Health Canada 2019–2020 Departmental Results Report

The Honourable Patty Hajdu, P.C., M.P. Minister of Health

© Her Majesty the Queen in Right of Canada, represented by the President of the Treasury Board, 2020.

Catalogue No H1-9 / 32E-PDF
ISSN 2560-810X
Pub. 200031

This document is available on the Treasury Board of Canada Secretariat website.

This document is available in alternative formats upon request.

Table of Contents

• From the Minister
• Results at a Glance
  • Core Responsibilities
  • Key Results
  • Operating Context and Key Risks
• Results what we achieved
  • Health Canada’s Response to COVID-19
  • Core Responsibility 1: Health Care Systems
    • Description
    • Results
  • Core Responsibility 2: Health Protection and Promotion
    • Description
    • Results
  • Internal Services
    • Description
    • Results
  • Experimentation / GBA+
• Analysis of trends in spending and human resources
  • Actual expenditures
  • Actual human resources
  • Expenditures by vote
  • Government of Canada spending and activities
  • Financial statements and financial statements highlights
    • Financial statements
    • Financial statements highlights
• Additional information
  • Organizational profile
    • Raison d’être, mandate and role
    • Reporting Framework
  • Supporting information on the Program Inventory
  • Supplementary information tables
  • Federal tax expenditures
  • Organizational contact information
• Appendix: definitions

From the Minister

As the Minister of Health, I am committed to protecting the health and safety of all Canadians. I am pleased to present the 2019-20 Departmental Results Report for Health Canada, which outlines the important work and results that the Department achieved for Canadians over the past year.

Beginning in January 2020, Health Canada worked alongside the Public Health Agency of Canada and Canada's Chief Public Health Officer to lead a whole-of-government response to the COVID-19 pandemic. In partnership with the Agency, we established a dedicated Task Force and governance to provide a comprehensive, coordinated and multi-faceted response – one that involved other federal departments and agencies, provinces and territories.

Health Canada advanced strategic priorities for this response, including: helping to drive procurement of personal protective equipment; strengthening data sharing and communications; making early investments in research, vaccines and treatments; as well as implementing innovative and agile measures to prioritize and expedite the regulatory review of COVID-19-related health products. Health Canada ensured that consistent, transparent, accurate and timely information was shared with federal partners, provinces and territories, and Canadians. We did this without compromising Canada's high standards for safety, efficacy and quality.

I take great pride in the hard work, creativity, and unwavering determination of Health Canada employees during this response. I am especially thankful to all the front line workers and volunteers, both within the Department and across the country, who stepped forward to deliver services with care. Our leadership will continue to ensure a consistent national approach to tackling the pandemic and protecting Canadians. At the same time, my heart and thoughts go out to all Canadians as we face new and unparalleled changes and challenges in our day-to-day lives. I know that we will continue to support each other as we find our way in this new context.

In addition to the significant COVID-19 response mounted by Health Canada in 2019-20, we also continued to provide national leadership on appropriate, effective, and sustainable health care, and on enabling access to safe and effective health and consumer products, and food.

A key priority for Health Canada continued to be responding to the devastating effects caused by the ongoing opioid overdose crisis. The Department's efforts focused on supporting harm reduction for people who use substances by increasing access to evidence-based treatment services through the Emergency Treatment Fund, and expanding access to a safer drug supply.

Furthermore, during the past year, Health Canada worked with provinces and territories to implement the Common Statement of Principles on Shared Health Priorities. This agreement includes a targeted federal investment of $11 billion over 10 years to improve access to home and community care, and to mental health and addiction services. The Department supported collaboration among provinces, territories, and partners to address key health system issues, such as developing an organ and tissues donation and transplantation system.
Health Canada supported the Advisory Council on the Implementation of National Pharmacare, which led a national dialogue on how to best implement a national pharmacare system so that all Canadians have the drug coverage they need.

During this fiscal year, the Department launched both its Health and Biosciences Sector Regulatory Review Roadmap, and the Agri-food and Aquaculture Roadmap, in response to the Treasury Board Secretariat-led targeted regulatory reform agenda.

Health Canada also advanced its efforts to improve access to, and the affordability of, necessary prescription medications. As part of the Regulatory Review of Drugs and Devices initiative, the Department increased domestic and global collaboration regarding drug reviews and incorporated a more robust application of real world evidence.

In collaboration with stakeholders, Health Canada supported the delivery of the Government's commitment to strictly regulating and restricting access to cannabis. In October 2019, amendments to the Cannabis Regulations came into force, which set out the rules governing the legal production and sale of edible cannabis, cannabis extracts and cannabis topicals.

Recognizing the rising appeal of vaping, particularly among young people, Health Canada introduced and proposed several measures in 2019-20 to discourage our youth from taking up the practice, such as further regulating the sale, labelling and promotion of tobacco and vaping products. At the same time, the Department continued to implement Canada's Tobacco Strategy, a comprehensive and integrated approach to reducing tobacco use to less than 5% by 2035.

Health Canada continued to engage with Canadians on important health and safety information, and delivered evidence-based and innovative public awareness campaigns on such issues as opioids, cannabis, vaping, smoking, and healthy eating. For example, building on the new Canada's Food Guide, the Food Guide Snapshot is now available in 31 languages, including 9 Indigenous languages.

The Department has worked diligently across the board in applying and integrating Sex and Gender-Based Analysis Plus in its programs and decision-making processes – reflecting the Government's commitment to advance diversity and inclusion. If there is anything we have learned over these past months, a more inclusive, compassionate country benefits all of us.

The Honorable Patty Hajdu, P.C., M.P.
Minister of Health

Results at a Glance

Health Canada is the federal department responsible for helping Canadians maintain and improve their health. In keeping with the Department’s commitment to making this country’s population among the healthiest in the world, its main responsibilities are as a regulator, a catalyst for innovation, a funder, and an information provider. Health Canada also administers the Canada Health Act which embodies national principles to ensure a universal and equitable publicly-funded health care system.

In addition to working closely with provincial and territorial governments, the Department works with partners in the Health Portfolio, other federal departments and agencies, non-governmental organizations, other countries, Indigenous partners^{Footnote 1} and the private sector.

From coast to coast to coast, Health Canada employees—scientists and researchers, inspectors, doctors and nurses, policy analysts and administrative professionals, and many others—are working to help Canadians maintain and improve their health.

Core Responsibilities

Health Canada’s Departmental Results Framework (DRF) outlines two core responsibilities for the Department: Health Care Systems and Health Protection and Promotion. This reporting framework provides the structure for planned activities, which are organized according to these core responsibilities and their corresponding results.

Core responsibilities - Text description

Health Canada's Departmental Results Framework (DRF) outlines two core responsibilities.

• Core Responsibility 1: Health Care Systems
• Core Responsibility 2: Health Protection and Promotion

Under the Health Care Systems core responsibility, Health Canada provides national leadership to foster sustainable health care systems that ensure access for Canadians to appropriate and effective health care. This is mainly achieved through partnerships with provincial and territorial governments and support through targeted funding agreements to organizations and key pan-Canadian health partners that are contributing to health system improvements.

Within the Health Protection and Promotion core responsibility, Health Canada works with domestic and international partners to assess, manage and communicate the health and safety risks and benefits associated with health and consumer products, food, chemicals, pesticides, environmental factors, tobacco and vaping products, cannabis, and controlled substances. These risks are managed through rigorous regulatory frameworks and by communicating risks and benefits to Canadians so that they can make informed decisions.

Key Results

In 2019-20, Health Canada achieved the following key results that contributed to the health of Canadians.

Health Canada’s Response to COVID-19

• Beginning in January 2020, Health Canada collaborated with the Public Health Agency of Canada (PHAC) and Canada’s Chief Public Health Officer (CPHO) to lead a whole-of-government approach –  working closely with other federal departments and agencies, and provinces and territories to lay the groundwork for Canada’s comprehensive, coordinated and multi-faceted response to this public health crisis.
• Together, Health Canada and PHAC established a dedicated COVID-19 Task Force and governance structures to ensure collaboration and coordination across the federal government and actively engaged provincial and territorial governments from the onset, in order to provide consistent, transparent, accurate and timely information to Canadians.
• Health Canada advanced strategic priorities for this response, including: providing critical advice, including repatriation of Canadians and on occupational health and safety; helping drive procurement of personal protective equipment (PPE); strengthening data sharing and communications; making early investments in research, vaccines and treatments; as well as dedicating resources to prioritize and expedite the regulatory review of COVID-19-related health products.
• Health Canada’s response to COVID-19 derived from the initial work done in the final months of 2019-20. Specifically, branches within Health Canada worked collaboratively and creatively across the organization, the health portfolio and the country on initiatives to ensure that Canada’s preparedness and response measures to the outbreak were appropriate and adaptable, based on the latest science and the evolving situation.
• This work included: providing timely, trusted and evidence-based information; launching the “Canada COVID-19” online self-assessment tool; authorizing clinical trials; facilitating access to health products; and launching "Wellness Together Canada" to support mental health and substance use challenges.

Core Responsibility 1: Health Care Systems

• In support of the Department's mandate, Health Canada conducted research, analysis and policy work on health care system issues such as: health expenditures and funding; home care; palliative and end-of-life care; pharmaceuticals; impacts of health care systems modernization on the health workforce; quality of care; mental health; health care and service delivery innovation and emerging health system challenges/opportunities; as well as data and digital gaps and infrastructure.
• The Department supported multiple pan-Canadian health organizations that directly contribute to health system improvements in areas such as digital health, health information, drugs and technologies, mental health and addictions, cancer prevention and control, patient safety, and service delivery innovation.
• Health Canada released its Action Plan on Palliative Care, which aims to help improve quality of life for people living with life-limiting illness – as well as their families and caregivers – and enhance access, quality of care and health care system performance.
• In collaboration with provinces and territories, the Department released the Fourth Interim Report on MAID (Medical Assistance in Dying) using data volunteered by provinces and territories; implemented the federal monitoring regime for MAID; and undertook extensive public consultations towards amendments regarding eligibility requirements.
• Health Canada provided secretariat support to the Advisory Council on the Implementation of national pharmacare, which led a national dialogue on how to best implement a regime that is affordable for Canadians and their families, employers and governments. More than 32,000 individuals and organizations shared their views.
• The Department worked with the provinces and territories to prepare for the implementation of the Diagnostic Services Policy, which confirmed the longstanding federal position that medically-necessary diagnostic services (such as MRI and CT Scans) are considered insured health services, regardless of the venue where the services are delivered.
• Health Canada supported collaboration among provinces, territories, Canadian Blood Services, and other key stakeholders to develop an organ and tissues donation and transplantation system that gives Canadians timely and effective access to care. This included efforts to reduce barriers to plasma donation for men who have sex with men, while maintaining the safety of blood and manufactured plasma products for Canadians.
• The Department's Substance Use and Addictions Program provided funding for 105 projects across Canada representing a wide range of evidence-informed and innovative problematic substance use prevention, harm reduction and treatment initiatives at the community, regional and national levels. Initiatives targeted a range of controlled drugs and substances, including opioids, stimulants, cannabis, alcohol, nicotine and tobacco.

Core Responsibility 2: Health Protection and Promotion

• Health Canada launched its Health and Biosciences Sector Regulatory Review Roadmap and Agri-food and Aquaculture Roadmap, which outline the Department’s regulatory innovation agenda to modernize its regulatory frameworks over the next 3-5 years.
• Health Canada helped lead the federal response to problematic substance use. The Department maintained its strong response to the opioid overdose crisis, deploying a public health approach that was coordinated, collaborative, evidence-based and compassionate. This involved extensive engagement with other jurisdictions and stakeholders, including people with experience of substance use as well as with Canadians who have and treat chronic pain. Health Canada also continued to work closely with provinces and territories on the implementation of the Emergency Treatment Fund (ETF) to improve access to evidence-based treatment services in the context of the opioid crisis.
• Health Canada continued to strictly regulate and restrict access to cannabis, demonstrating significant progress in establishing a tightly regulated cannabis industry capable of supplying the market with a sufficient supply of quality controlled products required to displace the illicit market. Amid extensive campaigns to inform and educate Canadians on the health and safety facts about cannabis use, amendments to the Cannabis Regulations allowed the legal production and sale of edible cannabis, cannabis extracts and cannabis topicals.
• Health Canada continued to advance its Healthy Eating Strategy, which aims to curb the rising burden of obesity and chronic disease by making the healthier choice easier for all Canadians. For example, the Department greatly extended the reach of Canada’s Food Guide by making the Food Guide Snapshot available in 31 languages, including 9 Indigenous languages.
• The Department continued to implement Canada's Tobacco Strategy, a comprehensive and integrated approach to reducing tobacco use to less than 5% by 2035 and took significant regulatory action to protect a new generation of Canadians from the risk of nicotine addiction and vaping-related harms, such as regulating the sale, labelling and promotion of tobacco and vaping products in Canada. Health Canada pre-published the Vaping Products Promotions Regulations, announced the final Vaping Product Labelling and Packaging Regulation, and consulted Canadians on additional potential regulatory measures. At the same time, the Department continued an aggressive vaping prevention campaign to discourage youth from taking up the practice.
• Health Canada maintained its leadership role in mitigating the impacts of drug shortages on Canadians, actively managing an average of 6 national, critical shortages per month and working closely with all jurisdictions and stakeholders to identify and implement mitigation measures, such as facilitating the importation of international supply.
• The Department announced 3 new sets of regulations under the Assisted Human Reproduction Act that: established a framework for third-party donor sperm and ova; identified the categories of expenditures for which donors, surrogates or a person maintaining or transporting in-vitro embryos can be reimbursed, as well as requirements for the reimbursement of loss of work-related income for surrogate mothers.
• Health Canada continued to work to improve the responsible use of antimicrobials in animals. The Department helped stakeholders adapt to the requirement that all medically important antimicrobials are now sold by prescription only. It was also the first year that manufacturers, importers and compounders were required to report to Health Canada the volume of medically important antimicrobials sold for use in animals.

Experimentation

2019-20 marked the second year of Health Canada’s Solutions Fund: Powering Employee Innovation. Employees submitted 16 proposals, 6 of which were approved for funding. These projects included testing the use of satellite technology to inspect licensed outdoor cannabis operations; understanding how machine-learning can extract information from inspection reports to improve the quality of assessments; and using smartphones to “scrape” information from health product labels to identify instances of non-compliance.

This report also details several other examples where the Department explored innovative projects and experimented to keep pace with emerging technologies and the evolving demands and expectations of Canadians. These included: issuing challenges to the private sector under the Government's Innovative Solutions Canada program for the development and early stage testing of new solutions to health problems; developing innovative digital solutions under the Innovative Solutions Canada Testing Stream to improve the ability of health providers and individuals to communicate virtually; launching new micro-grants funding wherein low-risk, small-scale projects are eligible to receive $1000 grants under the Substance Use and Addictions Program; as well as selecting and funding 3 finalists under the Department's Drug-Checking Technology Challenge.

Sex and Gender-Based Analysis Plus (GBA+/SGBA+)

Health Canada continued to build on its Sex and Gender Action Plan, to strengthen the systematic application and integration of sex, gender and other factors (such as age and language) in Departmental work and decision making. Each branch identified at least one signature initiative. This report details progress in the areas of: enhanced capacity building; strengthened sex and gender related evidence and expertise; as well as implementing SGBA+ across Health Canada programs.

Operating context and key risks

Information on operating context and key risks is available on Health Canada’s website.

For more information on Health Canada’s plans, priorities and results achieved, see the “Results: what we achieved” section of this report.

Results what we achieved

Health Canada’s Response to COVID-19

Health Canada monitors and responds to health issues, identified at home and internationally, that affect the health and safety of Canadians. This includes the 2019 novel coronavirus (COVID-19), which originated in December 2019 and was declared a global pandemic by the World Health Organization (WHO) on March 11, 2020.

Beginning in January 2020, Health Canada worked alongside PHAC and the CPHO to lead the initial response to this unprecedented public health crisis, in close collaboration with other federal departments and agencies, and provinces and territories – laying the groundwork for Canada's comprehensive, coordinated and multi-faceted approach.

