Ministerial Briefing Volume I: Overview of the Health Portfolio

Table of Contents

• Health Portfolio overview
  • Placemat: Overview of the Health Portfolio and federal role in health
  • Health Portfolio: A partner in health for all Canadians
• Health Portfolio organizations
  • Health Canada's mandate and vision
  • Public Health Agency of Canada
  • Canadian Institutes of Health Research
  • Canadian Food Inspection Agency
  • Patented Medicine Prices Review Board
• Legislation and decision-making in the Health Portfolio
  • Key legislation
  • Overview of legislative and regulatory responsibilities
  • Regulatory oversight of products pre- and post- market
• Federal-provincial/Territorial (FPT) relations
  • Overview of Federal-provincial/Territorial (FPT) roles and relations in health
  • List of Provincial and Territorial ministers responsible for health
• Relationships with health system players
  • An overview of Pan-Canadian health organizations
  • Other key players and stakeholders in health
• Relationships with International Community
  • Overview of the Health Minister's role in the International Community and Portfolio Engagement

Health Portfolio overview

Placemat: Overview of the Health Portfolio and federal role in health

Responsible for helping Canadians maintain and improve their health

Under your direct purview

Health Canada (HC)

Promotes and helps protect the health and safety of Canadians by regulating products such as drugs, medical devices, consumer products, cosmetics, food and managing the health risks of substances. HC supports universally accessible, publicly funded health care for Canadians through stewardship of the Canada Health Act, leadership on issues such as mental health, substance use and digital health and collaboration with provinces and territories on health system improvements.

Public Health Agency of Canada (PHAC)

Protects Canadians against health emergencies through national leadership to mitigate the impacts. Prevents and reduces chronic and infectious diseases, injury and disability. Promotes health, well-being and equity.

Canadian Food Inspection Agency (CFIA)

Protects Canada and Canadians from food, plant, and animal health risks inherent in the modern environment, while supporting Canadian agri-food businesses as they compete, innovate and grow in domestic and global markets.

Arm's-length organizations

Canadian Institutes of Health Research (CIHR)

Canada's federal funding agency for health research. Composed of 13 institutes, CIHR collaborates with national and international partners to support discoveries and innovations that improve Canadians' health and strengthen Canada's health care system. CIHR is a source of scientific evidence to inform the Government's decisions.

Patented Medicine Prices Review Board (PMPRB)

Quasi-judicial body that protects consumers and contributes to health care by ensuring that the prices of patented medicines sold in Canada are not excessive. The PMPRB also informs Canadians by reporting on pharmaceutical trends.

Role of Health Portfolio

Managing risks to health

• Maintaining readiness and responding to public health threats and emergencies (e.g. COVID-19 pandemic), such as providing domestic and international health security leadership, pandemic preparedness, border and travel health, rapid research mobilization and nuclear emergencies (PHAC, HC, CIHR)
• Assessing, managing, and supporting research on health risks of controlled substances, alcohol, antimicrobial resistance, consumer products, cosmetics, chemicals, radiation, pesticides, climate change and addressing population harms of tobacco, in collaboration with partners and Indigenous peoples (HC, PHAC, CIHR)
• Managing food-related health risks through strong food safety regulations, surveillance, research and enforcement (HC, PHAC, CFIA, CIHR)
• Promoting mental health and well-being for Canadians (HC, PHAC) and providing mental and occupational health advice and services to the federal public service (HC)
• Overseeing the legal cannabis regime, including administering the Cannabis Act, granting licences for production, and monitoring compliance with regulations (HC)
• Taking compliance and enforcement actions in relation to relevant acts and regulations (HC)

Supporting health research and science, data collection and surveillance capacity

• Funding research to generate knowledge, improve health or health services, inform government priorities and decision-making, and support health innovation (CIHR)
• Investing in knowledge mobilization and the dissemination of research evidence and data to improve the health care system (CIHR)
• Building research capacity in under-developed areas, and training the next generation of health researchers (CIHR)
• Promoting equity, diversity and inclusion in the research system and their incorporation in research design and activities, including to support indigenous health research, knowledge mobilization and capacity-building (CIHR)
• Strengthening surveillance, research and public education on chronic and emerging infectious diseases (PHAC)
• Improving diagnostic and scientific capacity through national labs, to detect serious and emerging diseases (PHAC, CFIA)
• Reporting on pharmaceutical trends of all medicines, and research and development spending by patentees (PMPRB)
• Conducting research, monitoring and surveillance on health impacts of environmental contaminants, climate change and substances (HC)

Enabling access to safe and effective health products

• Assessing, and regulating health products, including vaccines, to ensure their safety, effectiveness and quality, through a world class, modern regulatory regime (HC)
• Monitoring health product safety and communicating risks to Canadians (HC)
• Funding and overseeing clinical trials to ensure the integrity of the data and participants (HC, CIHR)
• Working with stakeholders to mitigate shortages of therapeutic products (HC)

Strengthening Canada's universal health care system

• Stewardship of universally accessible, publicly-funded health care for Canadians through administration of the Canada Health Act (HC)
• Providing leadership on emerging issues such as mental health, substance use, and digital health, and working multilaterally and bilaterally with provinces and territories on system improvements (HC)
• Leading pan-Canadian initiatives on system innovation and quality improvements in new and emerging areas of health care (HC)
• Investing in Pan-Canadian Health Organizations to drive progress on health system priorities (HC)
• Managing federal grants and contributions programs to support health system innovation and priorities (HC, CIHR)
• Enhancing the affordability, accessibility and appropriate use of prescription drugs (HC, PMPRB)
• Improving cultural safety, humility and responsiveness in the health system to improve Indigenous health and address racism (HC)

Supporting Canadians in making safe and healthy choices

• Informing and engaging Canadians by being a trusted source of information on health and safety (HC, PHAC, CFIA), including:
  • The COVID-19 global pandemic (PHAC, HC)
  • The opioid overdose crisis (HC, PHAC)
  • A range of health and safety issues, such as food and alcohol choices, health products, smoking prevention and cessation, youth vaping, cannabis use, concussion treatment, consumer product safety, safe food practices, and the safe use of hazardous products (HC,PHAC)
• Addressing root causes of health inequalities and common risks that are important in preventing and avoiding disease, including disease surveillance, creating environments that support healthy choices, reduce chronic diseases, and support healthy aging (PHAC, HC, CIHR)

Provincial/Territorial (PT) partners

• PTs administer public health insurance plans for medically necessary services; plan and finance hospital care, physician and allied health services; deliver other services (drug plans, home care, etc.) on a discretionary basis; administer aspects of public health; collect and manage data critical for PH reporting and decision-making; and negotiate fee schedules for health professionals
• FPT governments must often collaborate to advance key health priorities for Canadians

Indigenous partners

• Engage with First Nations, Inuit and Métis to improve health outcomes and work to address inequities experienced by Indigenous Peoples

Federal government departments

• Work collaboratively with other government departments on areas of shared priority/responsibility

Health partners/Industry/Community stakeholders

• Work with health stakeholders, including professional associations, regulatory bodies, standards development organizations, the research community, patient groups, communities with a stake in public health, social media influencers/risk communicators and industry to ensure responsive approaches to Canadians' health needs

International partners

• Engage internationally to protect and advance Canadian health interests
• Participate in multilateral fora, particularly the World Health Organization
• Foster bilateral relationships with key partners and regions
• Partner on health research that affects Canadians and the global community, and position Canadian researchers as leaders

Health Portfolio: A partner in health for all Canadians

The Health of Canadians – the COVID-19 pandemic

• The impacts of the COVID-19 pandemic, and the response to it, have affected Canadians for nearly two years. Not only has the pandemic led to fundamental changes in our daily lives, but many Canadians have experienced its tragic consequences including the suffering and loss of loved ones, lost jobs and livelihoods, reduced social connections and increased isolation.
• From the beginning, the Health Portfolio has been at the centre of efforts to respond to the pandemic. These efforts continue as Canada is currently experiencing a fourth wave of the COVID-19 pandemic, which is fuelled by the highly contagious Delta variant.

The Chief Public Health Officer of Canada

• The Chief Public Health Officer of Canada (CPHO) advises you, as the Minister of Health, on public health related matters, and provides leadership by communicating with other levels of government, voluntary organizations, the private sector and Canadians on public health issues.
• The CPHO has played a key role in the COVID response providing evidence-based, public health advice to the government, and working with PT counterparts to support Canadians.

The health of Canadians

Despite the significant ongoing challenges with COVID-19, Canadians generally experience good health.

• Canada ranks among the top and middle third performers among Organization for Economic Cooperation and Development (OECD) member states for most health indicators
• Public health efforts across the Canadian health system, including vaccination programs, have reduced the risks of infectious diseases considerably
• Efforts are underway to address systemic health inequities especially for Indigenous, racialized and marginalized populations (e.g., new immigrant, low-income, 2SLGBTQQIA+)

Canada's health care system is a source of pride for many Canadians and one of the reasons for the overall good health Canadians enjoy. However, it faces a number of challenges.

The health of Canadians – key challenges

Chronic disease

Chronic diseases such as cancer, heart disease and diabetes continue to be the greatest cause of disease burden in Canada. While Canadians are generally healthy, 44% of adults 20+ have at least 1 of 10 common chronic diseases, and over 4 out of 5 have at least one preventable risk factor.

Infectious disease

Rates of HIV and hepatitis C are slow to decrease, while rates of other sexually transmitted infections have increase exponentially. Overall, infectious syphilis rates have increased by 124% nationally from 2016 to 2020. Canada is not meeting its vaccination targets for certain diseases such as measles.

Mental health

While many Canadians live with positive mental health, 1 in 3 have, or will have had, a mental illness by the time they reach 40 years of age and, on average, 10-12 Canadians die by suicide every day. COVID-19 has exacerbated mental health challenges for Canadians with higher rates of reported anxiety and depression since the onset of the pandemic.

Opioid overdose crisis

There were 21,174 opioid-related deaths between January 2016 and December 2020. This has contributed to a slowing or stagnation in the growth of Canadians' overall life expectancy, particularly among men, who did not have an increase in life expectancy from 2016-2018.

Alcohol, tobacco and vaping

While smoking rates in Canada are at their lowest level in decades, rates of youth vaping are high. While vaping may be less harmful than smoking for those who switch completely, it is not harmless, and the long-term health effects of vaping remain unknown. Alcohol is the most prevalent substance used in Canada and results in significant public health harms. Its normalization and problematic use led to over 18,000 deaths in 2017.

Antimicrobial Resistance (AMR)

Antibiotics are rapidly becoming ineffective because the bacteria they are designed to eliminate are becoming resistant to these drugs. AMR is a complex problem that can result from any use of antibiotics and is made worse by overuse and misuse in people and animals. In 2018, the estimated number of AMR-related deaths in Canada was 5,400.

Climate change

Canadians are already experiencing health impacts from changes to Canada's climate such as increased injury and fatalities related to extreme weather events, mental health challenges, heat and food-related illness, increased food insecurity, and the spread of infectious and vector-borne diseases such as Lyme disease.

Health inequities

Significant health inequities continue to exist in Canada between Canadians with different socioeconomic status and certain populations, including Indigenous peoples. Disparities exist in areas of life expectancy, infant mortality, mental illness hospitalizations among others. Stigma and discrimination prevent people from accessing resources they need to be healthy and put them at greater risk of disease, violence and injury.

The Health of Canadians – Pandemic impacts

Long-term care

The pandemic has emphasized the need for improving the care of seniors in long-term care facilities, with more than 15,000 residents tragically dying since the onset of the pandemic.

Backlogs in diagnosis and treatment

The pandemic has resulted in cancelled or delayed medical procedures for many Canadians, resulting in a backlog of approximately 580,000 surgeries to date. These delays and cancellations are expected to have an impact on the morbidity and mortality of Canadians.

Mental health

The impacts of both the pandemic and the response to it (i.e. social isolation, job losses and school closures caused by lockdowns) pose risks to mental health, increasing substance abuse, and other social issues. COVID-19 has exacerbated mental health challenges for Canadians across all age groups, with individuals reporting higher rates of anxiety and depression since the onset of the pandemic.

Opioid overdose crisis

The COVID-19 pandemic exacerbated the opioid overdose crisis. For example, nationally there were 5,148 opioid-related deaths between April and December 2020, an 89% increase compared to the same time period in 2019.

Alcohol/other substance use

Between March and September 2020, the total number of all (alcohol, cannabis, opioids, stimulants) substance-related deaths increased in emergency departments (by 12%) and hospitals (by 13%) compared to the same period in 2019.

Disproportionate impacts on existing inequalities

While the COVID-19 pandemic has affected all Canadians, some have faced disproportionately higher impacts than others due to existing health and social inequalities. These include low-wage workers, older adults, young people, racialized workers, remote communities, Indigenous Peoples, and women. These vulnerable groups are also those that have seen the strongest decline in their mental health and life satisfaction.

The health system in Canada

Roles and responsibilities for health care services in Canada are shared between provincial and territorial governments (PTs) and the federal government.

• PTs are responsible for the management, organization and delivery of health care services for their residents.
• The federal government is responsible for:
  • Setting and administering national standards for the health care system through the Canada Health Act (CHA);
  • Providing funding support for provincial and territorial health services;
  • Supporting the delivery of health care services to specific groups (i.e. First Nations on reserve; Inuit; serving members of the Canadian Armed Forces; veterans; some groups of refugee claimants, etc.);
  • Providing other health related functions including the regulation of products (e.g., food, consumer products), health research, health promotion and protection, and disease monitoring and prevention.

Healthcare spending

• 49% of national healthcare spending comes from PT governments (not counting federal funding that flows through PTs).
• 19% of national healthcare spending comes from the federal government.
• Public sector share of total health spending: 70.4%.
• Private sector share of total health spending: 29.6%.
• Federal spending is 27.8% of total public spending.

The Canada Health Transfer (CHT) is the key federal funding vehicle for supporting health care, allocated to PTs on an equal per-capita basis.

The Canada Health Act (CHA) establishesrequirements PTs must fulfillto get the full amount of their cash entitlement under the CHT.

The CHA states that the primary objective of Canadian health policy is: "to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers".

The 5 CHA criteria are:

• Public administration;
• Comprehensiveness;
• Universality;
• Portability;
• Accessibility.

The health system – national health expenditures

As health needs and approaches to delivering care have changed, so too has the focus of spending. The proportion of spending going toward hospitals has declined over time, while spending on drugs and other spending — such as on other institutions and home and community care — have increased.^{Footnote 1}

Spending for hospitals decreased from 45% in 1975 to 26% in 2019.

Spending for physicians remained the same from 1975 to 2019 at 15%.

Spending for drugs increased from 9% in 1975 to 15% in 2019.

Spending in other areas increased from 31% in 1975 to 44% in 2019.

Source: Canadian Institute for Health Information, National Health Expenditure Trends, 1975 to 2019; National Health Expenditure Trends, 2020

The health system – key trends and drivers in the health context

The COVID-19 pandemic

Resulted in greater FPT and stakeholder collaboration to scale up testing and tracing, mobilize resources, approve, acquire and distribute vaccines, therapeutics and diagnostics, and communicate key messages and information to ensure Canadians' health and safety.

Climate change

Impacting the health of Canadians by, for example, altering the spread and intensity of certain diseases, and causing extreme weather events. The Health Portfolio is taking action to protect Canadians from the growing risk landscape, including working with FPT partners.

Evolving expectations of the health system

Changes in how Canadians seek health information, advancements in health technologies, and the desire for "anywhere, anytime" monitoring, diagnosis and treatment, have implications for Health Portfolio communication strategies, health care delivery and regulatory decisions.

Changing demographics

Population aging and increasing chronic conditions shift needs toward services and care provided in the home and in the community rather than in hospitals. Some regions have younger age demographics (e.g., northern communities) while others have higher proportions of recent immigrants, creating unique regional health care needs.

Innovation in science and technology

Rapid rise of digital health, advancement of mRNA vaccines, growing artificial intelligence (AI), and precision medicine using genome sequencing are examples of areas where the Health Portfolio is taking action to ensure Canadians benefit without compromising safety.

New ways data is collected and used

Health systems are generating more data which can help forecast trends, support decision-making and improve health outcomes and health system efficiency. With the rise of "big data" and use of AI technologies, there are also challenges in addressing new regulatory, ethical and privacy concerns.

Health inequities

Health inequities in Canada became worse with COVID-19 and there is growing awareness of the need to address systemic racism and discrimination in the health system. Ensuring that a cultural safety lens is applied to health system delivery will be key to curbing the growing inequalities among Canadians.

Globalization and global supply chains

Globalization has afforded access to products from around the world and increased the complexity of the medical supply chain. The Health Portfolio continues to partner with international stakeholders to ensure safety in the global supply chain, while also working towards a whole-of-government approach to security of supply.

The Health Portfolio operates in a dynamic and complex environment, with external trends and factors influencing the health landscape in Canada, as well as priorities for FPT collaboration.

Roles and responsibilities of the health portfolio

As Minister of Health, you are responsible for five dynamic, science-based organizations, each playing a unique and important role in the health and safety of Canadians.

Under your direct purview

• Health Canada (HC)
• Public Health Agency of Canada (PHAC)
• Canadian Food Inspection Agency (CFIA)

Arms-Length organizations

• Patented Medicine Prices Review Board (PMBRB)
• Canadian Institutes of Health Research (CIHR)

The Health Portfolio's main activities include:

• Responding to public health emergencies, including the current COVID-19 pandemic;
• Strengthening Canada's universal health care system;
• Enabling access to quality, safe and effective health products/regulatory role;
• Managing risks to health;
• Supporting Canadians in making safe and healthy choices; and
• Supporting health research and science, data collection and surveillance capacity.

Roles and responsibilities – responding to public health emergencies, including the COVID-19 pandemic

• Developing health security measures / Preparing for and responding to health emergencies
• Supporting border and travel health
• Providing domestic and international health security leadership
• Protecting against vaccine-preventable diseases
• Responding to the threat posed by antimicrobial resistance

The National Microbiology Laboratory (NML)

• The NML works with public health partners in Canada and internationally to prevent the spread of infectious disease. It is the only "Level 4 Lab" in Canada, meaning it is able to work with the world's most dangerous pathogens.
• The NML enables informed public health action through delivery of innovative approaches to advance laboratory science, testing services, lab-based surveillance, outbreak response and national public health laboratory leadership.

