2020-2021 Raison d'être, mandate and role: who we are and what we do - Health Canada

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.

As a partner in health, Health Canada:

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 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.

Operating Context

Health Canada operates in a complex and dynamic environment where many health challenges – such as the COVID-19 pandemic and the opioid overdose crisis – require a multi-jurisdictional approach. Thus, the Department works collaboratively and collectively with federal partners, provinces and territories (P/Ts), Indigenous organizations, industry, and international regulators.

Responding to the COVID-19 pandemic

COVID-19 has challenged Canadians and health systems across the country. The COVID-19 virus has increased the demand and urgency for drugs and health products including vaccines, treatments and medical devices. It has also negatively affected the mental health of many Canadians; disproportionally impacted those living in long-term care homes; worsened the opioid overdose crisis; and intensified the demand for surge capacity for front line workers and scientific experts.

In response, Health Canada mobilized and leveraged all its resources to minimize the impacts of COVID-19 on Canadians' health and safety. The Department, similar to other organizations across the country and the world, had to adapt to working virtually to ensure organizational resilience and agility. Existing programs still had to be delivered while simultaneously responding to an unprecedented health crisis. Health Canada's workforce had to innovate, collaborate and rapidly assess and share information to support informed decision-making in this rapidly changing context.

In 2020-21, the Department approved 5 vaccines (Pfizer-BioNTech, Moderna, AstraZeneca, Serum Institute of India, and Janssen) and the vaccines were rolled out across the country, providing protection to those most at risk. The Department implemented innovative and agile regulatory measures to authorize clinical trials and approve vaccines, treatments and therapies, sanitizers and disinfectants, and medical devices; launched digital tools to support public mental health; developed notification apps to alert Canadians on risk of exposure to control the outbreak; adopted new technologies for collaboration and remote work; and, reinforced comprehensive strategies to protect public servants' mental health and wellness during this challenging time.

Protecting the Canadian health care system

A strong health care system is a cornerstone of good health. Canada's publicly funded health care system is dynamic – it must respond to changes within medicine and throughout society. The basics, however, remain the same – universal coverage for medically necessary health care services provided on the basis of need, rather than the ability to pay.

Improving the quality of care and health outcomes requires close collaboration across jurisdictions, as well as a willingness to leverage resources and technological advances. This is especially so during a pandemic. Health Canada worked closely with P/T governments and stakeholders to develop national approaches to health systems issues and promote the pan-Canadian adoption of best practices in areas such as: sharing medical data; working to establish national standards for long-term care and mental health; and, implementing virtual health services and free digital tools to address challenges posed by mental health and substance use.

Regulating in the context of a global supply chain

The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain is a key challenge for regulators in the 21st century. Effectively regulating new, innovative and complex products, substances, food and emerging product categories in a global marketplace requires a global approach. As such, the Department focused on building and strengthening relationships with its domestic and international partners in order to leverage cooperation and best practices, and accelerate regulatory reviews.

Managing drug and medical device shortages

Although there are benefits to relying on a global marketplace for Canada's supply of drugs and medical devices, some of the risks became more apparent over the course of the pandemic. For example, a shortage of key supplies early on required Health Canada to immediately begin working with industry to develop "made in Canada" capability for producing everything from ventilators to surgical gowns. In addition, shortages in vaccine deliveries due to interruptions in the global supply chain highlighted key gaps in Canada's pandemic response. As a result, the Department is collaborating with Innovation, Science and Economic Development Canada, F/P/T governments, and stakeholders to build a robust domestic bio-manufacturing sector.

Addressing the opioid overdose epidemic

While the pandemic negatively affected the health of many Canadians it especially impacted those in populations at higher risk. It created new barriers and challenges for those already suffering from mental illness and substance use. Pandemic social distancing restrictions resulted in reduced access to health and social services. Closed borders disrupted the supply of opioids and resulted in an increase in contaminated (and toxic) street drugs. These factors contributed to an increased number of deaths due to overdose (up 89% from before the pandemic).

Guided by the federal Canadian Drugs and Substances Strategy, Health Canada has developed a public health-focused approach to this crisis. Working alongside other orders of government, Indigenous Peoples, substance use experts, first responders, and people with lived and living experiences, the Department supported community-led initiatives, such as: facilitating access to mental health and addiction support services; setting up supervised injection sites and facilitating access to safer supply; and strengthening prevention efforts, including increased access to naloxone kits.

Building an inclusive workforce

The COVID-19 pandemic and other global events such as the Black Lives Matter movement have highlighted the inequities that persist in communities and workplaces across the country. While COVID-19 affects everyone, the health impacts have been worse for seniors, essential workers, visible minorities, people living with disabilities and women. Diversifying the healthcare and public workforce increases access to quality health care for all populations, reduces health disparities, improves cross-cultural communication, and contributes to health equity. Increasing diversity and nurturing deeper inclusion across the Public Service is a top priority and is part of Health Canada's core business. The Department's values – fostering a diverse and inclusive workplace that is free of racism and discrimination and where all employees are treated with respect, dignity and fairness – form the foundation of who we are, what we do, and how we do our work.

Increasing transparency and privacy protection

Canadians continue to expect their Government to be open and transparent and to effectively engage them in decision-making. As such, Health Canada is committed to openness, transparency, clarity on direction and sharing information as it becomes available to build trust, work in partnership with F/P/Ts and stakeholders, and protect the health and safety of Canadians. Additionally, Canadians expect the Department to provide high quality, scientific and evidence-based health information. This is critical to helping Canadians make informed health decisions for themselves and their families – especially when there is an increasing amount of information available to the general public of varying scientific quality and accuracy.