In partnership with PHAC, the Department established a dedicated COVID-19 Task Force and governance structures to ensure collaboration and coordination across the federal government.

Every aspect of Health Canada's subsequent response to COVID-19 derived from the initial work done in the final months of 2019-20, from enhancing the Government-wide ability to monitor the situation, to strengthening the health system's capacity to protect vulnerable populations and high-risk communities, to supporting greater testing and contact-tracing capacity across the country.

The COVID-19 Task Force will continue to provide leadership and direction to address the current pandemic priority areas and needs, such as: testing and contact tracing; supply-demand and stockpiling of PPE and medical supplies; and development of vaccines and medical countermeasures.

Branches within Health Canada worked collaboratively and creatively across the organization, the health portfolio and the country on initiatives to ensure that Canada's preparedness and response measures were appropriate and adaptable, based on the latest science and the evolving situation. These initiatives included:

Providing timely, trusted and evidence-based information

From the onset of the COVID-19 outbreak, Health Canada and PHAC provided Canadians and health care providers with the timely, clear and evidence-based information they needed to protect themselves, their families, their communities and their businesses. The organizations used the following channels (among others) to provide information and updates to Canadians:

• A dedicated Canada.ca/coronavirus website, linking to Health Canada and PHAC pages on the COVID-19 response, had more than 61 million visits from its launch on January 16, 2020 to March 31, 2020;
• 34 media briefings or press conferences from January 20, 2020 to March 31, 2020, often with the Minister of Health present;
• A toll-free information line [1-833-784-4397] with interpretation service available in 200+ languages open from 7:00 a.m. to midnight, 7 days a week;
• Social media; and
• TV, radio, print and digital advertising.

The Department also applied a variety of methods to ensure that Canadians who may not have access to or use the Internet, or who live in rural or remote communities, received the information they needed to help them make informed decisions and protect their health. For example, beginning in March 2020, 15.5 million mail-outs were distributed nation-wide on COVID-19, reaching nearly every household in Canada.

Throughout the outbreak, Health Canada employees were kept apprised of guidance and announcements from public health authorities, the Treasury Board Secretariat and the Public Service Occupational Health Program, through a variety of tools and platforms, including new web-based digital channels.

Launching the “Canada COVID-19” online self-assessment tool

Health Canada formed a digital surge team to explore, assess and support the procurement of digital tools and solutions in response to COVID-19. The response from Canadian researchers and innovators in the early stages of the pandemic was extremely strong, and the Department was able to rapidly put in place an online self-assessment tool to help Canadians assess their symptoms and make informed decisions regarding the best actions to take. By March 31, 2020, this service had been accessed more than 3.3 million times. Health Canada also launched an app called “Canada COVID-19” on March 31, 2020 to enable mobile access to the self-assessment tool and create a hub for Canadians to access information and resources to remain informed about COVID-19.

Authorizing clinical trials

As of March 31, 2020, Health Canada authorised 8 clinical trials to investigate the prevention or treatment of COVID-19. In addition, the Special Access Program facilitated access to remdesivir for the treatment of COVID-19. The Department also began publishing online the list of authorized drugs and vaccines being investigated in clinical trials.

Facilitating access to health products

Health Canada played a key role in the Government’s response to COVID-19 by implementing innovative and flexible measures to help prioritize and expedite the regulatory review of health products of greatest need without compromising Canada’s high standard of safety.

These measures included: introducing temporary legislative and regulatory measures to expedite relevant health product reviews; implementing a COVID-19 priority list surveillance strategy for drugs and medical devices; coordinating communications and updates with other government partners; and launching a centralized COVID-19 health product industry web page.

Maintaining Canadians’ access to an adequate supply of health products is important, especially during a pandemic. On March 18, 2020, the Minister of Health signed an Interim Order that allowed for the expedited authorization of medical devices, including COVID-19 testing devices, so that they could be imported and sold in Canada at an accelerated pace. As of March 31, 2020, the Department had authorized 22 devices, including 7 applications for testing devices and 15 applications for other medical devices (masks, gloves, and a thermal camera) to fight COVID-19.

Health Canada accelerated the issuance of Medical Device Establishment Licences by reducing the review and approval timeframe from 120 days to 15 days to supply needed medical devices in support of COVID-19 response efforts. Furthermore, the Department expedited the review of hand sanitizers from 60 days to 24 hours. As of March 31, 2020, 218 product licenses were approved, as well as 143 site licenses.

On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. This temporary measure introduced regulatory flexibilities to support Canada’s supply chain during the pandemic, allowing for a rapid response to critical supply issues should food and health product shortages occur. It also introduced a mandatory mechanism for the Minister to be notified of shortages of medical devices considered to be critical during the pandemic.

Health Canada adapted its compliance and enforcement approach in response to the pandemic by using virtual inspection tools and desk-based reviews to monitor compliance, and allowed industry stakeholders greater flexibility in complying with regulatory requirements where the risk was deemed to be low.

Facilitating access to treatment

On March 19, Health Canada issued a short-term subsection 56(1) exemption from the Controlled Drugs and Substances Act. This exemption allowed practitioners to verbally prescribe, and authorized pharmacists to prescribe, sell, or provide controlled substances in limited circumstances, or transfer prescriptions for controlled substances. It also allowed for individuals to deliver controlled substances to those in isolation.

Supporting mental health

In March 2020, Health Canada worked to create a free, online portal to connect Canadians with mental health and substance use resources and supports during COVID-19. The Wellness Together Canada portal was launched in April 2020.

Also, when supporting federal responders during the COVID-19 repatriation efforts (February to April 2020), the Department's Employee Assistance Program ensured that gender sensitive psychosocial teams were deployed to quarantine sites to support affected Canadians during this particularly stressful situation.

Enhancing Internal Services

All of Health Canada’s Internal Services provided focused support to areas across the Department in response to technological and financial resources needs created by the COVID-19 pandemic. The Department prioritized work with Shared Services Canada to increase its capacity for remote network connectivity capacity over VPN, implemented Zoom for collaboration using unclassified information, and started planning to implement Microsoft Teams in a secure environment as an employee collaboration tool.

These preparedness activities better positioned the Department for the delivery of critical services and commitments during the COVID-19 pandemic.

Core Responsibility 1: Health Care Systems

Description

Health Canada provides national leadership to support and encourage sustainable and adaptable health care systems that ensures access for Canadians to appropriate and effective health care services.

Results

Departmental Result 1: Canada has modern and sustainable health care systems

Health Canada works closely with provincial and territorial governments, domestic and international organizations, health care providers and other stakeholders to develop and implement innovative approaches that improve the efficiency and sustainability of Canadian health care systems.

In support of the Department's mandate, Health Canada conducted research, analysis and policy work on such health care systems issues as: health expenditures and funding; home care; palliative and end-of-life care; pharmaceuticals; impacts of health care systems modernization on the health workforce; quality of care; mental health; health care and service delivery innovation and emerging health system challenges/opportunities; as well as data and digital gaps and infrastructure. Specific highlights of Health Canada's research, analysis and policy work over the course of 2019-20 include:

Health expenditure and funding

Health Canada conducted research and analysis on domestic and international health expenditures and funding, and their implications for health care delivery in Canada.

Specifically, the Department monitored and analyzed key data sources, including the Canadian Institute for Health Information (CIHI)’s National Health Expenditure Trends; federal/provincial/territorial (F/P/T) budgets; and other academic, non-academic, and international sources. Health Canada also supported and analyzed research by the Organisation for Economic Co-operation and Development (OECD) on trends in health spending, funding and fiscal sustainability among OECD countries. The results of Health Canada’s analyses were used to advise the Government regarding drivers of future health spending growth and composition (e.g., supportive care for seniors), in Canada and internationally.

Home care

In support of the Government’s ongoing commitment to make home care more available to Canadians in their communities, Health Canada engaged with experts and key stakeholders to advance knowledge and the uptake of proven approaches and best practices. This included funding projects that: facilitated the expansion of paramedics providing preventative care and other services in homes and the community; built capacity in primary care to support Canadians with dementia at home; supported decision makers to adopt improvements in home-based palliative care; provided home care professionals with the skills to empower family caregivers; and strengthened post-acute care for seniors.

Palliative and end-of-life care

In August 2019, the Department launched a 5-year Action Plan to advance and improve palliative care. This document articulates the federal Government’s commitment to working with partners to advance and improve palliative care in key areas, such as: awareness raising; training and education; removing access barriers; research; pan-Canadian data collection; as well as supports for innovation.

Pharmaceuticals

In 2019-20, Health Canada amended the Patented Medicines Regulations in order to modernize the way patented drug prices are regulated in Canada. This first substantive update to the regulations in more than 20 years was supported by 3 sets of consultations spanning more than 2 years. Once the revised regulations come into force in 2020-21, the update is expected to save Canadians $13.2 billion in drug spending over the next 10 years.

Impacts of health care systems modernization on the health workforce

Health Canada conducted research and policy analysis in the areas of primary care and health workforce management, including through its secretariat role for the F/P/T Committee on Health Workforce. This pan-Canadian forum for collaborative action provides policy and strategic advice to jurisdictions and to the Conference of Deputy Ministers of Health regarding health workforce challenges and emerging issues. For example, the Department supported the provinces and territories in developing a vision for the future of nursing in Canada, to strengthen pan-Canadian health human resources planning, as well as to optimize the role of nurses in health service delivery.

Quality of care

Monitoring, research, analysis and policy work conducted by Health Canada on such issues such as timely access to care, patient safety and health care quality served to guide a number of approaches in response to the Department’s mandate. For example, the results supported the Government’s testimony in the Cambie court challenge in British Columbia that could have an impact on the public nature of health care delivery in Canada.

Mental health

Health Canada undertook numerous research, analysis and policy projects related to mental health over the course of 2019-20. In early 2020, an internal Task Team was established to advance the Minister’s mandate to set national access standards for mental health services. The Task Team engaged with federal partners and Pan-Canadian Health Organizations, prepared an analysis and diagnostic of the P/T landscape for standards, and hosted an expert workshop generating specific recommendations to the Minister regarding key considerations moving forward.

Health care and service delivery innovation and emerging health system challenges/opportunities

During 2019-20, Health Canada worked closely with Innovation Science and Economic Development Canada to advance health system priorities within the organization’s innovation agenda, including with respect to the Strategic Innovation Fund and Superclusters.

Recognizing the potential of public sector and private sector innovation to enhance the quality and sustainability of care, the Department studied the impact of new approaches and tools on the health system and the levers at its disposal to support efforts that provide value. This helped to shape Health Canada’s advice regarding data and digital issues and supported the associated work of various pan-Canadian health organizations.

Data and digital gaps and infrastructure needs

During 2019-20, a short-term Health Canada task force conducted a focused analysis on health data and digital needs, and the implications for Canadian health systems. This work analyzed gaps, challenges and opportunities with respect to health data and digital supports within these systems. This focused initiative was supported by Statistics Canada, PHAC, and CIHI and was strengthened through engagement with leading experts and stakeholders on the key issues. The results advanced Health Canada’s understanding of the issues and laid the groundwork for future efforts to respond to COVID-19, including, for example, the federal approach to supporting provinces and territories with regard to the rapid deployment of needed virtual health care services.

Over the course of 2019-20, Health Canada has made important investments to support several organizations that directly contribute to health system improvements. As part of this support, the Department provided:

• $84.3 million to Canada Health Infoway to advance digital health innovation, including the development of a pan-Canadian e-prescribing system and virtual care initiatives. As well, the funding continued to support the adoption and use of electronic medical records, to help patients to access their own health records electronically, and to better link electronic health record systems to improve access by all providers and institutions.
• $88.2 million to the Canadian Institute for Health Information (CIHI) for funding to deliver comparable and actionable data analysis and information to accelerate improvements in health care, health system performance and population health across the continuum of care. CIHI made progress on the collection of pan-Canadian data in order to close existing data gaps and  enhance coverage in key areas, including: primary health care, home care, community mental health, addictions, palliative care, pharmaceuticals, patient-reported outcomes and the health of Indigenous populations.

• $23.1 million to the Canadian Agency for Drugs and Technologies in Health to strengthen the management of drugs and non-drug technologies. The funding supported health system effectiveness and sustainability by promoting, through the development of evidence, the cost-effective and optimal use of drugs and other health technologies by health care decision-makers such as public drug plans and healthcare practitioners.
• $17 million to the Canadian Foundation for Healthcare Improvement (CFHI) to accelerate, identify and continue to support adoption of promising and proven health service delivery transformation. Projects completed by CHFI in 2019-20 included implementing their Appropriate Use of Antipsychotics Approach, which engages people living with dementia, families and staff to safely reduce or discontinue antipsychotics in patients without a psychosis diagnosis.

• $8.5 million in support of neuroscience discovery research through the Canada Brain Research Fund, which is administered by the Brain Canada Foundation. Health Canada is matching private and charitable funds raised by the Foundation, up to $160 million by end of fiscal year 2021-22.

Through the above investments, Canadians have gained greater access to their own medical records and health care providers were able to coordinate patient care using digital technologies. Policy makers had access to better information on the performance of the health care system and cost-effectiveness of drugs and technologies to support evidence-based decision-making. Promising innovations and best practices in service delivery were more readily identified and shared across jurisdictions. Progress on these initiatives was monitored through indicators on drug spending and health expenditure at the system level.

Departmental Result 2: Canadians have access to appropriate and effective health services

The federal government plays an important role in providing financial contributions to provinces and territories through the Canada Health Transfer to support publicly-funded health care services (more than $40 billion for 2019-20) and through targeted funding to support improved access to home and community care and mental health and substance use services (Budget 2017 $11 billion over ten years).

Through Health Canada, the federal government is also responsible for promoting and defending the core national principles of the Canada Health Act – public administration, comprehensiveness, universality, portability and accessibility. The Department continued to work closely with provinces and territories to ensure Canadians have reasonable access to insured hospital and physician services without financial or other barriers such as patient charges.

To ensure that Canadians have access to appropriate and effective health services, Health Canada focused its 2019-20 efforts on the following priority activity areas: palliative care; medical assistance in dying; national pharmacare; thalidomide survivors support; diagnostic services; organ, tissues and blood donation and transplantation; as well as further strengthening partnerships and collaboration.

Palliative care

Released in 2019, the Action Plan on Palliative Care represents the implementation of the Framework on Palliative Care. This Action Plan aims to help improve quality of life for people living with life-limiting illness – as well as their families and caregivers – and enhance access, quality of care and health care system performance. It complements current financial support provided to provinces and territories under the Common Statement of Principles on Shared Health Priorities.

In parallel to the above, Health Canada conducted in 2019-20 a literature review of palliative care engagement activities specific to Indigenous populations, spanning the past 2 decades. The resulting document is informing current engagement activities and will contribute to the development of a distinctions-based Framework on Palliative Care for Indigenous Peoples. Health Canada also collaborated with Indigenous Services Canada to include palliative care as part of their engagement with First Nations on the continuum of care – a process that was developed in 2019-20 for roll out in 2020-21.

Medical assistance in dying

In 2019-20, Health Canada supported ongoing implementation of MAID legislation, in collaboration with provinces and territories, in order to meet federal commitments under the law. In April 2019, Health Canada released the Fourth Interim Report on MAID using data volunteered by provinces and territories. The Department also implemented the federal monitoring regime for MAID, which collects information from relevant practitioners and pharmacists. Health Canada used this data to produce the Government’s first official annual report on MAID, which was released in July 2020.

In September 2019, the Superior Court of Québec ruled that the federal MAID eligibility requirement that a person’s natural death must be reasonably foreseeable, was unconstitutional. The effect of the ruling was suspended to allow for federal changes to the MAID legislation. To inform these legislative amendments, the Department supported public consultations through an online survey, and with experts/stakeholders through 10 cross-country Ministerial roundtable meetings. This feedback was summarized in a “What We Heard” report and findings from independent reviews were also examined in the development of policy options and draft legislation. On February 24, 2020, the Ministers of Justice, Health and Employment, Workforce Development and Disability Inclusion introduced Bill C-7, An Act to amend the Criminal Code (medical assistance in dying) in Parliament, which will be further debated when the House of Commons convenes again in the fall.

