volume and complexity of information, and the cross-cutting nature of many risk issues (e.g. contaminants in air, water, and food), make it impossible for a single individual or group to maintain the necessary expertise to deal with most health risks of concern to the Department. Working together can increase efficiency, effectiveness, and consistency of decisions, reduce duplication of effort, and identify gaps in science and policy.

Maintain sufficient in-house expertise to support policy making, to implement regulations, to set standards and regulations, and to respond to emerging health issues. To supplement this, take advantage of the expertise that exists within other national and international organizations, including those involved in health protection, academia and industry. Don't duplicate existing efforts where they meet the level of scientific and health protection standards of the Department, taking current jurisdictional constraints into account.

Make Effective Use of Sound Science Advice Success in maintaining and improving our health requires an evidence based approach to decision making. This can only be achieved by making effective use of sound science advice. Such an approach helps to address public confidence that decision makers are using science in the best interests of Canadians, that science advice is credible, and that decision makers are confident that this advice is based on a rigorous and objective assessment of all available information. In order to achieve these goals, the decision making process must include measures to ensure the quality, integrity and objectivity of science advice (Council of Science and Technology Advisors, 1999, Industry Canada, 2000).

Use a Precautionary Approach.
A key feature of managing health risks is that decisions are often made in the presence of considerable scientific uncertainty. A precautionary approach to decision making emphasizes the need to take timely and appropriately preventative action, even in the absence of a full scientific demonstration of cause and effect. This emphasis in decision making is reflected in the final report of the Krever Commission of Inquiry. It concludes that a lack of full scientific certainty should not be used as a reason not to take preventive measures when reasonable evidence indicates that a situation could cause some significant adverse health effect.

This general concept has been expressed in a variety of contexts, especially in the area of environmental protection. The most widely quoted is Principle 15 of the Declaration of the Rio Conference on Environment and Development (1992).In the Canadian context, the Canadian Environmental Protection Act (1999) provides that "... the government of Canada is committed to implementing the precautionary principle that, where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation".

There is considerable debate, both nationally and internationally, over the use of the phrases "precautionary approach" and "precautionary principle". No definition is universally accepted. The Health Canada Decision Making Framework treats the concept of precaution as pervasive. As such it does not require extremes in the actions taken. Instead, risk management strategies reflect the context and nature of the issue, including the urgency, scope and level of action required.

Tailor the Process to the Issue and its Context.
Maintain flexibility throughout the risk management decision-making process. Using a flexible approach can lead to more effective and more acceptable risk management decisions. While recognizing there are urgent situations that require quick action, the emphasis on timeliness and flexibility should never be at the cost of thorough and thoughtful, even if rapid, consideration of all the steps and considerations identified in the framework.

Using a flexible approach includes: undertaking the process in a way that is best suited to different agents and situations; limiting the depth and breadth of the process to take into account the requirement for a timely response; revisiting previous steps when new findings provide important insights related to earlier deliberations and decisions; incorporating significant new information that may emerge throughout the process or following evaluation; using a variety of risk management options and levels of response as needed to provide a given level of health protection; and revisiting decisions periodically to determine whether a revised risk management approach or strategy is needed.

Using a flexible approach may also involve implementing a "two-track" process in certain situations. Such a process could include a reactive and timely response, involving an interim risk management strategy, and the pro-active, systematic development of longer term strategy, which enhances the Department's capacity to anticipate, prevent and respond to the new instances of the risk issue. Using a two-track approach allows the decision-making process to move forward without having to delay necessary action until more comprehensive work is done.

Clearly Define Roles, Responsibilities, and Accountabilities.
Clearly define the roles, responsibilities, and accountabilities of all parties who participate in the risk management decision-making process, as well as Health Canada's relationship with each of them. This includes identifying who is responsible for undertaking comprehensive risk assessments in cases where precautionary action has been implemented. Clearly delineating roles, responsibilities, and accountabilities helps to ensure that participants and other interested and affected parties know what is expected and what commitments have been made, and thereby can lead to more efficient and effective risk management strategies. It also helps in the allocation of resources.

The responsibility for improving and maintaining health is one shared by individuals, communities, industry, and all levels of government. Health Canada has a primary role in protecting the health and safety of Canadians at the national level; however it is but one component of a complex system of health protection, which includes, among others, various levels of government, government agencies, the health care and medical professions, the academic and health sciences research and development communities, manufacturers and importers, consumer groups, and individual Canadians. This makes it important to identify potential conflicts (e.g. conflicting regulations and overlapping jurisdictions of governments and related agencies), to eliminate gaps, and to ensure that health protection programs are delivered seamlessly across the country. It is also important to be specific about accountabilities, especially when there is shared responsibility, and to avoid giving the impression that Health Canada is accountable for matters outside the Department's mandate or jurisdiction.

In addition to specifying the roles of various organizations, it is necessary to differentiate between the roles of scientists and policy makers. While both teams may contribute to issue identification, their primary roles are to undertake risk assessment and risk management, respectively. The role of scientists is to assess risk based on the science (both biophysical data and information on risk factors), and to identify potential risk management options that are related to the level of risk. The role of policymakers is to consider the results of risk assessments, together with a broad range of other considerations, and use this information to make risk management decisions.

Strive to Make the Process Transparent.
Clearly document all activities, considerations, assumptions, uncertainties, and decisions, to ensure that all aspects of the risk management decision-making process are clear and easily understandable. Bearing in mind any requirement for confidentiality, make this information accessible to interested and affected parties. Individuals who review the documentation should be able to understand how and why things were done, what decision-making processes were used, and who is accountable and responsible for various activities and decisions. Although it is important to maintain clear and comprehensive documentation, the extent of documentation needs to be balanced by resources and priorities, especially when the timeliness of the response is critical.