Throughout the pandemic, Health Canada provided timely and evidence-based information, through a range of online and traditional communication tools and channels. The Department developed a new web portal for Canadians, health professionals and academics with regulatory information on vaccines and treatments for COVID-19. It also created an industry-specific site with up-to-date information on the rapidly changing regulatory context for health products.

Finally, Canadians also expect that their privacy be protected while accessing government sources and apps. Health Canada adhered to privacy provisions and ensured Canadians' personal information was secured.

Key Risks

Health Canada has a well-established risk management process that enables the Department to respond proactively to change and uncertainty by understanding and monitoring its operating environment and the factors that drive risks.

Key Risk for Health Canada's Response to COVID-19

1. Health Canada's ability to achieve its mandate may be at risk due to challenges posed by major health events (like COVID-19).
Risk Response Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or Government-Wide Priorities

Provided timely, trusted and evidence-based information

Core Responsibility 2:
Health Protection and Promotion

Internal Services

Mandate Letter Commitment:
Support openness, effectiveness and transparency in government. Improve digital capacity and services for Canadians.

Government-Wide Priority:
Keeping Canadians Safe and Healthy

Authorized clinical trials, and facilitated access to health products

Core Responsibility 2:
Health Protection and Promotion

Mandate Letter Commitment:
Ensure Canadian researchers have the tools and resources they need to advance discoveries of vaccines and therapeutics to combat COVID-19.

Government-Wide Priority:
As above

Fostered engagement and collaboration

Core Responsibility 1:
Health Care Systems

Mandate Letter Commitment:
Continue to help P/Ts increase COVID-19 testing and tracking; deploy approved tests; and expand the new federal Testing Assistance Response Team to meet surge capacity needs, including in remote and isolated communities.

Work with P/Ts and Indigenous leaders to ensure COVID-19 vaccines continue to be distributed to Canadians.

Government-Wide Priority:
As above

Enhanced internal services

Internal Services

Mandate Letter Commitment:
Ensuring a safe, respectful, rewarding and welcoming place of work.

Government-Wide Priority:
Commitment to implement Government plans aimed at protecting and supporting Canadians through challenging times.

Delivering on its mandate to ensure Canadians stay safe and healthy during a pandemic

During this unprecedented time, Health Canada used every tool available, leveraged resources and collaborated with F/P/T partners to protect the health of Canadians. The Department immediately implemented risk responses to mitigate the risk to continue delivering on its mandate during 2020-21.

Key examples of Health Canada's risk responses:

Provided timely, trusted and evidence-based information

Authorized clinical trials, and facilitated access to health products

Fostered engagement and collaboration

Enhanced internal services

Key Risk for Core Responsibility 1: Health Care Systems

2. Health Canada's ability to effectively uphold the Canada Health Act(CHA) could be put at risk by challenges in administering the Act.
Risk Response Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or Government-Wide Priorities

Implemented new policies

Core Responsibility 1:
Health Care Systems

Mandate letter commitment:
Continue to ensure compliance with the Canada Health Act on matters of private delivery and extra billing

Government priority:
Keeping Canadians Safe and Healthy

Worked to resolve issues with provinces and territories

As above

As above

Monitored litigation

As above

As above

Monitored changes in health care delivery

As above

Mandate letter commitment:
Work with PTs to ensure that all Canadians have access to appropriate a primary health care team and expand virtual health care, critical health and mental health resources and services.

Government priority:
As above

Uphold the Canada Health Act

Health Canada upholds the Canada Health Act(CHA) in an ever-changing environment. The Department's proactive responses have mitigated the risks associated with the CHA during the 2020-21 fiscal year.

Key examples of Health Canada's risk responses:

Implemented new policies

Worked to resolve issues with provinces and territories

Monitored litigation

Monitored changes in health care delivery

Key Risks for Core Responsibility 2: Health Protection and Promotion

3. Canadians may lose confidence in Health Canada's ability to help protect their health if the Department is not regarded as a trusted regulator and used as a credible source of information.
Risk Response Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or Government-Wide Priorities

Implemented informative initiatives

Core Responsibility 2:
Health Protection and Promotion

Government priority:
Keeping Canadians Safe and Healthy

Provided more engagement opportunities with Canadians and stakeholders

As above

As above

Improved communication tools

As above

As above

Maintain confidence in Health Canada as a trusted regulator

To ensure that Health Canada continues to be seen as a trusted regulator and credible source of information, and to help Canadians make informed health and safety decisions, the Department successfully implemented effective risk responses in the 2020-21 fiscal year.

Key examples of Health Canada's risk responses:

Implemented informative initiatives

Provided more engagement opportunities to Canadians and stakeholders

Improved communication tools

4. Health Canada's ability to help protect the health of Canadians may be weakened due to the increasing complexity of the global supply chain and the rapid pace of innovation.
Risk Response Link to the Department's Core Responsibilities Link to Mandate Letter Commitments or Government-Wide Priorities

Strengthened oversight

Core Responsibility 2:
Health Protection and Promotion

Mandate letter commitment:
Safe and sustainable use of effective pesticide products in Canada

Government priority:
Keeping Canadians Safe and Healthy

Collaborated internationally

As above

Government priority:
As above

Increased the use of regulatory and non-regulatory activities

As above

Government priority:
As above

Protect Canadians from the risks of products

To help protect Canadians from the risks of products in an innovative and globalized environment, the Department successfully implemented risk responses to alleviate the risk.

Key examples of Health Canada's risk responses:

Strengthened oversight

Collaborated internationally

Increased the use of regulatory and non-regulatory activities

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