National pharmacare

Over the course of 2019-20, Health Canada provided secretariat support to the Advisory Council on the Implementation of national pharmacare, which led a national dialogue on how to best implement a national pharmacare regime that is affordable for Canadians and their families, employers and governments.

The Council engaged with provincial, territorial and Indigenous governments, as well as with a wide range of organizations and stakeholders. It consulted with patients, Canadians at large, and representatives and experts in relevant fields, including healthcare providers, private insurers, businesses, labour and the pharmaceutical industry. More than 32,000 individuals and organizations shared their views through online interactions, written submissions, and in-person meetings, roundtables and community dialogue sessions held in every province and territory. The Council's final report was delivered in June 2019.

Thalidomide survivors support

The Canadian Thalidomide Survivors Support Program (CTSSP) replaced the previous Thalidomide Survivors Contribution Program in 2019. The purpose and long-term outcome of the program remained unchanged and Health Canada continued contributing to meeting the lifetime needs of Canadian thalidomide survivors, allowing them to age with dignity. The application period for the new program, launched on June 3, 2019, used a 3-step probability-based medical assessment process to determine eligibility. In 2019-20, 132 applications were submitted and assessed at Step 1 of the 3-step process, and of those, 51 were approved to move on to Step 2. The application period remains open until June 2024.

In 2019-20, the CTSSP provided financial support to 121 confirmed thalidomide survivors. Based on the 2019-20 annual survey, completed by 72 survivors, 88% reported a better ability to age with dignity, and 63% reported better access to care, treatment and/or support from ongoing payments. Adding clarification and precision to the survey questions yielded improved results over the previous 2018-19 survey.

Diagnostic Services

Over the course of 2019-20, the Department worked with the provinces and territories to prepare for the implementation of the Diagnostic Services Policy, which took effect on April 1, 2020. It confirms the longstanding federal position that medically-necessary diagnostic services (such as MRI and CT Scans) are considered insured health services, regardless of the venue where the services are delivered.

Organ, tissues and blood donation and transplantation

In 2019-20, Health Canada supported collaboration among provinces, territories, Canadian Blood Services, and other key stakeholders to develop an organ and tissues donation and transplantation system that gives Canadians timely and effective access to care. Activities included:

• Formalizing the Organ Donation and Transplantation Collaborative;
• Providing funding to Canadian Blood Services, CIHI, Canada Health Infoway and others to support priority, pan-Canadian projects such as developing a common data and performance system and improving governance and organ-sharing;
• Developing leading practices and public awareness activities;
• Supporting a call through Innovative Solutions Canada for the development of machine learning technology in order to improve organ donation rates and donor-recipient matches.

Effective June 3, 2019, Health Canada reduced the deferral period for blood donation for men who have sex with men (MSM) from 1 year to 3 months. This brought Canada in line with other countries that had already implemented a 3-month deferral period for MSM (including England, Scotland and Wales). The US and Australia subsequently approved three-month MSM blood donor deferral periods in April 2020.

With the support of an additional $2.4 million Health Canada investment over 3 years from Budget 2019, Canadian Blood Services began work with Héma-Québec at the beginning of 2019-20 to support research to address barriers for MSM to donate plasma. The research is identifying further opportunities to reduce barriers to MSM plasma donation, while maintaining the safety of blood and manufactured plasma products for Canadians.

Further strengthening partnerships and collaboration

In 2019-20, strengthening partnerships and collaboration was critical to enabling access to appropriate and effective health services. In addition to the other priority activity areas outlined above, Health Canada worked collaboratively with provinces and territories to support Canadian health systems through implementation of the F/P/T agreement on a Common Statement of Principles on Shared Health Priorities and a targeted federal investment of $11 billion over 10 years. New investments in 2019-20:

• Enabled patients to receive more professional services and better coordinated and integrated care to address their individual needs;
• Enhanced infrastructure through improved digital connectivity, and the use of remote technology, resulting in more Canadians getting the care they need, when and where they want it;
• Supported caregivers with more educational opportunities and expanded respite services;
• Improved access to palliative and end of life supports, such as greater hospice resources.

All jurisdictions took steps in 2019-20 to strengthen home and community care. With Health Canada’s support, provinces and territories also worked to improve access to mental health and addiction services, and integrate the delivery of services in recognition of the need to provide people-centred care that is coordinated across the health care system. Specifically, investments in these areas:

• Developed children and youth school-based initiatives for better early prevention, detection and treatment;
• Increased the availability of mental health and addiction services in the community;
• Expanded access to crisis intervention services and integrated multidisciplinary professional services;
• Implemented more comprehensive, collaborative and compassionate approaches based on the best available evidence for providing care to address substance use.

In 2019-20, the Substance Use and Addictions Program (SUAP) provided funding for 105 projects across Canada representing a wide range of evidence-informed and innovative problematic substance use prevention, harm reduction and treatment initiatives across Canada at the community, regional and national levels. Initiatives targeted a range of controlled drugs and substances, including opioids, stimulants, cannabis, alcohol, nicotine and tobacco. SUAP is a partner in the Canadian Drugs and Substances Strategy (prevention, harm reduction and treatment pillars) and Canada's Tobacco Strategy, and supports the objectives of Health Canada's Tobacco Control, Controlled Substances and Cannabis Programs.

Funding decisions are based on recommendations from subject matter experts across the Health Portfolio and with input from external stakeholders, including the provinces and territories. In 2019-20, SUAP supported projects aimed at public education, research, and service delivery addressing substance use and health priorities in a number of areas, including:

• 67 projects addressing a variety of needs around controlled drugs and substances, including responding to the opioid overdose crisis as well as problematic alcohol use;
• 31 projects aimed at increasing the evidence and informing Canadians concerning the safe use of cannabis;
• 7 projects to inform Canadians about the harms of tobacco use and vaping and support cessation efforts.

Overall, projects reported developing some 1,700 knowledge products (guidelines, toolkits, reports) and delivering over 2,300 learning opportunities (workshops, presentations, webinars).

SUAP also invested $10 million to fund the core activities of the Canadian Centre on Substance Use and Addiction, to provide national leadership in addressing problematic substance use in Canada, with an additional funding of $2.3 million to advance research and evidence on cannabis use. Furthermore, the Program provided funding of $1.4 million to the Mental Health Commission of Canada to assess the impacts of cannabis use on the mental health of Canadians.

In addition, Health Canada made important investments over the course of 2019-20 in several other programs and organizations that directly support access to appropriate and effective health services for Canadians. These are summarised below.

For more detailed results information on these and other grants and contributions, please see the Supplementary Information Table “Details on transfer payment programs of $5 million or more.”

Results achieved for Core Responsibility 1: Health Care Systems

Departmental Result 1: Canada has modern and sustainable health care systems

Departmental Result Indicators	Target	Date to achieve target	Actual Results
National health expenditure as a percentage of Gross Domestic ProductFootnote 1 (Baseline 10.9% of GDP in 2014-15)	Between 10 and 12%	March 31, 2020	2017-18: 11.5%Footnote 2 2018-19: 11.5%Footnote 2 2019-20: 11.6%Footnote 2
Real per capita health expenditure (1997)Footnote 1 (Baseline $4,014 per person in 2014-15)	Between $4,133.60 and $4,216.27Footnote 3	March 31, 2020	2017-18: $4,245Footnote 2 2018-19: $4,293Footnote 2 2019-20: $4,347Footnote 2Footnote 3
Drug spending as a percentage of Gross Domestic ProductFootnote 4 (Baseline 1.74% in 2014-15)	Between 1 and 2%	March 31, 2020	2017-18: 1.79%Footnote 2 2018-19: 1.77%Footnote 2Footnote 4 2019-20: 1.77%Footnote 4
Percentage of family physicians using electronic medical recordsFootnote 5,Footnote 6 (Baseline 73% in 2015)	80%	March 31, 2022	2017-18: 73%Footnote 5 2018-19: 86%Footnote 6 2019-20: 86%Footnote 6
Table 1 Footnote 1 These two complementary indicators demonstrate how national health expenditures grow relative to the economy as a whole (i.e., first indicator) and in real terms (i.e., net of inflation and population growth); data for these two indicators can be found on the Canadian Institute for Health Information (CIHI) website; click on “Data tables: Health spending” on the quick links table on the right side of the screen. Return to footnote 1 referrer Table 1 Footnote 2 These numbers have been updated based on annual CIHI revisions to reflect the most current published data. Return to footnote 2 referrer Table 1 Footnote 3 The planned target range for 2019-20 contains an error. The range should actually have been $3,864 to $4,722, which represents a target range of plus or minus 10%, relative to the most recent or previous year’s value (2018-19 in this case). In fact, real per capita health spending did increase from $4,293 in 2018-19 to $4,347 in 2019-20, which falls within the correct target range. Return to footnote 3 referrer Table 1 Footnote 4 Source: CIHI. This ratio (percentage) demonstrates how much Canada spends on drugs (prescribed and over the counter) relative to the size of the Canadian economy. Both the ratio’s numerator (drug spending) and the denominator (GDP) are expressed in Canadian dollars. Return to footnote 4 referrer Table 1 Footnote 5 Source: CIHI. How Canada Compares: Results From The Commonwealth Fund 2015 International Health Policy Survey of Primary Care Physicians. 2016. Data collected every three years. Return to footnote 5 referrer Table 1 Footnote 6 Source: CIHI. How Canada Compares: Results From the Commonwealth Fund’s 2019 International Health Policy Survey of Primary Care Physicians. 2020. Data collected every three years. Return to footnote 6 referrer

Departmental Result 2: Canadians have access to appropriate and effective health services

Departmental Result Indicators	Target	Date to achieve target	Actual Results
Percentage of Canadians (aged 15+) with a mental disorder who have expressed that they have an unmet mental health care need (Baseline: According to Statistics Canada in 2012, 26% of Canadians aged 15+ with a mental health disorder expressing they have an unmet mental health need)	Under 15%	March 31, 2021	2017-18: 26%Footnote 1 2018-19: 24.3%Footnote 2 2019-20: 24.8%Footnote 3
Percentage of Canadians (aged 15+) who have expressed that they have an unmet need for access to home care services (Baseline: According to Statistics Canada in 2012, 1.6% of Canadians aged 15+ reported that they had not received help, even though they needed it (during the previous 12 months for a chronic health condition)	Under 1.0%	March 31, 2020	2017-18: 1.5%Footnote 4 2018-19: 1.7%Footnote 5 2019-20: 1.7%Footnote 6
Percentage of Canada Health Act compliance issues addressed within 24 months of identification (Baseline 53% in 2016)Footnote 7	85%	March 31, 2020	2017-18: 94% 2018-19: 94% 2019-20: 96%
Percentage of Canadians who did not fill a prescription for medicine because of the cost (Baseline 7.1% in 2014)	Under 5%	March 31, 2022	2017-18: 7.1%Footnote 8 2018-19: 5.0%Footnote 9 2019-20: 5.0%Footnote 10
Table 2 Footnote 1 Source: Statistics Canada – Canadian Community Health Survey (CCHS), 2012 (Data collected between January and December 2012). Return to footnote 1 referrer Table 2 Footnote 2 Source: Statistics Canada – CCHS, 2018 (Data collected between January and December 2018). Return to footnote 2 referrer Table 2 Footnote 3 Source: Statistics Canada – CCHS, 2019 (Data collected between January and December 2019). Return to footnote 3 referrer Table 2 Footnote 4 Source: Statistics Canada – CCHS, 2016 (Data collected between January and December 2016), which only reports on this indicator for the age group 18+. Return to footnote 4 referrer Table 2 Footnote 5 Source: Statistics Canada – CCHS, 2017 (Data collected between January and December 2017), which only reports on this indicator for the age group 18+. Return to footnote 5 referrer Table 2 Footnote 6 Source: Statistics Canada – CCHS, 2019 (Data collected between January and December 2019). The target is an aspirational target; this indicator will track progress toward the target over the course of the Government of Canada’s ten-year $6 billion investment in home and community care, from 2017 to 2027. Return to footnote 6 referrer Table 2 Footnote 7 Source: Canada Health Act Division Database. Return to footnote 7 referrer Table 2 Footnote 8 Source: CCHS, 2014 (Data collected between January and December 2014). Return to footnote 8 referrer Table 2 Footnote 9 Source: CCHS, 2018. The actual result excludes data from the territories. Return to footnote 9 referrer Table 2 Footnote 10 Actual result is from 2018-19 CCHS Survey. CCHS data for 2019-2020 is not currently available. Previous year result added as a place holder, because data for this indicator will be updated when available in Fall 2021. Return to footnote 10 referrer

Budgetary financial resources (dollars) for Core Responsibility 1: Health Care Systems

2019-20 Main Estimates	2019-20 Planned spending	2019-20 Total authorities available for use	2019-20 Actual spending (authorities used)	2019-20 Difference (Actual spending minus Planned spending)
1,609,336,578	1,609,336,578	1,623,522,760	1,601,069,150	-8,267,428
Note: The variance of $8.3 million between actual and planned spending is mainly due to lower than anticipated draws in Thalidomide ex-gratia payments and contribution funds, including the reprofile of funding for the Canada Brain Research Fund Program.

Human resources (full-time equivalents) for Core Responsibility 1: Health Care Systems

2019-20 Planned full-time equivalents	2019-20 Actual full-time equivalents	2019-20 Difference (Actual full-time equivalents minus Planned full-time equivalents)
289	215	-74
Note: The variance in FTE utilization is mainly due to attrition and longer than anticipated staffing processes.

Financial, human resources and performance information for Health Canada’s Program Inventory is available in the GC InfoBase.

Core Responsibility 2: Health Protection and Promotion

Description

Health Canada works with domestic and international partners to assess, manage and communicate the health and safety risks and benefits associated with health and consumer products, food, chemicals, pesticides, environmental factors, tobacco and vaping products, cannabis, and controlled substances.

Results

In 2019-20, the Department launched its Health and Biosciences Sector Regulatory Review Roadmap and Agri-food and Aquaculture Roadmap, in response to the Treasury Board Secretariat-led targeted regulatory reform agenda announced in Budget 2018. These Roadmaps outline Health Canada’s regulatory innovation agenda plans to modernize its regulatory frameworks over the next 3-5 years. Some of the key components include:

• Modernizing regulations to be more agile and responsive for clinical trials, drugs and medical devices;
• Implementing a new regulatory pathway for advanced therapeutic products – those that are novel, complex, and distinct, for which current regulations are not equipped to handle;
• Enabling a more flexible and agile approach to inspection and enforcement;
• Creating modern and agile food regulations, including: the introduction of new regulatory pathways for safe and innovative foods, and of clinical trials for foods serving special dietary purposes; as well as strengthening clarity and predictability of regulatory processes and requirements;
• Improving the way we communicate with Canadians and industry about health products and food, including regulatory requirements and processes.

Departmental Result 3: Canadians have access to safe, effective and quality health products

In 2019-20, Health Canada continued to make investments towards ensuring Canadians have timely access to safe, effective and quality health products (including prescription and non-prescription drugs, biologic and radiopharmaceutical drugs, natural health products, and medical devices) and to meet the needs of the health care system. Improvements introduced this year helped accelerate market access for innovative, breakthrough products along with cost effective alternatives, such as generic drugs.

Progress on achieving Health Canada’s commitments over the course of this fiscal year was made in relation to the following key activity areas: addressing drug shortages; promoting timely access to health products; modernizing the way we provide special access to drugs; applying real-world evidence; management of prescription drugs (including opioids); strengthening regulatory oversight; modernizing compliance and enforcement; supporting assisted human reproduction (AHR); combatting antimicrobial resistance (AMR); fostering international collaboration and coordination; as well as promoting access to new and renewed technologies.

