Health Canada 2018–2019 Departmental Results Report
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Organization: Health Canada
Published: 2020
© Her Majesty the Queen in Right of Canada, represented by the President of the Treasury Board, 2019.
Catalogue No H1-9 / 32E-PDF
ISSN 2560-8118
Pub. 190041
This document is available on the Treasury Board of Canada Secretariat website.
This document is available in alternative formats upon request.
Table of contents
- Minister’s message
- Results at a glance
- Results: what we achieved
- 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
- Supplementary information
- Supporting information on the Program Inventory
- Supplementary information tables
- Federal tax expenditures
- Organizational contact information
- Appendix: Definitions
Minister’s message

As the Minister of Health, I am pleased to present Health Canada’s 2018-19 Departmental Results Report. This report outlines the key initiatives that my Department carried out during the 2018-19 fiscal year to help improve the health and safety of all Canadians.
Over the course of 2018-19, Health Canada continued to provide national leadership to foster sustainable health care systems that ensure Canadians have access to appropriate and effective health care. The Department also helped Canadians lead healthier lives by providing protection from unsafe health, consumer and commercial products and substances.
A top priority for 2018-19 was responding to the national opioid overdose crisis, which is Canada’s most serious public health challenge today. Through Budget 2018, the Government of Canada committed more than $350 million to respond to the crisis, with measures focused on prevention, treatment, enforcement and harm reduction. This included a $150-million Emergency Treatment Fund that was signed onto by all provinces and territories. Health Canada significantly increased the number of new supervised consumption sites across Canada, bringing the total number to 41.
The Department also consulted with Canadians on new and innovative ways to address the harms associated with problematic substance use. It launched a national public education campaign to raise awareness about the stigma surrounding people who use drugs and to provide information on harm reduction. It took a holistic approach by establishing the Canadian Pain Task Force, focusing on improving Canadians’ access to a range of evidence-based strategies required to effectively manage pain.
In 2018-19, Health Canada supported delivery of the Government’s commitment to legalizing, strictly regulating and restricting access to cannabis. The Cannabis Act, which received Royal Assent in June 2018, created a strict framework for controlling its production, distribution, sale and possession in Canada in order to keep cannabis out of the hands of young Canadians, while preventing criminals and organized crime from profiting.
The Government made public education and awareness a fundamental component of its public health approach, ensuring that Canadians are equipped with the credible, balanced and evidence-based information they need to make informed decisions about their health. At the same time, the Department continued to support Indigenous and community-based organizations as well as healthcare professionals across the country in increasing public education and awareness among youth and young adults, pregnant and breastfeeding individuals, and other key segments of the Canadian population.
During 2018-19, the Department concluded bilateral agreements with all provinces and territories that set out how jurisdictions will use federal funding to improve access to home and community care and mental health and addiction services. All partners in health collaborated to establish a focused set of common indicators to measure progress and report annually to Canadians on overall improvements in this critical area. These partners also worked to develop national approaches to other key health system issues, such as expanding the use of digital technologies.
In addition, the Department advanced several new initiatives under the Canada Health Act, establishing a reimbursement policy, a diagnostic services policy, as well as strengthened reporting. It also supported the Advisory Council on the Implementation of National Pharmacare over the course of its consultations with Canadians on how to implement affordable national pharmacare.
The Department continued to implement its multi-year, comprehensive Healthy Eating Strategy to help Canadians make informed and healthier food choices. In 2018-19, it unveiled the new Canada’s Food Guide, which provides the foundation for healthy eating. The revised guide offers dietary guidance that better meets the needs of all Canadians, including the public, policy makers and health professionals.
In 2018-19, Health Canada strengthened tobacco control in Canada, helping to ensure our country remains a world leader in the field. Following Royal Assent of the Tobacco and Vaping Products Act in May 2018, the Department developed plain packaging requirements for all tobacco products and launched Canada’s Tobacco Strategy. It also undertook a national public education campaign to inform youth of the health risks of vaping and consulted on regulatory proposals to restrict vaping products and their promotion.
Health Canada worked with both domestic and international partners to assess, manage and communicate the health and safety risks associated with consumer products, food, health products, pesticides, tobacco and vaping products, and controlled substances. The Department also reinforced its efforts to ensure that Canadians have access to safe, effective and quality health products. Finally, the pages ahead will demonstrate how the Department took bold new steps in the areas of experimentation, innovation and Sex and Gender-Based Analysis (SGBA).
By collaborating with our many partners on these and other important initiatives, Health Canada delivered significant results for Canadians over 2018-19 while setting the stage for new developments to come.
The Honourable Patty Hajdu, P.C., M.P.
Minister of Health
Results at a glance
Resources used to achieve results for Canadians
Health Canada’s total actual spending for 2018-19: $2,369,749,252
Health Canada’s total actual full-time equivalents for 2018-19: 7,671
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 (summarized on page 54).
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 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. This work relates to the health and safety of health and consumer products, food, chemicals, pesticides, environmental factors such as air and water quality, tobacco and vaping products, and controlled substances, including cannabis.
Key Results
In 2018-19, among the many others detailed in this report, Health Canada achieved the following key results that contributed to the health of Canadians.
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 system modernization on the health workforce; opioids; mental health; quality of care; health care innovation; and health technology.
- To protect the integrity of Canada’s publicly funded health system, Health Canada worked closely with provinces and territories to ensure compliance with requirements of the Canada Health Act.
- To ensure that Canadians have access to appropriate and effective health services, Health Canada worked in partnership with provincial and territorial governments to implement bilateral funding agreements linked to the Common Statement of Principles on Shared Health Priorities developed jointly by Federal-Provincial-Territorial governments. Under these agreements, the federal government is providing targeted funding of $11 billion over 10 years to improve access to home and community care (including palliative care), as well as to mental health and addictions services.
- Health Canada worked closely with provinces and territories and key system partners to improve the affordability and accessibility of prescription drugs. The department also provided secretariat support for the Advisory Council on the Implementation of National Pharmacare led by Dr. Eric Hoskins.
- The Department made important investments to support eight pan-Canadian health organizations that directly contribute to health system improvements in key areas such as digital health, health information, drugs and technologies, mental health and addictions, cancer prevention and control, patient safety, and service delivery innovation.
- The Department supported implementation of medical assistance in dying (MAID) legislation in collaboration with provinces and territories to meet federal commitments under the law. In 2018-19, activities included: enactment of Ministerial regulations for a monitoring and reporting system on MAID; receipt and tabling in Parliament of independent reviews on questions requiring further examination; and, release of the first official annual public report on MAID in Canada.
Core Responsibility 2: Health Protection and Promotion
- With our partners, Health Canada continued to take action in 2018-19 on the national opioid overdose crisis by coordinating a collaborative approach that is grounded in compassion, innovation and evidence. The Department introduced legislative and regulatory changes that enable frontline overdose prevention, and invested significantly to expand mental health and substance use treatment services across the country. Health Canada funded 71 projects under the Substance Use and Addictions Program and streamlined the process to establish supervised consumptions sites, increasing from 2 to 40 approved sites (as of March 31, 2019).
- Approaching the opioid issue holistically, the Department also announced the creation of the eight-member Canadian Pain Task Force, which was given a three-year mandate to provide advice to the Department regarding evidence and best practices for the prevention and management of chronic pain.
- The Department implemented the Cannabis Act and associated regulations, Canada’s new, public-health-based framework that restricts access to cannabis and establishes a regulated supply chain that aims to displace the illegal market. Significant investments were made to support Canadians in making informed health decisions around cannabis use. Leading up to and following the implementation of the Act, Health Canada increased the number of licensed sites from 41 in March 2017 to 123 in March 2019, in order to meet the demand for this new industry while protecting Canadians and ensuring that access to cannabis for medical purposes was maintained.
- The Minister of Health launched the new Canada’s Food Guide. The Guide is an online suite of resources that better meets the needs of different users, including the general public, policy makers and health professionals.
- Health Canada launched Canada’s Tobacco Strategy with the goal of achieving less than 5% tobacco use by 2035. The Strategy commits $330 million over 5 years to help Canadians who smoke to quit while protecting the health of young people and non-smokers from the dangers of tobacco and nicotine use.
- In response to the growing use of vaping products, the Department implemented the new Tobacco and Vaping Products Act regulating the manufacture, sale, labelling and promotion of tobacco and vaping products in Canada. It also posted a Notice of Intent that outlines regulatory measures being considered to reduce the impact of vaping product advertising on youth and non-users of tobacco products.
- Health Canada developed and released Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality to accelerate its effort to strengthen the regulation of medical devices in Canada.
- The Department launched a process to modernize the regulatory framework underlying the Controlled Drugs and Substances Act (CDSA) in order to rectify inconsistencies and gaps; make it more responsive and adaptable; reduce the administrative burden on industry; and enable the implementation of new and innovative health care service delivery models.
- Health Canada took action to respond to the serious global public health issue of antimicrobial resistance (AMR) as it relates to the use of antimicrobial products in animals. Companies that manufacture, import or compound medically important antimicrobials now need to report annually sales of these drugs. In addition, Health Canada now requires veterinary prescriptions for all medically-important antimicrobials for use in all animals.
- Draft regulations under the Assisted Human Reproduction Act were pre-published for consultation. The regulations aim to help protect the health and safety of people who use, or are born of, assisted human reproduction.