Roles and responsibilities – Strengthening Canada's universal health care system

• Stewardship of universally accessible, publicly funded health care for Canadians through administration of the Canada Health Act
• Providing leadership on emerging issues and working multilaterally and bilaterally with provinces and territories on system improvements
• Enhancing the affordability, accessibility and appropriate use of prescription drugs
• Investing in Pan-Canadian Health Organizations to drive progress on health priorities (see Annex 1)
• Managing federal grants and contributions programs to support health care and public health innovation and priorities

Virtual care

• In response to the challenges of delivering health care during the pandemic, and to support PTs in accelerating their efforts to put in place tools and supports for virtual services, Health Canada worked with these jurisdictions to institute a range of digital supports that helped Canadians find the information, resources, and care they needed.
• As of August 13, 2021, all 13 bilateral agreements with PTs have been signed, with funding focused on advancing shared priorities on virtual care.

Roles and responsibilities – enabling access to safe and effective health products

• Assessing and regulating health products to ensure their safety, effectiveness and quality
• Modernizing regulatory regimes to increase access to safe and effective treatment options for Canadians
• Monitoring health product safety and adverse events arising from use and communicating risks to Canadians

Health Portfolio regulatory responsibilities

Health Canada regulates:

• More than 14,000 prescription and non-prescription drugs;
• More than 700 biologics and biotechnology products;
• More than 1,500 veterinary drugs and over 2,500 low-risk veterinary health products;
• More than 150,000 natural health products;
• More than 45,000 medical devices;
• More than 8,000 registered pesticides.

PHAC regulates:

• More than 1,000 facilities that handle human pathogens and toxins.

CFIA conducts:

• Approximately 3,150 food safety investigations and an average of 200 primary recalls and 400 total recalls each year.

The regulatory oversight process is organized from pre-market to post-market and consists of the following stages:

• Pre-clinical trials
• Clinical trials
• Regulatory product submission
• Submission review
• Market authorization decision
• Public access
• Safety, monitoring, surveillance, inspection, compliance, verification, enforcement

Roles and responsibilities – Managing risks to health

In addition to maintaining readiness to respond to public health threats and emergencies, the Health Portfolio plays a number of other important roles in managing risks to health:

• Managing food-related health risks through strong food safety regulations, surveillance and enforcement;
• Assessing and managing the health risks of consumer products and cosmetics;
• Implementing comprehensive approaches to minimize the health risks associated with legal and illegal substances;
• Overseeing the legal cannabis framework;
• Reducing environmental health risks.

Health Portfolio role in food safety

• The Safe Food for Canadians Regulations, which came into force in 2019, make our food system even safer by focusing on the food industry's prevention of food safety risks during production and allowing for faster removal of unsafe food from the marketplace.
• Under these regulations, food businesses that import or prepare food for export or to be sent across provincial/territorial boundaries must meet key requirements related to licensing, preventive controls, and traceability.

Roles and responsibilities – Supporting Canadians in making safe and healthy choices

• Promoting the health and well-being of Canadians by addressing risk factors and underlying determinants of health and health inequities
• Promoting healthy behaviours and practices to improve health
• Building protective factors and addressing health equity
• Supporting Canadians in making better food choices
• Informing and engaging Canadians by being a trusted source of information on health and safety

A social determinants of health approach to improve health for at-risk groups

• An individual's health is determined by the social determinants of health – a broad range of personal, social, economic and environmental factors – such as income, housing, education, physical environment, gender and culture.
• The Health Portfolio researched and analyzed the impact of the pandemic on at-risk populations, which highlighted how disproportionately these groups had been affected. Recommendations were made to reduce or close the gap, such as ramping up efforts in visible minority communities to reduce vaccine hesitancy. The Health Portfolio also worked to ensure the needs of at-risk populations were considered and incorporated in pandemic responses.

Roles and responsibilities – Supporting health research and science, data collection and surveillance capacity

• Funding research that generates new knowledge, improves health or health services, informs priorities and supports health innovation
• Funding National Collaborating Centres that promote the use of evidence by public health practitioners and policy makers
• Strengthening surveillance, evidence and public education on chronic and infectious disease
• The primary research arm of the Health Portfolio is CIHR, which invests over $1.2 billion annually to support world-class researchers and trainees across Canada in a broad range of research, from basic science to knowledge mobilization and policy.
• PHAC has approximately 85 surveillance systems and data holdings used to generate reports, bulletins and health advisories, and to inform the development of programs and policies.
• During the pandemic, PHAC built a Public Health Data Platform to facilitate the sharing of COVID case and vaccination data from the PTs, and to support PTs in assessing their data against the national picture. Lessons learned through the pandemic and other research and audits are now being addressed through the development of a pan-Canadian Health Data Strategy.

Partnerships and collaboration – FPT context

• At the federal level, the Health Portfolio works collaboratively with a number of other government departments and agencies.
• Ongoing FPT collaboration is maintained through well-developed formal structures including:
  • FPT Health Ministers' Meeting (HMM);
  • Conference of Deputy Ministers of Health (CDM);
  • Pan-Canadian Public Health Network (PHN);
  • Collaborative work with FPT partners through engagement and leadership on several committees.

FPT collaboration on vaccines

• Vaccination is one of the most effective public health strategies for protecting populations against infectious diseases.
• In collaboration with PT governments and stakeholders, the Health Portfolio maximizes the impact of PT vaccination programs by:
  • serving as federal coordinator and focal point for information on vaccine safety; and
  • working with the PTs to collect, analyze, and report information on adverse events following immunization, and vaccination coverage across Canada.
• The Health Portfolio continues to lead Canada's COVID-19 response, including securing and distributing vaccines, ensuring their safety, building public confidence in vaccination, and monitoring and reporting vaccine data in collaboration with PTs.

Partnerships and collaboration – Indigenous organizations and governments

• Indigenous Services Canada (ISC) funds or directly provides services for First Nations and Inuit that supplement PT services
• Engagement is often done in collaboration with other federal departments, such as ISC and Crown-Indigenous Relations and Northern Affairs Canada (CIRNAC)
• The Health Portfolio works with other Indigenous health system partners to close gaps in health outcomes for Indigenous Peoples and address systemic barriers to accessing safe and equitable health services. Examples of partners include the Indigenous Physicians Association of Canada (IPAC), Canadian Indigenous Nurses Association (CINA), First Nations Health Authority (FNHA), National Consortium for Indigenous Medical Education, and National Aboriginal Council of Midwives (NACM).
• The Portfolio also contributes to whole-of-government efforts to advance reconciliation with Indigenous Peoples by implementing the Truth and Reconciliation Commission's Calls to Action and supporting the federal response to the National Inquiry into Missing and Murdered Indigenous Women and Girls

CIHR's Network Environments for Indigenous Health Research program is a national network of centres focused on capacity development, research, and knowledge translation centered on Indigenous Peoples. It aims to provide supportive research environments for Indigenous health research driven by, and grounded in, Indigenous communities in Canada.

Partnerships and collaboration – International partners

• As Minister of Health, you will typically engage multilaterally by leading Canada's delegation at international and political fora, and bilaterally with key counterparts from other countries or regional partners.
• E.g.,
  • World Health Organization (WHO)
  • Organisation for Economic Co-operation and Development (OECD)
  • G7 and G20 Health Ministers meetings
• As Minister of Health, you will also engage with counterparts from other countries or regions to advance bilateral collaboration on health issues of common concern.
• E.g.,
  • Health Canada shared information and expertise with international regulatory counterparts to support the review and post-market monitoring of COVID-19 health products.

Example – Antimicrobial Resistance (AMR)

• Recognizing the international nature of the threat posed by AMR, Canada actively engages multilaterally through a number of fora including CODEX, the Trans-Atlantic Task Force on AMR, the Global Health Security Agenda, and the Alliance of Champions.

Annex 1 – List and mandate of the Pan-Canadian Health Organizations (PCHOs)

The Canadian Institute for Health Information (CIHI) is the main national body charged with collecting, analyzing and reporting health data (e.g., wait times, quality of care and outcomes, health expenditures, allocation of health professionals). CIHI data and information supports health system improvements, and is used by Canadian governments, policy-makers and health system managers in making health policy decisions and in supporting effective health system management. CIHI relies heavily on PTs for collection of health data.

The Canadian Agency for Drugs and Technologies in Health (CADTH) provides decision-makers with evidence and advice to help provincial/territorial health ministries and federal- provincial/territorial (FPT) drug plans make informed decisions about the effectiveness and efficiency of drugs, medical devices and other health technologies. CADTH's Reimbursement Reviews make recommendations to governments on drugs that are included on public drug plan formularies.

Canada Health Infoway (Infoway) works with PTs, health care providers and other partners to accelerate the development and adoption of electronic health information systems with compatible standards on a pan-Canadian basis. Infoway is currently focused on pan-Canadian initiatives including virtual care, patient access to digital records, and an electronic prescribing system.

Healthcare Excellence Canada is the newly amalgamated organization of the Canadian Patient Safety Institute and the Canadian Foundation for Healthcare Improvement. It works with patients and other partners to share proven innovations and best practices that lead to lasting improvements in patient safety and healthcare quality (most recently, its 'LTC+' program provided seed funding and programming support to long-term care and retirement homes to strengthen their pandemic preparedness and response).

The Canadian Partnership Against Cancer (CPAC) provides national leadership on the implementation of the Canadian Strategy for Cancer Control (which addresses primary cancer prevention, screening and early detection, standards and cancer guidelines, the cancer journey, health human resources, research, and surveillance), and coordinates efforts of PTs, cancer experts and stakeholder groups. CPAC recently led a refresh of the Strategy, released in June 2019.

The Mental Health Commission of Canada (MHCC) acts as a catalyst for improving the mental health system and changing the attitudes and behaviours of Canadians around mental health issues (for example, by reducing the stigma associated with mental health illness and treatment). Its work focuses on four priority areas: population-based initiatives, suicide prevention, the integration of mental health and substance use, and engagement with Canadians.

The Canadian Centre on Substance Use and Addiction (CCSA) provides research, effective knowledge exchange and expertise for the substance use field, promotes increased awareness among Canadians and health system stakeholders about substance use and addiction, convenes stakeholders across sectors (including those with lived and living experience) to reduce the harms of substance use, and promotes the use of programs shown to be effective in combating problematic substance use. CCSA is the only PCHO created by federal legislation.

Health Portfolio organizations

Health Canada's mandate and vision

• Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health.
• Health Canada is committed to improving the lives of all of Canada's people and to making this country's population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system.
• As a regulator, service provider, promoter of innovation, and trusted source of information, we are a partner in health for all Canadians.

Health Canada's core business lines

Strengthening Canada's health care system

Supporting universally accessible, publicly funded health care for Canadians through administration of the Canada Health Act, leadership on emerging issues, and cooperation with provinces and territories on system improvements

Enabling access to safe and effective health products

Enabling access to safe and effective health products by assessing and regulating health products, such as drugs and medical devices, to ensure their quality, safety, and effectiveness

Managing risks to health

Managing the health risks of harmful substances, cannabis, tobacco, controlled substances, consumer products, cosmetics, chemicals, radiation and pesticides, and reducing environmental health risks such as climate change

Supporting Canadians in making safe and healthy choices

Supporting Canadians in making safe and healthy choices through public education and awareness campaigns to communicate health and safety information

How the federal government can act in health

• Legislation and regulation
• Spending
• Research, surveillance and monitoring
• Policy development, engagement and advice
• Communication
• Program and service delivery
• Leadership / convening power

Core business lines

Strengthening Canada's health care system

Supporting universally accessible, publicly funded health care for Canadians through administration of the Canada Health Act, leadership on emerging issues, and cooperation with provinces and territories on system improvements

Health Canada acts as the steward of medicare for Canadians and provides leadership and support for Canada's public health care system

• Administers and ensures compliance with the Canada Health Act (e.g. public administration, comprehensiveness, universality, portability, accessibility, and no patient charges)
• Works multilaterally and bilaterally with provinces and territories on common health priorities, and oversees bilateral funding agreements (e.g. mental health and addictions, home, community and palliative care, and virtual care)
• Partners with and funds seven Pan-Canadian Health Organizations to catalyze system innovation and improvements in priority areas (e.g. cancer, mental health, problematic substance use, healthcare quality and patient safety, assessment of drugs and health technologies, health information, and digitization)
• Provides advice and leads pan-Canadian initiatives on system innovation and quality improvements in new and emerging areas of health care (e.g., organ donation and transplantation, medical assistance in dying, and virtual care)
• Manages federal health grants and contributions programs supporting health system innovation/priorities and minority official language communities
• Advances the affordability, accessibility, and appropriate use of prescription drugs
• Improves cultural safety, humility and responsiveness in the health care system to address systemic barriers and improve Indigenous health outcomes

Core business lines – Enabling access to safe and effective health products

Enabling access to safe and effective health products by assessing and regulating health products, such as drugs and medical devices, to ensure their quality, safety, and effectiveness.

Health Canada is the science-based regulator that ensures the safety, effectiveness and quality of health products.

• Provides regulatory oversight through pre- and post-market risk assessments (e.g. vaccines, drugs, biologics, medical devices, and veterinary drugs)
• Ensures that appropriate regulatory pathways are available to bring treatment options to Canadians (e.g., Special Access Programs for critical drugs not sold in Canada)
• Leads scientific and technical analysis of health product submissions to ensure the safety, efficacy and quality of approved drugs
• Oversees clinical trials conducted by industry and academics to ensure the protection of participants and the integrity of the data
• Monitors health product safety and adverse events arising from real-world use and communicates risks to Canadians
• Optimizes the use of real world evidence for regulatory decision-making to improve the extent and rate of access to medical products in Canada
• Works in collaboration with stakeholders to mitigate and prevent shortages of therapeutic products

Core business lines – Managing risks to health

• Managing the health risks of harmful substances, cannabis, tobacco, controlled substances, consumer products, cosmetics, chemicals, radiation and pesticides, and reducing environmental health risks such as climate change
• Health Canada helps Canadians manage the health risks of consumer products, cosmetics, chemicals, radiation, pesticides, cannabis and other harmful substances
• Regulates and sets safety standards for consumer products through pre- and/or post-market risk assessments e.g. cosmetics, natural health products, food, chemicals, radiation, and pesticides
• Takes compliance and enforcement action in relation to acts and regulations administered by Health Canada
• Implements a departmental data strategy to support evidence-based decision making and transparency
• Provides information to Canadians to make informed decisions on their health e.g., recalls, product seizures, and drug shortages
• Conducts research, monitoring and surveillance on environmental health and the health impacts of climate change
• Oversees the legal cannabis regime e.g. granting licences for production, coordinating with FPT partners, and monitoring compliance with regulations
• Develops and implements approaches to address the harms associated with certain products and substances e.g. tobacco, alcohol, and opioids
• Maintains readiness to respond to public health threats and emergencies
• Provides assistance services and occupational health advice to employees of the federal public service

Core business lines – Supporting Canadians in making safe and healthy choices

• Supporting Canadians in making safe and healthy choices through public education and awareness campaigns to communicate health and safety information
• Health Canada assesses, manages and communicates health and safety risks and benefits to support Canadians in making safe and healthy choices
• Works with domestic and international partners to assess, manage and communicate the health and safety risks and benefits associated with consumer products e.g. cosmetics, food, chemicals, radiation, pesticides, cannabis, controlled substances, environmental factors, and climate change
• Conducts public awareness campaigns to educate Canadians on safe food practices and consumer products safety
• Supports Canadians in making healthier food choices through the Canada Food Guide and other healthy eating initiatives
• Helps Canadians to make choices about alcohol use, through the Canadian Low-Risk Drinking Guidelines
• Informs and engages Canadians as a trusted source of information on health and safety
• Informs and engages Canadians on the opioid crisis and how to reduce harm while working to reduce stigma around substance use to promote help-seeking and compassionate care
• Undertakes public education and awareness activities, to provide Canadians with the information they need to make informed decisions and minimize health and safety harms associated with cannabis use
• Provides public education resources, information and programming on smoking prevention, cessation, health effects and youth vaping, to reduce tobacco-related diseases and deaths
• Works with FPT partners to ensure workers have the right safety information to protect themselves when using workplace hazardous products

COVID-19 response

A dominant part of all business lines has been our COVID-19 response. Since the beginning of the COVID-19 pandemic, Health Canada has taken a leadership role to address the health impacts of the pandemic on Canadians.

• COVID-19 fundamentally impacted the department's operations, increased the oversight of the Health Portfolio and dominated the federal provincial planning and governance agendas.
• The magnitude of the COVID-19 pandemic required strategic and wide-ranging collaboration with all of Health Canada's partners in health – other federal government departments and agencies, provinces and territories (F/P/Ts), municipalities, Indigenous communities, academic and science and tech organizations, private sector companies, frontline workers and other stakeholders.
• In support of the COVID-19 response, a Health Canada COVID-19 Taskforce was established to coordinate the portfolio's response and provide leadership on health issues, specifically Personal Protective Equipment, Testing and Vaccines.

In 2020-21, the Department approved 5 vaccines and they were rolled out across the country, providing protection to those most at risk.

Departmental actions during the COVID-19 response:

Vaccines

• Implemented innovative and agile regulatory measures to authorize vaccines, as well as treatments and therapies
• Led work on expert advice and investment in research and vaccine treatments

Testing & tracing

• Developed notification apps to alert Canadians on risk of exposure to control the outbreak
• Scaled up testing and tracing

Support to PTs

• Purchased PPE and supplies; Developed PPE supply and demand model
• Enhanced healthcare capacity
• Mobilized resources to provide surge capacity and support
• Launched digital tools to support mental health of Canadians (Wellness Together Canada)

Communications and public engagement

• Providing timely, trusted, and evidence-based pandemic information to Canadians

Other

• Reinforced comprehensive strategies to protect public servants' mental health and wellness

Health Canada's key partners

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.