Addressing drug shortages

Over the course of 2019-20, Health Canada continued its leadership role in mitigating the impacts of drug shortages on Canadians. The Department actively managed an average of 6 national, critical shortages per month, working closely with provinces/territories, industry, health care associations and patient representatives, to identify and implement mitigation measures, such as facilitating the importation of international supply.

Health Canada also continued to facilitate collaboration via the Multi-Stakeholder Steering Committee on Drug Shortages. Lastly, the Department enhanced approaches, including the establishment of a multi-stakeholder Tier Assignment Committee to make recommendations on drug shortage significance and expected impacts, anchored in practitioner and expert advice, with Tier 3 shortages being those with the greatest potential impact on Canada’s drug supply and health care system.

Promoting timely access to health products

In 2019-20, Health Canada continued to provide Canadians with timely access to safe health products by reviewing the safety, efficacy and quality of pharmaceutical and biologic drugs, medical devices and natural health products. The Department approved 62 new pharmaceutical drugs for human use, of which 24 were drugs containing new active substances not previously approved in Canada, as well as 7 new veterinary drugs for use in companion and food-producing animals. In addition, a total of 6,208 natural health products were also approved.

Health Canada also approved 348 requests for significant changes (referred to as ‘supplements’) to pharmaceutical drugs for human use already on the market. These supplements include changes such as new uses, new manufacturing methods, and new dosing recommendations for existing drugs. 19 of these new drugs and supplements were approved through an expedited pathway, to address unmet medical needs. The Department also approved 188 new generic drugs for human use and 9 new veterinary generic drugs. Generic drugs contain the same medicinal ingredients and are considered to be bioequivalent to the brand name drug. Generic drugs generally tend to cost less, so approving more of them can result in considerable savings to the healthcare system.

Health Canada approved 31 new biologic drugs for human use, of which 12 were drugs containing new active substances not previously approved in Canada. The Department also approved 191 supplements for significant changes to biologic drugs for human use already on the market. Market authorizations were issued for 11 biosimilar drugs (ones demonstrated to be highly similar to a biologic drug previously authorized in Canada), thereby increasing therapeutic options available to Canadians.
The Department also approved 1,548 new Class II, III, or IV medical devices, as well as 2,536 requests for significant changes to medical devices already on the market, such as design changes and new manufacturing methods.

As part of the Government’s ongoing efforts to modernize its approach to regulating health products and to meet healthcare system needs, Health Canada carried out several initiatives and activities to support the work related to the Regulatory Review of Drugs and Devices.

Modernizing the way we provide special access to drugs

Health Canada’s Special Access Program for human drugs and the Emergency Drug Release Program for veterinary drugs deal with requests for drugs for emergency treatment that are unauthorized for sale in Canada. In 2019-20, 12,309 requests were authorized under the Special Access Program for human drugs, and 485 requests authorized under the Emergency Drug Release Program for veterinary drugs. Practitioners who request human drugs under the Special Access Program are required to report any adverse reactions to the Canada Vigilance Program. For 2019-20, no such reports were received.

In May 2019, Health Canada published draft regulations for consultation that would amend the current medical emergency provisions to support a modernized Special Access Program and Emergency Drug Release Program. The intent is to allow for a more flexible and streamlined process for practitioners requesting drugs and manufacturers supplying the drugs through these programs. The Department also proposed a new regulatory framework in May 2019 that will enable public health officials responsible for public and military health to request access to human drugs for emergency preparedness and response activities that are unavailable in Canada.

Health Canada continued to align its drug submission review processes with those of Health Technology Assessment organizations (the Canadian Agency for Drugs and Technologies in Health and l'Institut national d'excellence en santé et en services sociaux). This alignment allows industry to opt-in to a parallel review process for all biologic and pharmaceutical new drug submissions. Since this process was operationalized in June 2018, 44 aligned reviews were completed and 13 more are ongoing, thereby helping to improve timely access for Canadians to the therapeutic products they need.

Applying real-world evidence (RWE)

Health Canada continued its work to optimize the use of RWE for regulatory decisions, in order to improve the extent and rate of access to prescription drugs in Canada.
In April 2019, the Department published the Notice “Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making” to encourage high-quality RWE submissions from industry partners: (1) that aim to expand the evidence-based indications for populations often excluded from clinical trials (e.g., children, seniors, and pregnant women); (2) for drugs/diseases where clinical trials are unfeasible such as potentially the case with rare diseases; and/or (3) where clinical trials are unethical, such as during emergencies where dosages from animal studies may need to be extrapolated to treat humans potentially exposed to chemical or biological threats.

An accompanying document to the Notice, “Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle”, highlighted 15 elements that sponsors wishing to include RWE in their health product submissions should consider and address.

Management of prescription drugs (including opioids)

In 2019-20, Health Canada continued to update the Canadian labelling (Product Monograph and Prescribing information) for prescription opioid products. Labelling was updated for cough and cold products containing codeine, normethadone and hydrocodone, and no longer indicates the use of these products for children under 18 years old.
In June 2019, additional Terms and Conditions came into force restricting all Class B opioid-related information or marketing materials aimed at health care professionals to only statements authorized by Health Canada in the product monograph.

Health Canada continued to review mandatory risk management plans for prescription opioids. Additional monitoring, education and safety measures resulted in establishing a more informed community of opioid prescribers, pharmacists, other healthcare professionals, and patients.

Over the course of 2019-20, the Department continued to work with all stakeholders to achieve an optimal balance between regulatory oversight and patient care and access, including the formation of the Canadian Pain Task Force which released its first report on the state of chronic pain in Canada in June 2019.

Strengthening Regulatory oversight

The creation of Health Canada’s new Medical Devices Directorate in January 2020 has helped the Department become more responsive and adaptive to the rapid growth and changes happening in the medical devices environment, while further strengthening oversight of medical devices and being more open and transparent with Canadians with regard to regulatory activities and medical device safety information.

The Action Plan on Medical Devices, launched in December 2018 and completed over the course of 2019-20, provided a framework to advance work on new and emerging technologies, and improve access to needed devices. Regulatory oversight was advanced by improving safeguards for Canadian participants of medical device testing, aligning Canadian approaches with international best practices, proposing regulations to improve post-market surveillance of medical devices, increasing inspections, and setting higher standards of evidence required before pre-market approval of medical devices. Under the action plan, the Department undertook a number of initiatives, summarized below.

In April 2019, the Minister of Health announced the members of the new Scientific Advisory Committee on Health Products for Women. The chair and 9 core committee members come from across Canada and represent a wealth of knowledge, skills, and expertise. The committee is providing timely advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs, and is examining issues across the product lifecycle –from development to real-world use – with a focus on patient perspectives and experiences.

The Advisory Committee met twice in 2019-20 in order to consider the following issues: clinical evidence requirements for medical devices; lifecycle management of medical devices (using mesh implants as a case study); and knowledge transfer to patients (using breast implants as a case study).

The Department conducted a series of technical stakeholder sessions with consumer and patient safety groups, health professionals groups, academia, and industry associations on policy proposals to modernize the regulatory framework for self-care products. The objective of this initiative is to tailor the level of oversight for these products to their level of risk and improve labelling of natural health products to better inform consumer choice.

In May 2019, Health Canada published the Fees in Respect of Drugs and Medical Devices Order in Canada Gazette II and its Final Fee Report, which summarized the findings from the consultation process and provided insight into how the revised fees were determined. The revised fee structure was implemented on April 1, 2020, and will be phased in over a period of 4 years for human drugs and medical devices and up to 7 years for veterinary drugs.

Modernizing compliance and enforcement

As part of its Compliance and Enforcement Modernization and Transformation priority, Health Canada is setting the certification standards and training requirements and standardizing administrative processes to designate inspectors and analysts for each particular Act under the Department’s purview (a ‘qualified’ inspector or analyst is ‘designated’ under the Act). In 2019-20, this process was completed through the development of the Cannabis Act Ministerial designation directive, and consultations began to develop the Ministerial designation directive under the Tobacco and Vaping Products Act and the Assisted Human Reproduction Act.
Health Canada also implemented across the country a revised national compliance and enforcement curriculum for inspectors and over 70 courses were delivered. The new curriculum focused on the foundations of regulatory inspections and inspector safety. Building on the Department’s Occupational Health and Safety Program for inspectors and field staff, Health Canada completed the Occupational Health and Safety assessment for Tobacco and Vaping and Cannabis inspectors and undertook the development of safe work practices for high-risk tasks.

A National Training Policy for the Assisted Human Reproduction Act (AHRA) was created and successfully implemented in 2019-20. The certification standards were drafted as part of the AHRA Designation Directive that identify the mandatory training that inspectors and scientific analysts must successfully complete prior to designation under the Act.
Health Canada completed 54 inspections of clinical trials in 2019-20 and continued to expand its oversight to include new types of inspections (both domestic and foreign) such as clinical trial sponsors, contract research organizations (CROs) and clinical trials that support drug submissions. The shift in focus to data integrity represents a more effective and efficient use of resources as sponsors and CROs manage numerous trials at one time.

Supporting assisted human reproduction (AHR)

In June 2019, the Minister of Health announced 3 new sets of regulations under the Assisted Human Reproduction Act (AHRA). The new regulations:

• Established a health and safety framework for third-party donor sperm and ova;
• Identified the categories of expenditures for which donors, surrogates or a person maintaining or transporting in-vitro embryos can be reimbursed, as well as requirements for the reimbursement of loss of work-related income for surrogate mothers;
• Established procedures regarding the administration and enforcement of the Act.

The regulations also included a new directed donation process that offers more flexibility for recipients who wish to use sperm or ova from a donor whom they know, and updates to the existing consent regulations (including the introduction of a record retention requirement). These improvements reflect the latest scientific advancements, help protect the health and safety of people who use, or are born of, assisted human reproduction, and offer Canadians more options for building their families.

Also in 2019-20, Health Canada developed and began to implement a new compliance and enforcement program in order to further protect the health, safety, dignity and rights of individuals who use or are born of AHR in Canada. The program includes: the hiring and training of inspectors; the implementation of a registration and notification scheme for greater oversight over the supply chain; compliance promotion and monitoring activities, including inspections; as well as responding to complaints under the AHRA.

Combatting antimicrobial resistance (AMR)

In 2019-20, Health Canada took additional action to address AMR, which is considered an emerging global health threat. The Department’s work to improve the responsible use of antimicrobials in animals included helping stakeholders adapt to the requirement that all medically important antimicrobials are now sold by prescription only. A variety of tools were developed, such as prescription templates and fact sheets.

This past year marked the first year that manufacturers, importers and compounders were required to report to Health Canada the volume of medically important antimicrobials sold for use in animals. The Department is using this information to gain a better understanding of the volume of antimicrobials available for use in animals, support surveillance and interpretation of patterns and trends of antimicrobials resistance, and assess the impacts on human health from the use of specific antimicrobials in animals. Following a transition period, the requirements to have a Drug Establishment Licence in order to fabricate, package/label, test or import veterinary active pharmaceutical ingredients came into effect in July 2019.

As part of the efforts highlighted in the “Federal Action Plan on Antimicrobial Resistance and Use in Canada: Building on the Federal Framework for Action”, labels for all prescription brand name and generic antibiotic drugs for human use were updated to include antimicrobial stewardship statements that encouraged the careful prescription and use of antimicrobials.

Health Canada led the development of a statement released by the International Coalition of Medicines Regulatory Authorities to raise global awareness of AMR. It commits regulators of medicines to work together to streamline regulatory requirements and calls on all stakeholders, including industry, healthcare practitioners, health leaders, researchers and media, to play an active role in combatting AMR.

The second annual AMR Symposium, held in November 2019, brought together human and animal health experts to raise awareness as part of global Antibiotic Awareness Week. Health Canada continued to support PHAC on the ongoing development of the Pan-Canadian Action Plan on AMR.

Fostering international collaboration and coordination

Health Canada continued its participation in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, which brings together international regulatory authorities and industry representatives to develop technical guidelines on scientific and technical aspects of pharmaceuticals. The Council’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. Similarly, the Department participated in the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products.

The Department continued its partnership under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium to share the regulatory review of submissions, promoting international alignment and greater efficiencies. In 2019-20, the Consortium established the New Active Substance work-sharing initiative to focus on developing opportunities within a regulatory program through the greater alignment of regulatory approaches and technical requirements. Three cancer treatment drugs and an influenza treatment drug were approved under the initiative. The consortium also continued to review generic drug submissions under the established Generic Medicines Work Sharing Initiative.

In addition, international regulatory cooperation helps bring new veterinary drugs to the Canadian market. For example, through the Canada-United States Regulatory Cooperation Council, Health Canada's Veterinary Drugs Directorate and the United States Food and Drug Administration Center for Veterinary Medicine conduct the simultaneous review of veterinary drugs. This initiative is increasing the number of veterinary drugs available concurrently in both countries, providing Canadian animal owners with more treatment options. As of March 31, 2020, 11 drugs had been approved in Canada via this pathway, with 17 more accepted for review. Health Canada also jointly reviewed products with the Australian Pesticides and Veterinary Medicines Authority and the New Zealand Ministry for Primary Industries.

Promoting access to new and emerging technologies

To keep pace with new and emerging technologies such as artificial intelligence and telerobotics, Health Canada established the Medical Device Digital Health Review Division. In 2019-20, it assessed the safety and effectiveness of over 20 medical devices that employ machine learning, and co-chaired an international working group on medical device cybersecurity that published recommendations for medical devices including home care devices.

Over 2019-20, the Department continued consultations with a variety of stakeholders to better understand the changing health product development context, which helped to inform regulatory review efforts and identify a number of regulatory modernization projects. These proposals aim to support more agile and flexible regulatory structures that are grounded in science, enable innovative and safe health products and respond to industry concerns by removing unnecessary requirements and creating a more streamlined and easy to understand regulatory framework.

In July 2019, Health Canada launched the discussion paper “Agile regulations for advanced therapeutic products and clinical trials,” which sought feedback on modernizing approaches to regulating clinical trials and novel therapeutic products such as devices enabled by artificial intelligence. The feedback received via these consultations is informing Health Canada’s work as it implements its regulatory innovation agenda.

Departmental Result 4: Canadians are protected from unsafe consumer and commercial products and substances

Helping Canadians lead healthier lives and providing protection from unsafe consumer and commercial products and substances have remained an important focus of Health Canada’s work. Over the course of 2019-20, the Department’s efforts in this regard have concentrated on the following priority activity areas: taking a comprehensive approach to problematic substance use; regulating cannabis; improving chemical safety through the Chemicals Management Plan; supporting the safety of consumer products and cosmetics; improving workplace safety through the safe use of chemicals; as well as strengthening pesticide regulation and communications.

Taking a comprehensive approach to problematic substance use

Throughout 2019-20, Health Canada played a crucial role in leading the federal response to problematic substance use. The Department maintained its strong response to the opioid overdose crisis, deploying a public health approach that was coordinated, collaborative, evidence-based and compassionate. This involved extensive engagement with other federal departments, provinces and territories, and a wide range of stakeholders, including people with lived and living experience of substance use as well as with Canadians who have and treat chronic pain. For example, Health Canada worked with federal partners to host a roundtable with people with lived experience of substance use and the federal correctional system. This ongoing engagement helped to ensure the Government's response remained informed by the diverse perspectives of people directly affected by the crisis.

In April 2019, the 8-member Canadian Pain Task Force (CPTF) was officially announced, followed by the recruitment of a 16-member External Advisory Panel. The CPTF held a two-day workshop in the spring of 2019 and reviewed pain-related evidence, culminating in the public release of their first report on the state of chronic pain in Canada in June 2019. From July to March 2020, the CPTF held 6 regional roundtables, several specialized workshops, and individual meetings and site visits to explore best practices, gaps, and elements of an improved approach to pain, involving over 400 stakeholders nationwide. A public online consultation was also launched in February 2020.

To further support people who use drugs during the COVID-19 pandemic, the Department adopted policies to allow existing supervised consumption sites to expand their physical space and made it easier for overdose prevention sites to be rapidly established in temporary community shelters for vulnerable (e.g., homeless/housing unstable) individuals exposed to COVID-19.