Experimentation / Innovation
In support of the directive on experimentation from the Treasury Board Secretariat, Health Canada launched a new funding program known as the Solutions Fund: Powering Employee Innovation. The fund is consistent with the Government of Canada’s commitment to supporting experimentation to instill a culture of measurement, evaluation and innovation in program and policy design and service delivery. In addition, this report details several other key examples of experimentation / innovation within the Department, including initiatives related to: food labelling; the statistical evaluation of the average daily sodium intakes of Canadians; consumer product safety; and the Drug-Checking Technology Challenge.
Sex and Gender-Based Analysis Plus (GBA+/SGBA+)
Launched in 2017, Health Canada’s three-year Sex and Gender Action Plan provides a framework that strengthens the integration of sex, gender and diversity considerations (such as age and ethnicity) in externally as well as internally facing work of the Department. The action plan is designed to support the Government of Canada’s priority on the advancement of gender equality. This report details achievements in the areas of: cannabis; evaluation; health product labelling; risk communications; home care, pest management; vaping; and workplace health.
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
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. Over the course of 2018-19, the Department led multiple initiatives as well as new and existing funding agreements that advanced a number of priority health issues.
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 system modernization on the health workforce; opioids; mental health; quality of care; health care innovation; and health technology.
Over the course of 2018-19, Health Canada made important investments to support several pan-Canadian organizations that directly contributed to health care system improvements. As part of this support, the Department:
- Provided $49.8 million out of the $300 million over five years to Canada Health Infoway, and an additional $14.3 million in statutory spending to advance digital health innovation, including to develop pan-Canadian e-prescribing system and virtual care initiatives, as well as continuing to support the adoption and use of electronic medical records, help patients to access their own health records electronically, to better link electronic health record systems to improve access by all providers and institutions.
- Provided $83.9 million to the Canadian Institute for Health Information for funding to deliver comparable and actionable data and information to accelerate improvements in health care, health system performance and population health across the continuum of care.
- Provided $20.1 million to the Canadian Agency for Drugs and Technologies in Health to strengthen the management of drugs and non-drug technologies to support health system effectiveness and sustainability by promoting, through the development of evidence, the cost-effective and optimal use of drugs and other health technologies.
- Provided $17.0 million to the Canadian Foundation for Healthcare Improvement to work with provinces and territories to accelerate, identify and continue to support adoption of promising and proven health service delivery transformation.
- Contributed $23.5 million to support brain research through the Canadian Brain Research Fund, which is administered by the Brain Canada Foundation. Health Canada is matching private and charitable funds raised by the Brain Canada Foundation, up to $120 million by 2020.
Through these 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
Over the course of 2018-19, the federal government played an ongoing role in providing financial support through fiscal transfers to the provinces and territories, maintaining the core principles of the Canada Health Act, and supporting collaboration across the country.
To ensure that Canadians have access to appropriate and effective health services, Health Canada worked in partnership with provincial and territorial governments to implement bilateral agreements linked to the Common Statement of Principles on Shared Health Priorities. Under these agreements, the federal government will provide targeted funding of $11 billion over 10 years to support provincial and territorial initiatives in home and community care (including palliative care), as well as mental health and addictions services. These investments will enable provinces and territories to improve access to these services. Progress on these initiatives is being monitored through a focused set of indicators developed jointly by governments and the Canadian Institute for Health Information.
The Department collaborated with the provinces and territories to improve access to necessary prescription medications and identified priorities to improve the organ donation and transplantation system to enable timely and effective access to care. It also authorized a request by blood operators to reduce the deferral period for blood donation for men who have sex with men from one year to three months, consistent with supporting blood donation policies that are both safe and non-discriminatory.
Health Canada monitored provincial and territorial health care insurance plans and worked with provinces and territories to address patient charges and to strengthen reporting on the Canada Health Act.
The Department supported implementation of medical assistance in dying (MAID) legislation in collaboration with provinces and territories to meet federal commitments under the law. In 2018-19, activities included: enactment of Ministerial regulations for a monitoring and reporting system on MAID; receipt and tabling in Parliament of independent reviews on questions requiring further examination; and, release of the first official annual public report on MAID in Canada.
Health Canada also implemented the requirements under Bill C-277 to initiate consultations with provinces and territories and palliative care experts for the development of a framework on palliative care for Canadians, which was tabled on December 4, 2018. Development of an implementation plan followed.
The Department also provided funding to address the health care needs of specific populations such as residents of the three territories and official language minority communities.
In addition, over the course of 2018-19, Health Canada made important investments in several programs and organizations that directly support access to appropriate and effective health services for Canadians. These are summarised on the page opposite.
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.”
Health Canada’s collaboration funding in 2018–19 supporting access to appropriate and effective health services for Canadians included the following:
- Provided $269 million under the Substance Use and Addictions Program to support evidence-informed and innovative health promotion, prevention, harm reduction and treatment initiatives to address substance use, including core funding for the Canadian Centre on Substance Use and Addiction.
- Supported, through targeted funding agreements, organizations and key pan-Canadian health partners to contribute to health system improvements and provided:
- $14.2 million to the Mental Health Commission of Canada to advance specific priorities in the area of mental health such as: substance misuse; suicide prevention; engagement with federal partners and other stakeholders consistent with findings outlined in the 2016 Evaluation of Mental Health and Mental Illness Activities of Health Canada and the Public Health Agency of Canada (PHAC).
- $43.0 million to the Canadian Partnership Against Cancer Corporation to continue its work on key health issues in cancer control, accelerate uptake of new knowledge and coordinate approaches to advance cancer control in Canada.
- $7.6 million to the Canadian Patient Safety Institute to support efforts to improve patient safety and quality of care across Canada, including the development of a new strategic plan to accelerate the pace of safety improvements in future years.
- Provided $9.5 million to address federal priorities under the Health Care Policy and Strategies Program, which include health care system innovation, palliative and end-of-life care through collaborative working arrangements with provinces, territories, academic institutions, and non-governmental organizations.
- Provided $36.1 million to community-based organizations, governments and academic institutions to improve access to health services for English-speaking communities in Quebec and French-speaking communities elsewhere in Canada. Funded activities included: the integration of bilingual health personnel through postsecondary training initiatives; the development of strategies and partnerships with health system stakeholders through community networking; and the implementation of projects aimed at improving access to bilingual health services and fostering knowledge development and dissemination.
- Provided $9.5 million to Crawford & Company (Canada) to administer the Thalidomide Survivors Contribution Program, which aims to meet the lifetime needs of Canadian thalidomide survivors so they may age with dignity. Funded activities included distribution of ongoing annual tax-free support payments to eligible thalidomide survivors as well as administering an Extraordinary Medical Assistance Fund to help survivors pay for home and vehicle adaptations or specialized surgeries not covered by provincial/territorial health care plans.
- Continued funding to support territorial efforts to innovate and transform their health care systems, and ensure Northerners have access to the health care they need. The three territories received a total of $27 million as part of the Territorial Health Investment Fund. Of this amount, $6.4 million was allocated to Yukon, $7.1 million to the Northwest Territories, and $13.5 million to Nunavut.
Results achieved
Performance Indicator | 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, 2019 | 2016-17: 11.5% 2017-18: 11.3% 2018-19: 11.3% |
Real per capita health expenditure (1997)Footnote 1 (Baseline $4,014Footnote 2 per person in 2014-15) |
Between $4,133.60 and $4,216.27Footnote 3,Footnote 4 | March 31, 2019 | 2016-17: $4,165.10Footnote 2 2017-18: $4,228.40 2018-19: $4,295.00Footnote 4 |
Drug spending as a percentage of Gross Domestic ProductFootnote 5 (Baseline 1.74% in 2014-15) |
Between 1 and 2% | March 31, 2019 | 2016-17: 1.82%Footnote 2 2017-18: 1.78% 2018-19: 1.78%Footnote 5 |
Percentage of family physicians using electronic medical recordsFootnote 6 (Baseline 73% in 2015) |
At least 80% | March 31, 2022 | 2016-17: 73%Footnote 6 2017-18: 73%Footnote 6 2018-19: 73%Footnote 6,Footnote 7 |
|
Performance Indicator | 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: 26% in 2012)Footnote 1 |
At most 15% | March 31, 2021 | 2016-17: 26%Footnote 1 2017-18: 26%Footnote 1 2018-19: 26%Footnote 1,Footnote 2 |
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)] |
At most 1% | March 31, 2019 | 2016-17: 1.6%Footnote 1 2017-18: 1.6%Footnote 1 2018-19: 1.3%Footnote 3 |
Percentage of Canada Health Act compliance issues addressed within 24 months of identification (Baseline 53% in 2015-16)Footnote 4, Footnote 5 |
At least 85% | March 31, 2019 | 2016-17: 86%Footnote 4 2017-18: 94%Footnote 6 2018-19: 94% |
Percentage of Canadians who did not fill a prescription for medicine because of the cost (Baseline 7.1% in 2014) |
At most 5% | March 31, 2022 | 2016-17: 7.1%Footnote 7 2017-18: 7.1%Footnote 7 2018-19: 5.0%Footnote 8 |
|
2018-19 Main Estimates |
2018-19 Planned spending |
2018-19 Total authorities available for use |
2018-19 Actual spending (authorities used) |
2018-19 Difference (actual minus planned) |
---|---|---|---|---|
1,270,981,764 | 1,270,981,764 | 1,309,249,998 | 1,289,851,245 | 18,869,481 |
Note: The variance of $18.9 million between actual and planned spending is mainly due to the following: Additional funding of $38.3 million for Cannabis Public Education, Funding for the Substance Use and Addiction Program, Addressing the Opioid Crisis, Supporting Canada's Official Languages, and statutory funding for payments pursuant to section 103 of the Patent Act as well as Canada Health Infoway. This is offset by $19.4 million mainly resulting from delays in the call for project proposals and lower than anticipated draws of contribution funds. |
2018-19 Planned |
2018-19 Actual |
2018-19 Difference (actual minus planned) |
---|---|---|
276 | 210 | -66 |
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
Departmental Result 3: Canadians have access to safe, effective and quality health products
In 2018-19, Health Canada continued to make investments towards ensuring Canadians have timely access to safe, effective and quality health products (including pharmaceutical drugs, biologics and radiopharmaceuticals, and medical devices) and to meet the needs of the health care system. Improvements introduced this year helped to accelerate access to market for innovative, breakthrough products along with cost effective alternatives, such as biosimilars and generics. In addition, the Department continued to strengthen its capacity to ensure timely review of drug submissions and to anticipate, enable and respond to innovative technologies coming to market.
