2023-24 Raison d’être and Operating context and key risks: Health Canada

Raison d'être

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

Mandate and role

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

As a partner in health, Health Canada:

• Protects Canadians from unsafe food, health and consumer products.
• Promotes innovation in health care.
• Informs Canadians so they can make healthy choices.
• Expands access to oral health care.

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

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

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

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

For more information on the Department's organizational mandate letter commitments, see the Ministers' mandate letters.

Operating context

Health Canada operates in a complex and dynamic environment, facing several challenges as it works to deliver results for Canadians. Many of these challenges – such as ensuring the health workforce is well supported, broader substance use-related harms, global supply chain issues, and climate change – are beyond the sole control of the Department. Solving complex challenges involves working collaboratively with federal partners, non-governmental stakeholders, provinces and territories (P/Ts), Indigenous organizations, industry, and international regulators.

In 2023-24, Canada's health workforce continued to experience challenges. The ongoing shortage of health workers contributed to difficult working conditions, high patient workloads and significant overtime requirements that put added strain on the health workforce. Canadians felt the impacts as emergency rooms continued to be overwhelmed, particularly in rural, remote and isolated communities which still experience occasional closures, while many Canadians lacked a primary care provider, and wait times for priority procedures continued to be higher than pre-pandemic averages across the health system. Finally, additional emerging health threats (e.g., various respiratory viruses) continued to challenge Canada's healthcare systems. In 2023-24, Health Canada funded Health Workforce Canada, a new independent organization, established with the support of the Canadian Institute for Health Information to improve the accessibility of health workforce data and share practical solutions and innovative practices addressing gaps and implementation challenges in health workforce planning.

Health care systems in Canada faced numerous challenges in terms of sustainability, access to services, and service delivery. Health care delivery is primarily under P/T jurisdiction with federal funding administered via the Canada Health Transfer. Health Canada advanced the Government's Working Together to Improve Health Care for Canadians plan, to support P/Ts on shared priorities: expanding access to family health services; supporting health workers and reducing backlogs; improving access to quality mental health and substance use services; modernizing the healthcare system with standardized health data and digital tools; and helping Canadians age with dignity and closer to home. In 2023-24, the Government of Canada signed bilateral agreements with all P/Ts, providing funding to support shared health priorities to strengthen Canada's universal public healthcare system. Additionally, the Department continued to explore and experiment with new technologies such as artificial intelligence and remained agile in its delivery of essential programs and services.

Canadians faced increasing costs-of-living and expensive prescription drugs due to inflation, high-interest rates, and fiscal restraints. This created socioeconomic and geographical barriers to essential, high quality, and timely health care services, including oral health care. The effects were felt most acutely by vulnerable populations, contributing to financial hardships, and deteriorating overall health outcomes. The Government of Canada invested in health care services via bilateral agreements to provincial and territorial governments and through pan-Canadian and community-based health organizations to support access for all residents of Canada to appropriate and effective health services, including prescription drugs, sexual and reproductive health, and territorial health systems. Health Canada has also begun to support eligible Canadian residents and their families to access oral health care services.

The effects of climate change and extreme weather events such as wildfires, heat waves, floods, and droughts, continued to intensify across Canada, affecting the health of Canadians. In addition to supporting efforts to respond to such events, in 2023-24 Health Canada developed a Departmental Climate Change Adaptation Plan. The purpose of the Plan is to increase Health Canada's resilience to the impacts of climate change and to guide the response to identified departmental risks affecting programs, services, and operations.

A dangerous synthetic illegal drug supply, including fentanyl and emerging synthetic opioids, is driving a severe overdose crisis in Canada. To address this, the Government of Canada is working to connect people with treatment, recovery services, harm reduction, and other supports like housing support. In 2023-24, Health Canada renewed the Canadian Drugs and Substances Strategy (CDSS) which supports a comprehensive, culturally appropriate, collaborative, compassionate, equitable and evidence-based approach to the overdose crisis and substance use related harms. The renewed CDSS builds on the work and momentum of the previous strategy to address substance use-related harms and deaths, including the dangerous, synthetic illegal drug supply and overdose crisis in Canada. The strategy focuses on health, social well-being and public safety, recognizing that more needs to be done to help people and keep communities safe.