Multilateral engagement with provincial and territories counterparts was further advanced through the Problematic Substance Use and Harms F/P/T committee. The committee developed an ambitious workplan and established associated working groups in the thematic areas of Treatment and Recovery Services; Prevention, Stigma and Training; and Data and Evidence.

Health Canada also continued to work closely with provinces and territories on the implementation of the Emergency Treatment Fund (ETF), which was announced in Budget 2018. This fund provided $150 million in one-time support to provinces and territories by way of matching investments to implement multi-year projects that improve access to evidence-based treatment services in the context of the opioid crisis. P/T progress reports indicate that over 10,000 new treatment spaces, beds or services have been implemented and are attributable to ETF investments. Four reports indicate that over 500 health care providers were trained and/or hired to provide treatment services via ETF investments.

Health Canada engaged closely with partner organizations to address the stigma associated with problematic substance use, including via a Stakeholder Substance Use Working Group, which has bolstered collaboration and stigma reduction action between multiple national organizations working in the substance use field. Health Canada also worked closely with PHAC on resources for health professionals and health care system stakeholders to reduce substance use stigma across the health system.

To further engage the public on the issue of substance use and stigma, the Department launched Phase 3 of an anti-stigma campaign to challenge negative perceptions around people who use drugs. Stigma reduction is also a key component of Health Canada’s “Know More” tour, which engaged teens and young adults on the facts surrounding the opioid overdose crisis, reaching 140 high schools and 30 post-secondary schools in 2019 alone. Furthermore, the Department hosted a Public Education Partnership Symposium, which brought together public education professionals to talk about information needs and gaps in substance use public education and awareness.

On an international front, Health Canada and the United Nations Office on Drugs and Crime co-hosted an international technical consultation on stigma in January 2020 to discuss how stigma impacts people who use drugs and the interventions currently in place. The Department continued to promote the use of non-stigmatizing approaches during discussions and negotiations with other countries at the March 2020 Session of the Commission on Narcotic Drugs.

Supervised consumption sites (SCS) have saved thousands of lives, and Health Canada continued to expand their reach across the country. Since 2017 (to March 31, 2020), these sites have received almost 2.2 million visits, reversed nearly 17,400 overdoses without a single death at a site, and made over 84,000 referrals to health and social services.

The Department continued to conduct compliance visits of SCS that focus on compliance promotion. Compliance visits ensure the issuance/renewal exemptions for these sites allowing them to operate and provide services to the public. A total of 15 SCS were inspected in 2019-20.

The Canadian Drugs and Substances Strategy covers a broad range of substances, including alcohol, cannabis, prescription drugs and illegal drugs. In July 2019, Health Canada released “What We Heard: Strengthening Canada’s Approach to Substance Use Issues”, which includes ideas on potential next steps under the Strategy. As the Department considers the input received from this and other sources, it will continue to develop and adopt initiatives to respond to the COVID-19 pandemic and move forward with a public-health focused approach to problematic substance use.

The Canadian Alcohol and Drugs Survey completed its data collection for calendar year 2019. The Canadian Postsecondary Alcohol and Drugs Survey was launched in November and continued to collect data up to March 2020.

In June 2019, Health Canada hosted a consultation workshop with the Post-Secondary Education Partnership on Alcohol Harms, focused on nation-wide campus efforts to reduce alcohol-related harms.

In November 2019, Health Canada officials participated in a consultation at the WHO in Geneva towards a discussion paper on the implementation of the Global Strategy to Reduce the Harmful Use of Alcohol (2010), which was presented to the WHO Executive Board in February 2020. The Department also provided input to the WHO Global Survey on Alcohol and Health.

Regulating cannabis

Health Canada supports the delivery of the Government’s commitment to strictly regulating and restricting access to cannabis. Over the course of 2019-20, the Department demonstrated significant progress in supporting the establishment of a tightly regulated cannabis industry capable of supplying the market with a sufficient supply of quality controlled products required to displace the illicit market.

In October 2019, the Government of Canada amended the Cannabis Regulations to allow the legal production and sale of edible cannabis, cannabis extracts and cannabis topicals. The Department worked closely with provinces and territories, Indigenous communities, the regulated industry, public health organizations and law enforcement to successfully implement the newly amended regulations.

Early results regarding the displacement of the illegal market show that spending on legally-sourced cannabis (medical and non-medical) grew from $133 million in the third quarter of 2018 (just prior to the coming into force of the Cannabis Act) to $703 million in the first quarter of 2020, with the share of legal spending on cannabis increasing from 9% to 46% during that same period. Legal spending on cannabis between the fourth quarter of 2018 and the first quarter of 2020 totaled just over $3.2 billion.

On October 17, 2018, Health Canada marked a major milestone in legalizing and regulating cannabis with the coming into force of the Cannabis Act and Cannabis Regulations. The legal cannabis industry continued to grow month-over-month and reached a total of 344 sites (as of March 2020) licensed for cultivation, processing, and/or sale for medical purposes. There were an additional 1,513 sites licensed for research, analytical testing, industrial hemp, and cannabis drug licences.

Health Canada introduced changes to the cannabis licence application process in May 2019 to better align the administration of regulatory requirements with other sectors. As a result, the Department has been issuing licences at an average rate of 17 per month since May 2019 compared to an average of 3 per month prior to October 2018 (which were issued pursuant to the Access to Cannabis for Medical Purposes Regulations made under the Controlled Drugs and Substances Act). In addition, the policy on managing industrial hemp varieties, which sets out the plant varieties that licensed hemp cultivators are permitted to sow under the Industrial Hemp Regulations, was revised to modernize it, reduce regulatory burden and respond to stakeholder requests for a faster process for listing new cultivars.

Health Canada implemented an updated Compliance Promotion Strategy in Fall 2019 to increase awareness, improve understanding and foster ongoing compliance with the Cannabis Act, including the amended Cannabis Regulations governing the production and sale of edible cannabis, extracts, and topicals. In accordance with its risk-based approach, Health Canada conducted 425 inspections and 381 compliance verifications with an overall industry compliance rate of 98% with controls established under the Cannabis Act.

In 2019-20, 7,662 new product notices were submitted by processing licence holders to Health Canada, as mandated by the Cannabis Regulations. As a result, the Department identified several proposed products that were potentially non-compliant with the regulations or that could pose a risk of injury to human health.

Health Canada continued to administer the regulatory framework that provides reasonable access to cannabis for medical purposes. The number of individuals registered to access cannabis for medical purposes continued to grow, albeit at a slower pace than prior to the introduction of the Cannabis Act.

Lastly, the Department successfully completed consultations with Canadians on a regulatory approach for health products containing cannabis that do not require practitioner oversight for humans and animals. The information gathered through these activities will inform next steps on the development of a regulatory pathway for cannabis health products.

Improving chemical safety through the Chemicals Management Plan (CMP)

Over the course of 2019-20, Health Canada continued assessing the safety of existing substances under the CMP, with approximately 89% (3,894 substances) of the total targeted for assessment by March 2021 completed by end of the fiscal year. While the Department progressed towards its target, it also took action to address challenges posed by the scientific complexity of some assessments and the additional time required to determine appropriate risk management approaches. Steps included prioritizing regulatory packages and acquiring surge capacity to support more assessments.

Health Canada, in collaboration with Environment and Climate Change Canada, continued to assess all new substances (397 in 2019-20) before these were imported into or manufactured in Canada under the authority of the Canadian Environmental Protection Act, 1999. Where the Department identified risks, measures to manage them were instituted in order to protect human health and the environment.

The Department also conducted research, monitoring and surveillance activities in support of the CMP, to address existing and emerging chemicals of concern, to inform risk assessment needs and risk management activities, and to address outstanding questions and knowledge gaps related to the effects and exposure of chemical substances on humans.

The Department also actively communicated to the public about environmental health over the course of 2019-20. Most notably, the Healthy Home Campaign completed its first full year. The campaign aims to raise awareness on the health risks of chemicals and pollutants that may be found in and around the home, and to motivate Canadians to take action to protect their health. Practical tips for Canadians on topics such as home renovations, household chemical safety, and lead in drinking water were promoted through videos, virtual tours, social media, search engine marketing, traditional media (print articles, radio) and at face-to-face public engagement events. The campaign also provided summaries for the public on specific CMP substances (such as salicylic acid, parabens and terpenes).

A partnership with digital influencers (e.g., parenting bloggers) disseminated Healthy Home messaging and increased traffic to the web site (74% increase to Canada.ca/healthy-home and 850% increase to Canada.ca/maison-saine).

To raise Canadians’ awareness about health risks from chemicals of concern and pollutants that may be found in and around the home, Health Canada released updated tips and information on various drinking water pollutants such as chloramines, copper and manganese. Health Canada’s Drinking Water webpages are the top 3 most viewed webpages related to environmental health on Canada.ca.

Lastly, Health Canada collaborated with program partners to begin developing a comprehensive proposal to renew the CMP and advance recommendations related to the reform of the Canadian Environmental Protection Act, 1999. The most recent program evaluation found that the CMP had made progress in all functional activity areas. There was also some evidence that the CMP has reduced the potential for exposure to harmful substances.

Supporting the safety of consumer products and cosmetics

In 2019-20, Health Canada facilitated ongoing information sharing through the communication of 230 consumer product and cosmetic recalls. To facilitate international coordination, 69 of these were posted as joint recalls in coordination with the United States and/or Mexico.

In addition, in order to enable more timely response to potential risks posed by consumer products, Health Canada and the European Commission began exchanging information through an Administrative Arrangement under the Comprehensive Economic and Trade Agreement. Exchanges included industry and product information, as well as details of any corrective action taken on consumer products and cosmetics that may present a risk to consumers.

To further share insights with international regulators and engage industry stakeholders on issues related to the safety of cosmetics, the Department also hosted the International Cooperation on Cosmetics Regulations 13^th annual meeting in Montreal.

Health Canada participated in internationally coordinated consumer product awareness campaigns, including the Organisation for Economic Co-operation and Development’s 2019 Global Awareness Campaign on Product Recalls, as well as a joint campaign between Canada and the EU on button battery safety.

Health Canada also continued to protect the health and safety of Canadians through the modernization of regulations, such as the publication of new regulations under the Canada Consumer Product Safety Act to reduce the strangulation hazard of corded window coverings, as well as new regulations on vaping products and their packaging to protect children from ingesting vaping substances.

Health Canada also worked with the Retail Council of Canada and the Standards Council of Canada to fund development of a voluntary safety standard for BBQ brushes sold in Canada, to help mitigate the risk of brush bristles being ingested and becoming lodged in the throat.

Improving workplace safety through the safe use of chemicals

Health Canada published amendments to the Hazardous Materials Information Review Act, which came into force in March 2020. These amendments will help Health Canada more efficiently and effectively assess claims to exclude Confidential Business Information from the labels and safety data sheets of products used in the workplace, while enabling Canadian workers to have the information they need to safely use and store hazardous products in the workplace. This addresses a key issue also raised in the evaluation of the Workplace Hazardous Products Program.

In addition, this evaluation of the Workplace Hazardous Products Program cited engagement with stakeholders as a strength, which contributed to increasing the number of inspections conducted by the Program’s provincial, territorial and federal partners under the Hazardous Products Act. At the same time, the evaluation identified areas for improvement around compliance and enforcement activities, as well as enhancing certain communication and guidance materials. Health Canada developed an action plan to address these issues, to be implemented over the next two years.

To support implementation of the Globally Harmonized System of Classification and Labelling of Chemicals under the Regulatory Cooperation Council Work Plan for workplace chemicals, the Department co-developed guidance with the U.S. that was published, along with Guidance on the Use of Concentration Ranges Pursuant to the Hazardous Products Regulations, on Canada.ca.

Strengthening pesticide regulation and communication

Over the course of 2019-20, the Department undertook an assessment of the Pesticide Post-Market Review Program that led to the development of a new, integrated, continuous evaluation approach that will improve oversight, transparency and stakeholder engagement of post-market pesticide reviews.

Health Canada is nearing the end of a two-year, high priority pesticide re-evaluation process that saw the Department undertake risk assessments, risk management, consultations, special reviews and final regulatory decisions for 68 priority pesticides. In 2019-20, final decisions were completed for 11 priority pesticide re-evaluations and 1 priority special review. Proposed decisions were completed for 5 priority pesticide re-evaluations and 3 priority special reviews.

In addition to publishing these re-evaluation decisions, the Department engaged with Canadians through a Public Opinion Research campaign “Awareness and Confidence in Canada’s Pesticide Regulatory System” and with stakeholders through semi-annual webinars, F/P/T committees as well as industry forums.

Departmental Result 5: Canadians make healthy choices

Helping Canadians make healthy choices in their day-to-day lives is part of Health Canada’s Health Protection and Promotion core responsibility. Health begins with the initial choices we make of what to put into our bodies. Over the course of 2019-20, the Department’s efforts in this regard were concentrated on these priority activity areas: promoting healthy eating; reducing tobacco use and responding to the increase in youth use of vaping products; as well as increasing health and safety of cannabis use through public education, research and surveillance.

Promoting Healthy eating

Health Canada continued to advance initiatives under the Healthy Eating Strategy, which aims to curb the rising burden of obesity and chronic disease by making the healthier choice easier for all Canadians.

The Department advanced policy and regulatory work under the Child Health Protection Act (Bill S-228), which would have provided the authority to regulate those factors that determine when advertising is directed at children, as well as the nutrient criteria for those foods subject to advertising restrictions. The Bill did not come to a final vote before the 2019 federal election.

Health Canada continued work to introduce restrictions on advertising of foods that contribute to excess consumption of sodium, saturated fat and sugars to children. In order to further inform its policy and regulatory work on this issue and assess the impact, the Department maintained its open and ongoing engagement with stakeholders and developed a monitoring strategy to collect data on the current state of food advertising to children.

Another key element of the Healthy Eating Strategy is the revised Canada’s Food Guide, a mobile-friendly web application that provides Canadians with easier access to information about healthy eating, wherever they are, at any time. It includes many resources, such as Canada’s Dietary Guidelines for Health Professionals and Policymakers, and Canada’s Healthy Eating Recommendations.

To engage with Canadians in an ongoing way, Health Canada launched the Canada’s Food Guide e-newsletter in April 2019. It offers monthly healthy eating highlights and tips from the Food Guide, as well as recipes and resources to help subscribers eat well and live well. In addition, the Food Guide Snapshot is now available in 31 languages, including 9 Indigenous languages. Providing the Snapshot in multiple languages is helping more people in Canada access and benefit from the Food Guide’s key recommendations.

In spring 2019, Health Canada ran a digital public awareness campaign to promote tips for eating on a budget. The Department continued to promote the Food Guide through its various social media channels, including Facebook, Twitter, Instagram and LinkedIn. In addition, Health Canada hosted a Food and Nutrition Stakeholder Engagement Session to discuss innovation in the food system and associated challenges and opportunities, on the theme of The Future of Food.

In 2019-20, Health Canada continued to engage extensively with key food industry stakeholders to better understand challenges faced in meeting the previous voluntary sodium processed food targets. Their feedback informed the revised targets for processed foods, which are expected to be published in 2020-21. Over recent years, the Department has also worked with the Colleges and Institute Canada to determine education needs for promoting sodium reduction at a grassroots level, particularly for culinary students and other professionals working in food preparation.

The Department continued to work on finalizing the front-of-package nutrition labelling regulations in order to deliver on this mandate letter commitment.

Health Canada also worked towards a regulatory framework permitting the sale of human milk fortifiers for pre-term or very low birthweight infants, who often need these products to meet their nutritional and growth requirements. Multiple consultations were held in 2019-20 with hospitals, health experts, and manufacturers to help develop a framework that both meets current needs and is responsive to future innovation.

Reducing tobacco use and responding to the increase in youth use of vaping products

The Department continued to implement Canada's Tobacco Strategy, a comprehensive and integrated approach to reducing tobacco use to less than 5% by 2035. On May 1, 2019, final regulations were published requiring certain tobacco products and packages to have a plain and standardized appearance with restricted brand colours, logos and graphics in order to reduce their appeal, particularly to young Canadians. Most requirements came into force on November 9, 2019.