Progress on achieving the Department’s commitments over the course of 2018-19 was made in relation to the following key activity areas: fostering a more agile regulatory system based on health care system needs; addressing drug shortages and discontinuations; promoting timely access to therapeutic products; expanding the priority review pathway; applying real-world evidence; mandating the reporting of adverse effects; fostering international collaboration; supporting risk-based compliance and enforcement; expanding regulatory oversight for clinical trials; increasing surveillance and inspections; modernizing the program for special access to drugs; supporting assisted human reproduction; improving stewardship of veterinary antimicrobial drugs; modernizing the framework for self-care products; updating fees charged to industry; as well as supporting transparency.
Fostering a more agile regulatory system based on health care system needs
In May 2018, Health Canada published final regulations in the Canada Gazette, Part II, to provide better information for patients on the safe use of opioids. These regulations make warning stickers and patient information handouts mandatory for all opioids dispensed at pharmacies or in doctor’s offices across Canada, beginning in October 2018. Under the new regulations, the Minister can impose terms and conditions on opioid authorizations. Opioid manufacturers will have to develop and implement risk management plans to help characterize, monitor, prevent, and manage risks associated with the use of their opioid products.
In March 2019, Health Canada proposed additional restrictions on the marketing and advertising of Class B opioid products (equal to or stronger than morphine) provided to health care professionals. Under Health Canada’s proposal, all promotional materials about Class B opioids provided to health care professionals, including print and electronic ads and pamphlets, must be limited to only statements that have been authorized by Health Canada in the Product Monograph.
In December 2018, Health Canada developed and released Health Canada’s Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality to accelerate its effort to strengthen the regulation of medical devices in Canada. The plan lays out a three-part strategy to improve how medical devices enter the market, to strengthen the monitoring and follow-up of devices once they are being used by Canadians, and to provide more information to Canadians about the medical devices they use. Activities completed in 2018-19 included developing a searchable database on medical device incidents and recalls, making Regulatory Decision Summaries (RDSs) for all new Class III medical devicesFootnote 1 available online, and posting of the Compliance Monitoring Project (CMP) on Decorative Contact Lenses.
The Department also published final regulations in Canada Gazette, Part II to allow for the public release of clinical information on drugs and medical devices. Making available more information about the safety and efficacy of these products can have widespread benefits for patients and the health care system by supporting independent analysis and research. This information could help health professionals make more informed decisions about the appropriate use of these products.
In addition, Health Canada sought nominations to establish a new external Scientific Advisory Committee on Health Products for Women. The committee will provide Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs.
Addressing drug shortages and discontinuations
Drug shortages and discontinuations impact the lives of Canadians, caregivers and the health care system. Health Canada continued to work closely with provinces and territories in order to manage these in 2018-19, including co-chairing, with provincial or territorial counterparts, a Multi-Stakeholder Steering Committee on Drug Shortages comprising industry and health care representatives. Health Canada also chairs regular meetings with international regulatory counterparts (including the U.S., the U.K., the European Union, Australia) to promote cooperation and collaboration in managing global drug shortages.
Promoting timely access to therapeutic products
The Department continued to provide Canadians with timely access to safe health products by reviewing the safety, efficacy and quality of pharmaceuticals. It approved 81 new pharmaceutical drugs for human use, of which 26 were drugs containing new active substances not previously approved in Canada, as well as 6 new veterinary drugs for use in companion and food-producing animals. Health Canada also approved 325 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 drugs already on the market. 27 of these new drugs and supplements were approved through an expedited pathway, to address unmet medical needs. The Department also approved 149 new generic drugs for human use and 7 new veterinary generic drugs. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. Generic drugs generally tend to cost less, so approving generic drugs can mean considerable savings to the healthcare system.
Health Canada approved 34 new biological drugs for human use, of which 14 were drugs containing new active substances not previously approved in Canada. The Department also approved 176 supplements for significant changes to biological 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.
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 (R2D2).
Health Canada aligned its review processes with those of Health Technology Assessment organizations (the Canadian Agency for Drugs and Technologies in Health [CADTH] and l'Institut national d'excellence en santé et en services sociaux [INESSS]). This allowed industry to opt-in to a parallel review process for all biological and pharmaceutical new drug submissions. Since this process was operationalized in June 2018, 19 aligned reviews were completed and 9 more are ongoing, thereby helping to improve timely access to needed therapeutic products.
Expanding the priority review pathway
Health Canada provides a faster review for drugs which meet unmet medical needs and which treat serious diseases. This is called “priority review”. In order to improve Canadians’ access to these important medicines, Health Canada began exploring several process improvement options in 2018-19. The Department consulted with patients, industry and other stakeholders to develop an expanded proposal with a view to allowing additional products that meet the needs of the health care system to become available to Canadians sooner.
Applying real-world evidence
Real world evidence (RWE) is the evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of real world data. The Department held a workshop in October with the Canadian Agency for Drugs and Technologies in Health (CADTH), the Canadian Association of Population Therapeutics, and the Institute of Health Economics to explore and advance the appropriate and strategic use of real-world evidence (RWE) across the health product life cycle. It included provincial cancer agencies, provincial payer agencies, the pan-Canadian Pharmaceutical Alliance, researchers and clinicians, patient stakeholder groups, and industry. As a result, CADTH and Health Canada committed to developing a joint RWE framework to define how RWE can be used to support regulatory and reimbursement decision-making.
In addition, the Department published in April 2018 a Notice of Intent to draft regulations on strengthening the use of RWE and regulations for medical devices. The proposed regulations would allow Health Canada to compel manufacturers to provide information on medical device safety and effectiveness. Such information could include: any documents and reports associated with a medical device; the results of any tests or studies conducted; the requirement for a manufacturer to reassess a product; and/or notification of any issues occurring in other countries.
Mandating the reporting of adverse drug reactions
Proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations were published in Canada Gazette, Part I, in June 2018 that would expand requirements for reporting serious adverse drug reactions and medical device incidents to include hospitals in order to help Health Canada better monitor the post-market safety of these products. In addition, draft guidance was posted for public consultation that would assist hospitals in complying with the new requirements.
Fostering international collaboration
In July 2018, the Department approved a new drug for the treatment of prostate cancer though a joint review with the Therapeutic Goods Administration of Australia. This work-sharing initiative helped to strengthen international partnerships in submission review and to accelerate the approval of a drug for the benefit of Canadians. The Department continues to undertake international regulatory cooperation for veterinary drugs with the US Food and Drugs Administration - Center for Veterinary Medicine, Australian Pesticides and Veterinary Medicines Authority and the New Zealand Ministry of Primary Industries. As of March 31, 2019, 12 drugs had been authorised for sale in Canada since the start of regulatory cooperation efforts.
In addition, Health Canada took a leadership role in managing global risks related to prescription drugs. Starting in 2018, the Department led an international regulatory working group resulting in recalls for a class of blood pressure drugs known as angiotensin receptor blockers or “sartans”. Health Canada continues to share information and coordinate international efforts on inspections, risk assessments and communications to help mitigate the associated health risks.
Furthermore, in order to improve its risk-based compliance and enforcement strategies, Health Canada implemented, and continues to refine, a system for planning and scheduling inspections based on the risks associated with domestic and foreign sites. The Department also conducted 12 joint inspections with international regulators, including the U.K.’s Medicines and Healthcare products Regulatory Agency, the U.S. Food and Drug Administration, the European Medicines Agency, and Australia’s Therapeutic Goods Administration.
Supporting risk-based compliance and enforcement
In 2018-19, Health Canada updated its Compliance and Enforcement Policy (POL-0001) that outlines the overarching approach to compliance and enforcement for health products regulated under the Food and Drugs Act and its regulations. The policy is a critical tool in communicating the organisation’s mandate and expectations to stakeholders. It provides clarity on the Department’s compliance expectations for regulated parties, as well as openness and transparency about regulatory decision-making.
Expanding regulatory oversight for clinical trials
Over the course of 2018-19, Health Canada continued to modernize the Clinical Trial Compliance Program to expand oversight contributing to enhanced patient safety and the integrity of trial data. The Department conducted 14 pilot inspections, including expanding the locations and the types of clinical trials it inspected. In addition, it provided new training to all clinical trial inspectors to enhance their ability to identify problems with data submitted to Health Canada. This aligns with international regulators (e.g., the U.K.’s Medicines and Healthcare products Regulatory Agency and U.S. Food and Drug Administration).
Increasing surveillance and inspections
With an increased number of inspectors, Health Canada implemented the National Border Enforcement Strategy that enabled the program to focus inspections on higher risk products such as Active Pharmaceutical Ingredients used in street drugs, counterfeit drugs and sexual enhancement products.
