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

Preface

Background

Canadians are among the healthiest people in the world. An important factor in achieving this success is our willingness to exploit opportunities provided by scientific discovery and technological innovation for improvement. Almost every aspect of our lives is affected by new technologies. These include the development of therapeutic and other health products, innovations affecting the quality and safety of our food supply, and the creation of new industrial and other consumer products. While our health and general standard of living has improved through technological advances, it is important to realize that all processes, activities and products have the potential to adversely affect our health. In fact, many of the modern challenges to health are a consequence of complex interactions between our physical and social environments together with our personal and life style choices. In order to properly address this complexity, maintaining and improving health requires a structured, analytical and deliberative approach to mitigating and controlling health risks. In Canada, maintaining and improving our health is a responsibility shared by individuals, communities, industry, and all levels of government.

Health Canada helps protect the health of Canadians with programs and regulatory measures concerning: the quality, safety and effectiveness of drugs, medical devices and pesticides; the safety of consumer products and workplace substances; the safety and nutritional quality of food; exposure to toxic substances in the environment; and the quality of air and water [Health Canada, 1998]. The Department also helps Canadians to prevent, and reduce the incidence and severity of disease, injury and disability, through for example, prevention and control programs for specific diseases (such as HIV, cancer or cardiovascular disease) and for groups or individuals at higher risk [Health Canada, 1998]. The assessment of health risks, and the selection and implementation of effective risk management strategies, form the basis for many of Health Canada's activities.

In 1993, Health Canada published a formal framework, which defined and described the risk assessment and risk management process in a structured way [Health Canada, 1993]. While the 1993 approach served its purpose well, in recent years there have been a number of changes in society, science and technology, that have prompted the Department and other public health agencies to reexamine the way that they deal with health risks. These changes have had an enormous impact on public health and the work of health protection. Health Canada has recognized the need to modernize its approach to risk assessment and risk management, to deal effectively with these new 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.

Project Overview

In the summer of 1997, Health Canada launched a fundamental review of its health protection operations. This effort, known as "Health Protection Branch (HPB) Transition," was aimed at helping Health Canada and its partners to better manage risks to the health of Canadians into the next century [Health Canada, 1998]. Through HPB Transition, Health Canada developed a decision-making framework and a number of documents that provide guidance in dealing with related considerations. Implementation of the framework, its underlying principles, and the associated guidance documents, will help the Department to deal with the challenges of the current environment, in a consistent, comprehensive and coordinated fashion, and consequently will improve the effectiveness of the risk management decision-making process across its health protection programs.

Contributors

Appendix A lists the members of the Risk Management Framework Project Team, who provided direction, coordination, technical expertise, and assistance for the project, and developed this document (or its earlier versions), based on a variety of input. An accompanying document lists the names and memberships of the numerous Groups that provided program-related input and developed guidance and other documents. A number of other individuals also provided comments that contributed to the development of the framework and guidance documents, through their participation in focus groups held in the winter of 1997/98, and comments on earlier drafts. Comments made during public consultations in the fall of 1998, and various presentations throughout 1999 also contributed to the development of this document.

Purpose of the Framework and Guidance Documents

The purpose of this document is to provide a description of the key challenges which led to the development of the revised framework, the general principles that underlie the framework, a detailed description of the steps in the framework, and an overview of the considerations that are dealt with in various guidance documents.

A summary document is available, which includes only the key challenges, the general principles, an overview of the steps in the framework, and a limited glossary. Draft guidance documents dealing with the following considerations are also available under separate covers: conducting environmental risk assessments; conducting socioeconomic analyses; communicating risk-related information; involving interested and affected parties; integrating population health and risk management decision-making; developing health-based outcome measures; and setting priorities.

The framework and guidance documents are intended to provide a common, general basis for risk management decision-making throughout the Department. The documents in themselves are not intended to be implementation manuals; rather they can be used by individual programs to develop specifically tailored procedures to meet their particular needs.

Intended Audience

The framework and guidance documents are intended for use by Health Canada managers and staff, including scientists and public health professionals, who are responsible for, or involved in carrying out, various aspects of the risk management decision-making process. The documents will be of particular interest to those individuals responsible for developing program-specific implementation procedures.

Intended Application

The framework and guidance documents are intended to be applicable to the range of agents that fall within Health Canada's mandate. These agents include: diseases (both communicable and noncommunicable); substances (chemicals, radiation, microbes); and products (food, medical devices, drugs, tobacco, consumer products). In addition, a document has been developed to provide guidance for undertaking environmental risk assessments on products of biotechnology (as required due to legislative obligations).