Underserved Canadians continued to bear the brunt of health events. Facilitating access to quality health care, mental health care, addiction programs and support services required a collaborative approach between all F/P/T partners and key stakeholders. All levels of government have been adjusting to the changing needs and expectations of Canadians and leveraging technological advances to improve quality of care and health outcomes. As a partner in the national health care system, the Department worked closely with P/T governments and stakeholders to develop national approaches to health systems issues and to promote the Pan-Canadian adoption of best practices. In collaboration with PT partners, Health Canada is advancing a Joint F/P/T Action Plan to deliver on the health data commitments outlined in the Working Together to Improve Health Care for Canadians plan, and support modernizing the healthcare system with standardized health data and digital tools.

Rising commodity prices, inflation, debt and economic slowdown resulted in additional challenges for both Health Canada and Canadians in terms of acquiring and affording necessary health and food products, which in turn exposes ongoing inequalities in communities. In addition, geopolitical issues and supply chain challenges (e.g., extreme weather events due to climate change) impacted manufacturers' abilities to meet Canadian market demand for certain drugs and medical devices. Health Canada increased surveillance and data collection to improve oversight of the supply of and demand for critical drugs and supported approaches to develop a more resilient supply for Canada.

The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain are key challenges for regulators. Effectively regulating new and innovative products, substances, food and emerging product categories in a global marketplace requires flexible regulatory approaches. Creating and strengthening relationships with domestic and international partners was key to facilitating cooperation and developing consistent approaches to novel products. However, limited resources, challenges in properly assessing and addressing security threats such as cyberattacks, and political barriers to government collaboration could have a detrimental effect on Health Canada's ability to participate on the international stage. Health Canada has responded to these challenges by exploring how virtual and remote tools for inspections can be leveraged to maintain oversight in domestic and foreign inspection programs, supporting advancements of international standards, and adapting to changing business models in the supply chain. The Department worked with international partners to explore how remote inspections might improve oversight in foreign inspections. This included participating in the International Coalition of Medicines Regulatory Authorities collaborative hybrid inspection pilot.

Canadians expect the Department to provide high quality, scientific, and evidence-based health information. However, public trust in Health Canada as a source of credible information is threatened by increasing misinformation and disinformation regarding health products, other regulated substances, policies, and practices. These originate from a wide range of sources easily accessible to the public. This poses a challenge to regulators in terms of responding quickly and decisively in the face of eroding trust in scientific bodies and health regulators. Canadians continue to expect their government to be open and transparent and to effectively engage them in decision-making. Clarity on direction and sharing accurate and timely information with stakeholders and the public helps ensure that the Department is viewed as a trusted source of information and that individuals and organizations have the information needed to act on their health and safety. The Department continued to provide high quality, scientific and evidence-based health information through a range of online and traditional communication tools and channels.

Inequities persist in health care, communities, and workplaces across the country. Diversifying the health care and public workforce increases access to quality health care for all populations, reduces health disparities, improves cross-cultural communication, and contributes to health equity. The Department's values - fostering a diverse and inclusive workplace that is free of racism and discrimination and where all employees are treated with respect, dignity, and fairness - form the foundation of who we are, what we do, and how we do our work. Health Canada remained committed to its ongoing response to the Clerk's Call to Action on Anti-Racism, Equity, and Inclusion in the Federal Public Service, the Clerk's Call to Action Forward Direction Message to Deputies, the Deputy Ministers' Commitments on Diversity and Inclusion, and the President of the Treasury Board's Priorities for actions to increase diversity and inclusion in the public service.

Key risks

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

Key risk for core responsibility 1: health care system

1. Upholding the Canada Health Act Risk: Health Canada's ability to effectively uphold the Canada Health Act (CHA) could be put at risk by challenges in administering the Act.

Technological advances and evolutions in health care treatment and delivery requires Health Canada to uphold and administer the CHA in an ever-changing health care landscape. The Department's proactive responses have mitigated the risks associated with the administration of the CHA during the 2023-24 fiscal year. Specifically, Health Canada undertook the following:

Monitored and reported on compliance:

Monitored and reported on compliance with the CHA. For example:

• Monitored compliance with the CHA through P/T reports on patient charges as per the Extra-billing and User Charges Information Regulations.
• Worked with P/Ts and other relevant parties to gather data to form a clear picture of patient charges for insured services.
• Reported to Parliamentarians on the administration and operation of the CHA.