The Department works collaboratively and collectively with federal partners, provinces and territories (P/Ts), Indigenous organizations, industry, and international regulators.

Health Portfolio partners

• Public Health Agency of Canada
• Canadian Food Inspection Agency
• Canadian Institutes of Health Research
• Patented Medicine Prices Review Board

Provincial and territorial governments

• Multilateral and bilateral machinery (including annual FPT Health Ministers' Meetings and the Pan-Canadian Public Health Network)

Health system partners

• Seven Pan-Canadian Health Organizations (e.g., Canadian Institute for Health Information
• National Non-governmental organizations (health professional associations, regulatory and accreditation authorities, disease-specific organizations)
• Hospitals and patient safety organizations
• Advocacy groups

Industry / Consumer groups

• Private sector enterprises (including manufacturers, distributors, and retailers)
• Industry associations
• Consumer groups
• Standards development organizations (e.g., CSA Group)

Indigenous partners

• National and regional First Nations, Inuit and Métis partners
• Indigenous Health Professional Organizations

Federal departments and agencies

• Environment and Climate Change Canada
• Innovation, Science and Economic Development Canada
• Agriculture and Agri-Food Canada
• Public Safety/Canada Border Services Agency
• Indigenous Services Canada
• Women and Gender Equality Canada
• Department of Justice
• Global Affairs Canada
• Finance Canada/Treasury Board

International partners

• Multilateral fora (e.g., World Health Organization, Pan-American Health Organization, United Nations)
• Bilateral relationships with key partners and regions (e.g., U.S. Food and Drug Administration, European Medicines Agency, and Australian Therapeutic Goods Administration)

Health Canada financial overview

Budget by Core Responsibility and Internal Services

• Core Responsibility 1 – Health Care Systems. This consists of 276 full-time employees with an annual budget of $2.457 million which represents 63.6% of the total budget.
• Core Responsibility 2 – Health Protecton and Promotion. This consists of 5,933 full-time employees with an annual budget of $1.104 million which represents 28.6% of the total budget.
• Internal Services – this consists of 1,804 full-time employees with an annual budget of $302 million which represents 7.8% of the total budget.

Budget by Vote

• Vote 1 – Operating Expenditures has an annual budget of $1,306.4 million which represents 33.8% to the total budget.
• Vote 5 – Capital Expenditures has an annual budget of $17.5 million which represents 0.5% of the total budget.
• Vote 10 – Transfer Payments (Grants and Contributions) has an annual budget of $2,538.9 million which represents 65.7% of the total budget.

Total Resources: 8,013 FTEs and budget of approximately $3.863B

Notes:

• Budgets based on 2021-22 Main Estimates (not including Supplementary Estimates A); approximately 25% ($950M) is for COVID response, and 54% for bilateral agreements with PTs ($2B)
• Internal Services include Corporate Services, Communications, Finance and Legal Services
• Vote 1 Operating Expenditures include Statutory Authorities of $165.3M

Deputy Minister of Health - Dr. Stephen Lucas

Associate Deputy Minister - Heather Jeffrey

Strategic Policy Branch (SPB)
Kendal Weber, ADM
Eric Bélair, Associate ADM
Jocelyne Voisin, Associate ADM
Susan Fitzpatrick, Head of the Canadian Drug Agency Transition Office

Health Products and Food Branch (HPFB)
Pierre Sabourin, ADM
Manon Bombardier, A/Associate ADM

Controlled Substances and Cannabis Branch (CSCB)
Jacqueline Bogden, ADM
Shannon Nix, Associate ADM

Regulatory Operations and Enforcement Branch (ROEB)
Stefania Trombetti, ADM

Healthy Environments and Consumer Safety Branch (HECSB)
Isabella Chan, ADM

Pest Management Regulatory Agency (PMRA)
Peter Brander, Executive Director

Chief Financial Officer Branch (CFOB)
Serena Francis, ADM and Chief Financial Officer

Corporate Services Branch (CSB)
Debbie Beresford-Green

Communications and Public Affairs Branch (CPAB)
Pamela Aung-Thin, A/ADM
Cathy Allison, A/Associate ADM

Legal Services
Christian Roy, Senior General Counsel

Chief Medical Advisor
Dr. Supriya Sharma

COVID-19 Task Force organizational structure

Testing, Contact Tracing and Data Strategies Secretariat
Nancy Hamzawi, A/Federal Lead

Strategy and Integration
Zoe Kahn, A/ADM

Chief Data Officer and Workforce Health and Safety
Dr. Raman Srivastava, A/ADM

Science Policy and SRA Implementation
Tim Singer, A/ADM

Reporting and Digital Innovation
Cameron MacDonald, A/ADM

Workplace Screening and Private Sector Engagement
Christopher Johnstone, ADM

Policy and Programs
Sebastien Aubertin-Giguere, A/ADM

Public Health Agency of Canada

PHAC's mandate

PHAC was created in 2004 in order to:

• Promote health, well-being, and equity
• Protect against health emergencies and mitigate the impacts
• Prevent and reduce disease, injury, and disability

The Agency was created through enabling legislation and is led by a President (Deputy Head) and a Chief Public Health Officer of Canada (CPHO) working collaboratively.

• The President is the Deputy Head, accountable for the Agency including policy, programs, management of the Agency operations and staff, and leads Agency support for the Minister of Health in meeting his or her responsibilities and accountability to Parliament.
• The role of the CPHO is to advise the Minister of Health and President on public health matters, and communicate with public health authorities, stakeholders and the general public (see slide 10 for additional information).

PHAC advances its mandate through collaboration with a wide range of partners and stakeholders, including provinces and territories, Indigenous and International partners, other federal departments and agencies, private/non-profit sectors, and municipalities.

Delivering on public health functions and levers

Public health is the organized efforts of society to achieve optimal health and well-being for all people in Canada

Functions:

• Emergency preparedness and response
• Disease and injury prevention
• Health surveillance
• Population health assessment
• Health protection
• Health promotion

Levers:

Legal and regulatory – Acts or regulations that define areas of responsibility for public health and establish enforceable requirements

Economic – Public expenditure, public ownership, contracts, grants and contributions

Policy – Standards and guidelines, policies, frameworks, strategies or guidance documents

Information and education – Communications, education campaigns (e.g., combating misinformation), supports to implementation

Partnerships – Formal/informal networks, domestic, international agreements

Historical contributions of PHAC

Since 2004, PHAC has made significant contributions to public health, including:

2004 – Establishment of the Public Health Agency of Canada

2005 – Establishment of the Pan-Canadian Public Health Network

2008 – Response to Listeriosis outbreak

2009 – Response to H1N1 influenza outbreak

2013-14 – Ebola outbreak in West Africa; National Microbiology Laboratory plays key role in developing Ebola vaccine

2015 – PHAC supports resettlement of Syrian refugees

2017 – Present – Response to the epidemic of opioid overdoses

2020 – Present – Response to COVID-19

PHAC advances this work through leadership, partnerships, innovation, preparedness, and action in public health, both at the domestic and global level.

Leadership during a public health emergency

In the event of a public health emergency, PHAC is at the centre of the federal response and must pivot its resources to meet the challenge.

Specific responsibilities include:

• coordinating Canada's national response,
• liaising with domestic and international partners,
• leading Canada's border and travel health measures,
• leveraging expert science and public health advice,
• developing national public health guidance,
• providing subject-matter expertise and surge support to public health and health system partners,
• providing surveillance, epidemiological, diagnostic and other scientific and technical leadership and support, and
• communicating risk and public health advice to the public in a highly evolving context.

PHAC during the COVID-19 response

While emergency preparedness and response has always been a key part of PHAC's mandate, COVID-19 has stretched the Agency in unprecedented ways.

• The Agency rapidly scaled up existing operations and entered into new areas to support Canada's COVID-19 response (e.g., National Microbiology Laboratory (NML) supporting PT labs to scale up for COVID-19 testing).
• While some of this expansion is temporary, certain elements are likely to require PHAC to play an ongoing role in both the short and long term (e.g., enhanced border measures, and national vaccine strategy).

Examples of activities during the COVID-19 response

• Securing and distributing essential PPE, medical equipment, and supplies. Purchased 3.5B items to date, from N95 masks to syringes
• Delivered 64M vaccines to provinces, territories and Indigenous partners and provided guidance on their use (through the National Advisory Committee on Immunization and PHAC experts), for the largest immunization program in Canada's history
• Communicating and advancing science: modelling, epidemiology, vaccines, testing and therapeutics and making real-time information available to Canadians through public health guidance and updates
• Borders and quarantine: For 18M travellers since March 2020, set policy and operate border systems to enhance public health at 35 points of entry (e.g., test and quarantine travellers)
• Surge Response: Through the Health Portfolio Operations Centre (HPOC), PHAC provides a single portfolio window to coordinate federal health supplies and health human resource responses to provincial requests during pandemic surges
• Increasing engagement with domestic and international partners to support enhanced coordination on public health policy, guidance and communications

Addressing complex public health challenges

While responding to COVID-19, the Agency continued to advance a broad range of public health priorities.

• Substance use: Developed a simulation model to estimate potential opioid-related deaths during the COVID-19 outbreak in 2020 and 2021 in partnership with Health Canada.
• Antimicrobial resistance (AMR): Mobilized multi-stakeholder community to formulate a Pan-Canadian AMR Framework to guide action, and have developed a draft Action Plan that now needs advancement.
• Climate change: Supported the implementation of the Pan-Canadian Framework on Clean Growth and Climate Change through the Infectious Disease and Climate Change Program and policy renewal.
• Mental health: Sponsored and helped design Survey of COVID-19 and Mental Health to study the impacts for Canadians on topics including positive mental health, anxiety, depression, parenting, and others in collaboration with Statistics Canada.
• Health inequity: Collaborated with the Mental Health of Black Canadians Working Group and released a summary of evidence on health inequities among Black communities in September 2020.
• Healthy living: Supported 38 community-based projects that deliver interventions to address physical inactivity, unhealthy eating, and tobacco use.
• Non-communicable diseases: Funded 189 projects that aim to increase knowledge about dementia and/or improve the quality of life of those impacted by dementia.
• Outbreaks: Assessed 251 enteric illness events and led the response to 28 multi-jurisdictional outbreaks.

PHAC financial overview

Budget (in millions)

• O&M: $11,665.9 million which represents 89% of the total budget
• Gs&Cs: $844.3 million which represents 6% of the total budget
• Salaries: $454.1 million which represents 3% of the total budget
• Capital: $101.1 million which represents 1% of the total budget
• Statutory: $82.1 million which represents 1% of the total budget

Budget by Core Responsibility

• Infectious Disease Prevention and Control: $9,785.0 million which represents 74% of the total budget
• Health Security: $2,735.3 million which represents 21% of the total budget
• Health Promotion and Chronic Disease Prevention: $354.0 million which represents 3% of the total budget
• Internal Services: $272.5 million which represents 2% of the total budget

Total Authorities 2015-16 to 2024-25

Total Authorities 2015-16 to 2024-25 (in millions as of July 13, 2021)

• 2020-21 authorities include $11.5B in authorities that are re-profiled to 2021-22 and beyond.
• COVID-19 funding ($12,513.1M) makes up more than 95% of PHAC's total 2021-22 budget ($13,147.5M)

President
Dr. Harpreet S. Kochhar

Executive Vice-President
Kathy Thompson

Chief Public Health Officer
Dr. Theresa Tam

COVID-19 Vaccine Rollout Acting Vice President
Stephen Bent

National Digital Transformation Office Senior Vice President and Chief Technology Officer
Luc Gagnon

Emergency Management Branch (EMB) (inclusive of NESS) Vice President
Cindy Evans

Health Security and Regional Operations Branch (HSROB) Vice President
Brigitte Diogo

Border Measures Operations (BMO) Acting Vice President
Jennifer Lutfallah

Infectious Diseases Programs Branch (IDPB) Interim Vice President and Deputy Chief Public Health Officer
Dr. Howard Njoo

National Microbiology Laboratory Branch (NML) Vice President
Dr. Guillaume Poliquin

Health Promotion and Chronic Disease Prevention Branch (HPCDPB) Vice President
Candice St-Aubin

Corporate Data and Surveillance Branch (CDSB) Vice President
Rhonda Kropp

Strategic Policy Branch (SPB) Vice President
Anna Romano

Chief Financial Officer and Corporate Management Branch (CFOCMB) Vice President and Chief Financial Officer
Martin Krumins

Shared Services Supported by PHAC
Office of Audit and Evaluation (OAE) Director General Evaluations and Chief Audit Executive Shelley Borys

Office of International Affairs for the Health Portfolio (OIAHP) Branch Head
Michael Pearson

Shared Services Supported by Health Canada
Communications and Public Affairs Branch (CPAB) Acting Assistant Deputy Minister
Pamela Aung-Thin

Acting Associate Assistant Deputy Minister
Cathy Allison

Corporate Services Branch (CSB) Assistant Deputy Minister
Debbie Beresford-Green

Legal Services Senior General Counsel
Christian Roy

Chief Public Health Officer approach and priorities

Every year, the Chief Public Health Officer of Canada (CPHO) is mandated to provide the Minister of Health with an independent report on the health of Canadians. The 2021 report will be ready for tabling in Parliament by the Minister this fall. A briefing will be scheduled as a priority before its release.

These reports raise the profile of public health issues and stimulate dialogue. They can also lead to action on improving and protecting the health of Canadians.

Spotlight Reports

• Eliminating TB in Canada (2018)
• Preserving Antibiotics Now and Into the Future (2019)

Annual Reports

• Designing Healthy Living (2017)
• Prevention of Problematic Substance Use in Youth (2018)
• Addressing Stigma in the Health System (2019)
• From Risk to Resilience: An Equity Approach to COVID-19 (2020)

The CPHO reports address the areas of focus and priorities that were identified at the beginning of Dr. Tam's mandate.

An overall goal is to reduce health inequities – recognizing the health impact of persistent inequities between different communities and populations in Canada.

Key federal role within the Federal/Provincial/Territorial landscape

• The federal government holds key responsibilities in areas such as protecting health and safety, emergency preparedness and response, Indigenous health, and health promotion/disease prevention, while PTs are responsible for setting public health standards and delivering public health functions and programming.
• To advance shared FPT public health priorities, PHAC:
  • Fosters collaboration and senior public health decision-making and public health perspectives on health system business at the Conference of Deputy Ministers of Health (CDMH) and FPT Health Ministers Meetings (HMM), working with and convened by Health Canada.
  • Convenes and leads the Pan-Canadian Public Health Network (PHN), co-led by Canada's Chief Public Health Officer, which serves as the governance structure for collaboration between senior public health officials including Council of Chief Medical Officers of Health and PHN steering committees.
  • Convenes and supports strategic and technical tables that address a wide range of public health issues, including the Canadian Immunization Committee, the FPT Steering Committee on Antimicrobial Resistance, FPT Coordinating Committee on Dementia, and the FPT Sport, Physical Activity and Recreation tables (together with Sport Canada).
  • Fosters relationships with local medical officers of health, key stakeholders and Indigenous partners who also shape the FPT health system and public health landscape.
• In January 2020, a FPT Special Advisory Committee (SAC) on COVID-19 was activated as a time-limited governance mechanism under the PHN to lead a coordinated public health response, supported by technical committees (Technical Advisory Committee (TAC), Logistics Advisory Committee (LAC), Working Group on Remote and Isolated Communities, Communications). A parallel SAC on the epidemic of opioid overdoses also remains active.

Collaboration with other partners

International

Minister's role

• Plays a leading role in international activities related to public health by advancing priorities at various fora (e.g., G7 and G20 Health Ministerial Meetings, World Health Assembly; and United Nations General Assembly) and bilaterally with counterparts in other countries to advance key health priorities.

Agency's role

• Works closely with multilateral partners (World Health Organization [WHO], Pan American Health Organization [PAHO], G7, G20, and key bilateral/ regional partners (U.S., Mexico, UK, the Caribbean Public Health Agency)
• Acts as Canada's focal point for International Health Regulations
• Leads development, analysis, and negotiation of Canadian positions and political declarations to shape global health policies
• Manages the International Health Grants Program to facilitate funding for international projects and payment of Canada's assessed and voluntary contributions
• Supports health working group/committee work
• Hosts the WHO Collaborating Centre on Non Communicable Disease Policy and the WHO Collaborating Centre for Biosafety and Biosecurity

Federal departments and agencies

Minister's role

Works with Cabinet colleagues and bilaterally with counterparts on key public health priorities:

• Minister of Seniors (e.g., dementia)
• Minister of Crown-Indigenous Relations and Minister of Indigenous Services (e.g., Indigenous health)
• Minister of Public Safety and Emergency Preparedness (e.g., Post-Traumatic Stress Injuries, emergency management)

Agency's role

Works closely with a number of departments and agencies responsible for ensuring healthy lives and promoting well-being including:

• Health Portfolio Partners
• Crown-Indigenous Relations and Northern Affairs Canada
• Indigenous Services Canada
• Employment and Social Development Canada
• Canadian Heritage
• Public Safety Canada
• Canada Border Services Agency
• Global Affairs Canada
• Innovation, Science and Economic Development
• Correctional Services Canada
• Immigration, Refugees and Citizenship Canada
• Public Services and Procurement Canada
• Transport Canada

Other partners

Minister's role

• Ministerial Advisory Bodies: the Dementia Advisory Board and the National Seniors Council (with Minister of ESDC)
• The Minister is also a member of Federal-Indigenous Permanent Bilateral Mechanisms with First Nations. Inuit, and Metis

Agency's role

• Works with Indigenous partners to advance reconciliation and Indigenous public health priorities
• Collaborates and works with national health organizations (e.g., health professional organizations, NGOs, academia, community based organizations), innovative partners from outside of the health sector and people with lived and living experience on science, guidance, programs and policy to support public health outcomes

Annex A – Essential public health functions

• Emergency preparedness and response – Planning for both natural and man-made disasters to minimize serious illness, overall deaths and social disruption
• Population health assessment – Understanding the health of communities or specific populations, as well as the factors that underlie good health or pose potential risks, to produce better policies and services
• Disease and injury prevention – Investigation, contact tracing, preventive measures to reduce risk of infectious disease emergence and outbreaks, activities to promote safe, healthy lifestyles to reduce preventable illness and injuries
• Health protection – Actions to ensure water, air and food are safe, a regulatory framework to control infectious diseases, protection from environmental threats, and expert advice to food and drug safety regulators
• Health surveillance – The ongoing, systematic use of routinely collected health data for the purpose of tracking and forecasting health events or health determinants
• Health promotion – Preventing disease, encouraging safe behaviours and improving health via public policy, community-based interventions, public participation, and advocacy and action on environmental and socio-economic determinants of health

Annex B – Branch mandates

Health Promotion and Chronic Disease Prevention branch (HPCDP)

Promotes health and funds community health partners

• Promotes and improves environments and behaviours that support positive physical and mental health across all stages of life by:
  • Undertaking public health surveillance, monitoring, and research on health promotion and chronic disease prevention;
  • Supporting community-based initiatives, and sharing knowledge of best practices to promote healthy behaviours, prevent chronic disease and improve overall health.
• Supports efforts to measure health inequalities and address their root causes.

