Supplementary Information on raison d’être, mandate and role

Raison d'être, mandate and role: who we are and what we do

Raison d'être

Health Canada regulates specific products and controlled substances and supports innovation and information sharing in Canada's health system to help Canadians maintain and improve their health.

The Minister of Health is responsible for this organization.

Mandate and role

At Health Canada, our role is to help Canadians maintain and improve their health. While the provinces and territories are responsible for delivering health care to the majority of Canadians, the federal government also has a number of key roles and responsibilities in areas that affect health and health care. In addition to working closely with provincial and territorial governments, we also work with partners in the Health Portfolio, other federal departments and agencies, non-governmental organizations, other countries, Indigenous partners and the private sector to help achieve our goal of making Canada one of the healthiest countries in the world.

As a partner in health, Health Canada:

  • protects Canadians from unsafe food, health and consumer products;
  • promotes innovation in health care; and,
  • informs Canadians to make healthy choices.

The meals we serve our families, the pesticides farmers put on crops, the herbal remedies, vitamins and drugs in our medicine cabinets, the toys we buy our children - they are all products regulated by Health Canada for safety. Hundreds of new products, with new ingredients and new purposes, are introduced by industry every year in Canada. Health Canada's decisions are made with the best interest of Canadians in mind, whether to approve the safety and quality of new products or to provide advice after they are on the market. Our actions are supported by scientific evidence.

Our Department is committed to upholding the Canada Health Act and protecting our publicly funded health care system, which helps to ensure Canadians have access to quality, universal health care based strictly on their medical needs, not their ability and willingness to pay. We also promote innovation and the use of best practices across Canada.

Health Canada's vision is to help make Canada's population among the healthiest in the world. From coast to coast to coast, Health Canada employees - scientists and researchers, inspectors, doctors and nurses, policy analysts and administrative professionals, and many others - are working to help Canadians maintain and improve their health.

As a regulator, service provider, promoter of innovation, and trusted source of information, we are a partner in health for all Canadians.

For more information on the Department's organizational mandate letter commitments, see the Minister's mandate letter.Footnote 1

Operating context and key risks

Operating context

Health Canada operates in a complex and dynamic environment, facing several challenges as it works to deliver results for Canadians. Many of these challenges are beyond the sole control of the Department and involve working collaboratively with a range of partners, including stakeholders, the public and various levels of government. 

Canada's public health care systems were designed more than half a century ago. All levels of government are aware of the need to adjust to the changing needs and expectations of Canadians and leverage technological advances in support of improving health outcomes and quality of care. As a partner in the national health care system, the Department works closely with provincial and territorial governments and stakeholders to develop national approaches to health systems issues and to promote the pan-Canadian adoption of best practices.

The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain challenges the Department's ability to effectively regulate new, innovative and complex products, substances, food and emerging product categories. Given the evolving and expanding nature of the global marketplace, a key area of focus is on creating and strengthening relationships with domestic and international partners in order to leverage cooperation and best practices.

Canadians continue to expect their Government to be more open and transparent and to effectively engage them in decision-making. The provision of credible and timely information is critical to helping Canadians make informed health decisions for themselves and their families. However, the Department is one of many sources of health information for Canadians. The varying scientific quality and accuracy of information available to the general public can hinder the Department's efforts to reach Canadians, but also provides an opportunity for leadership in the provision of high quality, evidence-based health information.

The Department is also undergoing an internal transformation. On December 4, 2017, the Government of Canada announced the creation of the Department of Indigenous Services Canada (DISC) and the transfer of First Nations and Inuit health programs and services from Health Canada to this new Department. Health Canada will ensure the smooth transition of these programs and resources to DISC while minimizing the impact of the transition on employees. The Department will also provide internal support services to these programs until all First Nations and Inuit-health-related internal support services are transferred to the new Department.