Implemented new policies:

The Department continued to develop policies to ensure that the integrity of core Medicare services are safeguarded as new modes of health care delivery and are integrated into the Canadian healthcare system, specifically:

• Engaged with P/Ts on the development of a CHA interpretation policy on physician-equivalent services and virtual care.
• Worked with P/Ts to ensure reporting on patient charges for diagnostic services as per the Diagnostic Services Policy.
• Continued to administer the CHA's Reimbursement Policy. Under the policy, mandatory Canada Health Transfer deductions may be reimbursed, provided the implicated P/T carries out a Reimbursement Action Plan to eliminate patient charges and the circumstances that led to them. For example, Manitoba received a full reimbursement in March 2024 for eliminating patient charges for diagnostic services, and Newfoundland and Labrador received a full reimbursement for eliminating patient charges for cataract services. At the same time British Columbia, Alberta, Ontario, and Quebec received partial reimbursements of deductions under the Reimbursement Policy in recognition of progress made at eliminating these charges.

Worked to resolve issues with P/Ts:

• Worked with P/Ts to resolve CHA issues, recommended Canada Health Transfer deductions if necessary and communicated the process required for a P/T to receive a reimbursement as stipulated in the Reimbursement Policy. For example, deducted amounts for the insured services provided at private diagnostic clinics, private surgical clinics and for access to insured abortion clinics that occurred in 2023-24.

Monitored litigation:

• Monitored any litigation that may implicate the CHA (e.g., New Brunswick abortion case with the Canadian Civil Liberties Association; Quebec patient charge cases, and several forced sterilization cases), particularly those that challenge the federal government's administration of the CHA, and supported federal involvement as required.

Monitored changes in health care delivery:

• Monitored the delivery of health care to ensure that insured services under the CHA remain covered regardless of changes in how the care is provided or who is providing the care. For example, monitored the introduction of Artificial Intelligence as a new means of delivering health care services.

2. Reputational Risk: Partners, stakeholders and Canadians may lose confidence in Health Canada's ability to lead complex and multijurisdictional initiatives if the Department does not deliver on commitments and programs in a timely and effective manner.

To ensure that Health Canada continues to lead complex and multijurisdictional initiatives in a timely and effective manner, the Department successfully implemented effective risk responses in the 2023-24 fiscal year. Specifically, Health Canada undertook the following:

Fostered collaborative partnerships:

Foster collaborative partnerships with other government departments and agencies, and P/Ts to share resources, expertise and responsibilities when implementing complex initiatives. For example:

• Continued to negotiate bilateral agreements and signed 26 bilateral agreements with P/Ts to address their individual health system needs and priorities and support the health and well-being of Canadian residents. This collaboration continues as Health Canada works with P/Ts to sign Aging with Dignity agreements amendments to provide funding supports for Personal Support Workers.
• Continued engagement with P/Ts to advance oral health priorities including how the Canadian Dental Care Plan (CDCP) will intersect with existing social dental programs.
• Established and maintained partnerships with other federal departments and agencies to deliver complex programs, such as the CDCP, through a whole-of-government approach.
• Worked through established F/P/T tables such as the Committee on Health Workforce to develop and deliver on key priorities for the health workforce including those agreed to by Health Ministers in fall 2023.
• Strengthened pan-Canadian leadership for digital health and health data with P/Ts through a common vision, principles and key elements for collective action as part of the 2023 Working Together to Improve Health Care for Canadians plan.
• Continued to foster support and engage with stakeholders, including professional associations, organizations, patients and Indigenous partners at all stages of the initiatives.

Ensured openness and transparency:

Provided regular updates to other federal government departments and agencies, P/Ts, Indigenous partners, stakeholders and people in Canada to manage expectations and build trust. For example:

• Continued to leverage communication platforms and services to provide trusted, accurate, accessible, and culturally appropriate information that puts all people in Canada first in its design and functionality.
• Continued to optimize digital content so that it is more findable, easy to read and understand, and accessible to support increased trust of government web and media content. This included the enhancement of data analysis and reporting through the collection of meaningful data in collaboration with partners.
• Communicated on Government of Canada priorities, such as improving Canadians' access to oral health care, advancing shared healthcare system priorities with P/Ts through the Working Together funding agreements and news releases and on a broad range of health and safety related issues. This included effective communication on CDCP expectations and eligibility for the public through products, such as the CDCP website, stakeholder toolkit, factsheets, information sessions for providers and advocacy organizations, and posting the Benefits Guide and CDCP Benefits Grids.