Health Canada remains very concerned about the alarming rise in youth vaping and took additional regulatory action over the past year to protect a new generation of Canadians from the risk of nicotine addiction and other vaping-related harms. In December 2019, the Department pre-published Vaping Products Promotion Regulations, which set out measures to further restrict the promotion of vaping products to youth under the Tobacco and Vaping Products Act.

The Department also announced the final Vaping Product Labelling and Packaging Regulations that require vaping products containing nicotine to display the nicotine concentration and a health warning about the addictiveness of nicotine. In addition, the products must be packaged in child-resistant containers and display a toxicity warning and first-aid treatment statement. All vaping substances must display a list of ingredients, regardless of nicotine content. The majority of these new regulations began to take effect on July 1, 2020, with the exception of child-resistant containers, which comes into force on January 1, 2021.

Furthermore, the Department consulted Canadians on additional potential regulatory measures to reduce youth access and appeal of vaping products, including measures to restrict the concentration and/or delivery of nicotine, prohibit the manufacture and sale of vaping products with certain flavours or flavour ingredients, and/or prohibit the promotion of certain flavours. The Department published a “What We Heard: Reducing Youth Access and Appeal of Vaping Products” report summarizing the over 24,000 submissions received.

The Department also continued to implement a youth vaping prevention campaign – “Consider the Consequences of Vaping” – to reach youth (13 to 18 years of age) and their parents. The campaign aimed to discourage youth uptake of vaping by: educating them about the harms and risks associated with using vaping products; providing parents, adults and educators with resources to support conversations with youth about vaping; and increasing awareness of where to get more information. A variety of tactics were used to capture the attention of youth and parents (summarized on page 53).

Increasing health and safety of cannabis use through public education, research and surveillance

In 2019-20, Health Canada undertook significant efforts – in collaboration with provinces and territories, Indigenous partners and other organizations – to inform and educate the Canadian public on the health and safety facts about cannabis use, the implications of cannabis on travel and crossing the border, workplace impairment, and the risks and consequences of drug-impaired driving. In addition to these ongoing activities, the Department developed:

• New and updated health warning messages, and an updated consumer information sheet, to cover all cannabis products;
• New evidence-based resources and updated web content about new cannabis products, their health effects and risks, and lower-risk use, to support consumers in making informed decisions.

Health Canada advertising focused on educating Canadians about lower-risk use of cannabis, including edible cannabis products, the importance of safe storage, and the risks of drug impaired driving. The campaign generated more than 244 million impressions on digital platforms with videos viewed more than 25.8 million times and more than 400,000 visits to campaign websites through search engine marketing.

The Department recognizes that ongoing research is fundamental to understanding the benefits and harms of cannabis, for both medical and non-medical purposes. In 2019-20, Health Canada worked closely with the Canadian Institutes of Health Research, the Canadian Centre on Substance Use and Addiction and the Mental Health Commission of Canada on cannabis research priorities to better inform Canadians on the benefits and risks of cannabis use.

While it is still too early to fully assess the impact of the Cannabis Act on public health, initial 2019-20 data from the National Cannabis Survey indicate that rates of cannabis use have not changed among young people (e.g., remained stable at 27% when comparing the third quarters of 2018 and 2019). Among individuals who reported having used cannabis in the past year, there was no increase in the proportion of those using cannabis on a weekly or daily basis, which is one of the high-risk behaviours closely monitored by Health Canada (Canadian Cannabis Survey, 2019).

Results achieved for Core Responsibility 2: Health Protection and Promotion

Departmental Result 3: Canadians have access to safe, effective and quality health products

Departmental Result Indicators	Target	Date to achieve target	Actual Results
Percentage of new drug decisions issued within service standardsFootnote 1	93%	March 31, 2020	2017-18: 88% 2018-19: 98% 2019-20: 96%
Percentage of Risk Management Plan reviews for new drug decisions completed within service standardsFootnote 2 (Baseline varies across product lines).	90%	March 31, 2020	2017-18: 91% 2018-19: 98% 2019-20: 93%
Percentage of drug companies deemed to be compliant with manufacturing requirements under the Food and Drugs Act and associated regulations	Between 85 and 95%Footnote 3	March 31, 2020	2017-18: 96% 2018-19: 94% 2019-20: 96%
Table 3 Footnote 1 As of 2017-18 and moving forward, this indicator now includes prescription and non-prescription pharmaceutical drugs for human use; disinfectants; biologic; and radiopharmaceutical drugs. New drugs (pharmaceutical and biologic / radiopharmaceutical) can only be sold in Canada after the products have been reviewed by Health Canada and found to meet the necessary regulatory requirements. This indicator measures whether the Department has done so within service standards. Return to footnote 1 referrer Table 3 Footnote 2 Risk Management Plan reviews are an important component of improving the health and safety of Canadians. Completed within service standards, Risk Management Plan reviews protect Canadians from preventable hazards, and contribute to effective engagement with partners and stakeholders. The workload associated with Risk Management Plans varies from year to year, both in terms of quantity of Plans required and the complexity thereof, and is driven by factors beyond the government’s control. With finite, set resources, unexpectedly high volume can result in performance drops. Return to footnote 2 referrer Table 3 Footnote 3 Health Canada is implementing a risk-based approach and will be targeting companies that present a higher risk. Given the change in approach, the results moving forward are expected to decrease. Return to footnote 3 referrer

Departmental Result 4: Canadians are protected from unsafe consumer and commercial products and substances

Departmental Result Indicators	Target	Date to achieve target	Actual Results
Percentage of domestic consumer product recalls communicated to Canadians in a timely manner (Baseline 86% in 2016-17)	85%	March 31, 2020	2017-18: 87% 2018-19: 93% 2019-20: 86%
Percentage of actions taken in a timely manner to protect the health of Canadians from substances found to be a risk to human health (Baseline 85% in 2016-17)	100%Footnote 1	March 31, 2020	2017-18: 86%Footnote 1 2018-19: 88%Footnote 2,Footnote 3 2019-20: 100%
Percentage of actions taken in a timely manner to protect the health of Canadians from pesticides found to be a risk to human health and the environment (Baseline 94% in 2018-19)Footnote 4	80%	March 31, 2020	2017-18: N/AFootnote 5 2018-19: N/AFootnote 5 2019-20: N/AFootnote 5
Table 4 Footnote 1 Managing risks to human health and the environment from substances is complex, as it often includes research, consultations with stakeholders and analyzing socio-economic impacts. As a result, delays in development of proposed and final risk management actions may occur. The program will continue to streamline processes and look for further efficiencies to move towards the target of 100%. Return to footnote 1 referrer Table 4 Footnote 2 In 2018-19, this indicator was revised to focus exclusively on substances found to be a risk to human health. The historical result also includes actions taken by Environment and Climate Change Canada on substances found to be a risk to the environment. Return to footnote 2 referrer Table 4 Footnote 3 12% of risk management actions were delayed because of scientific complexity. The three actions have since been completed. Return to footnote 3 referrer Table 4 Footnote 4 For fiscal year 2018–19, 94% of re-evaluation decisions prescribed risk management actions that must be taken by registrants within the policy timelines (24 months for amendments and up to 3 years for phase outs based on a full cancellation decision, where risk concerns are not considered serious or imminent). This is a partial result as any actions resulting under the Policy on Cancellations and Amendments Following Re-evaluation and Special Review have not yet come due. Return to footnote 4 referrer Table 4 Footnote 5 A result for this indicator is not available. The 2018 Policy on Cancellations and Amendments includes multiple milestones and timelines for measuring the timeliness of Pest Management Regulatory Agency actions and stakeholder compliance. Reconciling these multiple data points to produce a meaningful result is not possible at this time. This indicator will be amended as part of the 2021-22 Departmental Results Framework / Program Inventory amendment process. Return to footnote 5 referrer

Departmental Result 5: Canadians make healthy choices

Departmental Result Indicators	Target	Date to achieve target	Actual Results
Percentage of Canadians (aged 15+) who have used any tobacco productFootnote 1 in the past 30 days (Baseline 17.4% in 2015-16)Footnote 3	5%Footnote 2	March 31, 2035	2017-18: 15.5%Footnote 4 2018-19: 17.8%Footnote 5 2019-20: 17.8%Footnote 6
Percentage of Canadians (aged 15-24) who have used cannabis in the last 12 months (Baseline 25.5% in 2016-17 [17.5% of Canadians aged 15-17 and 28.4% of Canadians aged 18-24])Footnote 4	To be established by Dec. 31, 2020	To be established by Dec. 31, 2020	2017-18: 25.5%Footnote 4 (17.5% of Canadians aged 15-17 and 28.4% of Canadians aged 18-24) 2018-19: 26.9%Footnote 5 (14.2% of Canadians aged 15-17 and 31.4% of Canadians aged 18-24) 2019-20: 26.9%Footnote 5 (14.2% of Canadians aged 15-17 and 31.4% of Canadians aged 18-24)
Percentage of Canadians who use dietary guidance provided by Health Canada	60%Footnote 7	March 31, 2021	2017-18: 47%Footnote 8 2018-19: 47%Footnote 8 2019-20: 47%Footnote 8
Table 5 Footnote 1 For the purposes of the Canadian Tobacco, Alcohol and Drugs Survey (CTADS) and this indicator, a tobacco product includes cigarettes, cigars, little cigars or cigarillos, smokeless tobacco, a pipe or waterpipe with tobacco. Return to footnote 1 referrer Table 5 Footnote 2 Tobacco use rates are expected to decline slowly over time, as we continue working towards achieving the Government's commitment of no more than 5% tobacco use by 2035. Achieving this goal will require a long term approach that continues to take action to save the lives of Canadians, while remaining flexible to adapt to emerging scientific evidence on new products. Return to footnote 2 referrer Table 5 Footnote 3 Source: CTADS 2013 (Data collected between February and December 2013). CTADS is conducted biennially.  Return to footnote 3 referrer Table 5 Footnote 4 Source: CTADS 2015 (Data collected between February and December 2015). CTADS is conducted biennially. Return to footnote 4 referrer Table 5 Footnote 5 Source: CTADS 2017 (Data collected between February and December 2017). CTADS is conducted biennially. Return to footnote 5 referrer Table 5 Footnote 6 Source: CTADS 2017 (Data collected between February and December 2017). Data for 2019-20 is not available and CTADS 2017 is the most recent data. In 2019, the CTADS was discontinued and replaced with the Canadian Tobacco and Nicotine Survey (CTNS) and the Canadian Community Health Survey (CCHS) Return to footnote 6 referrer Table 5 Footnote 7 Source: Statistics Canada – Canadian Community Health Survey 2016 (Data collected between January and December 2016). The exact results is 46.5% not 56.6% as reported in previous Departmental Result Reports (2017-18 and 2018-19), which was an administrator error. As such, the target was revised from 60% to 50% in the 2020-21 Departmental Plan. Return to footnote 7 referrer Table 5 Footnote 8 Source: Statistics Canada – Canadian Community Health Survey 2016 (Data collected between January and December 2016). The exact results is 46.5% not 56.6% as previously reported which was an administrator error. The 2017-18 and 2018-19 results were corrected to 46.5% from 56.6%. The next survey will be conducted in 2020 with results expected in 2021 at which time the Department hopes to meet or exceed the target. Return to footnote 8 referrer

Budgetary financial resources (dollars) for Core Responsibility 2: Health Protection and Promotion

2019-20 Main Estimates	2019-20 Planned spending	2019-20 Total authorities available for use	2019-20 Actual spending (authorities used)	2019-20 Difference (Actual spending minus Planned spending)
598,278,433	598,278,433	737,512,277	728,899,756	130,621,323
Note: The variance of $130.6 million between actual and planned spending is mainly due to additional in-year funding for Core Regulatory Operations related to Therapeutic Products, Bringing Innovation to Regulations, Enhancing the Federal Response to the Opioid Crisis in Canada, as well as funding for out-of-court settlements.

Human resources (full-time equivalents) for Core Responsibility 2: Health Protection and Promotion

2019-20 Planned full-time equivalents	2019-20 Actual full-time equivalents	2019-20 Difference (Actual full-time equivalents minus Planned full-time equivalents)
5,690	5,785	95
Note: The variance in FTEs utilization is mainly due to in-year resources received for Core Regulatory Operations related to Therapeutic Products and Bringing Innovation to Regulations.

Financial, human resources and performance information for Health Canada’s Program Inventory is available in the GC InfoBase.

Internal Services

Description

Internal Services are those groups of related activities and resources that the federal government considers to be services in support of programs and/or required to meet corporate obligations of an organization. Internal Services refers to the activities and resources of the ten distinct services that support Program delivery in the organization, regardless of the Internal Services delivery model in a department.

The ten service categories are: Management and Oversight Services; Communications Services; Legal Services; Human Resources Management Services; Financial Management Services; Information Management Services; Information Technology Services; Real Property Management Services; Materiel Services; and Acquisition Services.

Results

Health Canada's greatest strength is an engaged, empowered and well-equipped workforce with employees that have the competencies (including science and regulatory skill sets), tools and opportunities to succeed in the pursuit of excellence in program and service delivery.

As part of the road ahead in the Twenty-Sixth Annual Report to the Prime Minister on the Public Service of Canada, the Clerk noted that our collective hard work on diversity and inclusion, mental health, and harassment – as well as our experimentation with new ideas – has given momentum to renewal. Health Canada supported the government-wide goals of Public Service Renewal, through initiatives that foster a more inclusive, agile and equipped workforce.

Health Canada undertook the following key initiatives in 2019-20 in the area of Internal Services:

Building a healthy, diverse and inclusive workforce

Health Canada continued to focus on supporting its employees and attracting and retaining a high performing, inclusive, bilingual and agile workforce within a healthy and accessible workplace. 2019-20 highlights included:

• Developing a comprehensive Staffing Modernization Strategy and designing new and streamlined tools and resources that better support managers, teams, employees and students;
• Using employment equity staffing inventories such as Employment Opportunity for Students with Disabilities Program, Indigenous Student Employment Opportunity, Federal Internship for Newcomers Program and the LiveWorkPlay initiative to recruit and hire a diverse workforce;
• Streamlining access to services that accommodate and respond to the needs of persons with disabilities, illnesses and injuries, as well as the reporting of occupational health and safety incidents and accidents;
• Encouraging bilingualism through the promotion of various events and a Post-Secondary Recruitment Strategy that includes raising awareness of departmental career opportunities at French speaking institutions;
• Implementing a comprehensive Beyond 2020 plan for Health Canada that identified projects such as the SOS Challenge, which called on employees to identify activities that should be stopped or problems that should be solved, and a strategy for increasing employee capacity to do more innovation and experimentation in the workplace and how we serve Canadians.

The Ombudsman, Integrity and Resolution Office – a key organizational resource responsible for identifying workplace issues, trends and providing recommendations to senior management – revised and implemented a communications and education strategy in order to better promote its mandate and services within the Department as an early consideration when faced with a workplace issue.

Modernizing the workplace to enable a safe and productive workforce with access to modern tools and facilities

Health Canada continued to modernize the workplace in order to enable a safe and productive workforce, providing employees with access to modern tools and facilities. 2019-20 highlights included:

• Implementing a Digital Modernization Framework for making strategic investments in shifting to a digital government;
• Completing the third year of the multi-year IT Security Strategic Plan, resulting in an updated suite of IT security standards that were widely communicated to users in the Department;
• Improving infrastructure stability and enabling capacity for remote connectivity of a considerable workforce;
• Implemented a new Data Strategy to strengthen the Department’s ability to strategically use data as an asset to provide credible information, reliable advice and quality services;
• Updating the Occupational Health and Safety (OHS) Hazard Identification, Assessment and Mitigation and the Harassment and Workplace Violence Tools;
• Delivering 13 projects across 4 provinces and 8 cities at approximately $6.6 million as part of implementing year two of the 2018-22 National Accommodation Strategy.