Emergency Management Branch (EMB)

Point of coordination for emergency response

• Represents the Agency as a federal authority in public health emergency management, leading on emergency preparedness, emergency response, and the National Emergency Strategic Stockpile.

Health Security and Regional Operations Branch (HSROB) and Border Measures Operations (BMO)

Running PHAC border and quarantine presence

• Addresses health and safety risks associated with:
  • the use of pathogens and toxins;
  • enforcing regulations governing food safety and water quality on conveyances;
  • administering and enforcing the Quarantine Act to prevent entry of travel-related infectious diseases into Canada; and
  • informing Canadian travellers on how to protect themselves from travel-related public health risks (Border Measures Operations).
• Also supports Agency programs and priorities through regional operations across six regions.

Essential public health functions

• Emergency preparedness and response
• Population health assessment
• Disease and injury prevention
• Health protection
• Health surveillance
• Health promotion

Infectious Diseases Programs Branch (IDPB)

Protecting against infectious diseases

• Leads the development and implementation of programs to assess, prevent, reduce, and respond to the threat and control of infectious diseases.

National Microbiology Laboratory Branch (NMLB)

Laboratory science and scientific excellence

• Leads Agency-wide advancement of laboratory science, and provides support through testing services, lab-based surveillance, outbreak response, basic and applied research on infectious diseases, and medical countermeasure development.
• Also provides pan-Canadian leadership to national public health laboratories to ensure consistency in responses to infectious disease threats, and contains the country's level 4 laboratory.

COVID-19 vaccine rollout

Coordinating the vaccination of Canadians

• Manages a transparent and coordinated national COVID-19 vaccination campaign in close collaboration with federal, provincial, territorial, Indigenous representatives and other stakeholders.
• Supports the vaccination campaign through the selection and acquisition of vaccines; managing national logistics for allocation and delivery to jurisdictions; providing training, equipment and guidelines for storage and handling; and national monitoring and surveillance of vaccine coverage, safety and effectiveness.

Corporate Data and Surveillance Branch (CDSB)

Data management and behavioural sciences

• Provides enterprise-wide leadership for data innovation and management, public health surveillance, and behavioural sciences.
• Also provides services for Agency programs related to advanced analytics, knowledge translation, and data acquisition and visualization.

Strategic Policy Branch (SPB) – Agency enabler

Develops and implements the PHAC policy agenda

• Leads the Government of Canada's public health agenda by developing and implementing PHAC's policy agenda and priorities, fosters strong partnerships and effective governance, and drives for results through planning and reporting.
• Leads PHAC's renewal initiative, which is focussed on creating an optimal future for the Agency as a world-class public health organization.

Chief Financial Officer and Corporate Management Branch (CFOCMB) – Agency enabler

Oversees the agency's financial resources

• Provides strategic leadership, stewardship, risk management, control and the performance of the Agency's financial resources.
• Provides the leadership and strategic management of corporate services, as well as the business transformation of both the financial management and corporate service functions to meet both the immediate and longer-term business and service requirements of the Agency.

National Digital Transformation Office – Agency enabler

Modernizing health IT systems

• Develops strategies and plans to introduce new technologies, standards and processes to modernize Health IT systems and applications including leading research and development of next generation digital products and services for PHAC.
• Leads VaccineConnect digital platform for managing vaccine roll-out supply chain management, immunization coverage & safety and end-to-end vaccine program execution at Points of Administration.

Annex C – Enabling services

Office of Audit and Evaluation (OAE)^{Footnote 2}

Performs audit, evaluation and risk management functions

• Provides independent and objective advice and assurance to Public Health Agency of Canada (PHAC) and Health Canada (HC) senior management on the effectiveness of risk management, controls, and governance, as well as the relevance and performance of programs.

Office of International Affairs for the Health Portfolio (OIAHP)^{Footnote 2}

Lead for the Health Portfolio's international engagement

• Strategically advances the Health Portfolio's international priorities in support of Canada's domestic health policy and foreign policy objectives, and ensures Canada's interests and values are reflected in the global health agenda.
• Provides strategic intelligence, policy advice, and logistical support for international engagement to the Minister of Health and Deputy Heads.
• Leads on the Portfolio's international engagement with key multilateral, regional, and bilateral partners, including incoming visits.
• Manages the International Health Grants Program.

Communications and Public Affairs Branch (CPAB)

Leads communications for Health Canada and PHAC

• Acts as the primary liaison with communications personnel in the Minister's Office and with Privy Council Office Communications, and provides communications support to both Health Canada and the Public Health Agency of Canada through a shared services agreement. Provides four primary services that support regular business as well as the COVID-19 pandemic response:
• Strategic and Ministerial Communications
• Marketing, Advertising and Creative Services
• Digital Communications
• Public Engagement and Research

Corporate Services Branch (CSB)

Oversees corporate services

• Provides corporate support and services nationally for Health Canada and the Public Health Agency of Canada.

Legal services

Provides legal services to Health Canada and PHAC

• Provides legal services to Health Canada and PHAC. These services include: legal advice; opinions; the development of legislative proposals; and, litigation support to the Minister, Deputy Minister and senior managers.
• Reports to the Department of Justice on an organizational, functional and professional basis.

Canadian Institutes of Health Research

CIHR overview

• As Canada's federal funding agency for health research and member of the Health Portfolio, CIHR is using the power of research to improve the health of Canadians, solve health challenges and make our health care system more efficient and effective
• Working with international and domestic partners to set research priorities and support health research, CIHR is investing in world-class research conducted in Canadian post-secondary institutions and their affiliated hospitals and research institutes

CIHR mandate

As stated in the CIHR Act (2000), the objective of CIHR is to "excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system"

A Brief overview of CIHR

• Invests over $1.2 billion annually to support over 14,000 world-class researchers and trainees
• Funds the creation of new knowledge, builds research capacity, and promotes the dissemination of research results in order to improve the health of Canadians and make our health care system more efficient
• Plays a catalyst role in collaborating with international and domestic partners, including the other federal research granting agencies (i.e., the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council) to support and mobilize Canada's research enterprise
• Offers the Minister of Health tools and resources to:
  • develop evidence-based policies and programs
  • demonstrate leadership in health innovation
  • engage positively with provinces and territories

Our institutes

• A unique model for health research, CIHR Institutes share the responsibility for fulfilling its mandate
• Each institute is led by an internationally renowned scientist and represents a network of researchers brought together to support a broad spectrum of research in its topic areas
• The model enables optimal use of existing knowledge to fill research gaps in priority areas, maximize cooperation and minimize duplication

Areas of responsibility

• Population and Public Health
• Aging
• Cancer Research
• Circulatory and Respiratory Health
• Gender and Health
• Genetics
• Health Services and Policy Research
• Human Development, Child and Youth Health
• Indigenous Peoples' Health
• Infection and Immunity
• Musculoskeletal Health and Arthritis
• Neurosciences, Mental Health and Addiction
• Nutrition, Metabolism and Diabetes

How CIHR supports research

Two approaches drive research:

Investigator

• Support the best research ideas proposed by researchers and trainees
• We call this investigator-initiated research

Health priorities

• Address the changing health needs and priorities of Canadians
• We call this priority-driven research

Process:

• Researchers apply for funding
• CIHR receives applications
• Applications are evaluated by independent experts
• CIHR makes final funding decision and releases funds
• Researchers conduct research
• Knowledge mobilization

Key business lines

Health research – advancing CIHR's renewed vision

• Implementing CIHR's new Strategic Plan (2021-2031) – A Vision for a Healthier Future to support a vibrant health research community and improve the health of Canadians by:
  • Advancing research excellence in all its diversity
  • Strengthening Canadian health research capacity
  • Accelerating the self-determination of Indigenous Peoples in health research
  • Pursuing health equity through research
  • Integrating evidence in health decisions
• CIHR's Global Health Research Framework will guide strategic investments and activities in global health research from 2021-2026, positioning Canada as a world leader in leveraging the power of research to accelerate global health equity for all

Federal priorities – Collaborating with the Health Portfolio and other government partners

• Provide research evidence needed to develop sound, evidence-based policies on health priorities (e.g., COVID-19 response, future pandemic preparedness, opioid crisis, AMR Action Plan, National Dementia Strategy, diabetes, Post-Traumatic Stress Disorder, standards for mental health, national strategy on high-cost drugs for rare diseases)
• Work as a member of the Canada Research Coordinating Committee to improve the coordination efforts of Canada's research granting agencies (CIHR, Social Science and Humanities Research Council, Natural Science and Engineering Research Council) in priority areas, including research security

CIHR financial overview

• CIHR's annual budget has remained relatively stable between $1 and $1.2 billion for the last 10 years, notwithstanding additional time-limited funding received in 2020-21 in support of COVID-19 research resulting in $1.4 billion in expenditures
• CIHR's operating budget is approximately 5.6% of its total budget, and CIHR faces increasing pressure to deliver CIHR's expanding health research priorities

Budget 2021-22 by category (in millions)

The Canadian Institutes of Health Research's Financial Overview for Budget 2021-22 by category: grants and awards, salaries, and operating and maintenance. As reported in Main Estimates and CIHR's Departmental Plan, the total budget is $1,254 million and resources include 511 full-time employees.

The budget by category is comprised of the following:

• grants and contributions with $1,183.8 million;
• salaries with $55.7 million; and
• operating and management with $14.4 million.

Further financial information

In 2020-21, CIHR invested a total of $1.440B in Grants and Awards broken down into discretionary investments, non-discretionary investments, and statutory authorities.
Discretionary investments totaled $790.9M and included:

• Training and Career Support ($25.3M). The majority of CIHR support for training is provided indirectly, through grants to researchers reported in the other categories;
• Research in Priority Areas - Institute and Corporate-led Initiatives ($134.4M),
• Investigator-Initiated Research - Project & Foundation Grants ($631.2M).

Non-discretionary investments totaled of $445.0M and included:

• Government of Canada Priorities - Ring-fenced Initiatives ($189.7M);
• Tri-agency Programs - Separately listed grants ($255.3M)

Statutory authorities totaled $203.6M for time-limited funding for COVID-19 research pursuant to the Public Health Events of National Concern Payments Act.

CIHR organizational structure

CIHR consists of a single head office in Ottawa, under the lead of the following senior executives:

• Michael J. Strong – Deputy Head/President
• Catherine MacLeod Executive Vice-President
• Vacant Vice-President Research Programs
• Tammy J. Clifford Vice-President Learning Health Systems
• Chrsitian Sylvain Associate Vice- President Government and External Relations
• Dwayne Martins Associate Vice- President Corporate Services
• Adrian Mota Associate Vice- President Research Programs – Operations
• Sarah Viehbeck Associate Vice- President Evidence Integration

Canadian Institutes of Health Research’s (CIHR) governance structure

The CIHR governance structure describes the roles and responsibilities that each governance area oversees. At the top of CIHR's governance structure is Parliament and the Minister of Health. Directly under the Minister of Health is CIHR Governing Council (GC), then the CIHR President, and a Science Council (SC) and a Senior Leadership Committee (SLC) that report to the CIHR President.

The CIHR Governing Council is responsible for:

• Developing strategic directions, goals and policies;
• Evaluating performance/appointments of scientific directors;
• Approving budget/by-laws;
• Establishing, maintaining, terminating and providing mandates for CIHR's institutes.

The CIHR President is responsible for:

• Day-to-day management of CIHR;
• Approving funding for research;
• Providing advice to the Minister of Health.

CIHR's Science Council is responsible for:

• Leadership on research and knowledge translation strategy
• Leadership on funding for CIHR.

CIHR's Senior Leadership Committee is responsible for:

• Leadership on corporate policy and management.

*As a Government of Canada agency within the Health Portfolio, CIHR reports to Parliament (e.g., Departmental Results Report), advises the Minister of Health in respect of any matter relating to health research or health policy, and supports federal government policy directions (e.g., participate in parliamentary committee hearings)

Annex: A key player in the Government of Canada's science and technology structure

Numerous key players are involved in the Government of Canada's Science and Technology Structure.

At the top of the Government of Canada's Science and Technology Structure is the Prime Minister of Canada. Under the Prime Minister is the Minister of Health, the Minister of Innovation, Science and Industry, and other Cabinet Ministers.

Those reporting to the Minister of Health are Health Canada, the Public Health Agency of Canada, the Canadian Food Inspection Agency, and the Canadian Institutes of Health research.

Those reporting to the Minister of Innovation, Science and Industry are Innovation, Science and Economic Development Canada, the National Research Council, the Canadian Space Agency, Statistics Canada, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council.

Other Cabinet Ministers include National Resources Canada, Global Affairs Canada, National Defence, Defence Research and Development Canada, Fisheries and Oceans Canada, Transport Canada, Public Safety Canada, and Environment and Climate Change Canada.

Of the above list, the following are departments with national laboratories: Health Canada, Innovation, Science and Economic Canada, National Resources Canada, Global Affairs Canada, National Defence, Fisheries and Oceans Canada, Transport Canada, Public Safety Canada, and Environment and Climate Change Canada.

The following are federal agencies conducting research: the Public Health Agency of Canada, the Canadian Food Inspection Agency, National Research Council, the Canadian Space Agency, Statistics Canada, and Defence Research and Development Canada.

The following research funding agencies: the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council, and the Social Sciences and Humanities Research Council.

Annex: A key player in federal science and technology investments (2021-22)

Numerous key players invest in Federal Science and Technology. Below is a list of federal committees, organizations, departments & agencies along with their investments in science and technology for 2020-2021. Data collected in June 2021.

Canada Research Coordinating Committee members:

• Canadian Institutes of Health Research ($1239M), Natural Sciences and Engineering Research Council ($1379M), Social Sciences and Humanities Research Council ($819M), Canada Foundation for Innovation ($443M).

Research and Technology Organization:

• National Research Council ($1334M)

Federal Agency:

• Canadian Spacy Agency ($362M), Natural Resources Canada ($693M)

Federal Department:

• Statistics Canada ($901M), Global Affairs Canada ($581M), Environment and Climate Change Canada ($825M), Fisheries and Oceans ($354M), National Defence ($503M), Innovation, Science and Economic Development ($816M), Agriculture and Agri-Food Canada ($526M), Health Canada ($399M).

Canadian Food Inspection Agency

CFIA mandate

Develop and deliver inspection and other services to:

• Prevent and manage food safety risks (e.g. food recalls);
• Protect plant resources from pests, diseases and invasive species (e.g. emerald ash borer);
• Prevent and manage animal diseases, including diseases that threaten human health (e.g. avian influenza);
• Contribute to consumer protection (e.g. labelling claims); and
• Facilitate market access for Canada's food, plants and animals.

Division of responsibilities between Ministers

Two (2) ministers have responsibilities with respect to the Canadian Food Inspection Agency (CFIA). They are the Minister of Health and the Minister of Agriculture and Agri-Food.

Responsibilities for Minister of Health:

• Overall direction for the CFIA
• Power to order recalls of regulated products
• Approving and tabling CFIA reports to Parliament

Health Canada and CFIA administer a number of standards and acts.

Health Canada:

• Sets food safety standards
• Sets food safety requirements under the Food and Drugs Act
• Conducts human health risk assessments

CFIA:

• Enforces food safety provisions of the Food and Drugs Act
• Sets inspection program requirements and enforces food safety under Safe Food for Canadians Act

The Minister of Agriculture and Agri-Food is responsible for:

• Agriculture and agri-food economic and trade issues
• CFIA commodity-specific legislation for plants and animals as well as non-food safety provisions of the Safe Food For Canadians Act and the Food and Drugs Act (FDA)

Agriculture and Agri-Food administer a number of acts that fall under three (3) main areas:

• Plants: Fertilizers Act, Plant Protection Act, Seeds Act, Plant Breeders' Rights Act
• Animals: Feeds Act, Health of Animals Act
• Food: All non-food safety activities in the Safe Food for Canadians Act, and the Food and Drugs Act

Core business lines

Food safety

Safeguard Canada's food supply

• Includes health and safety and labelling
• Administering and enforcing the Safe Food for Canadians Regulations and Food and Drugs Regulations

Minimize health and safety risks to Canadians' by:

• Protecting Canadians from preventable food safety hazards
• Managing food safety investigations and recalls effectively

Contributes to consumer protection by:

• Verifying that information provided to Canadian consumers through labels and advertising is truthful and not misleading

Plant Health

Protect Canada's plant resource base

• Includes crops, horticulture, nurseries, forest resources and products, greenhouses, seeds, fertilizers, plants with novel traits, invasive alien species

Protect Canada's plant resource base, environment and plant-related industries by:

• Preventing the introduction and spread of pests that could damage Canadian production and the income of Canadian producers
• Verifying farmers have access to safe, effective and innovative agricultural inputs (e.g., seed, fertilizer) that support environmental sustainability
• Fostering innovation through protection of intellectual property (i.e., plant breeders' rights)
• Maintaining the reputation of Canadian agricultural products in the global marketplace as being high-quality, pest free and safe

Animal health

Protect Canada's animal resource base and Canadians from disease

• Includes livestock, poultry, animal feeds, vaccines and fish and seafood

Minimize risks to Canada's terrestrial and aquatic animal resource base, and ensure the safety of animal feeds, products and vaccines by:

• Protecting Canada's animals, including aquatic animals, from diseases
• Managing animal disease incidents and emergencies (e.g. avian influenza)
• Promoting and regulating animal welfare, in transportation and in slaughter
• Verifying that animal feeds and vaccines are safe and effective

International trade

Facilitate market access for Canada's plants, animals and food

Contributing to market access for Canadian agriculture and agri-food by:

• Influencing the development of international rules and standards for plant protection, animal health and food safety through international standard-setting bodies
  • World Organization for Animal Health (OIE)
  • Codex Alimentarius Commission (CODEX) (Food)
  • International Plant Protection Convention (IPPC)
• Engaging trading partners
• Negotiating import / export conditions and technical agreements and standards
• Working in collaboration with Agriculture and Agri-Food Canada and Global Affairs Canada

CFIA's strategic plan

Modern Regulatory Toolkit

• Protect Canada's food, plant and animal resource-base while supporting innovation.
• Outcome-based regulations and new compliance tools that focus on safety, allowing industry to innovate and the Agency to adapt in response to emerging risks.