Strengthened oversight and governance:

Maintained oversight while upholding principles of accountability and ethical decision-making. For example:

• Maintained robust and resilient governance frameworks and processes across the Department to uphold sound stewardship and to achieve the best value of assets and acquired services.
• Strengthened the governance framework for procurement activities, particularly contracts for professional services. This included new approval requirements and increased oversight by senior management and other stakeholders to enable informed decision making and to allow for early identification and mitigation of potential risks.
• Continued to uphold clear roles, responsibilities, and financial frameworks.
• Maintained regular monitoring and reporting on resource and procurement management in accordance with guidelines and standards.
• Continued to establish an external oversight committee to oversee large scale initiatives, this includes seeking advice from experts using external advisory bodies.

Encouraged innovation and operational efficiency:

Fostered a culture of creativity and problem-solving, where the Department can seek novel solutions to complex problems. For example:

• Encouraged innovation and catalyzed change to support operational improvements. For example, through the Solutions Fund and the Strategic Science Fund.
• Continued to provide training and development opportunities for employees involved in leading and delivering complex initiatives, focusing on areas such as communication skills, data analysis and reporting, conflict resolution, ethical decision-making and fraud risk management.

Key risks for core responsibility 2: health protection and promotion

3. Public Trust Risk: Canadians may not trust Health Canada's ability to help protect and improve their health if the Department is not regarded as a reliable regulator and considered as a credible source of information.

To ensure that Health Canada continues to be seen as a trusted regulator and credible source of information and to help Canadians make informed health and safety decisions, the Department successfully implemented effective risk responses in the 2023-24 fiscal year. Specifically, Health Canada undertook the following:

Implemented informative initiatives:

Increased and updated regulatory health and safety information that is made available to Canadians in a simple and accessible way. For example:

• Published information on Health Canada's Clinical Trials Database on authorized clinical trials for drugs and vaccines and natural health products.
• Continued to develop a proposal for modernized clinical trials regulations and published a draft guidance document to increase transparency by encouraging industry to register trial information in a publicly accessible registry.
• Published supply notices on key health product shortages and worked towards upgrading drug and medical device shortages websites to make them more user-friendly.
• Published reports regarding industry non-compliance on the Health Canada website outlining key results of vaping compliance and enforcement activities.
• Conducted a survey and research on opioid awareness, knowledge, and behaviours to help inform public education campaigns and gauge level of awareness over time.
• Continued to deliver evidence- and fact-based public education campaigns, providing Canadians with the necessary information to make informed decisions about the potential risks, harms, and benefits of psychoactive substances such as cannabis, alcohol, controlled substances (e.g., opioids, stimulants, psychedelics, etc.), tobacco, vaping, and nicotine pouches. For example, continued the Ease the Burden, Know More: Opioid public awareness, and Get the Facts campaigns.
• Updated public information on supervised consumption sites and published information on data and trends in the use of alcohol, psychoactive pharmaceuticals, and illegal drugs through the Canadian Student Alcohol and Drugs Survey, and the Canadian Postsecondary Education Alcohol and Drug Use Survey.
• Released a guidance document for selected non-prescription drugs from recognized countries or regions, addressing recent regulatory changes under the Canada-United States-Mexico Agreement.
• Published public health advisories on cannabis, research findings on trends in cannabis indicators over time, serious adverse reactions including in children and youth, data on cannabis for medical purposes, and data on the cannabis market. This includes public opinion research findings from the Canadian Cannabis Survey, National Cannabis Survey, Cannabis Use Among Sexual and Gender Minorities Across Canada, Cannabis Use Among Older Adults in Canada, and frequent cannabis consumers.
• Continued to implement the Department's Open Science Action Plan and Framework for Science and Research Excellence to ensure federal science is transparent and accessible for all Canadians. For example, supported activities to make scientific publications and new research data freely available to the public.
• Increased awareness of food safety behaviour through development of tools, resources, and public education campaigns to prevent mishandling of food preparation such as properly handling frozen raw breaded chicken. The Department also published food safety education and food safety for vulnerable populations.
• Promoted infant safe sleep practices through the Safe Sleep Week campaign with the theme "decorate the room not the crib".