Health Canada’s laboratory modernization continued to meet the Department’s needs and align with Government of Canada enterprise direction. 2019-20 highlights included:

• Delivering the multi-year program of capital and repair projects across the Health Canada laboratory portfolio to replace and repair aging building systems and to improve functionality for science programs;
• Completing upgrades to the Sir Frederick Banting Research Centre to support the Chemicals Management Program;
• Participating in all aspects of Phase 1 of Laboratories Canada for the replacement of existing Healthy Environments and Consumer Safety Branch and Regulatory Operations and Enforcement Branch laboratories with new, highly functional, IM/IT enabled and green infrastructure.

Pay system stabilization

In 2019-20, Health Canada continued to implement measures to ensure that no employee would face financial hardship because of a Phoenix pay issue. The Department worked hand in hand with Public Services and Procurement Canada’s Pay Centre to successfully implement the new Pay Pod Model and align our service delivery models.

Health Canada led the Public Service in improving its “on-time” performance for staffing actions affecting pay from around 30% in 2018-19 to 90% in the last two quarters of 2019-20. This has led to notable reduction in new pay issues.

Communications

Health Canada continued to engage Canadians with vital health and safety information in 2019-20, applying a range of traditional, digital and innovative communication strategies that also supported the Minister in delivering on Government priorities. Communication channels included social media, web content, digital and traditional advertising, experiential events and partnerships, in addition to more traditional tools such as news releases and proactive media relations.

The Department delivered evidence-based and innovative public awareness campaigns and worked with provinces, territories and stakeholders to inform Canadians about such priority topics as opioids, cannabis, vaping, tobacco, healthy eating as well as regulatory updates.

Opioids

Health Canada continued to deliver its public awareness campaign to inform Canadians about opioids and their related health risks, and to address the stigma that creates barriers for those seeking treatment. 2019-20 highlights included:

• Launching the third wave of an advertising campaign, featuring ads on television, social media and the Internet;
• Completing the Know More tour – since its launch in 2018, the tour engaged more than 144,114 youth and young adults across Canada. The website www.knowmoreopioids.ca was launched in March 2019 to feature the Know More resources online, including activities and awareness products;
• Fostering partnerships with federal and stakeholder organizations to further public education efforts, including the Department of Canadian Heritage, Service Canada, the Canadian Association of Fairs and Exhibitions, the Canadian Aboriginal Aids Network and Canada’s Building Trades Unions;
• Enhancing and promoting the Interactive Map: Canada’s response to the opioid crisis on Canada.ca, which shows locations of opioid-related prevention, harm reduction, treatment and enforcement activities across Canada and published 8 episodes of “In Plain Sight”, an audio series profiling experiences of those affected by opioids;
• Conducting research on opioid awareness, knowledge and behaviours as a follow-up to a 2017 baseline survey (findings suggested that awareness had increased by 6% since 2017).

Cannabis

Health Canada continued to keep Canadians informed about the legalization and regulation of cannabis. 2019-20 highlights included:

• Running the fourth phase of the advertising campaign in April and June 2019 (health and impaired driving) and relaunching the “Pursue Your Passion” interactive engagement tour as a do-it-yourself kit in April 2019. The advertising campaign generated more than 244 million impressions on digital platforms;
• Publishing new educational resources and deploying engaging social media on the new classes of cannabis products;
• Releasing the latest cannabis evidence via results of the Canadian Cannabis Survey 2019 in December.

Vaping

Health Canada intensified public education efforts to address youth vaping. 2019-20 highlights included:

• Launching a national public education campaign – Consider the Consequences of Vaping – to inform youth and their parents of the harms and risks of vaping;
• Launching a youth-oriented digital influencer program, and continuing the digital influencer program for parents;
• Partnering with the Canadian Paediatric Society to adapt the Talk with your teen about vaping tip sheet into a co-branded brochure, as well as a complementary poster for doctor’s offices;
• Distributing vaping prevention resources to healthcare providers and schools.

Tobacco

The Department launched an updated tobacco cessation public awareness campaign – “Break It Off” – including advertising, the use of digital influencers, social media channels managed by the Canadian Cancer Society, along with web resources and updates to the campaign’s mobile app. Advertisements on search engines and Instagram story ads led to 4 million impressions, 75,000 video views, and 13,500 clicks to web content.

Healthy Eating

Health Canada continued to promote the Healthy Eating Strategy through communications and marketing efforts. The Department ran the Canada’s Food Guide advertising campaign in May and June 2019. Advertising appeared as banner ads on websites, mobile banner ads on The Weather Network and Météo Media, and on Facebook and Instagram social media channels. Ads were viewed more than 13 million times and achieved almost 70,000 clicks to web content.

Regulatory updates

Health Canada provided communications support for the rollout of the final report of the Advisory Council on the Implementation of National Pharmacare in June 2019.

In August 2019, the Government of Canada published final amendments to the Patented Medicines Regulations in the Canada Gazette, Part II and the Department conducted a media and stakeholder technical briefing and prepared a full suite of communication materials.

For more information on Health Canada’s plans, priorities and results achieved, see the “Results: what we achieved” section of this report.

Budgetary financial resources (dollars) for Internal Services

2019-20 Main Estimates	2019-20 Planned spending	2019-20 Total authorities available for use	2019-20 Actual spending (authorities used)	2019-20 Difference (Actual spending minus Planned spending)
262,477,397	262,477,397	350,416,744	345,420,163	82,942,766
Note: The variance of $82.9 million between actual and planned spending is mainly due to additional funding for the operating budget carry forward of which a portion was set aside to support strategic investments in 2020-21, and internal services resources received from various Treasury Board approved initiatives.

Human resources (full-time equivalents) for Internal Services

2019-20 Planned full-time equivalents	2019-20 Actual full-time equivalents	2019-20 Difference (Actual full-time equivalents minus Planned full-time equivalents)
1,698	2,164	466
Note: The variance in FTE utilization is mainly due a technical adjustment for the provision of shared services to the Public Health Agency of Canada, and additional resources received in-year for the internal support services from various Treasury Board approved initiatives.

Experimentation / GBA+

Experimentation

Innovation and experimentation are critical to Health Canada's ability to meet its mandate in the face of rapidly evolving science, new trends in the marketplace, and the changing demands and expectations of Canadians. The Department continued to invest in and foster employee-led innovation and experimentation through its Solutions Fund and through a number of other initiatives to increase employee capacity in this area. The aim of the Fund is to improve services to Canadians, improve departmental operations and functionality, and deliver greater value to taxpayers.

In 2019-20, the second year of the Solutions Fund, employees submitted 16 proposals, 6 of which were approved for funding. These projects included experiments that test:

• The use of satellite technology to inspect licensed outdoor cannabis operations;
• How machine-learning can extract information from inspection reports to improve the overall quality of assessments;
• Using smartphones to “scrape” information from health product labels to enable immediate identification of instances of non-compliance.

In 2019-20, Health Canada employees completed the solution-exploration phase of the following projects:

Project Cyclops – designed and developed a model that recognizes patterns to automate the information assessed during label inspections. This was achieved in collaboration with Statistics Canada and will be used in a mobile application that applies smartphone technology and machine learning.

FTIR spectroscopy – completed 80% of the reference database and initiated data analysis and the building of a prediction model, including software customization, and explored the application of FTIR (infra-red) spectroscopy for powdery mildew and fungi analysis.

Project Cipher – proceeded to experimentation phase, the results of which demonstrated the potential application of Cipher for risk based decision-making. A project plan was completed to build a viable product and test the application in 2020-21.

Other examples of Experimentation initiatives in 2019-20 included the following:

• Health Canada successfully launched a new initiative under the Government’s Innovative Solutions Canada program. In August 2019, three challenges were issued to the private sector for the development and early stage testing of new solutions to health problems – rapid point-of-care diagnostics to combat antimicrobial resistance, using machine learning to improve organ donation matches, and identification of microbial mixtures.
• The Department also sponsored the testing of two innovative digital solutions within Canadian health systems under the Innovative Solutions Canada Testing Stream aimed at improving the ability of providers and individuals to communicate virtually. It also managed a third agreement for testing of a digital platform for information sharing among a range of providers, caregivers and patients.
• As part of its policy focus, Health Canada undertook focused work on Artificial Intelligence in health and the potential implications of this new technology for driving improvements in care. CIHR approved a 2-day Best Brains Exchange with experts and others to consider the topic, which will help to inform Health Canada’s policy and regulatory work.
• The Department launched new micro-grants funding wherein low-risk, small-scale projects are eligible to receive $1,000 grants under the Substance Use and Addictions Program. In 2019-20, 176 applicants were awarded grants to support raising awareness about the health effects of cannabis and/or risks of vaping.
• Health Canada launched its Drug Checking Technology Challenge in 2018 to help the community of people who use drugs, and those who support them, to make more informed decisions based on the composition of a drug and to reduce harm. In 2019-20, 3 finalists were selected to develop innovative prototypes that addressed the main challenge criteria – rapid, accurate, easy to use, and low-cost. This will benefit: people who use drugs, to allow them to make decisions that may reduce their risk of overdose; peer support workers and workers at supervised consumption and overdose prevention sites; and emergency responders.
• The Department’s Hummingbird project launched and successfully completed its exploration phase, looking at how drones could be integrated within the current cannabis regulatory inspection framework and technical infrastructure. Two experimental flights (proof of concept) were successfully conducted and confirmed the majority of inspection needs were met.
• Health Canada launched the “Increasing Take-Up of Cannabis Micro Applicants Using Behavioural Insights” project in November 2019 to examine potential barriers to legal entry for small-scale cannabis business owners that might explain lower-than-anticipated uptake of applications and licensing. The results will be available in 2020-21 and will inform national scaling.

Sex and Gender-Based Analysis Plus (SGBA+ / GBA+)

Health Canada continued to build on the Sex and Gender Action Plan^{Footnote 2} launched in 2017. The Action Plan: i) provides a framework that strengthens the systematic integration of sex, gender and other intersectional factors (such as age and language) in Department work and decision making; and ii) supports the Government of Canada’s priorities of diversity and inclusion as well as the advancement of gender equality.

Priorities of the three-year Action Plan are to:

• Increase departmental capacity to apply SGBA+;
• Strengthen the sex, gender and diversity-related evidence base and expertise;
• Increase the accountability and transparency for implementing SGBA+.

Each branch identified at least one signature initiative. The Department, in collaboration with the Canadian Institutes of Health Research (CIHR), established research-policy partnerships, which support researchers, who have both subject matter and SGBA+ expertise, to engage with departmental staff on priority Health Canada initiatives. In 2019-20, key initiatives in support of the SGBA+ Action Plan include:

Enhanced capacity building

Health Canada provided employee training in several sex and gender related areas: increasing awareness of how SGBA+ could influence the development of policies and guidelines; the application of SGBA+ to risk communication; and the integration of the SGBA+ and Indigenous lenses in the development and delivery of National Inspector training.

Sex, gender and diversity sensitive resources, developed as part of a research-policy partnership, were incorporated into a Mental Health First Aid Toolkit for all employees – the resources focused on work-life stress and mental health; work life balance; workplace diversity, discrimination and bias; bullying and harassment; as well as stigma disclosure and access to support programs, services and resources.

The Department also launched a “Learning and Integration for Impact Initiative”, led by a project team of specialists on SGBA+, Knowledge Translation (KT) and Performance Measurement (PM). The project team collaborated with colleagues and funding recipients, providing advice, training and tools that promoted an organizational learning culture where the purposeful integration of KT, PM and SGBA+ at all stages helps to improve how we design, plan, manage, deliver, report and evaluate programs. As a result, this initiative increased the likelihood of achieving strategic outcomes and cultivated critical thinking, innovation and the capacity to link program management with positive outcomes for Canadians.

The Department offers an Employee Assistance Program (EAP) that provides services to employees in many federal departments and agencies, as well as to members of the Royal Canadian Mounted Police and Canadians Armed Forces, and veterans of these organizations. In 2019-20, the EAP applied a SGBA+ lens to its policies, procedures and services.

Strengthened sex and gender related evidence and expertise

Cannabis – Health Canada published the report “Sex, Gender and Cannabis”, reviewing existing research and data on cannabis use and its effects, and outlined possible implications for cannabis policy and public education from a sex and gender perspective. In addition, the 2019 Canadian Cannabis Survey collected additional demographic variables, including sexual orientation and if respondents were born in Canada, to better understand cannabis use and priority populations.

Informal Caregivers – In 2018-19, Health Canada launched an initiative in the area of home care to develop an evidence-based technology assessment framework that explicitly addressed sex, gender and diversity considerations for digital technology to support informal caregivers. In 2019-20, the Department disseminated results to stakeholders in the field and made a gender-sensitive technology assessment tool available to technological developers to support the development, implementation and evaluation of technologies to assist with caregiving.

Health product labelling – A policy-research partnership with McGill University investigated consumer perceptions and behaviours in relation to health product labelling for cosmetics, natural health products and non-prescription drugs. In July 2019, the partnership completed an SGBA+ comparative analysis of the Consumer Health Product Survey. The results are being used to inform a regulatory proposal to improve the labelling of natural health products. In addition, the research has demonstrated the importance of taking sex and gender into consideration from the outset of survey design development.

Implementing SGBA+ across Health Canada programs

Canada’s Food Guide – Health Canada delivered targeted healthy eating content and promotional material to reach Canadians across various settings, ages, and population groups. For example, the Canada’s Food Guide monthly e-newsletter featured tips and resources that are inclusive of different audiences, covering themes such as healthy eating on a budget and the importance of culture and food traditions.

Chemicals Management Plan – Research, monitoring, surveillance and risk assessment activities included greater consideration of populations vulnerable to specific health risks. The unique exposure of certain subpopulations was taken into account, as well as health effects linked to certain life stages (such as effects on the developing fetus). For example, the draft screening assessment for parabens estimated exposure from a number of products used by children. The consideration of populations more vulnerable to paraben exposures was carried through in risk management activities and actions proposed to reduce exposures to highly-exposed or susceptible populations.

Pesticides evaluation – Pesticides must undergo a high level of scientific evaluation prior to being registered for use in Canada. When a pesticide is evaluated for its potential risks to human health, the Department considers that chemicals may pose higher risks to certain groups of people based on differences in biology and behaviour – for example, differences due to sex, gender, age or occupation. In 2019-20, Health Canada published an infographic illustrating how sex, gender and susceptible populations are taken into account in the regulation of pesticides in Canada, for use in outreach activities.

Analysis of trends in spending and human resources

Actual expenditures

Departmental spending trend graph - Text description

The figure illustrates Health Canada's spending trend from fiscal year 2017-18 to fiscal year 2022-23 where spending, in millions of dollars, is shown on the vertical axis and time period, in fiscal years, is shown on the horizontal axis.

Health Canada's actual spending for fiscal year 2017-18: $3,491 million (Voted: $3,274 million, Statutory: $217 million); 2018-19: $2,370 million (Voted: $2,179 million, Statutory: $191 million); and 2019-20: $2,675 million (Voted: $2,489 million, Statutory: $186 million).

Health Canada's planned spending for fiscal year 2020-21: $2,728 million (Voted: $2,565 million, Statutory: $163 million); 2021-22: $2,874 million (Voted: $2,714 million, Statutory: $160 million); and 2022-23: $2,322 million (Voted: $2,174 million, Statutory: $148 million).