Integrated Risk Management

• Target resources to where they are needed most.
• Better use of our data, reports and surveillance to identify trends, allowing us to focus on risk and support program design, planning, compliance and enforcement efforts.

Consistent and Efficient Inspections

• Greater efficiency and agility to respond to emerging risks.
• An inspection approach carried out nationally in a fair, consistent and predictable manner that is focused on regulatory outcomes and supported by mobile tools and guidance.

Digital-First Tools and Services

• Embrace technology to make it easy to get information and services.
• To equip industry with a full range of electronic services and information to comply with regulations and employees with the necessary tools to carry out their work effectively and efficiently.

Global Leader

• Support international consensus to safeguard food, plant and animals while supporting market access.
• To pursue improved international standards, fairness in trade practices, enhanced use of technology and regulatory cooperation.

CFIA's talented staff are engaged and ready for the changes

• Ensure employees have the tools, training and a strong voice for changes.

Engaging with industry and partner

• Consider the perspectives of industry and our partners as we evolve.

CFIA Partners

International partners

• Set import requirements and verify export requirements
• Comparability and acceptance of relevant systems, and
• Develop international science-based rules, standards, etc.

Provincial, territorial and municipal governments

• Enforce jurisdictional food safety, plant and animal health requirements
• Collaborate in responding to food safety incidents, and
• Prevent and manage plant and animal health emergencies

Federal departments and agencies

• Health Portfolio
• Agriculture and Agri-Food Canada Portfolio
• Global Affairs Canada
• Canada Border Services Agency
• Fisheries and Oceans Canada
• Environment and Climate Change Canada
• Natural Resources Canada
• Shared Services Canada, and
• Innovation, Science and Economic Development
• Public Service and Procurement Canada

Industry

• Production of safe food
• Comply with regulatory requirements
• Develop and implement best management practices

Consumers

• Safe food handling and preparation
• Awareness of plant and animal risks (for example, transporting infested firewood)

CFIA financial overview

Budget 2021-22 by core business

Budget 2021 to 2022 by Core Business describes two (2) segments:

• 79% is devoted to safe food and healthy plants and animals, which has 5060 FTEs and a budget of $625 million
• 21% is devoted to Internal Services, which has 1005 FTEs and a budget of $161 million

Budget 2021-22 by vote (in millions)

CFIA financial overview for the 2021 to 2022 budget.

Budget 2021 to 2022 by Vote divides into 4 segments:

• Voted – Operating expenditures: totals $609 million and 77 percent of the total
• Voted – Capital expenditures: totals $30 million and 4 percent of the total
• Statutory revenue: totals $53 million and 7 percent of the total
• Other statutory: totals $94 million and 12 percent of the total

CFIA organizational structure

CFIA's organizational structure is led by two (2) senior executives. The President, Dr. Siddika Mithani, and the Executive Vice-President, whose position is currently vacant. Under the 2 senior executives are 11 executives that oversee different sections of CFIA.

Delivery of CFIA mandate:

• Sylvie Lapointe, Vice-President of Policy and Programs, provides strategic policy advice and sets out program policies and procedures
• Dr. Jaspinder Komal, Vice-President of the Science Branch, provides scientific advice and diagnostic and testing services
• Philippe Morel, Vice-President of the Operations Branch, delivers inspection programs and takes compliance and enforcement action
• Kathleen Donohue, Acting Assistant Deputy Minister of the International Affairs Branch, leads on market access and international regulatory trade issues
• David Nanang, Associate Vice-President of Operations, delivers inspection programs and takes compliance and enforcement action

Corporate services:

• Robert Ianiro, Vice-President of Human Resources, enables talent identification, acquisition and mobilization
• Jacques Cormier, Vice-President of Corporate Management and Chief Financial Officer, provides oversight of financial management and assets and security management
• Jane Hazel, Vice-President of Communications and Public Affairs, delivers internal and external communication services
• Joanne Butler, Chief Audit Executive and Head of Evaluation of Audit and Evaluation, provides evidence-based advice and assurance to senior management

Both corporate services and delivery of CFIA mandate:

• Amanda Jane (AJ) Preece, Vice-President of Innovation, Business and Service Development and Chief Information Officer, delivers on major projects and priority change initiatives and enables information and information technology

Shared services with Agriculture and Agri-Food Canada:

• Kristine Allen, Executive Director and Senior General Counsel, Legal Services, provides legal services to the CFIA and Agriculture and Agri-Food Canada (AAFC)

CFIA national presence

Area and Regional Offices

• Atlantic Area:
  • New Brunswick (Moncton)
  • New Brunswick (Fredericton)
  • Prince Edward Island (Charlottetown)
  • Newfoundland and Labrador (St. John's)
• Quebec Area:
  • Montreal East
  • Montreal West
  • St. Hyacinthe
  • Ste. Foy
• Ontario Area:
  • Northeast (Barrie)
  • Toronto (Downsview)
  • Central (Guelph)
  • Southwest (London)
• Western Area:
  • Manitoba (Winnipeg)
  • Alberta South (Calgary)
  • Alberta North (Edmonton)
  • British Columbia (Burnaby)

Patented Medicine Prices Review Board

Mandate

The PMPRB has a dual role:

• Regulatory: to protect consumers by ensuring that prices of patented medicines sold in Canada are not excessive.
• Reporting: to report on trends in pharmaceutical sales and pricing for all medicines and on research and development (R&D) spending by patentees.

Jurisdiction and legislation

• The PMPRB's powers and obligations are set out in ss. 79-103 of the Patent Act and associated Patented Medicines Regulations and Rules of Practice and Procedure. The PMPRB also publishes non-binding Guidelines intended to provide transparency and predictability to patentees regarding the triage and review process typically engaged in by public servant employees of the PMPRB in assessing whether an investigation or a hearing on the price of the patented medicine is warranted.
• The Patent Act establishes the PMPRB as an independent, quasi-judicial body.
• While the PMPRB is part of the Health Portfolio, it carries out its regulatory mandate at arm's length (i.e., independently) from the Minister of Health, due to its quasi-judicial nature.

Responsibilities of the Minister

The Patent Act authorizes the Minister of Health to:

• Table the Annual Report prepared by the PMPRB before Parliament;
• Recommend new or amended regulations to the Governor in Council;
• Refer matters to the PMPRB for inquiry.

The Minister of Health may (but is not obligated to):

• Participate as a party in a hearing before the PMPRB;
• Convene meetings with the PMPRB;
• Participate in PMPRB guideline consultations and designate representatives of consumer groups and of the pharmaceutical industry as participants in such consultations;
• Enter into agreements with provinces respecting the distribution of excess revenues collected by the PMPRB from pharmaceutical patentees;
• Under section 90 of the Act, make inquiries to the Board, which in turn is required to report to the Minister at the time and in accordance with the terms of reference established by the Minister;
• File a complaint that will trigger a PMPRB investigation into the price of any patented medicine which appears on the List of Drugs for Exceptional Importation and Sale pursuant to the March 30, 2020 Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 or on the list(s) published by Health Canada pursuant to the September 16, 2020 Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

Core business lines

Regulatory mandate

• The Guidelines set out the circumstances which trigger an investigation (in-depth review) by PMPRB staff into the price of a patented medicine. Once an investigation is commenced, it may be:
  1. closed upon further review;
  2. closed as a result of the patentee volunteering to lower its price and/or refund its potential excess revenues through a Voluntary Compliance Undertaking (VCU) of a medicine which, in the Chairperson's view, warrants closure of the investigation; or
  3. lead the Chairperson to refer the matter to a public hearing.
• At a hearing, a panel composed of Board members acts as a neutral arbiter between Staff and the patentee. If a panel finds that the price of a patented medicine is excessive, it can order the price be reduced to a non-excessive level. It can also order a patentee to make a monetary payment to the Government of Canada to offset the excess revenues earned and, in cases where the panel determines there has been a policy of excessive pricing, it can double the amount of the monetary payment.

Reporting mandate

• As required by the Act, the PMPRB reports annually to Parliament through the Minister of Health on its price review activities, the prices of patented medicines and price trends of all prescription medicines, and on the research and development expenditures reported by pharmaceutical patentees.
• Pursuant to an agreement by the F/P/T Ministers of Health in 2001, and at the request of the Minister of Health, pursuant to section 90 of the Act, the PMPRB conducts critical analyses of price, utilization and cost trends for patented and non-patented prescription medicines under the National Prescription Drug Utilization Information System (NPDUIS). This program provides F/P/T governments and other interested stakeholders with a centralized, objective and credible source of information on pharmaceutical trends.
• Among other initiatives under its reporting mandate, the PMPRB also hosts various forums, such as webinars, research forums and information sessions, with academics and policy experts to discuss and disseminate research on emerging areas for study on pharmaceutical trends in Canada and internationally.

Key files – modernizing the regulatory framework

• On August 21, 2019, Health Canada published amendments to the Patented Medicines Regulations in Canada Gazette, Part II, which represent the first substantive update of the PMPRB's regulatory framework in more than 30 years. The amendments provide PMPRB with modern tools and information to protect Canadians from excessive medicine prices:
  • Benchmarking prices against countries that are more like Canada economically and from a consumer price protection standpoint;
  • Regulating at the level of the actual prices being paid in Canada (requiring patentees to report price and revenue that is net of confidential rebates and discounts)^{Footnote 3};
  • Considering the value (cost effectiveness) and the overall affordability (market size) of a medicine when setting the maximum price.
• On October 23, 2020, the PMPRB published new Guidelines which will give effect to the Regulations when they come into force.
• Since their announcement, the coming into force of the Regulations has been delayed by six months on three occasions and are now slated to come into force on January 1, 2022.
• The PMPRB is currently consulting on three proposed amendments to the new Guidelines related to the delay the coming-into-force date of the Regulations. The PMPRB proposed changes to the definition of Gap medicines, the references to the comparator countries and the international price tests for Grandfathered medicines and their line extensions.

Budget 2021-22 by category (in millions)

Operational priorities budget (in millions) for each branch within PMPRB. The PMPRB has six branches: Executive Director, Board Secretariat, Corporate Services, Regulatory Affairs and Outreach, Policy and Economic Analysis, and Legal Services. The total resources are 85 Full-Time Equivalent (FTEs) and a budget of approximately $18.89 million.

The budgets for each branch are as follows:

• Executive Director has a budget of $1.11 million.
• Board Secretariat has a budget of $2.61 million.
• Corporate Services has a budget of $2.74 million.
• Regulatory Affairs and Outreach has a budget of $3.58 million.
• Policy and Economic Analysis has a budget of $3.63 million.
• Legal Services has a budget of $5.23 million.

The department's Core Responsibility is to regulate patented medicine prices and the Departmental Result is affordable patented medicine prices. The Department Budget is directed towards two priorities:

• Strategic Outcomes, which accounts for $15.81 million of the budget.
• Internal Services, which accounts for $3.09 million of the budget.

The Patented Medicine Prices Review Board's (PMPRB) organizational structure.

• The Board consists of up to five part-time Governor in Council-appointed members, including a Chairperson and a Vice-Chairperson
• The Chairperson is designated under the Patent Act as the Chief Executive Officer of the PMPRB, with the authority and responsibility to supervise and direct its work
• The Executive Director is responsible for the day-to-day administration of the PMPRB and oversight of its approximately 90 public servants staff

The organizational structure lists the senior management of PMPRB. At the top of PMPRB is the chairperson, Dr. Mitchell Levine.

Under the president, we find the vice-present and three members of the Council:

• Carolyn Kobernick;
• Dr. Ingrid Sketris;
• Matthew Herder;

The three senior staff of the PMPRB act under the direction of the Board:

• The Vice Chair Person, Mélanie Bourassa Forcier;
• Director of the Board Secretariat, Communication and Strategic Planning, Guillaume Couillard;
• Executive Director, Douglas Clark;
• General Counsel, Isabel Jaen Raasch;

The Executive Director oversees the Directors of the PMPRB's three other directorates:

• Director of Policy and Economic Analysis, Tanya Potashnik;
• Director of Regulatory Affairs and Outreach, Matthew Kellison;
• Director of Corporate Services, Devon Menard.

Legislation and decision-making in the Health Portfolio

Key legislation

Portfolios

• Health Canada
• Public Health Agency of Canada
• Canadian Food Inspection Agency
• Canadian Institutes of Health Research
• Patented Medicine Prices Review Board

Enabling Statutes

• Department of Health Act
• Public Health Agency of Canada Act
• Canadian Food Inspection Agency Act
• Canadian Institutes of Health Research act
• Patent Act

Assigned Statutes

• Assisted Human Reproduction Act
• Canada Health Act
• Canada Consumer Product Safety Act
• Canadian Environmental Protection Act, 1999 (with Minister of Environment)
• Cannabis Act
• Comprehensive Nuclear Test-Ban Treaty Implementation Act (Section 12(1))
• Controlled Drugs and Substances Act
• Criminal Code (section 241.31, regulations re medical assistance in dying)
• Emergency Management Act (supports Minister of Public Safety & Emergency Preparedness)
• Food and Drugs Act
• Framework on Palliative Care in Canada Act
• Hazardous Materials Information Review Act
• Hazardous Products Act
• Agriculture and Agri-Food Administrative Monetary Penalties Act (as it relates to pest control products)
• Patent Act [Patented Medicines (Notice of Compliance) Regulations]
• Pest Control Products Act
• Pesticide Residue Compensation Act
• Radiation Emitting Devices Act
• Tobacco and Vaping Products Act
• Department of Health Act
• Emergencies Act
• Emergency Management Act (supports Minister of Public Safety and Emergency Preparedness)
• Federal Framework on Lyme Disease Act
• Federal Framework on Post-Traumatic Stress Disorder Act
• Federal Framework for Suicide Prevention Act
• Health of Animals Act
• Human Pathogens and Toxins Act
• National Strategy for Alzheimer's Disease and Other Dementias Act
• Quarantine Act
• International Health Regulations
• National Framework for Diabetes Act
• Agriculture and Agri-Food Administrative Monetary Penalties Act
• Feeds Act
• Fertilizers Act
• Food and Drugs Act (as it relates to food)
• Health of Animals Act
• Plant Breeders' Rights Act
• Plant Protection Act
• Safe Food for Canadians Act
• Seeds Act
• Canadian Institutes of Health Research Act
• Patent Act (Industry Canada)

The Minister of Agriculture is responsible for the non-food safety legislation administered and enforced by the CFIA, including the facilitation of market access, animal health and plant protection.

Overview of legislative and regulatory responsibilities

Introduction

In Canada, health is an area of shared jurisdiction. Under the Constitution Act, 1867, provincial responsibilities include the establishment, maintenance and management of hospitals, local matters, and property and civil rights. Over time, courts have interpreted these constitutional provisions to mean that provinces and territories (PTs) are primarily responsible for health care delivery, the administration of provincial health insurance plans, and the regulation of health professions.

Federal authorities in health are grounded in the federal government's constitutional responsibilities for criminal law and taxation, and the federal spending power. These responsibilities provide the basis for helping to protect the health and safety of Canadians through the regulation of drugs, food, medical devices, controlled substances, cannabis, tobacco and vaping products, consumer products and cosmetics, pest control products, and medical assistance in dying.

Parliament also has the authority to spend money raised through taxation, and to attach terms and conditions to the authorized spending. Accordingly, the Canada Health Act establishes the criteria and conditions PT health insurance plans must meet to receive their full cash entitlement under the Canada Health Transfer.

Rooted in the "peace, order and good government" provisions of the Constitution, the federal government also has key functions in relation to national health emergencies, and where public health matters are issues of national concern. Since the 1970s, federal power in public health has been interpreted to also include efforts in health research and promotion, disease prevention and health information.

A number of other federal responsibilities include health elements, not all of which fall within the purview of the Health Portfolio. This includes: economic powers related to trade, commerce and patents, which apply to drugs; medical devices and technologies; responsibilities in foreign affairs and immigration that relate to migration health (e.g., admission of foreign nationals with international credentials, and relations with international bodies and foreign governments); and supplementary benefits and health services for certain populations (First Nations and Inuit, refugees, the military).

Health portfolio legislation and regulation

There is a range of legislative mechanisms that the government can use to meet its desired objectives. Legislative tools include Acts, Regulations, and Orders in Council, all of which are relevant in the Health Portfolio context. While Acts are laws enacted by Parliament, regulations also have legally binding effects. Normally, the power to make regulations is conferred by Parliament to the Governor in Council (Cabinet), a Minister, or, occasionally, an agency.

The Minister of Health is responsible for the administration and enforcement of aspects of approximately 40 Acts (and their associated regulations) that have a direct impact on the health and safety of Canadians.