Offered engagement opportunities to Canadians and stakeholders:

In line with the Government of Canada's Open Government initiative and Health Canada's Forward Regulatory Plan, provided opportunities for Canadians and stakeholders to become involved in decision-making processes, including the development of the regulatory process. For example:

• Consulted on multiple initiatives and posted activities on Consulting with Canadians and the Canada Gazette including guidance documents for machine learning-enabled medical devices, proposed agile regulations and guidance for licensing drugs and medical devices, modernization of Health Canada's lists of permitted food additives, a framework for foods for a special dietary use and infant foods and Biocides Regulations.
• Consulted Canadians and stakeholders, including consumer and patient groups, First Nations organizations, health partners and industry on a cost-recovery regime for Natural Health Products (NHPs) to recover some of the costs of reviewing NHP applications and promote access to safe, effective, and high-quality NHPs for people in Canada.
• Continued engagement with industry on a risk-based approach to the regulatory oversight of self-care products (i.e., the Self-Care Framework), including ways to support industry in implementing new labelling requirements aimed at making NHP labels easier to read and understand.

Modernized communications about Health Canada's role as a regulator:

Continued to acquire, develop and improve the tools, processes and resources needed to effectively communicate with, and engage, Canadians on Health Canada's digital platforms, including Canada.ca, Healthy Canadians' podcast, and Health Canada media channels. For example:

• Proactively released information about approved health products and provided updates on shortages through the Drug Shortages Canada website.
• Provided information on medical device shortages.
• Continued to optimize digital content so that it is more findable, easy to read and understand, and accessible to support increased trust of government web and social media content.
• Collaborated with federal partners to innovate, leverage, and/or optimize content and digital tools for Canadians and streamline and automate the publishing of data on Canada.ca, allowing Health Canada to publish information and updates in real time.
• Continued to implement a user-focused recalls and safety alerts system to enable Canadians to take action to protect themselves from unsafe products.
• Continued risk communication work to reach sub-target audiences who are most impacted or who perceive themselves to be most impacted.
• Improved transparency of pesticide regulatory decisions to increase understanding and enable meaningful public participation, including the use of plain language in regulatory documents and providing access to information and data used in regulatory decision-making.

Advance regulatory modernization initiatives:

Continued to modernize the federal regulatory system for health products and food through the Department's efforts to make the regulations more responsive to an innovative environment, while ensuring the system remains science and safety-based and more internationally aligned. For example:

• Continued to advance the Agile Licensing for Drugs and Medical Devices proposal which outlined amendments to the Food and Drug Regulations and Medical Devices Regulations to support a more agile, risk-based approach for drugs and medical devices, while also reducing regulatory burden. It will enhance safety by expanding post-market terms and conditions, while supporting innovation and growth by addressing some long-standing barriers identified by industry.
• Consulted on updated microbiological safety criteria and methods of analysis within Part B of the Food and Drug Regulations that enable timely revisions and efficient response to advances in science and technology and streamlined food additive rules.

4. Regulatory Risk: Health Canada's ability to help protect the health of Canadians may be weakened due to the increasing complexity of the global supply chain, the rapid pace of innovation, and increasing e-commerce from global sources.

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

Strengthened oversight:

Developed strategies and tools to strengthen market surveillance and oversight of emerging products and supply shortage. For example:

• Promoted, verified, and enforced compliance with the Cannabis Act and its regulations, consistent with the approach outlined in Health Canada's Compliance and Enforcement Policy. For example, Health Canada posted a safety advisory regarding illegal cannabis products.
• Published guidance for owners and operators of online marketplaces and launched the Canadian Product Safety Pledge, a voluntary commitment to Health Canada by certain online sellers to strengthen and improve the safety of consumer products and cosmetics sold online through a combination of preventative and corrective actions.
• Implemented revised editions of the Globally Harmonized System of Classification and Labelling of Chemicals to facilitate trade between the United States and Canada while maintaining the safe use of chemicals in the workplace.
• Consulted with regulated parties, health care partners, patients, and the public to support the development of a plan to build resilience against health product shortages. Published consultation findings to enhance early signal detection, monitoring, and data-sharing, necessary to mitigate the impacts of health product shortages and to move further towards preventing them.
• Engaged industry stakeholders to promote compliance with the prohibition on distributing Canadian-labelled drugs for use outside Canada if doing so could cause or worsen a shortage.
• Monitored and exchanged information on issues and risks related to food safety and nutrition through the International Social Science Liaison Group, the International Microbiological Food Safety Liaison Group, and the International Food Chemical Safety Liaison Group.
• Participated in the Codex Alimentarius Commission which develops international food standards focused on food safety, quality, and nutrition that protect the health of consumers and facilitates fair trading practices of foods.