Budgetary performance summary for Core Responsibilities and Internal Services (dollars)

Core Responsibilities and Internal Services	2019-20 Main Estimates	2019-20 Planned spending	2020-21 Planned spending	2021-22 Planned spending	2019-20 Total authorities available for use	2019-20 Actual spending (authorities used)	2018-19 Actual spending (authorities used)	2017-18 Actual spending (authorities used)Footnote *
Health Care Systems	1,609,336,578	1,609,336,578	1,777,284,741	1,978,657,709	1,623,522,760	1,601,069,150	1,289,851,245	N/A
Health Protection and Promotion	598,278,433	598,278,433	635,964,234	579,192,259	737,512,277	728,899,756	726,841,710	N/A
Subtotal	2,207,615,011	2,207,615,011	2,413,248,975	2,557,849,968	2,361,035,037	2,329,968,906	2,016,692,955	-
Internal Services	262,477,397	262,477,397	314,510,185	316,018,192	350,416,744	345,420,163	353,056,297	N/A
Budget Implementation	N/A	N/A	N/A	N/A	25,316,687	N/A	N/A	N/A
Total	2,470,092,408	2,470,092,408	2,727,759,160	2,873,868,160	2,736,768,468	2,675,389,069	2,369,749,252	3,491,052,712
Table 6 Footnote 1 The 2017-18 expenditures are not displayed due to a change in the approved reporting structure from the Program Alignment Architecture to the approved Departmental Results Framework. Return to footnote * referrer Note: At the outset of the 2019-20 fiscal year, Health Canada's planned spending was $2,470.1 million. Additional in-year funding received for Treasury Board approved initiatives and the operating and capital budget carry forwards, increased Health Canada's total authorities to $2,736.8 million. The additional funding received during 2019-20 relates mainly to the following initiatives: Core Regulatory Operations related to Therapeutic Products, Bringing Innovation to Regulations, Enhancing the Federal Response to the Opioid Crisis in Canada, as well as funding for out-of-court settlements. The variance of $61.4 million between total authorities and actual spending in 2019-20 is mainly the result of lower than anticipated draws in contribution funds, as well as setting aside a portion of the operating budget carried forward to support strategic investments in 2020-21. The $25.3 million for Budget Implementation relates to Budget 2019 measures that have not yet been accessed by the Department. Fiscal year 2017-18 actual spending is significantly higher compared to following fiscal years due to the transfer of the First Nations and Inuit Health Branch to the Department of Indigenous Services Canada, effective November 30, 2017, as per the Order in Council P.C. 2017-1465.

Actual human resources

Human resources summary for Core Responsibilities and Internal Services

Core Responsibilities and Internal Services	2017-18 Actual full-time equivalentsFootnote *	2018-19 Actual full-time equivalents	2019-20 Planned full-time equivalents	2019-20 Actual full-time equivalents	2020-21 Planned full-time equivalents	2021-22 Planned full-time equivalents
Health Care Systems	N/A	210	289	215	290	290
Health Protection and Promotion	N/A	5,193	5,690	5,785	5,898	5,667
Subtotal	-	5,403	5,979	6,000	6,188	5,957
Internal Services	N/A	2,268	1,698	2,164	1,757	1,722
Total	8,218	7,671	7,677	8,164	7,945	7,679
Table 7 Footnote 1 The 2017-18 actual full-time equivalents (FTEs) are not displayed due to a change in the approved reporting structure from the Program Alignment Architecture to the approved Departmental Results Framework. Return to footnote * referrer Note: The variance between the 2019-20 Planned and Actual FTEs is mainly due in-year resources received for Core Regulatory Operations related to Therapeutic Products, Bringing Innovation to Regulations, Enhancing the Federal Response to the Opioid Crisis in Canada, as well as a technical adjustment for the provision of shared services to PHAC. The planned FTEs decrease due to the expiry of budgetary spending authorities for Core Regulatory Operations related to Therapeutic Products in 2019-20 and the Chemicals Management Plan in 2020-21.

Expenditures by vote

For information on Health Canada’s organizational voted and statutory expenditures, consult the Public Accounts of Canada 2019-20.

Government of Canada spending and activities

Information on the alignment of Health Canada’s spending with the Government of Canada’s spending and activities is available in the GC InfoBase.

Financial statements and financial statements highlights

Financial statements

Health Canada’s financial statements (unaudited) for the year ended March 31, 2020, are available on the departmental website.

Financial statements highlights

Condensed Statement of Operations (unaudited) for the year ended March 31, 2020 (dollars)

Financial information	2019-20 Planned results	2019-20 Actual results	2018-19 Actual results	Difference (2019-20 Actual results minus 2019-20 Planned results)	Difference (2019-20 Actual results minus 2018-19 Actual results)
Total expenses	2,754,800,000	2,896,523,000	2,596,686,000	141,723,000	299,837,000
Total revenues	211,096,000	225,366,000	201,844,000	14,270,000	23,522,000
Net cost of operations before government funding and transfers	2,543,704,000	2,671,157,000	2,394,842,000	127,453,000	276,315,000

The Department’s total expenses in 2019-20 were $2,896.5 million 

There was an increase of total expenses of $141.7 million when comparing actual results against planned results for 2019-20. This is primarily a result of the following:

• an increase in funding for compensation related to collective agreements;
• an increase in the cost of services provided without charge for accommodations and the employer’s contribution to the health and dental insurance plans;
• an increase in funding for out-of-court settlements; and,
• an increase in expenses incurred for the provision of back office services to other departments.

When comparing year-over-year actual expenditures, there was an increase of $299.8 million. The significant changes were:

• an increase in transfer payments for strengthening Canada's Home and Community Care and Mental Health and Addiction Services Initiative;
• an increase in salaries and employee benefits due primarily to increased costs associated with the signing of collective agreements, an increase in the number of employees resulting from growth in the cannabis, controlled substances and opioid programs and an increase in the number of employees to address issues with the new pay system;
• an increase in other costs due mainly to out-of-court settlements of contingent liabilities and ex gratia payments made to individuals eligible for financial support under the Canadian Thalidomide Survivors Support Program; and,
• offset by a decrease in transfer payments related to opioids that were distributed to provinces and territories through the one-time Emergency Treatment Fund in 2018-19.

The Department's total revenues were $225.4 million in 2019-20 representing an increase of $14.3 million from planned results and an increase of $23.5 million over the prior year actual revenues. The year-over-year variance is primarily a result of an increase in demand for services under the employee assistance programs and for other regulatory services provided by the Department, annual fee increases to specific fee regimes, and an increase in revenues for the provision of back office services to other departments.

Condensed Statement of Financial Position (unaudited) as of March 31, 2020 (dollars)

Financial Information	2019-20	2018-19	Difference (2019-20 minus 2018-19)
Total net liabilities	$303,840,000	$347,847,000	$(44,007,000)
Total net financial assets	193,527,000	188,564,000	4,963,000
Departmental net debt	110,313,000	159,283,000	(48,970,000)
Total non-financial assets	140,612,000	140,022,000	590,000
Departmental net financial position	$30,299,000	$(19,261,000)	$49,560,000

Total net liabilities were $303.8 million at the end of 2019-20, representing a decrease of $44.0 million from the previous year. This variance is mainly due to the resolution of contingent liabilities, and is offset by an increase in liabilities for vacation pay and compensatory leave resulting from a deferral in the mandatory cash out provisions noted in the collective agreements.

The year-over-year increase in total net financial assets of $5.0 million is primarily a result of an increase in amounts due from the PHAC for recoveries of costs incurred for Canada's response to COVID-19 and a year over year timing difference in collections, which were delayed as a result of the COVID-19 pandemic.

Additional information

Organizational profile

Appropriate Minister: The Honorable Patty Hajdu, P.C., M.P.

Institutional Head: Dr. Stephen Lucas

Ministerial portfolio: Health

Enabling instruments: Assisted Human Reproduction Act, Canada Health Act, Canada Consumer Product Safety Act , Controlled Drugs and Substances Act, Department of Health Act, Food and Drugs Act, Cannabis Act, Hazardous Materials Information Review Act, Hazardous Products Act, Pest Control Products Act, Radiation Emitting Devices Act, Tobacco and Vaping Products Act.

List of Acts and Regulations

Year of incorporation / commencement: 1913

Raison d’être, mandate and role

“Raison d’être, mandate and role: who we are and what we do” is available on Health Canada’s website.

For more information on the department’s organizational mandate letter commitments, see the Minister’s mandate letter.

Reporting Framework

Health Canada’s Departmental Results Framework and Program Inventory of record for 2019-20 are shown below.

Departmental Results Framework and Program Inventory - Text description

Core Responsibility 1

Health Care Systems

• R 1: Canada has modern and sustainable health care systems
• I1: National health expenditure as a percentage of Gross Domestic Product
• I2: Real per capita health expenditure
• I3: Drug spending as a percentage of Gross Domestic Product
• I4: Percentage of family physicians using electronic medical records
• R 2: Canadians have access to appropriate and effective health services
• I5: Percentage of Canadians (aged 15+) with a mental disorder who have expressed that they have an unmet mental health care need
• I6: Percentage of Canadians (aged 15+) who have expressed that they have an unmet need for access to home care services
• I7: Percentage of Canada Health Act compliance issues addressed within 24 months of identification
• I8: Percentage of Canadians who did not fill a prescription for medicine because of the cost

Program Inventory under core responsibility one (from one -16) as follow:

• 1. Health Care Systems Analysis & Policy
• 2. Access, Affordability, & Appropriate Use of Drugs & Medical Devices
• 3. Home, Community & Palliative Care
• 4. Mental Health
• 5. Substance Use & Addictions
• 6. Digital Health
• 7. Health Information
• 8. Canada Health Act
• 9. Medical Assistance in Dying
• 10. Cancer Control
• 11. Patient Safety
• 12. Blood Systems, Organs, Tissue & Transplantation
• 13. Promoting Minority Official Languages in the Health Care Systems
• 14. Brain Research
• 15. Thalidomide
• 16. The Territorial Health Investment Fund (THIF)

Core Responsibility 2

Health Protection & Promotion

• R 3: Canadians have access to safe, effective and quality health products
• I9: Percentage of new drug decisions issued within service standards
• I10: Percentage of Risk Management Plan reviews for new drug decisions completed within service standards
• I11: Percentage of drug companies deemed to be compliant with manufacturing requirements under the Food and Drugs Act and associated regulations
• R 4: Canadians are protected from unsafe consumer and commercial products and substances
• I12: Percentage of domestic consumer product recalls communicated to Canadians in a timely manner
• I13: Percentage of actions taken in a timely manner to protect the health of Canadians from substances found to be a risk to human health
• I14: Percentage of actions taken in a timely manner to protect the health of Canadians from pesticides found to be a risk to human health and the environment
• R 5: Canadians make healthy choices
• I15: Percentage of Canadians (aged 15+) who have used any tobacco product in the past 30 days
• I16: Percentage of Canadians (aged 15-24) who have used cannabis in the last 12 months
• I17: Percentage of Canadians who use dietary guidance provided by Health Canada

Program Inventory under core responsibility two (from 17-33) as follow:

• 17. Pharmaceutical Drugs
• 18. Biologics & Radiopharmaceutical Drugs
• 19. Medical Devices
• 20. Natural Health Products
• 21. Food & Nutrition
• 22. Air Quality
• 23. Climate Change
• 24. Water Quality
• 5. Health Impacts of Chemicals
• 26. Consumer Product Safety
• 27. Workplace Hazardous Products
• 28. Tobacco Control
• 29. Controlled Substances
• 30. Cannabis
• 31. Radiation Protection
• 32. Pesticides
• 33. Specialized Health Services & Internationally Protected Persons Program

Internal Services

Supporting information on the Program Inventory

Financial, human resources and performance information for Health Canada’s Program Inventory is available in the GC InfoBase.

Supplementary information tables

The following supplementary information tables are available on Health Canada’s website:

• Departmental Sustainable Development Strategy
• Details on transfer payment programs of $5 million or more
• Gender-based analysis plus
• Horizontal initiatives
• Response to parliamentary committees and external audits
• Up-front multi-year funding

Federal tax expenditures

The tax system can be used to achieve public policy objectives through the application of special measures such as low tax rates, exemptions, deductions, deferrals and credits. The Department of Finance Canada publishes cost estimates and projections for these measures each year in the Report on Federal Tax Expenditures. This report also provides detailed background information on tax expenditures, including descriptions, objectives, historical information and references to related federal spending programs. The tax measures presented in this report are the responsibility of the Minister of Finance.

Organizational contact information

Edward de Sousa
Director General
Health Canada
Director General’s Office
70 Colombine Driveway, Tunney’s Pasture
Ottawa, Ontario K1A 0K9
Telephone: 613-948-6357
Fax: 613-946-0807
edward.desousa@canada.ca

Appendix: definitions

appropriation

Any authority of Parliament to pay money out of the Consolidated Revenue Fund.

budgetary expenditures

Operating and capital expenditures; transfer payments to other levels of government, organizations or individuals; and payments to Crown corporations.

Core Responsibility

An enduring function or role performed by a department. The intentions of the department with respect to a Core Responsibility are reflected in one or more related Departmental Results that the department seeks to contribute to or influence.

Departmental Plan

A report on the plans and expected performance of an appropriated department over a three-year period. Departmental Plans are tabled in Parliament each spring.

departmental priority

A plan or project that a department has chosen to focus and report on during the planning period. Priorities represent the things that are most important or what must be done first to support the achievement of the desired departmental results.

Departmental Result

A Departmental Result represents the change or changes that the department seeks to influence. A Departmental Result is often outside departments' immediate control, but it should be influenced by program-level outcomes.

Departmental Result Indicator

A factor or variable that provides a valid and reliable means to measure or describe progress on a Departmental Result.

Departmental Results Framework

Consists of the department's Core Responsibilities, Departmental Results and Departmental Result Indicators.

Departmental Results Report

A report on an appropriated department's actual accomplishments against the plans, priorities and expected results set out in the corresponding Departmental Plan.

experimentation

Activities that seek to explore, test and compare the effects and impacts of policies, interventions and approaches, to inform evidence-based decision-making, by learning what works and what does not.

full-time equivalent

A measure of the extent to which an employee represents a full person-year charge against a departmental budget. Full-time equivalents are calculated as a ratio of assigned hours of work to scheduled hours of work. Scheduled hours of work are set out in collective agreements.

gender-based analysis plus (GBA+)

An analytical process used to help identify the potential impacts of policies, Programs and services on diverse groups of women, men and gender differences. We all have multiple identity factors that intersect to make us who we are; GBA+ considers many other identity factors, such as race, ethnicity, religion, age, and mental or physical disability.

government-wide priorities

For the purpose of the 2018–19 Departmental Results Report, those high-level themes outlining the government's agenda in the 2015 Speech from the Throne, namely: Growth for the Middle Class; Open and Transparent Government; A Clean Environment and a Strong Economy; Diversity is Canada's Strength; and Security and Opportunity.

horizontal initiative

An initiative where two or more departments are given funding to pursue a shared outcome, often linked to a government priority.

non-budgetary expenditures

Net outlays and receipts related to loans, investments and advances, which change the composition of the financial assets of the Government of Canada.

performance

What an organization did with its resources to achieve its results, how well those results compare to what the organization intended to achieve, and how well lessons learned have been identified.

performance indicator

A qualitative or quantitative means of measuring an output or outcome, with the intention of gauging the performance of an organization, program, policy or initiative respecting expected results.

performance reporting

The process of communicating evidence-based performance information. Performance reporting supports decision making, accountability and transparency.

plan

The articulation of strategic choices, which provides information on how an organization intends to achieve its priorities and associated results. Generally a plan will explain the logic behind the strategies chosen and tend to focus on actions that lead up to the expected result.

planned spending

For Departmental Plans and Departmental Results Reports, planned spending refers to those amounts presented in Main Estimates.
A department is expected to be aware of the authorities that it has sought and received. The determination of planned spending is a departmental responsibility, and departments must be able to defend the expenditure and accrual numbers presented in their Departmental Plans and Departmental Results Reports.

program

Individual or groups of services, activities or combinations thereof that are managed together within the department and focus on a specific set of outputs, outcomes or service levels.

result

An external consequence attributed, in part, to an organization, policy, program or initiative. Results are not within the control of a single organization, policy, program or initiative; instead they are within the area of the organization's influence.

statutory expenditures

Expenditures that Parliament has approved through legislation other than appropriation acts. The legislation sets out the purpose of the expenditures and the terms and conditions under which they may be made.

target

A measurable performance or success level that an organization, program or initiative plans to achieve within a specified time period. Targets can be either quantitative or qualitative.

voted expenditures

Expenditures that Parliament approves annually through an Appropriation Act. The Vote wording becomes the governing conditions under which these expenditures may be made.