Modernizing the program for special access to drugs
Health Canada is modernizing the Special Access Programme (SAP) and Emergency Drug Release program in order to reduce the administrative burden for healthcare professionals when accessing products that are not currently available in Canada (SAP for human drugs and the Emergency Drug Release program for veterinary drugs). These programs facilitate access by practitioners to products that are not currently authorized for sale in Canada to treat patients and animals with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable.
In pursuing various considerations for modernizing the programs, Health Canada drafted a proposal that would amend the Food and Drug Regulations in order to provide appropriate authorities to improve program operations.
The Department also drafted a regulatory proposal that would facilitate access to unauthorized drugs that could be used to treat mass populations during a Canadian public or military health emergency (e.g., pandemic influenza vaccine, antivirals, etc.).
Supporting assisted human reproduction
In October 2018, draft regulations under the Assisted Human Reproduction Act were pre-published in Canada Gazette Part I for consultation. Stakeholders were also invited to provide input on the draft Health Canada Directive, a document that was incorporated by reference into the proposed regulations. The regulations aim to help protect the health and safety of people who use, or are born of, assisted human reproduction, reflect the latest scientific advancements, and offer Canadians more options for building their families. They also provide clarity related to reimbursement and set out procedures for administering and enforcing the Act.
Improving stewardship of veterinary antimicrobial drugs
Antimicrobial resistance (AMR) is a serious global public health issue. In 2018-19, Health Canada took action to address AMR as it relates to the use of antimicrobial products in animals. The Department continued to implement changes to the Food and Drug Regulations published in 2017. Companies that manufacture, import or compound medically important antimicrobials now need to report annually sales of these drugs. To help companies report, Health Canada, in collaboration with PHAC, launched an online sales reporting tool. Sales information from 2018 obtained by the Department will assist its surveillance programs.
Animal owners are looking for more options to improve animal health and reduce the need for antimicrobials. Through the Veterinary Health Products Notification Program, 506 products were notified for sale in Canada in 2018-19 to maintain and/or improve the health of companion and food producing animals.
In order to promote the responsible use of medically-important antimicrobials in animals and combat the increasing prevalence of AMR, effective December 1, 2018, Health Canada now requires veterinary prescriptions for all medically-important antimicrobials for use in all animals.
Modernizing the framework for self-care products
Through its Self-Care Framework initiative, Health Canada is modernizing its approach to regulating self-care products (cosmetics, natural health products and non-prescription drugs) while allowing for the ongoing availability of a wide range of products and better supporting consumers’ ability to make informed choices. Within the first phase of the Self-Care Framework, the Department published, in April 2019, Consulting Consumers on Self-Care Product Labelling: A Report on What We Heard. The report highlighted the results of focus group sessions held in 2018-19 with stakeholder groups on proposed improvements to the labelling of natural health products. Labels are an important tool to assist Canadians in making informed decisions when using health products.
Updating fees charged to industry
In May 2018, Health Canada published a revised Fee Proposal for Drugs and Medical devices and initiated a feedback process to collect input from stakeholders. Updated fees will be implemented beginning April 1, 2020 and will be phased in over four years for human products and seven years for veterinary products.
Supporting transparency
In support of the Government’s commitment to openness and transparency, Health Canada continued over the course of 2018-19 to provide credible and timely information to empower Canadians to make informed health decisions and reinforce businesses’ responsibility for the safety of their products. For example, in June 2018, the Department started to post listings of its communications between stakeholders and departmental officials on the Regulatory Review of Drugs and Devices (R2D2) initiative.
Health Canada made more information available to Canadians, and offered more opportunities for them to participate in discussions on government policies and priorities, including informing them of new approvals for drugs and Class IV medical devices (those representing the highest risk) via Twitter and LinkedIn using the hashtag #drugandmeddevice. The Department also provided quarterly updates listing the drugs and medical devices that had been authorized during the previous three months.
Furthermore, Canadians were informed of the many significant achievements of the year, including how Health Canada continued to make important medications and medical devices available to Canadians, through Health Canada’s Annual Highlights Report on New Drugs and Medical Devices.
Departmental Result 4: Canadians are protected from unsafe consumer and commercial products and substances
Health Canada helps protect Canadians from unsafe consumer and commercial products and substances by using appropriate tools to manage these risks and communicating them to Canadians. By improving risk communication and increasing public understanding of the risks of consumer and commercial products and substances, the Department continues to support the government’s commitment to openness and transparency while better empowering Canadians to take action to protect themselves. In addition, Health Canada continues to require industry to fulfill their regulatory obligations.
Progress on achieving the Department’s commitments over the course of 2018-19 was made in relation to the following key activity areas: responding to the national opioid overdose crisis and problematic substance use; identifying and developing regulatory priorities and policy frameworks; improving chemical safety through the Chemicals Management Plan; improving workplace safety through the safe use of chemicals; supporting the safety of consumer products and cosmetics; improving communication on pesticides decisions; as well as advising on the health impacts of major projects.
Responding to the national opioid overdose crisis and problematic substance use
With our partners, Health Canada continued to take action in 2018-19 on the national opioid overdose crisis by coordinating a collaborative approach that is grounded in compassion, innovation and evidence. This included extensive cooperation and engagement with a diverse range of stakeholders, including people with lived and living experience with substance use, so that the response is informed by the perspectives and expertise of those directly affected.
The Department introduced legislative and regulatory changes that enable frontline overdose prevention, and invested significantly to expand mental health and substance use treatment services across the country. In 2018-19, Health Canada signed bilateral agreements with all provinces and territories through the Emergency Treatment Fund. This $150 million federal investment was cost-matched by provinces and territories for a total of over $308 million to improve access to evidence-based treatment services for Canadians. Health Canada also funded 71 projects under the Substance Use and Addictions Program, including those to enhance treatment and improve access to harm reduction strategies.
In September 2018, Health Canada hosted an Opioid Symposium that brought together over 200 participants including federal, provincial and territorial ministers and officials; researchers, health experts and medical practitioners; representatives from Indigenous communities; members of law enforcement, public safety and corrections organizations; and over 50 people with lived and living experience related to opioid use in order to facilitate a better collective response to the opioid overdose crisis.
The Department also conducted a 90-day public consultation to gather new and innovative ideas on potential next steps under the Canadian Drugs and Substances Strategy and developed and implemented an agreement with the Ontario College of Pharmacists to improve data sharing and reporting.
Exemptions were issued to nurses that expanded their ability to transport, provide and administer controlled substances. At the same time, the Department implemented regulatory amendments that removed barriers to accessing diacetylmorphine (prescription heroin) and methadone for the treatment of opioid use disorder.
Health Canada streamlined the process to establish supervised consumptions sites, increasing from 2 to 40 approved sites (as of March 31, 2019) that offer services including drug checking and peer assistance. The Department also launched a national awareness campaign to reduce stigma towards people who use drugs, enhanced public health surveillance to improve availability of and access to data, and offered opioid overdose response information and training sessions to Health Canada and PHAC employees to encourage other employers to take similar action.
Approaching the issue holistically, Health Canada also announced the creation of the eight-member Canadian Pain Task Force, which was given a three-year mandate to provide advice to the Department regarding evidence and best practices for the prevention and management of chronic pain. Health Canada subsequently recruited External Advisory Panel members to ensure a broad range of knowledge, experience, expertise, and perspectives on the issue. Members of the Task Force and Advisory Panel include people with lived/living experience, as well as researchers, educators, and health professionals with experience and expertise in preventing and managing chronic pain. The Task Force convened in March 2019 to begin developing their first report, with a focus on how chronic pain is currently addressed in Canada.
Identifying and developing regulatory priorities and policy frameworks
Health Canada implemented the Cannabis Act and associated regulations, Canada’s new, public-health-based framework that restricts access to cannabis and establishes a regulated supply chain that aims to displace the illegal market. The Government also made significant investments in 2018-19 to support Canadians in making informed health decisions around cannabis use.
The Department closely monitored the impacts of cannabis legalization and regulation, and published the results of the Canadian Cannabis Survey in November 2018.
Health Canada also launched a process to modernize the regulatory framework underlying the Controlled Drugs and Substances Act (CDSA), which will rectify inconsistencies and gaps; make it more responsive and adaptable; reduce the administrative burden on industry; and enable the implementation of new and innovative health care service delivery models.
The Department also supported the Regulatory Modernization Agenda led by the Treasury Board Secretariat (TBS). In consultation with the public and stakeholders, it participated in the first round of regulatory reviews, which included the development of a regulatory roadmap for the Health and Biosciences Sector, and provided input to the Agri-food and Aquaculture Roadmaps.
Improving chemical safety through the Chemicals Management Plan (CMP)
Over the course of 2018-19, Health Canada continued assessing the safety of existing substances under the CMP, with approximately 83% (3,639 substances) of the total targeted for assessment by March 2021 now completed. While the Department is well on its way to meeting its 2021 target, it is also taking action to address challenges posed by the scientific complexity of some assessments and the additional time required to determine appropriate risk management approaches. Steps include prioritizing regulatory packages and acquiring surge capacity to support more assessments.
Health Canada, in collaboration with Environment and Climate Change Canada, also continued to assess all new substances (over 370 in 2018-19) before these were imported into or manufactured in Canada under the authority of the Canadian Environmental Protection Act, 1999. Where the Department identified risks, it instituted measures to manage them in order to protect human health and the environment.