Collaborated internationally:

Collaborated with international regulatory organizations and aligned where appropriate with foreign regulators. For example:

• Worked with international partners on antimicrobial resistance, clinical trials, regulatory reviews and market authorizations, increased diversity and transparency in clinical trials, risk assessments, post-market safety surveillance, regulatory standards, new technologies, emergent safety issues, and overall management of health product shortages.
• Promoted work-sharing for quicker access to drugs for Canadians (e.g., Project Orbis and Access Consortium).
• Worked with the International Council for Harmonisation of Technical Requirement for Pharmaceuticals for Human Use and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products to develop international standards.
• Consulted on updates to Biocides Regulations to improve access to a safe and effective supply of biocides in Canada via the introduction of a Use of Foreign Decisions application pathway which would allow businesses that want to bring biocides to the Canadian market to use the decisions of trusted foreign regulators.
• Contributed to implement the G7 Clinical Trials Charter.
• Communicated joint recalls of consumer products and cosmetics, including 271 consumer product and cosmetic recalls, of which 75 were joint recalls with the United States and/or Mexico.
• Participated in multiple international committees such as the Canada-U.S. Regulatory Cooperation Council and the Organisation for Economic Co-operation and Development Working Party on Consumer Product Safety to facilitate collaboration and alignment on hazardous workplace products, consumer products, and cosmetics.
• Led Canada's engagement in the development of a Global Framework on Chemicals - For a Planet Free of Harm from Chemicals and Waste, adopted in September 2023.
• Participated in an international effort led by INTERPOL, to disrupt the online sale of counterfeit and other illegal health products around the world.
• Continued to work with international partners such as the Transatlantic Task Force on Antimicrobial Resistance to exchange information and develop best practices to manage antimicrobial resistance.

Addressed changing business models in the supply chain:

Strengthened oversight of foreign sites involved in the manufacturing of health products. For example:

• Carried out foreign on-site Good Manufacturing Practices inspections to increase Health Canada's oversight of drug production earlier in the supply chain.
• Provided guidance on medical device establishment licensing to individuals in the medical device industry.
• Exchanged information on pharmaceutical inspections conducted in foreign jurisdictions with international partners.
• Worked towards implementing regulatory initiatives and plans (e.g., Health Canada Forward Regulatory Plan, Regulatory Cooperation Council Action Plan).

Key risks for internal services

5. People Risk: Health Canada's ability to deliver on its mandate effectively may be at risk due to challenges in maintaining a high performing, bilingual, and diverse workforce within a healthy workplace.

To ensure the Department continued building a healthy, diverse, inclusive, and ethical workforce; enabling a safe and productive workforce with access to modern tools and facilities; and communicated to Canadians that the Department successfully implemented effective risk responses in the 2023-24 fiscal year. Specifically, Health Canada undertook the following:

Supported workplace wellness initiatives:

Invested in initiatives to foster a healthy and safe workplace. For example:

• Promoted positive mental health and wellness through the Multi-Year Mental Health and Workplace Wellness Strategy and implemented strategies that align with the National Standard for Psychological Health and Safety in the Workplace.
• Provided guidance and support to employees in a healthy and respectful workplace.
• Provided, via the Centre for Ombuds, Resolution and Ethics, an independent, confidential, and informal safe space where all Health Canada employees can explore options, recourse, and resources to resolve a range of issues that could hinder workplace well-being.

Promoted diversity, values and ethics, bilingualism and inclusion:

Encouraged diversity, values and ethics, bilingualism and inclusion. For example:

• Worked on the Department's Multi-Year Diversity and Employment Equity Plan.
• Continued implementation of the Department's Official Languages Action Plan and expanded access to standardized language training through the Department's Single Window Access to Languages Training and the Equitable Access to Language Training Program.
• Continued addressing racism and discrimination through the Leadership Council on Diversity and Inclusion, and Employee Networks.
• Strengthened Health Canada's values and ethics framework and fostered renewed conversations, in response to the Deputy Ministers' Task Team on Values and Ethics Report to the Clerk of the Privy Council.
• Continued to provide services to employees at all levels to help them address racism and discrimination issues, as well as provide them with an opportunity for a confidential exit interview with the Ombuds. Health Canada also provided employees 11 workshops to better understand how to recognize and address microaggressions.
• Continued implementing strong employee networks with the support of their respective Champions.
• Implemented the commitments in Health Canada's first Accessibility Plan and provided results through the 2023 Health Canada Accessibility Progress Report.