1.4 Overview of the Framework

The proposed risk management decision-making framework is depicted in Figure 1 and consists of a series of inter-connected and inter-related steps, which may be grouped into three phases: issue identification (identify the issue and put it into context); risk assessment (assess risks and benefits); and risk management (identify and analyze options; select a strategy; implement the strategy; and monitor and evaluate the results). The framework reflects the involvement of interested and affected parties throughout the process, including partners, the public, and other stakeholders.

Generally speaking, the process begins at the top of the diagram, and proceeds clockwise through the other steps; although the steps are depicted as a series of circles, there is a general linear progression. Each step involves a decision point, as to whether to proceed to the next step, revisit a previous step, or end the process. The process is flexible in that one may move back and forth between steps or revisit steps based on available information. For example, a previous step may be revisited when there is a need to improve the accuracy and completeness of information, or when new information becomes available and needs to be considered.

Figure 1: Decision-Making Framework

Interested and affected parties, including partners, the public and other stakeholders can play a key role in issue identification, risk assessment and risk management. They can provide valuable information, knowledge, expertise, and insights throughout the process, and should be involved as early as possible. The roles, responsibilities, and accountabilities of all parties who participate in the process must be clearly defined for each issue being addressed.

The effective communication of risk-related information (i.e. risk communication) is an integral part of the process, because both the substance and the process of risk management decisions must be acceptable to a broad range of interested and affected parties. Effective risk communication assists in the exchange of information, and facilitates informed decision-making. The goal of effective risk communication is to ensure that there is an adequate understanding of the process by all interested and affected parties.

Documentation is also a key aspect of the process. Two types of documentation are needed for each step: first, a description of how the step should be undertaken, including data requirements, assumptions, considerations, and how decisions should be arrived at; and second, a summary of how the step was actually undertaken, the assumptions used, the uncertainties that exist, and how decisions were made, with an explanation given of any changes from the original plan. The requirement for detailed documentation may vary depending the issue being addressed and its context, with consideration being given to factors such as the importance of the decisions to be made, the level of concern, the resources available, and the need for timeliness. Consideration must also be given to the need and/or legal obligation to keep certain information confidential. Reasonable efforts should be made to document the process without generating excessive paperwork

While implementation of the framework will help to ensure that risks are addressed in a consistent and comprehensive manner, its application is not intended to be rigid or prescriptive. The manner in which the framework is applied to specific situations or specific risks may vary. Similarly, the relative importance of the steps, the extent to which they are carried out or revisited, and the tools, data, and specific considerations involved, can vary depending on the issue being addressed and its context. For example: the framework need not be invoked in a detailed way, for risk situations that are routinely and expeditiously managed (e.g. voluntary product recalls); in dealing with crises situations, steps may be undertaken rapidly or implicitly due to the need to act quickly; a more detailed risk assessment may be undertaken later, following the implementation of a risk management strategy.

The selection of a circle diagram as opposed to a linear one, reflects an emphasis on an integrated decision process, its component steps, and their interrelationships, and is similar to that proposed by the U.S. Presidential/Congressional Commission on Risk Assessment and Risk Management in 1997. It is recognized that certain programs within Health Canada and certain external organizations use different diagrams to depict the risk assessment and risk management process, and that the choice of diagram reflects an emphasis on different aspects of the same process. This includes for example: the roles, responsibilities, objectives, and functional autonomy of participants (e.g. Codex Alimentarius Commission; Health Canada's Food Program; the Canadian Food Inspection Agency); tasks and work flow (e.g. 1993 Health Canada Framework; Canadian Standards Association Q850 Framework); and a decision making process with continuous improvement (e.g. Health Canada's Therapeutic Products Program). It is important to note that the decision making processes noted above are consistent in approach despite being represented by different images or diagrams (i.e. they reflect similar tools, ideas, and goals).

Detailed descriptions of each of the steps in the decision-making framework are provided in section 2 below. With the exception of the first step (which is new), all steps are generally similar to those in the 1993 framework. The key differences lie in the integration of the underlying principles (described earlier) within the various steps. Of particular note are the emphasis on: providing opportunities for the involvement of interested and affected parties; communicating risk-related information; clearly documenting all aspects of the decision-making process; using a precautionary approach when warranted; taking a broader, population health perspective; and measuring the effectiveness of risk management strategies.

As noted earlier in the Underlying Principles section, these changes have already begun to take place in practice, over the last several years. Explicitly defining the steps (and the inherent principles) in the revised framework, can help to ensure a common understanding among individuals who participate in, are interested in, or affected by, the risk management decision-making process, and that the steps (and principles) are implemented in a more consistent manner across all health protection programs.

Taking Population Health Approach

Taking a "population health" approach to risk management decision-making means:

• making greater effort to identify subpopulations for which a health issue is of particular concern;
  
  
• incorporating information on social, cultural, economic, and other health determinants into risk assessments, when these factors are demonstrated to have an impact on the level of risk for specific
  populations;
  
  
• considering a greater variety of potential risk management options, particularly non-regulatory ones where they offer an acceptable level of health protection;
  
  
• paying greater attention to the unintended impacts of potential risk management options, particularly on social, cultural, and other factors that affect health;
  
  
• making greater use of multi-faceted risk management strategies, where possible, to improve effectiveness with different populations;
  
  
• involving a variety of partners in implementing strategies, and implementing these strategies on several levels, in several sectors, and using several methods, where possible, to improve effectiveness; and
  
  
• considering the effectiveness of risk management strategies, both in terms of traditional measures, and in terms of their impact on a variety of health determinants.

This approach has been evolving in practice over the past several years. It integration within the decisionmaking framework will help to ensure that it is applied routinely and consistently across all health protection issues (unless limited by legislative or other requirements or commitments).