Furthermore, Health Canada 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 respond to outstanding questions and knowledge gaps related to the effects and exposure of chemical substances on humans.
The Department also delivered environmental health outreach to the Canadian public over the course of 2018-19. Most notably, it launched the new Healthy Home Campaign in January 2019 to raise Canadians’ awareness about health risks from chemicals of concern and pollutants that may be found in and around the home (such as mould and asbestos). The campaign also provides plain language summaries for the public on specific CMP substances (such as furans, solvent violet 13, and talc) that were also promoted through social media (Facebook and Twitter). Many media outlets used the Department’s publication-ready print and web articles and radio clips, resulting in Health Canada messages being viewed or heard up to 40 million times.
Health Canada also educated and enabled key stakeholders such as those who work with vulnerable populations (e.g., daycare workers, nurses, Indigenous groups, and health practitioners). Public outreach materials and workshop products were also developed for ethnic populations and newcomers to Canada and distributed to Chinese, South Asian, and Arabic media channels.
Improving workplace safety through the safe use of chemicals
In 2018-19, the Department worked with federal, provincial, and territorial partners to conduct the first ever national inspection project on industrial cleaning chemicals, protecting the safety of Canadian workers through increasing awareness of industry’s responsibilities, and using compliance and enforcement actions where and when appropriate.
The Department also completed the transition to the Workplace Hazardous Materials Information System (WHMIS) 2015, which incorporates the new Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for workplace chemicals, thereby helping to create safer Canadian working environments.
Supporting the safety of consumer products and cosmetics
Over the course of 2018-19, Health Canada conducted over 8,000 inspections of consumer products, cosmetics, and establishments that manufacture, advertise, import or sell those products in Canada. The Department also communicated 236 recalls due to health or safety concerns affecting 5.5 million consumer product units ranging from USB chargers to bassinets.
In November 2018, Health Canada signed an information sharing agreement with the European Commission under the Comprehensive Economic and Trade Agreement which will allow Canada and Europe to react quicker to potential risks posed by consumer products and share information on new products entering the market.
In addition, Health Canada provided information and tools to help Canadians make informed health and safety decisions related to consumer products and cosmetics (such as through 27 social media campaigns), and conducted a series of targeted outreach activities to help businesses better understand their obligations under the Canada Consumer Products Safety Act.
Health Canada also modernized its safety requirements for playpens and children's toys by introducing updated regulations for products manufactured, advertised, imported or sold in Canada.
Improving communication on pesticide decisions
Following the publication of the Policy on Cancellation and Amendments Following Re-evaluation and Special Review in March 2018, Health Canada began publishing pesticide re-evaluation decision documents that describe the re-evaluation decision, outcomes of science evaluation, risk mitigation measures and next steps – including when any changes resulting from the re-evaluation will take effect.
In support of openness and transparency, in December 2018, the Department hosted a web session for stakeholders of the Pesticide Program, which covered such topics as pre-market and post-market activities, including compliance and enforcement.
Advising on the health impacts of major projects
The Department provided expert information and knowledge on potential human health impacts to support the federal review of proposed major projects (e.g., pipelines, mines, hydroelectric dams), developed new guidance documents, and prepared for implementation of the Impact Assessment Act (Bill C-69).
Departmental Result 5: Canadians make healthy choices
In 2018-19, Health Canada undertook a number of important activities to provide Canadians with access to evidence-based information, tools and innovative initiatives in support of a healthier lifestyle.
Progress on achieving the Department’s commitments over the course of 2018-19 was made in relation to the following key activity areas: reducing tobacco use; responding to the risks of vaping products; administering Canada’s new cannabis regime; overseeing the transformation of Canada’s Food Guide; restricting the commercial marketing of foods that contribute to excess consumption of sodium, saturated fat and sugars; and regulating front-of-package labelling.
Reducing tobacco use
In 2017, 18% (5.3 million) of Canadians aged 15 years and older reported using at least one tobacco product in the past 30 days, higher than the 15% (4.6 million) in 2015, which is concerning. According to the 2016-17 Canadian Student Tobacco Alcohol and Drugs Survey (CSTADS), the prevalence of ever trying an e-cigarette among students in grades 7-12 also increased to 23% from 20% in 2014-15 while 10% of students had used an e-cigarette in the past 30 days, an increase from 6% in 2014-15. In order to continue striving to reduce tobacco use, on May 31, 2018 the Department launched Canada’s Tobacco Strategy with the goal of achieving less than 5% tobacco use by 2035. The Strategy commits $330 million over 5 years to help Canadians who smoke to quit while protecting the health of young people and non-smokers from the dangers of tobacco and nicotine use.
Health Canada also proposed plain packaging regulations for tobacco products that will restrict brand colors, logos and graphics on tobacco products and packages in order to reduce their appeal to Canadians, particularly among youth. The regulations have since been published in the Canada Gazette, Part II and came into force on November 9, 2019.
Responding to the risks of vaping products
In response to the growing use of vaping products, Health Canada implemented the new Tobacco and Vaping Products Act in May 2018 to regulate the manufacture, sale, labelling and promotion of tobacco and vaping products in Canada. Given the Act’s emphasis on protecting young persons by restricting access to tobacco and vaping products and from inducements to use these products, the Department continued to monitor youth tobacco and vaping use through the Canadian Student Tobacco, Alcohol and Drugs Survey, collecting from October 2018 to June 2019. Heath Canada also supported the development of an electrical standard for vaping devices to protect users from hazards including electrical shock and fire. In January 2019, the Department launched a youth vaping prevention public education campaign with national reach to raise awareness about the harms and risks of vaping for youth. Additionally, in February 2019, the Department posted a Notice of Intent that outlined potential regulatory measures to reduce the impact of vaping product advertising on youth and non-users of tobacco products.
Administering Canada’s new cannabis regime
Leading up to and following the implementation of the Cannabis Act and Regulations, Health Canada increased the number of licensed sites from 41 in March 2017 to 123 in March 2019 in order to meet the demand for this new industry while protecting Canadians. Access to cannabis for medical purposes has been maintained. The Department also made significant efforts to promote and monitor compliance and found a 97% compliance rate during inspections in 2018-19.
In addition, Health Canada supported cannabis legalization and regulation with a strong digital, social media and mailout public education campaign that reached millions of Canadians. Activities included an advertising campaign entitled “Your Cannabis Questions, Answered. Get the Honest Facts”, which provides evidence-based answers to Canadians’ questions about cannabis; the “Pursue Your Passion” interactive tour to help youth and young adults learn about cannabis health and safety facts and encouraged them to make healthy lifestyle choices; and a national mailout that reached 15 million households on the new Cannabis Act (and Regulations) and the health effects of cannabis use.
The Department closely monitored the impacts of cannabis legalization and regulation, and published the results of the Canadian Cannabis Survey in November 2018.
Overseeing the transformation of Canada’s Food Guide
In January 2019, the Minister of Health launched the new Canada’s Food Guide. The Guide is an online suite of resources to better meet the needs of different users, including the general public, policy makers and health professionals. Canada’s new dietary guidance includes advice for Canadians on healthy food choices and healthy eating habits. The Food Guide encourages all Canadians to cook more often, enjoy food, be mindful of eating habits, and eat meals with others.
Restricting the commercial marketing of foods that contribute to excess consumption of sodium, saturated fat and sugars
To protect the health of our children, Health Canada continued to consult on approaches to restrict advertising primarily directed at children under 13 years old, of foods that contribute to excess consumption of sodium, saturated fat and sugars. The Department engaged extensively with stakeholders, health experts and academia through meetings and broader engagement sessions on the policy and application of the proposed regulations. Notably, Health Canada broadly distributed version 1.0 of the draft Guide to the application of the proposed regulatory approach for feedback. A report summarizing the comments received is available for order on the Department’s website.
The Department is also revising sodium reduction targets for pre-packaged foods and developing targets for restaurant foods to help reach the goal of a 30% overall reduction in sodium intake by 2025. Health Canada has been actively engaging stakeholders to help inform the development of these new targets.
Regulating front-of-package labelling
In 2018-19, Health Canada completed its analysis of front-of-package data and continued to advance proposed regulations for front-of-package symbols on foods high in sodium, sugars and saturated fat. This initiative will help Canadians to make better choices and encourage manufacturers to reduce sodium levels in many foods. In July 2018, the Department announced the “Sodium Intake of Canadians in 2017” report. According to the report, Canadians consume 2,760 milligrams of sodium each day. This is almost double the daily-recommended amount. High sodium diets can lead to high blood pressure, which is a major risk factor for heart disease and stroke.