Three of the Acts are enabling statutes, for which the Minister is responsible; that is, they create and provide the basis of the activities of the three largest Portfolio organizations- Health Canada, the Public Health Agency of Canada, and the Canadian Food Inspection Agency. These Acts set out specific responsibilities carried out by these organizations in relation to the Minister's statutory responsibilities. These include: the promotion of the physical, social, and mental well-being of Canadians (Department of Health Act); taking public health measures, identifying and reducing public health risk factors, and supporting national readiness for public health threats (Public Health Agency of Canada Act); and setting safety standards for food sold in Canada, as well as enforcing the food provisions of the Food and Drugs Act (Canadian Food Inspection Agency Act and the Public Service Rearrangement and Transfer of Duties Act). In addition, the Patent Act provides the legislative basis for the establishment and functioning of the Patented Medicine Prices Review Board. As well, the Canadian Institutes of Health Research Act created in 2000 the Canadian Institutes of Health Research (CIHR), an arm's-length agency that is under the management responsibility of its Governing Council and that reports to Parliament via the Minister of Health. The objective of the CIHR is to excel in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system.

The Minister also has important responsibilities in relation to the administration of the Canada Health Act (CHA), Canada's federal legislation on insured health services. The CHA defines the national principles that govern the Canadian health care system and aims to "… protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers." It establishes the criteria and conditions provincial and territorial health insurance plans must meet to receive their full cash entitlements under the Canada Health Transfer.

The Public Health Agency of Canada Act mandates the Public Health Agency of Canada and the Chief Public Health Officer to assist the Minister of Health "in exercising or performing the Minister's powers, duties and functions of public health", which includes public health emergency preparedness and response. Under the Emergency Management Act, the Minister of Health has specific responsibilities to identify risks pertinent to his or her mandate, and develop plans to address these risks. The Chief Public Health Officer also has explicit responsibilities in the Emergency legislation. Emergency plans have been developed by the Health Portfolio that address a variety of public health risks (for example, pandemic influenza and foodborne illness).

To prevent the introduction and spread of communicable diseases in Canada, the Quarantine Act gives the Minister (and other designated officials) the power to take comprehensive public health measures. Since the very beginning of the COVID-19 pandemic in early 2020, those powers were relied upon to support the COVID-19 response, for instance by designating quarantine facilities. The Quarantine Act also provides the Governor in Council the authority to issue emergency orders prohibiting or imposing conditions on travelers entering Canada. Between February 3, 2020, and August 24, 2021, 63 emergency orders were made under the Quarantine Act to minimize the risk of exposure to COVID-19, to reduce the risk of its importation from other countries, to repatriate Canadians, and to strengthen measures at the border. Under the Food and Drugs Act and the Pest Control Products Act, the Minister also has the authority to issue Interim Orders (IO) if immediate action is required to deal with a significant risk, direct or indirect, to health, safety, or the environment. During the COVID-19 pandemic, IOs were used to expedite access to important COVID-19 drugs, vaccines, disinfectants, and medical devices.

To help respond to COVID-19 related restrictions, which impacted access to prescription medications containing controlled substances, an exemption to certain restrictions under the Controlled Drugs and Substances Act was issued (e.g. permitting pharmacists to extend, renew and transfer prescriptions and allowing practitioners to verbally prescribe such medications).

The Cannabis Regulations were also amended to extend the validity of medical documents whereby health care practitioners authorize their patients to access cannabis for medical purposes.

In addition to enabling statutes, there are a number of statutes that assign the Minister of Health as the Minister responsible for that statute. There are assigned statutes that establish federal frameworks (e.g., palliative care, Lyme disease, post-traumatic stress disorder) or national strategies (e.g., dementia), which confer specific responsibilities on the Minister of Health.

The balance of the assigned statutes relevant to the Health Portfolio set out responsibilities to be carried out by the Minister of Health in the context of regulating food, pharmaceutical drugs, controlled substances, tobacco and vaping products, pest control products, medical devices, biologics, human toxins and pathogens, radiation-emitting devices, and consumer products and cosmetics.

There are significant differences in the nature of these various regulatory regimes. However, some principles of decision-making are common to many of the Acts for which the Minister of Health is identified as exercising a role. The following section sets out some key principles.

"Powers, duties and functions" in legislation

Most Acts of Parliament and associated regulations are administered by individual Ministers, and this responsibility can include a variety of powers, duties, and functions. Depending on the legislation (or regulations), the responsible Minister can be named in the Act itself or designated by the Governor in Council (i.e., Cabinet).

Typically, the various powers, duties and functions set out in an Act or regulations are assigned to the responsible Minister. However, in some circumstances, specific authorities are assigned to other identified individuals or groups of individuals. For example, powers to make regulations and amend Schedules to an Act are often assigned to the Governor in Council. In all cases, the Minister of Health would still be involved in setting overall policy direction for regulatory programs, developing regulations, and approving regulations recommended to the Governor in Council.

Who makes regulatory decisions?

Depending on the legislation, the authority to make decisions may be specifically assigned to the Minister, to other individuals (such as designated inspectors), or, occasionally, to the Governor in Council. The following section explains how these different types of decision-making authorities work.

The Minister of Health

1. Decisions made by the Minister or on the Minister's behalf

Decision-making authority in legislation often resides with the Minister. In the Health Portfolio context, this authority encompasses a large number of possible kinds of regulatory decisions, and on any given day, many of these decisions are made. Accordingly, the vast majority of decisions are made by governmental officials. This has four important advantages:

• Given the volume of regulatory decisions required, it is not practical for a Minister to personally exercise all of his or her authorities;
• The risk of perceived political interference in evidence-based decision-making is minimized;
• Many regulatory decisions are highly technical in nature and require a specialized (often scientific) expertise; and
• In the event that a decision is challenged in a court of law (subject to judicial review), the person who makes the decision may need to give evidence.

At all times, where the decision-making authority in legislation resides with the Minister, the responsible Minister retains the authority to personally make those decisions. However, the practice of allowing officials to exercise regulatory decision-making powers that are appropriate to their functions is common to all regulatory departments and agencies.

Regulatory decisions can be scrutinized by industry, the media, the public and the judiciary. Therefore, it is essential that the Minister – or appropriately-placed officials in the Health Portfolio who make those decisions on behalf of the Minister – are able to demonstrate integrity in their decision-making processes. It is important to demonstrate that each decision is the result of an objective – and, as applicable, science-based – assessment of all the information available to the regulator.

While routine and uncontroversial regulatory decisions are made every day by officials, if a decision is particularly sensitive in nature, additional background information may be provided so that the Minister is aware of the context and basis for a decision.

2. Ministerial decision-making authority where a delegation order is required

In some specific instances, legislation may include specific provisions that allow the Minister, as head of the institution, to make an order delegating particular powers, duties and functions to officers or employees of the institution (or to another institution within the Portfolio). Relevant examples in the context of the Health Portfolio include the Access to Information Act and the Privacy Act.

Other officials

Many Acts confer decision-making powers explicitly on individuals other than the Minister. For example, inspection powers (such as entry, examination of records, detention of substances, etc.) can only be exercised by a designated "inspector" in the Food and Drugs Act, the Controlled Drugs and Substances Act, and the Human Pathogens and Toxins Act, to name but a few. Under the Quarantine Act, a "quarantine officer" decides whether to require health assessments of individuals suspected of carrying a communicable disease. The Chief Public Health Officer is responsible for making certain decisions under the Emergency Orders issued under the Quarantine Act, including granting exemptions for essential workers and taking immediate public health measures to minimize the risk of introduction or spread of COVID-19 by imposing conditions on exempt persons.

In these instances, the Minister may request a briefing in relation to the decision-making process and discuss the decision with officials, but may not make, nor is directly involved in, the decision itself.

Independent tribunals

Some statutes create tribunals that operate independently of a minister. One such example in the Health Portfolio is the Patented Medicine Prices Review Board (PMPRB). The PMPRB is an independent, quasi-judicial body established under the Patent Act. The Board determines whether the patented drug price set by the manufacturer is excessive and, if so, the Board can order price reductions and/or the offset of excess revenues. Further, the Board has the authority to issue non-binding guidelines regarding the administration of the Board. However, before issuing any such Guidelines, the Board is required to consult with the Minister of Health, as well as other stakeholders.

Although the PMPRB carries out its mandate at arms-length from the Minister of Health and is independent of Health Canada, the Patent Act sets out a number of roles for the Minister of Health in relation to the PMPRB. This includes recommending new/amending regulations to the Governor in Council in relation to the PMPRB regime, and entering into agreements with any province to disburse funds collected by the PMPRB.

Governor in Council (Cabinet)

Legislation can expressly provide that the Governor in Council will exercise the decision-making power. An example of this is in the Health Portfolio is the emergency orders that can be made by the Governor in Council under the Quarantine Act, which prohibit or impose conditions on persons entering Canada. This can be done, for example, if they are coming from a country that has an outbreak of a communicable disease that could pose a threat to Canadians and no reasonable alternatives to prevent the introduction or spread of the disease are available. Since February 2020, the Governor in Council has exercised this authority to create prohibitions on entry into Canada and to impose mandatory isolation and quarantine on travelers to prevent the introduction and spread of COVID-19.

Another example is under the Pest Control Products Act, where the Governor in Council may make an order cancelling or amending the registration of a pest control product if considered necessary to implement an international agreement. Neither the Minister nor departmental officials may make these types of decisions on Cabinet's behalf.

Regulatory oversight of products pre- and post- market

Hundreds of new products are introduced by industry every year in Canada. Any health or consumer product, chemical, radiation emitting device, pesticide or food sold on the Canadian market must meet strict regulatory standards set by Health Canada. The Health Portfolio works to help Canadians lead healthier lives by providing access to products such as pharmaceuticals to improve their health, and by helping to protect them from products that are unsafe or high risk to their health (e.g. illegal opioids, tobacco, vaping products). The Portfolio regulates tens of thousands of products and monitors them through the administration and enforcement of over 160 regulations in more than 40 Acts.

A number of regulatory tools are used to review, assess and monitor products (see table below). The extent of the review of a given product generally depends on its risk level. For example, while health products and pesticides are subject to pre-market oversight (e.g., clinical trials for drugs, exposure modelling for pesticides) as well as post-market measures (e.g. safety monitoring, recalls), consumer products (such as toys and appliances) are managed through a robust post-market regime that includes the development of guidelines and outreach activities for industry, the development of national and international voluntary safety standards, and proactive testing and inspections to support regulatory compliance.

The Health Portfolio also regulates to protect Canadians from threats posed by infectious diseases. Risks posed by human pathogens and toxins to human health and safety are also mitigated through the regulation and licensing of facilities working with human pathogens and toxins.

Regulatory Oversight of Products

Products	"Pre-market": Before a product is on the market	"Post-market": Once a product is already on the market
Prescription drugs (human and veterinary use)	Health Canada conducts scientific reviews of drugs for: Safety Quality Efficacy	Health Canada: Monitors ongoing drug safety and efficacy Monitors adverse events Inspects facilities where the drug is produced Investigates complaints Conducts enforcement activities Does surveillance Orders a recall when necessary
Non-prescription products (human and veterinary use)	Health Canada conducts scientific reviews of drugs for: Safety Quality Efficacy	Health Canada: Monitors ongoing drug safety andeffectiveness Monitors adverse events Inspects facilities where the drug is produced Conducts enforcement activities
Natural health products	Health Canada reviews products on a risk basis for: Safety Quality Efficacy	Health Canada: Monitors adverse events Investigates complaints Conducts enforcement activities
Medical Devices	Health Canada reviews devices on a risk basis for: Safety Quality Effectiveness	Health Canada: Monitors the safety of devices Inspects facilities where devices are produced Orders a recall when necessary Conducts enforcement activities
Biologics and Radiopharma-ceuticals	Health Canada reviews biologics and radiopharmaceuticals for: Safety Quality Effectiveness	Health Canada: Monitors ongoing drug safety andeffectiveness Monitors adverse events Inspects manufacturing plants where the drug is produced Investigates complaints Does surveillance Conducts enforcement activities Orders a recall when necessary PHAC: Does surveillance (e.g. vaccine-related adverse event surveillance)
Food	Health Canada: Conducts pre-market assessments of food additives, novel foods, infant formulas, certain types of health claims and nutrient content claims Provides opinions, upon request by manufactures, on the chemical safety of food packaging materials, food processing aids and incidental additives PHAC: Monitors trends in antimicrobial use and antimicrobial resistance in selected bacterial organisms from healthy animals on farm and at slaughter through the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS). CIPARS is based on several surveillance components which can be linked to examine the relationship between antimicrobials used in food-animals and the associated health impacts	CFIA: Enforces food safety legislation Inspects food establishments Investigates complaints Manages food recalls Conducts surveys on the safety of food products, including contaminants and pathogens Conducts research and development on methods used for testing of food Health Canada: Provides regulatory oversight post-market through establishment of food standards, policies and guidelines Conducts health risk assessments and provides the results to the CFIA for appropriate follow-up/risk management action Undertakes studies/research to identify and assess risks from chemical and microbial hazards as well as nutrition adequacy Provides national reference services for foodborne pathogens Collects food and human biomonitoring contaminant data and food consumption information, in order to assess Canadians' exposure to contaminants (e.g., Canadian Community Health Survey, Canadian Health Measures Survey, Total Diet Study) PHAC: Monitors and enforces food safety and the potability of water on passenger conveyances (e.g., airplanes, cruise ships, passenger trains) Conducts surveillance of enteric diseases through the National Enteric Surveillance Program and PulseNet (detection and investigation of foodborne illnesses), and through FoodNet Canada to identify risks in the food chain Supports provinces in transitioning to Whole Genome Sequencing to improve detection of outbreaks and characterization of pathogens Monitors trends in antimicrobial use and antimicrobial resistance in selected bacterial organisms from human, animal and food sources across Canada through CIPARS
Consumer Products and cosmetics	Health Canada: No pre-market regulatory oversight	Health Canada: Reviews cosmetic notifications to verify whether prohibited or restricted ingredients are being used in cosmetics Monitors and tests products on the market for safety and compliance with regulations Oversees recalls on products deemed unsafe Monitors and assesses safety incidents associated with consumer products and cosmetics Conducts enforcement activities
Chemical Substances	Health Canada and Environment and Climate Change Canada: Assess the potential human health and environmental impacts of new chemical substances Introduce control measures as appropriate	Health Canada and Environment and Climate Change Canada: Assess the risks of existing chemical substances Take appropriate risk management action when warranted
Pesticides	Health Canada: Determines whether a pesticide can be used safely and effectively for its intended use without harming human health or the environment	Health Canada: Reviews all approved products every 15 years to determine continued acceptability for the Canadian market Monitors incidents Conducts compliance and enforcement activities
Controlled Substances	Health Canada: Inspects licensed dealers of controlled substances and precursor chemicals to ensure they meet security and other requirements prior to receiving a licence	Health Canada: Monitors adverse events Inspects licensed dealers/producers and pharmacies Investigates complaints Manages recalls Conducts enforcement activities
Tobacco and vaping products	Health Canada: No pre-market regulatory oversight	Health Canada: Conducts inspections to verify compliance with labelling and packaging requirements, including the ban on selected additives, the ignition propensity standard (cigarettes only), the access restrictions the promotion restrictions, and the reporting requirements Conducts enforcement activities
Cannabis	Health Canada: Requires cannabis licence applicants to meet product quality, physical security and personnel security standards prior to licensing Establishes strict product quality requirements (e.g., production standards, testing) Inspects sites	Health Canada: Safeguards the integrity of the supply chain (e.g., Cannabis Tracking and Licensing System, inventory controls) Monitors, promotes and enforces compliance through various measures (e.g., Administrative Monetary Penalties, Ministerial Orders) Inspects licenced producers of cannabis Monitors adverse events Monitors incident reports from manufacturers Investigates complaints Undertakes surveillance Manages product recalls, when necessary
Workplace Hazardous Products	Health Canada: Receives applications, which include Safety and Data Sheets for all workplace hazardous products for which Confidential Business Information protection is requested	Health Canada: Works with federal and provincial/territorial regulatory partners to monitor health and safety concerns, as well as compliance with labelling and Safety Data Sheet requirements Decision on applications for the protection of Confidential Business Information
Radiation Emitting Devices	Health Canada: No pre-market regulatory oversight	Health Canada: Regulates the importation, lease and sale of radiation emitting devices, including labelling, packaging, advertising, construction and performance Monitors and tests products on the market for safety and compliance with regulations Monitors incident reports from manufacturers

Federal-provincial/Territorial (FPT) relations

Overview of Federal-provincial/Territorial (FPT) roles and relations in health

Health is an area of shared responsibility among the federal government and provincial/territorial governments. Health services delivery, the administration of provincial/territorial health insurance plans, and the regulation of health professions fall within provincial/territorial jurisdiction.

The federal government supports universally accessible, publicly funded health care for Canadians through transfer payments to provinces and territories (PTs) via the Canada Health Transfer (CHT) and administration of the Canada Health Act (CHA). The CHA establishes the requirements that provincial/territorial health insurance plans must meet to receive their full cash contributions under the CHT. As the largest major transfer to PTs, the CHT is intended to provide long-term, predictable funding and currently represents approximately 23 percent of publicly-funded health sector expenditures by PTs.

Federal responsibilities include protecting health and safety through regulation, health security and emergency preparedness and response, health promotion and chronic disease prevention, infectious disease prevention and control, as well as support for health research and innovation.

While PTs must provide all residents with universally insured health services, the federal government is also responsible for the financing and administration of a range of health benefits and services for federal populations (i.e., primary health care services for members of the Canadian Armed Forces, inmates in federal penitentiaries, and refugee claimants; and supplementary benefits for registered/Status First Nations and recognized Inuit, the Royal Canadian Mounted Police, and veterans).

Shared areas of responsibility where both federal and provincial/territorial levers can support common objectives include all aspects of public health such as surveillance, infectious disease prevention and control, health promotion and chronic disease prevention, as well as health security and emergency preparedness (including coordinating pandemic response efforts). Federal environmental health guidelines and regulations also provide guidance for provincial/territorial implementation and stewardship efforts. Both levels of government and their respective health organizations share responsibility for the collection and analysis of health information, and for funding research and innovation initiatives.