Key risks

1. Health Canada's ability to effectively uphold the Canada Health Act (CHA) could be put at risk by challenges in administering the Act.
Risks Risk Response Strategy Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or to Government-Wide Departmental Priorities (as applicable)
The following risk elements have been identified:

Ability to uphold the CHA.
In response to this risk, Health Canada will:

Implement new policies; work to resolve issues with provinces and territories in a consistent manner; normalize the internal administration of the CHA through a delegation matrix; and monitor litigation that may impact the CHA and support legal services as required.
Core Responsibility 1: HealthCare Systems Mandate Letter Commitment: Promote and defend the CHA.
Government Priority:
Healthy Canadians
Organizational Priority I: Fostering Sustainable Health Care Systems.
2. Canadians will lose confidence in the safety of health and consumer products if Health Canada is not regarded as a trusted regulator and used as a credible source of information.
Risks Risk Response Strategy Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or to Government-Wide Departmental Priorities (as applicable)
The following risk elements have been identified:
Open and transparent regulatory information to Canadians.
In response to this risk, Health Canada will:
Expand the amount of regulatory health and safety information made available to Canadians in a simple and accessible way.
Core Responsibility 2 : Health Protection and Promotion Government Priority: Open and Transparent Government.
Organizational Priority II: Strengthen openness and transparency as modernization of health protection legislation, regulation and service delivery continues.
Involvement of citizens and stakeholders in regulatory decision-making. Increase opportunities for Canadians and stakeholders to provide input to be considered during the regulatory process. As above. As above.
Ability to communicate consistently with sufficient speed. Continue to implement a digital-first approach to inform, communicate and engage Canadians on and on approved Health Canada social media channels.
Continue to acquire, develop and improve the tools, processes and resources needed to effectively communicate and engage Canadians on our digital platforms, including on and on official HC social media channels.
Make online information easier to find and use from any device, accessible and compliant with Web 2.0 requirements.
As above. As above.
3. Health Canada's ability to protect Canadians from the risks of products may be weakened due to the changing integrity of the global supply chain and the rapid pace of innovation.
Risks Risk Response Strategy Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or to Government-Wide Departmental Priorities (as applicable)
The following risk elements have been identified:
Efficiency gains can be realized through information and work sharing with other regulatory organizations in the global market.
In response to this risk, Health Canada will:
Collaborate with international regulatory organizations, and align where appropriate with foreign regulators.
Core Responsibility 2 : Health Protection and Promotion  Organizational Priority II: Strengthen openness and transparency as modernization of health protection legislation, regulation and service delivery continues.
Existing legislative and regulatory frameworks are challenged by the pace of innovative new substances, technologies, products, pesticides, food and emerging product categories, along with new business models, fraudulent activities and healthcare service delivery strategies. Develop oversight strategies and tools to strengthen market surveillance and oversight of emerging products. As above. As above.
Pace of innovations in supply chains and manufacturing activities occurring at a multitude of foreign sites. Increase the use of regulatory and non- regulatory activities that address changing business models in the supply chain, specifically for foreign sites. As above. As above.

The above table outlines the Department's key external corporate risks for 2018-19. It also includes proposed strategies to manage the risks and how they link to Health Canada's Core Responsibilities. Each risk is monitored to ensure that the associated risk response strategies are helping to reduce its potential impact on the Department's ability to deliver its mandate of helping Canadians maintain and improve their health.

With responsibilities as a regulator, health service and information provider, Health Canada engages in the ongoing monitoring of risks to ensure sound stewardship of organizational resources and to effectively deliver on results to Canadians. A well-defined governance structure has been established to effectively manage risk and equip the Department to respond proactively to change, uncertainty and opportunities. A key output of this annual exercise is the Corporate Risk Profile (CRP). The CRP, which is aligned with the Departmental Plan, sets out the key threats and opportunities that have the potential to affect the achievement of the Department's plans and results, and outlines the management strategies to address these risks, and benefit from these opportunities.

The integrated risk management approach at Health Canada enables the Department to define and understand its operating environment and the factors that drive risks and enable risk-informed decision-making. It has been decided by senior management that the key external factors facing Health Canada remain generally unchanged from 2017-18, with the exception of the removal of risks pertaining to First Nations and Inuit health programming which has been transferred to the Department of Indigenous Services Canada.

The key factors include ongoing work around the Common Statement of Principles on Shared Health Priorities, new innovative products, technologies, substances, foods and emerging product categories, unforeseen health crises, the speed of scientific and technological changes, changing demographics, and rapid access to a plethora of health-related information from numerous sources of varying scientific quality and accuracy.

These trends, while posing a challenge to the Department's regulatory and service delivery responsibilities, also represent an opportunity for Health Canada to modernize regulatory frameworks and service delivery models, provide more timely and consistent engagement on regulatory decisions, undertake needs-based investments in health services, continue efforts to strengthen openness and transparency, and further engage with international regulatory partners and provinces.

Footnote 1

The Minister’s mandate letter,

Return to footnote 1 referrer

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