Results achieved
Departmental Result Indicators | Target | Date to achieve target | Actual Results |
---|---|---|---|
Percentage of new drug decisions issued within service standardsFootnote 1 (Baseline 88% in 2017-18) |
At least 93% | March 31, 2019 | 2016-17: 92%Footnote 1 2017-18: 88%Footnote 1 2018-19: 98% |
Percentage of Risk Management Plan reviews for new drug decisions completed within service standardsFootnote 2 (Baseline 91% in 2017-18) |
At least 90% | March 31, 2019 | 2016-17: 100% 2017-18: 91% 2018-19: 98% |
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, 2019 | 2016-17: 96% 2017-18: 96% 2018-19: 94% |
|
Departmental Result Indicators | Target | Date to achieve target | Actual Results |
---|---|---|---|
Percentage of consumer product recalls communicated to Canadians in a timely manner (Baseline 86% in 2016-17) |
Between 85 and 90%Footnote 1 | March 31, 2019 | 2016-17: 86% 2017-18: 87% 2018-19: 93% |
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 88% in 2018-19) |
100%Footnote 2 | March 31, 2019 | 2016-17: 85% 2017-18: 86% 2018-19: 88%Footnote 3,Footnote 4 |
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 environmentFootnote 5 (Baseline 94% in 2018-19)Footnote 6 |
At least 80% | March 31, 2019Footnote 7 | 2016-17: N/AFootnote 7 2017-18: N/AFootnote 7 2018-19: N/AFootnote 8 |
|
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,Footnote 6 |
At most 5%Footnote 2 | March 31, 2035Footnote 2 | 2016-17: 15.5%Footnote 4 2017-18: 15.5%Footnote 4 2018-19: 17.8%Footnote 5 |
Percentage of Canadians (aged 15-24) who have used cannabis in the last 12 months [Baseline 25.5% in 2016-17Footnote 4 (17.5% of Canadians aged 15-17 and 28.4% of Canadians aged 18-24)]Footnote 6 |
To be established by Dec. 31, 2020 | To be established by Dec. 31, 2020 | 2016-17: 25.5%Footnote 4 (17.5% of Canadians aged 15-17 and 28.4% of Canadians aged 18-24)Footnote 6 2017-18: 25.5%Footnote 4 (17.5% of Canadians aged 15-17 and 28.4% of Canadians aged 18-24)Footnote 6 2018-19: 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 CanadaFootnote 8 (Baseline 41% in 2012)Footnote 7 |
At least 60% | March 31, 2021 | 2016-17: 41%Footnote 7 2017-18: 57%Footnote 8 2018-19: 57%Footnote 8 |
|
2018-19 Main Estimates |
2018-19 Planned spending |
2018-19 Total authorities available for use |
2018-19 Actual spending (authorities used) |
2018-19 Difference (actual minus planned) |
---|---|---|---|---|
597,556,711 | 597,556,711 | 747,158,705 | 726,841,710 | 129,284,999 |
Note: The variance of $129.3 million between actual and planned spending is mainly due to the following: Additional in-year funding of $149.6 million for Addressing the Opioid Crisis, Funding to transition to new impact assessment and regulatory processes, as well as Renewing and Enhancing the Federal Tobacco Control Strategy. This is offset by $20.3 million mainly resulting from delays in project delivery, as well as delays in securing new accommodations. |
2018-19 Planned |
2018-19 Actual |
2018-19 Difference (actual minus planned) |
---|---|---|
5,591 | 5,193 | -398 |
Note: The variance in FTEs utilization is mainly due to the fact that planned FTEs are based on revenue the Department is authorized to collect and actual FTEs is based on the amount of revenue collected. |
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 activities and related 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 undertook the following key initiatives in 2018-19 in the area of Internal Services:
Human Resources Management Services
The Department continued its focus on supporting its employees and achieving its departmental results in the most effective and efficient manner possible. In support of workplace well-being, a Centre for Mental Health, Wellness and Respect in the Workplace was established and a Mental Health First Aid Toolkit was distributed to all employees.
Health Canada continued to enable a culture of high performance by providing learning, development and career opportunities to all staff. As well, the Department offered student placement opportunities to a record 980 students, a 29.5% increase over last year. It recruited 223 post-secondary graduates, a 36% increase from 2017-18.
Health Canada supported employee engagement and change management activities through Blueprint 2020 and Public Service Renewal initiatives, including:
- Health Talks events, where employees heard from experts on sex and gender-based analysis and generational stereotypes;
- “Health Canada: Working for Canadians” web series, which shared stories on topics such as the new Canada’s Food Guide, engaging youth about the risks of cannabis.
Health Canada fostered a corporate culture that supports workplace well-being, employment equity, and healthy working relationships that are free from harassment through such measures as the establishment of a Centre for Mental Health, Wellness and Respect in the Workplace. Furthermore, the Department continued implementation of Health Canada and PHAC’s Multi-Year Mental Health and Wellness in the Workplace Strategy by delivering sessions on a variety of topics (e.g., bullying in the workplace), distributing Mental Health First Aid Toolkits to all employees, organizing a variety of events during the year such as the the 3rd National Respect in the Workplace Annual Campaign and a national event for Bell Let’s Talk Day.
Health Canada also sustained efforts to meet requirements under the HC Multi-Year Diversity and Employment Equity Plan, which included closing employment equity gaps. As an example, the Department hired eight LiveWorkPlay (employees with intellectual disabilities) participants.
The Ombudsman, Integrity and Resolution Office (OIRO) acted as an early warning system for the organization as a whole, identifying workplace issues and trends and provided recommendations on how these can be addressed. Of all the services provided, coaching was the top intervention (coaching, Multi-Party Interventions, systemic interventions, general resolution strategies).
A national tour, with the Ombudsman and Senior Conflict Management Practitioners, took place providing guidance and direction and communicating on the services that are available. OIRO provided mechanisms and assistance to employees to all levels to raise, discuss and resolve issues of concerns in the workplace.
Finally, the Department enabled a culture of high performance through continued support for employee career development, post-secondary recruitment, performance management, and learning and development opportunities. Its Year-End completion rate for Performance Management Agreements was well above the core public service average. Health Canada employees also completed 7,921 learning activities at the Canadian School of Public Service and 7,349 in-house learning activities this past fiscal year.
Financial Management Services
In 2018-19, Health Canada supported Public Services and Procurement Canada in addressing pay issues faced by its employees, including those related to the Phoenix pay system (e.g., accurate and timely pay), by providing emergency salary advances and priority payments while building in-house compensation capacity to support the Public Service Pay Centre.
In addition, the Department enhanced controls over the Financial Management of Pay Administration and strengthened risk-based controls, including by establishing a salary management oversight team, providing cost-centre management training, and implementing a data analytics unit to more closely examine various types of expenditures. Furthermore, Health Canada is developing a roadmap to the next version of SAP. An investment planning framework was completed and a corporate approach to capital investments was applied, aligning to strategic priorities. The Department has strengthened performance measurement through implementing the Policy on Results and ensuring that the Departmental Results Framework is the basis for reporting to Canadians.
Information Management Services / Information Technology Services / Real Property Services
The Department continued to modernize the workplace in order to enable a safe and productive workforce, providing employees with access to modern tools and facilities. IM-IT Security awareness to mitigate cybersecurity threats was enhanced through training and a phishing awareness campaign. All activities planned for this second year of the multi-year IT Security Strategic Plan were completed, resulting in the introduction of new and revised IT security standards. Health Canada also continued to improve mobile access through the replacement of desktops with laptops, the adoption of modern smartphones, and WI-FI enablement.
In alignment with Government of Canada direction, the Department also updated its National Accommodations Strategy and launched a new Workplace Wellness Services Centre. In addition, it made infrastructure improvements to its custodial laboratories and office and health facilities across 8 provinces and 11 cities nationally, with an investment of $53.0 million received from the 2016 Federal Infrastructure initiative.
Communications Services
In 2018-19, Health Canada used digital and other innovative tactics to provide Canadians with timely communications on a number of priority files. These tactics included social media, web content, digital and traditional advertising, experiential events and partnerships, in additional to more traditional methods of communications such as news releases and proactive media relations. These activities provided information on a range of topics, including: tobacco cessation; vaping prevention; Canada’s Food Guide; food safety; consumer product safety; health product safety; legalization and regulation of cannabis; and increasing awareness of the opioid overdose crisis.
For example, cannabis communications featured a public education campaign on the health effects of cannabis, a redesigned web presence on Canada.ca, a postcard mailed to more than 15 million households, and a digital engagement kit. It also included an innovative experiential marketing tour (“Pursue Your Passion”) with interactive exhibits encouraging youth to pursue healthy and creative activities rather than consuming cannabis.
Ads on opioid awareness were viewed more than 2.5 million times. As a direct result, 17% of those who saw the ads said they discussed opioids with friends or family. The ‘Know More’ experiential marketing tour consisted of more than 220 events in 2018-19 and educated youth on the risks of opioids. In addition, the stigma awareness ads were viewed close to 6 million times. Post campaign evaluation revealed 57% believe that stigma creates a barrier to seeking treatment.
For more information on the Health Canada’s plans, priorities and results achieved, see the “Results: what we achieved” section of this report.
2018-19 Main Estimates |
2018-19 Planned spending |
2018-19 Total authorities available for use |
2018-19 Actual spending (authorities used) |
2018-19 Difference (actual minus planned) |
---|---|---|---|---|
302,976,567 | 302,976,567 | 369,038,879 | 353,056,297 | 50,079,730 |
Note: The variance of $50.1 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 2019-20, and internal services resources received from various Treasury Board approved initiatives. |
2018-19 Planned |
2018-19 Actual |
2018-19 Difference (actual minus planned) |
---|---|---|
1,687 | 2,268 | 581 |
Note: The variance in FTE utilization is mainly due a technical adjustment for the provision of shared services to PHAC, and additional resources received in-year for the internal support services from various Treasury Board approved initiatives. |
Experimentation / Innovation / GBA+
Experimentation / Innovation
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.
In support of the directive on experimentation from the Treasury Board Secretariat, in spring 2018, Health Canada launched a new funding program known as the Solutions Fund: Powering Employee Innovation. The Solutions Fund is consistent with the Government of Canada’s commitment to supporting experimentation to instill a culture of measurement, evaluation and innovation in program and policy design and service delivery.