Roles and responsibilities of FPT governments, including areas of overlap:

Federal Government

• Stewardship of Canadian Medicare
• Administration of the Canada Health Act (CHA)
• Uses "spending power" to provide financial support to PTs tied to CHA principles
• Supports health care improvement and innovation
• Regulates market access for drugs, medical devices, controlled substances, consumer and pest control products
• Regulates patented drug prices
• Provides funding and/or delivers some health care programs/services to federal populations such as federal inmates, military, and refugee claimants
• Coordinates national responses to public health emergencies and national public health surveillance
• Fund health care and public health
• Support health research and innovation
• Prevent, control and reduce infectious and chronic diseases
• Promote the health and well-being of Canadians
• Prepare for and respond to public health events and emergencies
• Collect and analyze health data and information
• Develop science-based public health advice
• Communicate risk and public health advice
• Fund health care for eligible First Nations and Inuit

Provinces/Territories (PTs)

• Administer PT health insurance plans and other health care programs (e.g., drugs)
• Deliver health services
• Determine organization and governance of the system
• Regulate health care facilities and professionals (e.g., physicians, nurses)
• Regulate private health insurance
• Manage capital investments
• Negotiate drug purchasing and pricing for their drug plans

Federal/Provincial/Territorial

• Fund health care and public health
• Support health research and innovation
• Prevent, control and reduce infectious and chronic diseases
• Promote the health and well-being of Canadians
• Prepare for and respond to public health events and emergencies
• Collect and analyze health data and information
• Develop science-based public health advice
• Communicate risk and public health advice
• Fund health care for eligible First Nations and Inuit

FPT collaboration

Canada's health system has been shaped by key FPT legislative activities and policies spanning over 60 years, and it has evolved to respond to changing population needs and fiscal capacity. Ongoing FPT collaboration is crucial, as both orders of government must collaborate to address many health issues. This is especially true in areas where responsibilities intersect, such as responding to public health emergencies, preventing chronic disease and the spread of infectious and communicable diseases, and health promotion, amongst others.

FPT governments continue to collaborate on a number of high profile priorities, including antimicrobial resistance, opioid response efforts, vaping, medical assistance in dying, drug shortages, and the affordability and accessibility of prescription drugs, to name a few. Many of these areas require ongoing and robust FPT engagement with other sectors (e.g., agriculture, justice, and public safety).

The identification of common priorities to guide FPT collaboration resulted in the Common Statement of Principles (CSOP) on Shared Health Priorities, signed in August 2017 and supported by federal targeted investments ($11B over 10 years) in home and community care, and, mental health and addictions services. Following adoption of the CSOP, the federal government negotiated and signed bilateral agreements with each PT that set out details on how each jurisdiction will use federal funding to improve access to home and community care, and, mental health and addiction services.

Bilateral health agreements have also been used to advance other common health objectives including:

• $150M Emergency Treatment Fund to support PTs in responding to the opioid crisis;
• $150M Virtual Care Bilateral Agreements to support PTs acceleration of virtual care during the pandemic; and
• $1B Safe Long-term care Fund (via amendments to the home care/mental health bilateral agreements).

Although the Health Portfolio generally acts as the primary focal point for engagement with PTs on health-related issues, other federal departments, including Indigenous Services Canada; Veterans Affairs; Immigration, Refugees, and Citizenship Canada; Correctional Service of Canada; and the Department of National Defence engage PTs on health-related matters, given their responsibilities for providing health services or supplementary health benefits.

FPT collaboration in the context of COVID-19

The level of FPT collaboration has grown immensely since the start of the COVID-19 pandemic in 2020 to ensure a pan-Canadian response. Areas of collaboration have focused on procurement and distribution of personal protective equipment and vaccines, public health and clinical guidance, communications and education, testing and screening, surveillance and national reporting, border measures, and health system capacity. Considerable federal funding, programs and procurement have backed these efforts, including health-related investments through the Safe Restart Agreement, and federal surge support made available through PHAC's single-window to assist jurisdictions with health human resources, physical assets and supplies, and vaccination and epidemiological support, among others.

Core FPT Health Machinery

Ongoing collaboration is maintained through well-developed formal structures including: FPT Health Ministers' Meetings (HMM), meetings of Deputy Ministers (known as the Conference of Deputy Ministers of Health, or CDM), and the pan-Canadian Public Health Network (PHN).

The HMM forum is the key intergovernmental forum through which FPT Ministers of Health discuss and provide collective direction on priority health issues and advance collaborative FPT work. A network of committees (standing and ad hoc) supports the HMM on various files. The federal Health Minister is the co-chair of the HMM, and the Deputy Minister of Health Canada acts as co-chair of the CDM. Provincial/territorial co-chairs are nominated at the provincial/territorial level, and usually rotate annually following the HMM. Ontario assumed the PT co-chair role in Fall 2019 and had extended its co-chair role during the pandemic. They are expected to hand over the co-chair role in Fall 2021 to another province.

Regular collaboration on public health occurs through the PHN structure and its network of steering and liaison committees. Through the PHN, jurisdictions work collaboratively on a broad range of issues to strengthen public health in Canada, including health promotion, chronic disease prevention, public health infrastructure, emergency preparedness and response, and infectious diseases. The 17-member PHN Council (comprised of Assistant Deputy Minister (ADM)-level FPT government officials responsible for public health) is accountable to the CDM, which provides direction and approves public health policy priorities for Canada. The Council of Chief Medical Officers of Health, which includes Chief Medical Officers of Health from all jurisdictions, is also responsible for technical collaboration and public health expert and scientific advice on technical issues and falls under the PHN.

In January 2020, as a time-limited emergency mechanism under the PHN, the FPT Special Advisory Committee (SAC) was activated to advise the CDM and provide public health leadership to support a pan-Canadian, coordinated public health approach to the COVID-19 response. SAC members include the Chief Medical Officers of Health from all provinces and territories, the Chief Public Health Officer of Canada, and Chief Medical Officers from key federal departments, along with ADMs of public health from jurisdictions. The Committee is chaired by the Co-Chairs of the PHN Council, Dr. Theresa Tam, Canada's Chief Public Health Officer, and the current PT co-chair, New Brunswick's Chief Medical Health Officer, Dr. Jennifer Russell. A parallel SAC committee continues to address the epidemic of the opioid crisis. During the early months of the pandemic, engagement at the CDM and HMM level was at an all-time high with weekly HMM teleconferences, and daily CDM calls, to ensure coordination and sharing of information at the most senior levels. Engagement at these tables remains frequent. In addition to regular weekly CDM calls, the Health Deputy Ministers table frequently meets jointly with their intergovernmental affairs Deputy Minister counterparts to ensure COVID-related information with broader sectoral implications (i.e. vaccine approvals, border decisions) is shared concurrently.

A number of supportive FPT tables were also established in response to the pandemic (e.g., virtual care, testing and screening, vaccines, drug shortages, personal protective equipment) feeding directly into CDM or via SAC and its sub-committees, as appropriate.

Additional FPT Machinery

The federal Minister of Health, supported by the Public Health Agency of Canada (PHAC), also co-chairs the FPT Ministers of Sport, Physical Activity and Recreation (SPAR) table, alongside the Minister of Heritage and a PT co-chair (currently Ontario). The SPAR table is comprised of three distinct, but interrelated sectors: sport, physical activity and recreation. SPAR Ministers' meetings are an opportunity to highlight current federal leadership on healthy weights and chronic disease prevention. PHAC's President is one of three co-chairs of the FPT Conference of Deputy Ministers of SPAR, with responsibility for physical activity items.

The President of the Canadian Food Inspection Agency (CFIA) participates at the FPT Ministers and Deputy Ministers of Agriculture annual meeting on matters pertaining to food safety, plant and animal health as well as trade and market access for the agriculture sector.

The Canadian Food Safety Information Network is a federal initiative led by CFIA and developed in partnership with Health Canada, PHAC and provincial/territorial food safety authorities. The purpose of the Network is to strengthen the ability of food safety authorities to anticipate, detect, and mitigate food safety hazards and respond quickly and effectively to food safety events. The FPT Food Safety Committee, on which Health Canada and CFIA participate, provides federal and provincial/territorial government leadership and partnership in food safety.

Additional FPT Committees have been established to address the opioid overdose crisis, cannabis legalization and regulation, problematic substance use and harms, antimicrobial resistance, health data, dementia, health workforce issues, medical assistance in dying, drug shortages, and interprovincial health insurance agreements, among others.

Indigenous Health

The provision of health services to Indigenous Peoples is an area of shared responsibility between FPT governments and Indigenous partners. Provincial/territorial governments provide universally accessible and publicly insured health services to all residents, including Indigenous Peoples (urban First Nations, Metis and Inuit Peoples, non-status or unrecognized First Nations and Inuit Peoples). In BC, the First Nations Health Authority delivers health programs and services to Indigenous people living in the province.

Indigenous Services Canada funds or directly provides supplemental health programs and services for registered/Status First Nations (primarily on-reserve) and recognized Inuit in addition to what is provided by PTs. In addition, Indigenous Services Canada administers the Non-Insured Health Benefits program, which provides eligible First Nations and Inuit clients, regardless of where they reside with a range of health benefits such as prescription drugs, vision and dental care and medical supplies and equipment and medical transportation to access health services. The PHAC also delivers off-reserve programs, such as the Aboriginal Head Start in Urban and Northern Communities Program.

Further, Indigenous governments and communities may be involved in directing, managing and delivering a range of health programs and services, which vary by PT.

The Health Portfolio is also involved in a range of activities, in collaboration with Indigenous, federal and provincial/territorial partners, to improve Indigenous health outcomes. For example, Health Canada is working closely with Indigenous Services Canada on the co-development of Indigenous health legislation and addressing anti-Indigenous racism in Canada's health systems. In addition, the Canadian Institutes of Health Research (CIHR) works to accelerate the self-determination of Indigenous Peoples in health research by supporting research that is driven by, and grounded in, Indigenous communities and that addresses the health challenges and inequities experienced by Indigenous Peoples, including racism within Canada's health care systems.

The CSOP on Shared Health Priorities also commits FPT governments to work together to ensure that health care systems continue to respond to the needs of Indigenous Peoples living in Canada. Recognizing the significant disparities in Indigenous health outcomes compared to the non-Indigenous population, FPT governments are committed to working with First Nations, Inuit and Métis to improve access to health services and health outcomes of Indigenous Peoples and discuss progress in these areas.

Health Research and Innovation

The Canadian Institutes of Health Research (CIHR) works closely with members of the National Alliance of Provincial Health Research Organizations as key partners in the Canadian health research ecosystem. Canada's Strategy for Patient-Oriented Research (SPOR) is a national coalition of stakeholders, led at the federal level by CIHR in close collaboration with FPT partners. SPOR is dedicated to the integration of research into patient care. SPOR-funded health research and platforms provide a collaborative, co-led and co-funded FPT mechanism to address jurisdictional and national priorities, improving the health of Canadians and the FPT health care systems, including their cost-effectiveness.

List of Provincial and Territorial ministers responsible for health

Supplementary contacts

Jurisdictions with Ministers responsible for issue-specific Portfolios

Relationships with health system players

An overview of Pan-Canadian health organizations

Overview

At different points over more than thirty years, the Government of Canada created pan-Canadian health organizations (PCHOs) to address specific health care system needs and issues. There are now seven such organizations (See Table A).

PCHOs were created to address priorities in the Canadian health care system, recognizing their potential to tackle issues in a more targeted, pan-Canadian and flexible way than the federal government – or any one PT – can do on its own or at intergovernmental tables, with diverse mandates and activities. For example, the Canadian Agency for Drugs and Technologies in Health (CADTH)'s Common Drug Review assesses the cost-effectiveness of drugs; Canada Health Infoway has directly supported provinces and territories (PTs) in the implementation of their virtual care and digital health needs; the Canadian Institute for Health Information (CIHI) reports on health system performance; and the Canadian Partnership Against Cancer and the Mental Health Commission of Canada have developed national strategies on pressing health issues (cancer control and mental health respectively). While most PCHOs were established exclusively through federal investment, two (CADTH and CIHI) were created in partnership with provincial/territorial governments.

The federal government remains the majority funder of all PCHOs, with an annual investment of approximately $368 million (2021-22) accounting for about 60-100% of total individual PCHO budgets (see Table A). Based on longstanding agreements, PTs provide financial support to CIHI (approximately 20% of its budget) and CADTH (approximately 15% of its budget), while Infoway cost-shares with PTs on some of the projects it funds.

As not-for-profit corporations, each PCHO is governed by a board of directors on which the federal government generally holds one seat (and in a few cases also designates the board chair). A senior public servant from Health Canada typically serves as the federal representative and PTs generally have public servant representation on PCHO boards. Although PCHOs are operationally independent, they are accountable to their majority funder – the Government of Canada – and have a vested interest in developing products and services that respond to the needs of the federal government and their primary partners, the PTs.

Table A. Pan-Canadian Health Organizations and Federal Funding Commitment

Organization	Year Established	Health Canada Contribution 2021-22	% of Budget
Canadian Centre on Substance Use and Addiction (CCSA)	1988	$13.35M	95
Canadian Agency for Drugs and Technologies in Health (CADTH)	1989	$29.1M	69
Canadian Institute for Health Information (CIHI)	1993	$101.4M	80
Healthcare Excellence Canada (HEC)	2020	$26.3M	98
Canada Health Infoway (Infoway)	2001	$128M	100
Canadian Partnership Against Cancer (CPAC)	2006	$52.5M	100
Mental Health Commission of Canada (MHCC)	2007	$17.5M	70

Mandate and Core Activities

The Canadian Institute for Health Information (CIHI) is the main national body charged with collecting, analyzing and reporting health data (e.g., wait times, quality of care and outcomes, health expenditures, allocation of health professionals). CIHI data and information supports health system improvements, and is used by Canadian governments, policy-makers and health system managers in making health policy decisions and in supporting effective health system management. CIHI relies heavily on PTs for collection of health data.

The Canadian Agency for Drugs and Technologies in Health (CADTH) provides decision-makers with evidence and advice to help provincial/territorial health ministries and federal- provincial/territorial (FPT) drug plans make informed decisions about the effectiveness and efficiency of drugs, medical devices and other health technologies. CADTH's Reimbursement Reviews make recommendations to governments on drugs that are included on public drug plan formularies.

Canada Health Infoway (Infoway) works with PTs, health care providers and other partners to accelerate the development and adoption of electronic health information systems with compatible standards on a pan-Canadian basis. Infoway is currently focused on pan-Canadian initiatives including virtual care, patient access to digital records, and an electronic prescribing system.

Healthcare Excellence Canada is the newly amalgamated organization of the Canadian Patient Safety Institute and the Canadian Foundation for Healthcare Improvement. It works with patients and other partners to share proven innovations and best practices that lead to lasting improvements in patient safety and healthcare quality (most recently, its 'LTC+' program provided seed funding and programming support to long-term care and retirement homes to strengthen their pandemic preparedness and response).

The Canadian Partnership Against Cancer (CPAC) provides national leadership on the implementation of the Canadian Strategy for Cancer Control (which addresses primary cancer prevention, screening and early detection, standards and cancer guidelines, the cancer journey, health human resources, research, and surveillance), and coordinates efforts of PTs, cancer experts and stakeholder groups. CPAC recently led a refresh of the Strategy, released in June 2019.

The Mental Health Commission of Canada (MHCC) acts as a catalyst for improving the mental health system and changing the attitudes and behaviours of Canadians around mental health issues (for example, by reducing the stigma associated with mental health illness and treatment). Its work focuses on four priority areas: population-based initiatives, suicide prevention, the integration of mental health and substance use, and engagement with Canadians.

The Canadian Centre on Substance Use and Addiction (CCSA) provides research, effective knowledge exchange and expertise for the substance use field, promotes increased awareness among Canadians and health system stakeholders about substance use and addiction, convenes stakeholders across sectors (including those with lived and living experience) to reduce the harms of substance use, and promotes the use of programs shown to be effective in combating problematic substance use. CCSA is the only PCHO created by federal legislation.

Ministerial Role and Engagement

As PCHOs are operationally independent, the Minister of Health has no direct involvement in their day-to-day activities. The administration of contribution funding to each organization is delegated to Health Canada officials. The Minister of Health has ultimate oversight of federal investments in these organizations, including the use of federal funding to advance priorities and requests through Cabinet for new funding to support emerging federal or FPT priorities.

Most federal board appointments are the prerogative of the Deputy Minister. However, the Minister is charged with nominating the Chair and one additional federal representative to the MHCC Board of Directors, and also recommends Governor in Council appointments for the Chair and up to four other representatives to the CCSA Board of Directors.

Given the close relationship between the department and the organizations, the Minister can also expect PCHOs to seek direct engagement from time to time on matters of relevance to their respective organizations.

Role in Health System

PCHOs play an important role in the health system. In Canada's decentralized system, they can be helpful in advancing federal interests in areas of provincial/territorial responsibility, on a pan-Canadian scale. PTs are often more receptive to PCHO engagement than to direct federal government intervention. This is attributable in part to the shared governance model adopted by most PCHOs.

In 2018, an external review of the role of the PCHOs was conducted and produced a series of recommendations, including structural changes. In it, Drs. PG Forest and Danielle Martin made clear that while these organizations have made significant contributions over the years, the suite of PCHOs needs to be reconfigured and/or re-mandated to meet the needs of Canada's health systems in the future. Since the issuance of the report, the COVID-19 pandemic has further reinforced the need for organizations to be focused and responsive to federal and PT needs and objectives.

The amalgamation of CFHI and CPSI was a key structural change in 2021. CCSA and MHCC have also been working closely together to develop and mobilize knowledge to governments, the public and key stakeholders, providing evidence-based guidance on how best to reduce those impacts over the short, medium, and longer-term. The mental health and substance use impacts of the COVID-19 pandemic have been profound, amplifying the significant and expanding needs of people with mental health or substance use concerns, and the close interrelationship between these two areas.

In addition, Health Canada has been undertaking several recommended process improvements aimed at ensuring the PCHOs, individually and collectively, contribute in a more impactful manner to federal and provincial/territorial priorities for health system improvement. For example, Health Canada is working to improve the efficiency of the contribution agreement process, and PCHOs are working together to drive progress on cultural safety.

To more effectively support Canadian health systems in their response to the pandemic, a PCHO Chief Executive Officer Table has also met biweekly to provide a coordinated response to urgent priorities with guidance from Health Canada. In addition, Health Canada has been working closely with PTs to ensure that individual PCHOs have the guidance and direction needed to better support work on specific priorities, such as Canada Health Infoway's work on virtual care. Over the summer, the PCHOs held two retreats at which they heard from FPT senior leaders on the challenges facing Canadian health systems now and in coming years, and how the organizations could support these efforts.

Other key players and stakeholders in health

Key Players in Health

The Health Portfolio works with a variety of key players in health, including provinces and territories, Indigenous partners, federally funded arm's-length health organizations, non-governmental organizations, professional associations, charities, Indigenous partners, international organizations, industry, the research community, other federal departments and agencies, foreign regulators and Canadians. This work includes partnering on research, surveillance, public consultation, collaborative policy and program development, sharing information to support health system improvement, best practice/knowledge sharing and engagement with people with lived and living experience.

Health System Stakeholders

• Health Professionals (e.g., Canadian Medical Association, Canadian Nurses Association, Canadian Pharmacists Association, Local Medical Officers of Health)
• Health Institutions (e.g., Hospitals, HealthCareCAN, Children's Healthcare Canada)
• Patient Groups (e.g., Institute of Safe Medicine Practices Canada, Patients Canada)
• Health Sector Labour Unions (e.g., Canadian Labour Congress, Professional Instititute of the Public Service of Canada)

Research & Academic Stakeholders

• Universities and Academic Organizations (e.g., Association of Faculties of Medicines of Canada, Association of Faculties of Pharmacy of Canada, U15 Group, Universities Canada, Canadian Academy of Health Sciences)
• Hospital-based Research Institutions (e.g., SickKids)
• Think Tanks (e.g, Conference Board of Canada, Public Policy Forum)
• Health Charities and Research Foundations (e.g., JDRF, MS Society, Gairdner Foundation)
• International Research Agencies (e.g., NIH, European Commission)

Industry Stakeholders

• Pharmaceutical and biologics (e.g., Canadian Generic Pharmaceutical Association, Group Purchasing Organizations, and distributors)
• Medical Devices (e.g., Medtech Canada)
• Natural Health Products and Non-prescription Drugs (e.g., Canadian Health Food Association)
• Food Products (e.g., Canadian Supply Chain Food Safety Coalition)
• Pesticides (e.g., CropLife Canada)
• Cannabis (e.g. Cannabis Council of Canada)
• Consumer Products (e.g., Retail Council of Canada)
• Workplace Hazardous Products (e.g., Responsible Distribution Canada)
• OGD tables with industry (e.g., National Cross Sector Forum)

Public Health Stakeholders

• Health Charities (e.g., Canadian Red Cross, Health Charities Coalition of Canada, Disease Specific – ALS, Alzheimers, etc.)
• National Public Health Associations (e.g., Canadian Public Health Association, National Collaborating Centres on Public Health funded by PHAC)
• Disease-based Advocacy Groups (e.g., Canadian Organization for Rare Disorders)
• Disease Prevention/Health Promotion NGOs (e.g., Canadian AIDS Society, YMCA Canada)
• People With Lived and Living Experience (e.g., Canadian Association of People who Use Drugs, Community Addictions Peer Support Association)

Other

• Provincial/Territorial Health Ministries & Public Health Agencies (and in specific cases, local health services)
• Pan-Canadian Health Organizations (PCHOs) e.g., Canadian Institute for Health Information, Mental Health Commission of Canada, Canada Health Infoway, Canadian Agency for Drugs and Technologies in Health. PCHOs are funded by Health Canada
• Non-traditional Stakeholders e.g., communities with a stake in public health (e.g., faith leaders, immigrants, seniors, youth, LGBTQ2+, racialized communities, etc.), social media influencers / risk
• Indigenous Organizations and Governments e.g., Assembly of First Nations, Inuit Tapiriit Kanatami, Métis National Council
• International Organizations e.g., US Food and Drug Administration, European Medicines Agency, World Health Organization, Pan-American Health Organization, United Nations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

Relationships with International Community

Overview of the Health Minister's role in the International Community and Portfolio Engagement

Increasingly, the health of Canadians is linked to complex global issues that cannot be addressed without collective action. COVID-19 has heightened the importance of health on a global scale and further illustrated that health is not solely impacted by local factors. The pandemic has exacerbated global health issues that have direct implications for the health of Canadians, especially those facing conditions of marginalization.

Now, more than ever before, it is vital to engage on health issues in a way that reflects the interconnectedness of global and domestic health priorities. Active international engagement to advance Canadian health priorities can serve to protect and promote the health of Canadians while demonstrating global leadership on issues where we can make a difference.

The Minister of Health plays a leading role internationally by engaging with bilateral, regional, and multilateral partners, which includes sharing Canadian experiences and good practices from across sectors and all levels of government with international partners.

Context

Both binding international agreements and non-binding international policy frameworks govern Canada's international engagement on health. Binding agreements include the World Health Organization Framework Convention on Tobacco Control (FCTC) and the International Health Regulations, 2005 (IHR). The FCTC requires Parties to develop and implement tobacco demand and supply reduction provisions. The IHR requires member states to develop and maintain the capacity to detect and respond to outbreaks and other public health events that can have a broader international impact on human health, thereby protecting global health security. A key non-binding international policy framework that guides Canada's foreign policy engagement, including health, is the United Nations Sustainable Development Goals (SDGs), a broad set of 17 non-binding international commitments adopted as part of the 2030 Agenda for Sustainable Development.

The Minister of Health works closely with the Ministers of Foreign Affairs and International Development to engage on health issues that have a predominant development focus (e.g., maternal and child health, HIV-AIDS, sexual and reproductive health and rights, gender equality, food systems, child and adolescents health). Similarly, the Minister of Health works with the Ministers of Foreign Affairs and International Trade to support trade negotiations, in particular by advocating for the protection of Canada's right to regulate in support of legitimate health objectives.

COVID-19 Engagement with Multilateral & Regional Partners

Canada continues to engage with key partners internationally to share best practices and expertise and influence the pandemic response and recovery agenda:

• United Nations (UN)
• World Health Organization (WHO)
• Pan American Health Organization (PAHO)
• Group of 7 / Group of 20 (G7/G20)
• Global Health Security Initiative (GHSI)
• Organisation for Economic Co-operation and Development (OECD)
• Asia-Pacific Economic Cooperation (APEC)
• Caribbean Public Health Agency (CARPHA)
• International Association of National Public Health Institutes (IANPHI)
• European Union/European Centre for Disease Prevention and Control (ECDC)

The WHO has played a critical role in the early and ongoing pandemic response and has convened several COVID-19 response reviews with the aim of identifying lessons learned and strengthening global pandemic preparedness and response for future health emergencies. In light of these lessons learned, Canada is working with other Member States to strengthen the WHO's capacity for health emergency preparedness and response efforts.

The presidencies of both the G7 and the G20 have included a focus on pandemic response and recovery in their respective agendas for this year.

Multilateral Engagement

Engaging in multilateral fora allows Canada to advance domestic and international health priorities; promote its values, including good governance, accountability and transparency; and advance broader foreign policy priorities beyond global health. Canada works with likeminded countries in multilateral fora to enhance its ability to respond to a broad range of global health challenges and to maintain situational awareness of emerging issues. Canada's strength comes from its reputation of being a convener and broker that facilitates agreements on key global health issues.

The Health Portfolio leads Canada's health-related engagement in several fora, including the G7^{Footnote 4} and G20^{Footnote 5}. The Health Portfolio engages these fora to build and maintain political momentum and commitment to action on priority health issues. The Health Portfolio also supports Canada's participation in other G7 and G20 tracks with implications for health, such as Finance, Agriculture, Environment, Development, and Transportation, and supports Canada's health interests at the Leader level. These fora also provide a unique opportunity to promote work across sectors to address complex health issues in support of domestic policies and programs such as the 2030 Agenda for Sustainable Development. The Minister of Health attends these meetings as the head of delegation to demonstrate Canada's commitment to addressing key global health threats and to endorse political commitments.

The Health Portfolio also works with the United Nations (UN), on specific health issues in high-level meetings and resolutions of the General Assembly as well as engagement with specialized UN agencies such as the Joint UN Programme on HIV/AIDS (UNAIDS), the Food and Agriculture Organization (FAO), the Convention on Biological Diversity (CBD), the UN Framework Convention on Climate Change (UNFCCC), the International Labour Organization (ILO) and the High-level Political Forum on Sustainable Development (HLPF). A recent example of joint work undertaken with the UN is the UN Research Roadmap for the COVID-19 Recovery led by the Canadian Institutes of Health Research (CIHR) to inform COVID-19 recovery and safeguard progress towards achieving the UN's SDGs.

Canada is an active member of the World Health Organization (WHO). The WHO is the specialized health agency of the UN system that provides leadership on global health matters, setting norms and standards, articulating evidence-based policy options, shaping the health research agenda, and monitoring and assessing health trends. The WHO also plays an important role in declaring and responding to global public health emergencies, such as COVID-19. The World Health Assembly (WHA) is the preeminent global gathering of Health Ministers and the highest decision making body at the WHO to set the Organization's strategic directions. The Minister of Health usually leads Canada's delegation to the WHA, held annually in May.

The Pan American Health Organization (PAHO) is the Regional Office of the WHO for the Americas and the specialized organization for health of the Organization of the American States (OAS). PAHO's mission is to lead strategic collaborative efforts among Member States and other partners to promote equity in health, to combat disease, and to improve the quality of, and lengthen, the lives of the peoples of the Americas. Actively engaging with PAHO provides the opportunity for Canada to be a regional leader and partner in advancing health objectives; to assist in finding joint solutions to regional challenges; to promote effective stewardship of the Organization; and to advance health security within the region in order to protect the health of Canadians.

The Health Portfolio also supports Canada's engagement with the Asia-Pacific Economic Cooperation (APEC), the Arctic Council, the International Association of National Public Health Institutes (IANPHI), and the Organisation for Economic Co-operation and Development (OECD), which discuss a range of health issues.

Bilateral and Regional Engagement

In addition to multilateral engagement, the Minister of Health engages bilaterally with counterparts from other countries, as well as heads of international organizations.

As North American partners, both the United States (U.S.) and Mexico play a role in preparing for and responding to health emergencies that may impact the continent. The U.S. is Canada's closest and most important relationship in health. Areas of collaboration include food and drug regulation, health security, health research, youth vaping, the opioid crisis, coordinating border policies based on science and public health criteria, sharing best practices on increasing vaccine acceptance and addressing food safety and chemicals management. Early engagement with the U.S. Secretary of Health will provide an opportunity to discuss continued bilateral collaboration and areas for collaboration in multilateral fora.

Other key partners in the Americas region include Mexico (primarily through trilateral engagement with the U.S.); Brazil (one of the largest and most influential players in Latin America); and the Caribbean (a priority region for bilateral engagement, particularly on global health security).

The Health Portfolio provides technical advice and support to the Caribbean Public Health Agency (CARPHA) and was instrumental in its creation. The Government of Canada shares the common goal with CARPHA of strengthening in-country capacity to prevent, detect and respond to current and emerging health threats. Post-COVID-19, PHAC is engaging with CARPHA to provide technical advice and support for long term governance, promote safe travel between Canada and the Caribbean and collaborate on emerging areas of interest such as climate change and health.

Since the onset of the pandemic, the European Union (EU) and its Member States have also increasingly played a stronger role in international fora, making them key strategic bilateral partners for Canada. Other key partners on health issues include the United Kingdom (UK), Australia and New Zealand. China also remains a country of interest on health given its increasingly important role on the global health landscape as a main player and key contributor to multilateral fora.

Key Areas of Health Portfolio Engagement

1. Health Security, Emergency Preparedness and Response

The Health Portfolio works closely with WHO and PAHO, and with regional partners, to address threats to Canadian and global health security. Recent discussions have shifted to encourage more leadership and coordination from the WHO in the area of global health security. Canada is a partner country in the North American Plan for Animal and Pandemic Influenza (NAPAPI) a trilateral platform that includes mechanisms for early notification, surveillance, and joint outbreak investigation. The UK has also become an increasingly important partner in global health security, through its G7 Presidency in 2021, and has recently established a new UK Health Security Agency.

Canada is also an active member of the Global Health Security Initiative (composed of G7 countries plus Mexico and the European Commission) and the Global Health Security Agenda (U.S.-led initiative with 44 countries). Created in 2001 and 2014 respectively, these two bodies, work to enhance global capacity to prepare and respond to a wide range of chemical, biological, radiological, and nuclear threats through early detection, risk assessment and joint exercises.

Canada, through CIHR, is also the current chair of the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), an international initiative that brings together research funding organizations on a global scale to facilitate an effective and rapid research of a significant outbreak of a new or re-emerging infectious disease with epidemic and pandemic potential.

2. Health Equity

The COVID-19 pandemic has highlighted gaps in health equity that persist both domestically and globally, leading to the erosion of health outcomes in vulnerable and marginalized populations. The Health Portfolio maintains an equity-focused approach to all areas of engagement with international partners, particularly as the pandemic has underscored the cracks that exist in our health and social systems. For Canada, ensuring that equity and gender equality are at the forefront of COVID-19 recovery is of critical importance, alongside addressing broader social, economic, and environmental determinants of health that drive existing problems and inequities. Canada will likely be expected to continue championing health equity and action on the determinants of health as the secondary impacts of the pandemic will remain a key focus for recovery efforts moving forward.

Mental Health and Well-being

The COVID-19 pandemic has underscored the gaps that exist in our mental health systems and has exacerbated existing inequities. As countries move towards pandemic and economic recovery, mental health is expected to be a key area of focus globally. Canada established a leadership role on global mental health in 2018, including by co-founding the Alliance of Champions for Mental Health and Wellbeing with Australia and the UK to catalyze and coordinate greater political momentum for action on mental health. Through the pandemic, Canada has continued to work with key partners (e.g., WHO, France, and the Netherlands) to champion equitable access to mental health supports and services, and the integration of mental health as part of COVID-19 response and recovery. There will be expectations for Canada to build on this history of leadership.

Health Promotion and Chronic Disease Prevention

Chronic, non-communicable diseases (NCDs) such as cancer and diabetes, and their common underlying risk factors of obesity, tobacco, and physical inactivity, are an ongoing health concern. NCDs have been further exacerbated throughout the COVID-19 pandemic due to the ongoing disruption of essential services and its potential long-term impacts. The public health impact of these diseases and conditions have spurred greater international efforts to coordinate research and collaboration. Canada, through PHAC, hosts the WHO/PAHO Collaborating Centre on Chronic Non-communicable Disease Policy, and works with global partners to share knowledge and tools to prevent chronic disease. Through CIHR, Canada is a member of the Global Alliance for Chronic Diseases (GACD), an alliance of major research funders that supports global activities to address the prevention and treatment of chronic NDCs. GACD multi-country, multi-disciplinary research focuses on the needs of low- and middle-income countries (LMICs), and vulnerable populations of more developed countries. CIHR's scientific director of the institute for cancer research is also Canada's representative on the International Agency for Research on Cancer (IARC) governing Council, and the current Council Chair.

3. One Health

Antimicrobial Resistance (AMR)

During their 2021 G7 Presidency, the UK introduced an ambitious agenda to advance market incentives for the development of novel antimicrobials, improving the resilience of antimicrobial supply chains, and considering environmental standards for the release of antimicrobials into the environment. It is expected that future G7 and G20 Presidents will include AMR on the agenda.

CIHR is also a founding member and major funder of the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR)—a collaboration of 28 member states aimed at coordinating research in AMR to achieve long-term reductions in resistance levels and better public health outcomes. Work is also ongoing with international regulators to harmonize regulatory requirements.

Environment, Climate Change and One Health

The One Health approach recognizes that we cannot focus only on human health, but recognize the linkages to animal, plant, and environmental health. Several international initiatives have been launched under the One Health banner, such as the WHO-FAO-OIE-UNEP One Health High Level Expert Panel and the PREZODE initiative. One Health is also a common theme in G7 and G20 discussions. This approach is also a the center of discussions under the Convention of Biological Diversity (CBD), as part of the post-2020 Global Biodiversity Framework as well as the development of a CBD-led Global Action Plan on Biodiversity and Health.

4. Science and Regulatory Cooperation

Cooperation with International Regulators

The Health Portfolio works with the U.S. Food and Drug Administration, the European Medicines Agency, Japan's Pharmaceutical and Medical Devices Agency, Australia's Therapeutic Goods Administration and others, to share information to inform regulatory decisions, harmonize standards, and address current and emerging health regulatory challenges. In an era of complex international trade and global supply chains, this cooperation with trusted regulatory partners helps ensure the safety of the products Canadians use and consume, and helps develop evidence-based risk mitigation approaches.

Food Safety

The Health Portfolio engages in multilateral organizations such as the Codex Alimentarius Commission, to develop international standards, guidelines and recommendations for food safety and fair practices in the food trade, and in the FAO, WHO, APEC Food Safety Cooperation Forum and other organizations to advance international and regional food safety initiatives. The Health Portfolio also works with bilateral partners such as the U.S., the E.U., and the Food Safety QUADS (Canada, U.S., Australia, and New Zealand) to closely align food safety regulations and food inspection practices, the surveillance of foodborne disease outbreaks and to enhance and share technical and scientific information.

Health Research

In addition to various examples of international health research collaborations mentioned in above sections, the Health Portfolio remains committed to leveraging the power of research to accelerate global health equity for all. Through the CIHR and the release of its new Framework for Action on Global Health Research, emphasis is being placed on equity, the forging of authentic partnerships, reciprocal learning, and transnational cooperation to tackle mutual health challenges. This work will continue contributing to cutting-edge science and improvements to the health of Canadians and citizens throughout the world.