In the first year of the Solutions Fund, 23 proposals were submitted. Proposals were thoroughly reviewed and by the end of fiscal 2018-19, the following 5 proposals had been approved for funding and had begun the solution-exploration or solution-experimentation phase:
- Project Cyclops – aimed at improving existing product labelling inspection processes by combining smartphone technology, machine learning, and augmented technology
- Systematic Review Approaches and Use of Artificial Intelligence (AI) in Risk Assessment – piloting the use of AI tools in systematic reviews to improve how we assess the risks of chemicals on human health;
- Project Cipher – an experiment involving AI and machine learning to pull data from inspection reports to enhance evidence and decision-making;
- Project Hummingbird – to explore the feasibility of using drones for the conduct of cannabis inspections; and
- FTIR spectroscopy – using FTIR (infra-red spectroscopy) to more rapidly identify visible impurities in health products and cannabis.
Funded project teams were provided with individualized coaching and professional development to help improve project outcomes. Additionally, workshops and learning sessions were offered to employees to help build experimentation capacity within the Department.
Other examples of Experimentation / Innovation include the following:
- In the context of food labelling, social research helps to ensure Canadians can more easily access food and nutrition information, understand it, and be able to compare, evaluate and apply this to make healthy food choices. An existing health literacy measurement tool was adapted and validated in the Canadian context and on-line. Complex and creative methodologies were developed for consultations: online Food Front-of-Package nutrition symbol consultation and food labelling concept testing such as the Front-of-Pack symbols on various food packages (e.g., online mock package trial and eye tracking study in a grocery store lab) to simulate real world food decision making.
- In addition, Health Canada has worked at implementing the statistical evaluation of Usual Intakes (the average daily sodium intakes of Canadians) using the National Cancer Institute (NCI) Method within the Canadian context. The NCI Method is a powerful tool for the evaluation of Usual Intakes. This work allows for the evaluation of Usual Intakes for nutrients as well as for food – whether they be consumed regularly or episodically. It also allows for the evaluation of Total Intake (intake of a nutrient from food and from supplement). This work will serve many people involved in research in the nutrition community across Canada.
- For the first time, Health Canada carried out a randomized test of its consumer product safety website comparing the current layout with a more accessible design. The results are being used to improve the frequency with which Canadians report unsafe consumer products to Health Canada.
- Health Canada launched the Drug-Checking Technology Challenge, under the Impact Canada Initiative. The challenge is designed to reduce harm by creating a rapid, accurate, easy to use, low cost testing device or instrument that can be used with minimal training and preparation work. This in turn, provides more valuable information to people who use drugs and those who support them, so they can make more informed choices, which can help lower the risk of overdose deaths. The Challenge has nine semi-finalists that received $25,000 each to develop prototypes for the next stage of the initiative.
Sex and Gender-Based Analysis Plus (SGBA+/GBA+)
Launched in 2017, Health Canada’s Sex and Gender Action Plan provides a framework that strengthens the integration of sex, gender and diversity considerations (such as age and ethnicity) in externally as well as internally facing work of the Department. Note that the terms Gender-Based Analysis Plus (GBA+) and Sex and Gender-Based Analysis Plus (SGBA+) refer to the same concept. Health Canada has chosen to use SGBA+ to emphasize the fact that differences between women, men and gender-diverse individuals can be biological (sex related) and/or socio-cultural (gender related). The Department’s Action Plan aims to:
- Increase positive impacts on health outcomes and the health status of Canadians by designing initiatives to address the diverse needs of Canadian women, men, girls, boys and gender-diverse individuals;
- Maximize positive impact on workplace health and engagement by developing policies and processes that respond to the diverse needs of our employees.
Current priorities of the three-year Action Plan are to:
- Increase departmental capacity to apply sex and gender-based analysis (SGBA+);
- Strengthen the sex, gender and diversity-related evidence base and expertise;
- Increase the accountability and transparency for implementing SGBA+.
Each branch has identified at least one signature initiative and the Department in collaboration with the Canadian Institutes of Health Research (CIHR) has established research-policy partnerships, which support researchers, with both subject matter and SGBA+ expertise, to engage with departmental staff on priority Health Canada initiatives.
Key related results include:
Cannabis
Health Canada, in collaboration with CIHR, co-funded a researcher with sex and gender expertise to consider sex and gender implications related to cannabis and help inform cannabis public education messaging. The Department also designed its new Canadian Cannabis Survey to collect additional demographic variables, including sex, gender identity and sexual orientation, to better understand cannabis use.
Evaluation
The Department piloted the application of PHAC’s Health Equity Tool in the evaluation of Health Canada’s Food Safety Program. Findings included: communications and outreach efforts to Canadians have been targeted toward those most at risk (i.e., seniors, those with compromised immune systems, pregnant women, and children under five years of age), and specific products (e.g., pamphlets and posters) have been developed to reach them. The Program has conducted surveys of Canadians’ knowledge and behaviours related to food safety, which helps to better target high-risk groups. In addition, the tool was updated to align with the Treasury Board Secretariat 2016 Policy on Results and guidance document “Integrating GBA+ into Evaluation”, and is now being applied as the Public Health Agency of Canada/Health Canada Program Evaluation Division’s SGBA+ Lens for Evaluation.
Health product labelling
Health Canada is proposing to change the regulations for the labelling of Natural Health Products to make them easier for consumers to read and understand. As part of this initiative, the Department, along with research partners from McGill University, completed a sex-based analysis on public opinion data. The results are being used to help support the proposal for improved labelling of natural health products.
Risk communications
The Department is applying a sex and gender lens to risk communications. An initial literature review indicated that there are gender-relevant considerations for risk communications such as differences in risk perception, negative dominance (tendency towards a negative interpretation), and trust determination concepts. These were incorporated into bilingual Sex Gender and Risk Communication Webinars provided over 2018-19. An advisory group was created to guide future work on this issue.
Vaping
The new Tobacco and Vaping Products Act was enacted in May 2018, regulating the manufacture, sale, labelling and promotion of vaping products. Health Canada is committed to integrating sex, gender and diversity considerations into all aspects of its emerging vaping products framework, including policy, programs, regulations, communications, surveillance, research and evaluations. The Department is incorporating sex and gender identity factors into new and existing surveillance activities, including public opinion research and a new grants and contributions stream through the Substance Use and Addictions Program that incorporates requirements for reporting SGBA+ data. The findings from these activities are expected to improve the quality of data used in policy development.
Pest management
Pesticides must undergo a high level of scientific evaluation before they can be registered for use in Canada. Companies applying to register a pesticide must provide Health Canada with a large number of health and environmental studies, which must follow internationally accepted scientific standards. When a pesticide is being evaluated for its potential risks to human health, the Department takes into account that chemicals may pose higher risks to groups of people based on differences in biology and behaviour, for example differences due to sex, gender, age and occupation. In 2018-19, Health Canada’s Pest Management Regulatory Agency (PMRA) produced a fact sheet illustrating how sex, gender and vulnerable populations are taken into consideration in the regulation of pesticides in Canada, for use in outreach activities.
Home care
Over 2018-19, Health Canada launched an initiative to develop an evidence-based technology assessment framework that explicitly addresses sex, gender and diversity considerations for digital technology to support informal caregivers. The process included a Canada-wide survey as well as interviews with informal caregivers, which suggest significant differences in technology preferences between male and female caregivers. The results are being disseminated to stakeholders in the field and can be used by Health Canada to develop sex, gender and diversity sensitive policies.
Workplace health
Health Canada is developing a toolkit that applies a sex and gender lens to mental health in the workplace. It will contribute to a better understanding of how sex, gender and diversity contribute to the experiences of mental health within a workplace. Based on early findings, a training session was provided to departmental staff and a gender sensitive “Mental Health in the Workplace Tool Kit” is being prepared to contribute to how sex, gender and diversity can impact workplace mental health.
Similarly, the Department is applying a sex, gender and diversity lens to Employee Assistance Service (EAP) policies, procedures and services through a review of the literature, key informant interviews and a mapping of processes. Based on the recommendations, a Management Response and Action Plan was created to implement and monitor progress. These findings will be used to better tailor services to employee needs.
Analysis of trends in spending and human resources
Actual expenditures
Departmental spending trend graph

The figure illustrates Health Canada's spending trend from fiscal year 2016-17 to fiscal year 2021-22 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 2016-17: $4,153 million (Voted: $3,948 million, Statutory: $205 million); 2017-18: $3,491 million (Voted: $3,274 million, Statutory: $217 million); and 2018-19: $2,370 million (Voted: $2,179 million, Statutory: $191 million).
Health Canada's planned spending for fiscal year 2019-20: $2,470 million (Voted: $2,313 million, Statutory: $157 million); 2020-21: $2,597 million (Voted: $2,439 million, Statutory: $158 million); and 2021-22: $2,755 million (Voted: $2,600 million, Statutory: $155 million).
Core Responsibilities and Internal Services | 2018-19 Main Estimates |
2018-19 Planned spending |
2019-20 Planned spending |
2020-21 Planned spending |
2018–19 Total authorities available for use |
2018-19 Actual spending (authorities used) |
2017-18Footnote 1 Actual spending (authorities used) |
2016-17Footnote 1 Actual spending (authorities used) |
---|---|---|---|---|---|---|---|---|
Health Care Systems | 1,270,981,764 | 1,270,981,764 | 1,609,336,578 | 1,744,723,658 | 1,309,249,998 | 1,289,851,245 | N/A | N/A |
Health Protection and Promotion | 597,556,711 | 597,556,711 | 598,278,433 | 591,526,928 | 747,158,705 | 726,841,710 | N/A | N/A |
Subtotal | 1,868,538,475 | 1,868,538,475 | 2,207,615,011 | 2,336,250,586 | 2,056,408,703 | 2,016,692,955 | - | - |
Internal Services | 302,976,567 | 302,976,567 | 262,477,397 | 260,427,976 | 369,038,879 | 353,056,297 | N/A | N/A |
Total | 2,171,515,042 | 2,171,515,042 | 2,470,092,408 | 2,596,678,562 | 2,425,447,582 | 2,369,749,252 | 3,491,052,712 | 4,153,217,124 |
Note: At the outset of the 2018-19 fiscal year, Health Canada's planned spending was $2,171.5 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 $2,425.4 million. The additional funding received during 2018-19 relates mainly to the following initiatives: Addressing the Opioid Crisis, Cannabis Public Education, Funding for the Substance Use and Addiction Program, Funding to transition to new impact assessment and regulatory process, Renewing and Enhancing the Federal Tobacco Control Strategy, and Supporting Canada's Official Languages. The variance of $55.7 million between total authorities and actual spending in 2018-19 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 2019-20. Fiscal year 2018-19 actual spending decreased significantly compared to prior 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
Core Responsibilities and Internal Services |
2016-17Footnote 1 Actual |
2017-18Footnote 1 Actual |
2018–19 Planned |
2018-19 Actual |
2019-20 Planned |
2020-21 Planned |
---|---|---|---|---|---|---|
Health Care Systems | N/A | N/A | 276 | 210 | 289 | 290 |
Health Protection and Promotion | N/A | N/A | 5,591 | 5,193 | 5,690 | 5,737 |
Subtotal | - | - | 5,867 | 5,403 | 5,979 | 6,027 |
Internal Services | N/A | N/A | 1,687 | 2,268 | 1,698 | 1,699 |
Total | 8,852 | 8,218 | 7,554 | 7,671 | 7,677 | 7,726 |
Note: The variance between the 2018-19 Planned and Actual FTEs is mainly due to a technical adjustment for the provision of shared services to PHAC. This is partially offset by actual FTEs related to revenues being lower than full authorities available. The 2018-19 actual FTEs decreased compared to prior 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. |
Expenditures by vote
For information on the Health Canada’s organizational voted and statutory expenditures, consult the Public Accounts of Canada 2018–2019.
Government of Canada spending and activities
Information on the alignment of the 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
The Health Canada’s financial statements (unaudited) for the year ended March 31, 2019, are available on the departmental website.
Financial statements highlights
Financial information | 2018–19 Planned results |
2018–19 Actual results |
2017–18 Actual results |
Difference (2018–19 Actual results minus 2018–19 Planned results) |
Difference (2018–19 Actual results minus 2017–18 Actual results) |
---|---|---|---|---|---|
Total expenses | 2,420,714,000 | 2,596,686,000 | 1,507,619,000 | 175,972,000 | 1,089,067,000 |
Total revenues | 208,525,000 | 201,844,000 | 183,300,000 | (6,681,000) | 18,544,000 |
Transferred operations | - | - | 2,194,398,000 | - | (2,194,398,000) |
Net cost of operations before government funding and transfers | 2,212,189,000 | 2,394,842,000 | 3,518,717,000 | 182,653,000 | (1,123,875,000) |
Pursuant to Orders-in-Council P.C. 2017-1465 and P.C. 2018-0381, Health Canada transferred the control and supervision of the First Nations and Inuit Health Branch (FNIHB) and First Nations and Inuit Health Internal Services Unit to the Department of Indigenous Services Canada (ISC) effective November 30, 2017, and April 1, 2018, respectively.
The Department’s total expenses from continuing operations in 2018-19 were $2,596.7 million.
There was an increase of total expenses of $176.0 million when comparing actual results against planned results for 2018-19. This is primarily a result of:
- an increase in funding to address the opioid overdose crisis;
- an increase in funding for the Cannabis Public Education Initiative; and,
- statutory payments to Canada Health Infoway Inc. and payments pursuant to section 103 of the Patent Act, which were not included in planned results.
When comparing year-over-year actual expenditures, there was an increase of $1,089.1 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 an increase in the number of employees resulting from growth in the cannabis, controlled substances and opioid programs;
- an increase in professional services and communication expenditures to support growth in the cannabis, controlled substances and opioid programs; and,
- a decrease in one-time ex gratia payments made to provinces during 2017-18.
The Department’s total revenues were $201.8 million in 2018-19 representing a decrease of $6.7 million from planned results and an increase of $18.5 million over the prior year actual revenues. The year-over-year variance is primarily a result of an increase in revenues for the provision of back office services to other departments, and an increase in demand for services under the employee assistance programs.
Transferred operations for the 2017-18 fiscal year of $2,194.4 million represent those expenses and revenues incurred by FNIHB and the First Nations and Inuit Health Internal Services Unit prior to their respective transfer to ISC.
Financial Information | 2018–19 | 2017–18 | Difference (2018–19 minus 2017–18) |
---|---|---|---|
Total net liabilities | 347,847,000 | 368,954,000 | (21,107,000) |
Total net financial assets | 188,564,000 | 201,796,000 | (13,232,000) |
Departmental net debt | 159,283,000 | 167,158,000 | (7,875,000) |
Total non-financial assets | 140,022,000 | 142,602,000 | (2,580,000) |
Departmental net financial position | (19,261,000) | (24,556,000) | 5,295,000 |
Total net liabilities were $347.8 million at the end of 2018-19, representing a decrease of $21.1 million from the previous year. This variance is mainly due to the transfer of the responsibility of the First Nations and Inuit Health Internal Services Unit to ISC and a $14.4 million reduction in the liability to Canada Health Infoway Inc. originating from the 2009 Budget.
The year-over-year decrease in total net financial assets of $13.2 million is primarily a result of a decrease in net accounts receivable and advance due to a year over year timing difference in amounts to be recovered from other departments.
Total non-financial assets had a net decrease of $2.6 million resulting primarily from the transfer of FNIHB real property assets to ISC.
Supplementary information
Corporate information
Organizational profile
Appropriate Minister: The Honourable
Institutional Head: Dr. Stephen Lucas
Ministerial portfolio: Health
Enabling instrument[s]: Assisted Human Reproduction Actii, Canada Health Act, Canada Consumer Product Safety Act, Controlled Drugs and Substances Act, Food and Drugs Act, Tobacco and Vaping Products Act, Cannabis Act, Hazardous Products Act, Hazardous Materials Information Review Act, Department of Health Act, Radiation Emitting Devices Act, Pest Control Products Act.
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 the Health Canada website.
Operating context and key risks
Information on operating context and key risks is available on the Health Canada website.
Reporting framework
Health Canada’s Departmental Results Framework and Program Inventory of record for 2018–19 are shown below.

Legend:
R: Result
I: Indicator
Text equivalent:
Departmental Results Framework
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:
- Health Care Systems Analysis & Policy
- Access, Affordability, & Appropriate Use of Drugs & Medical Devices
- Home, Community & Palliative Care
- Mental Health
- Substance Use & Addictions
- Digital Health
- Health Information
- Canada Health Act
- Medical Assistance in Dying
- Cancer Control
- Patient Safety
- Blood Systems, Organs, Tissue & Transplantation
- Promoting Minority Official Languages in the Health Care Systems
- Brain Research
- Thalidomide
- 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 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:
- Pharmaceutical Drugs
- Biologics & Radiopharmaceutical Drugs
- Medical Devices
- Natural Health Products
- Food & Nutrition
- Air Quality
- Climate Change
- Water Quality
- Health Impacts of Chemicals
- Consumer Product Safety
- Workplace Hazardous Products
- Tobacco Control
- Controlled Substances
- Cannabis
- Radiation Protection
- Pesticides
- Specialized Health Services & Internationally Protected Persons Program
Internal Services
Supporting information on the Program Inventory
Financial, human resources and performance information for the 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
200 Eglantine 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 Result
- Any change 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
- The department’s Core Responsibilities, Departmental Results and Departmental Result Indicators.
- Departmental Results Report
- A report on the actual accomplishments against the plans, priorities and expected results set out in the corresponding Departmental Plan.
- evaluation
- In the Government of Canada, the systematic and neutral collection and analysis of evidence to judge merit, worth or value. Evaluation informs decision making, improvements, innovation and accountability. Evaluations typically focus on programs, policies and priorities and examine questions related to relevance, effectiveness and efficiency. Depending on user needs, however,
evaluations can also examine other units, themes and issues, including alternatives to existing interventions. Evaluations generally employ social science research methods. - 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-diverse people. The “plus” acknowledges that GBA goes beyond sex 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 2019–20 Departmental Plan, government-wide priorities refers to 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 Information Profile
- The document that identifies the performance information for each Program from the Program Inventory.
- 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 the 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. - priority
- A plan or project that an organization 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.
- 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.
- Program Inventory
- Identifies all of the department’s programs and describes how resources are organized to contribute to the department’s Core Responsibilities and Results.
- 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.
- program
- A time-limited program that does not have an ongoing funding and policy authority. When the program is set to expire, a decision must be made whether to continue the program. In the case of a renewal, the decision specifies the scope, funding level and duration.
- 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.
- sunset program
- A time-limited program that does not have an ongoing funding and policy authority. When the program is set to expire, a decision must be made whether to continue the program. In the case of a renewal, the decision specifies the scope, funding level and duration.
- 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.
- Footnote 1
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A surgically invasive device that is intended to be absorbed by the body, or that is normally intended to remain in the body for at least 30 consecutive days
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