Attracted and retained skilled and talented employees:

Maintained a high-performing workforce with the appropriate skills and competencies. For example:

• Fostered career development through clear performance measures, training, and talent management.
• Continued to incorporate accessibility, diversity, and inclusion in all aspects of planning to support the workforce, work, and workplace, regardless of location.
• Implemented innovative and targeted staffing strategies to streamline human resources processes and recruitment.
• Supported timely hiring by ensuring that security screening services were effective and efficient, while maintaining compliance with Treasury Board guidance related to governance and insider risk management.
• Designed and implemented culturally competent recruitment strategies to address barriers to employment and increase representation for equity-deserving groups. For example, streamlined the management of staffing pools and inventories ensuring that candidates that self declare as a member of an employment equity group are prioritized when referrals are sent to hiring managers.
• Established the Career Connections Database to support the mobilization of temporary, indeterminate and determinate employees. Managers were encouraged to use it as a first step when staffing positions.

6. Technology and Infrastructure Risk: Health Canada's ability to deliver its programs and services may be at risk due to the Department's aging physical and IT infrastructure, deferred maintenance, limited funding, limited data analytics capacity and challenges in safeguarding IT assets from cyberattacks.

To ensure Health Canada continued to collaborate across the Health Portfolio to encourage and support the modernization and security of the workforce by providing access to up-to-date IM/IT tools and adapting IT systems to foster collaboration and support a productive hybrid workforce, the Department successfully implemented effective risk responses in the 2023-24 fiscal year. Specifically, Health Canada undertook the following:

Continued to update IT and lab infrastructure:

Equipped employees with modern, enhanced, and secure infrastructure. For example:

• Continued to modernize workplace facilities and provide novel and secure tools. For example, replaced over 2400 computing devices with newer machines and equipped boardrooms with specialized videoconferencing equipment to support hybrid work.
• Continued to review the security posture of the Department and its labs and reviewed the Departments Security Plan.
• Invested $18 million to modernize laboratories and reduce ongoing deferred maintenance.
• Continued to draft a Real Property Portfolio Strategy to better align real property investments with Health Canada priorities and to inform current and future needs of the Department's scientific and regulatory missions.
• Created a systematic approach to capital investment planning and management by centralizing the Department's capital budget and prioritizing investments to address highest priorities across investment classes.
• Continued with the Department's National Security Modernization project related to access management across the portfolio.
• Replaced closed-circuit video equipment across the country to support the security of Health Canada's facilities.
• Enhanced the security of employee laptops by introducing advanced antivirus software protection.
• Researched and considered modern, reliable, and robust security enterprise solutions that meet the needs of the Department and the future of work.
• Expanded the Government of Canada Secret Infrastructure network to accommodate evolving IT Security requirements.
• Continued to implement M365 collaboration tools and features, including several new M365 applications such as Booking and Stream, and other Power BI and Power App applications. Developed a 2024-25 roadmap to continue the rollout of additional capabilities.
• Grew the M365 Enthusiasts' Network to over 1,100 participants. This employee network throughout Health Canada and the Public Health Agency of Canada encouraged M365 adoption within their teams and influenced change across the organization to modernize the way work is done.
• Enhanced Health Canada's cloud offerings by modernizing Microsoft Azure services, implementing and upgrading the Amazon Web Services, and implementing a Google Cloud Platform.
• Deployed secure Wi-Fi network services to four Health Canada buildings. Over 1,000 employees benefited from these Wi-Fi services.
• Finalized the Management Response Action Plan for the IT Asset Management Audit.

Promoted digital transformation:

Established a Service and Digital Strategy to foster transformation and enhance efficiency and effectiveness of programs and services through the following:

• Advanced the Department's digital-data transformation under the people and culture pillar of Health Canada's Data Strategy by increased, targeted data-related communication (i.e., via the Office of the Chief Data Officer Portal, Health Canada Data Stewardship Network, Artificial Intelligence Community of Practice and Open Government Working Group).
• Ensured alignment with the 2023-2026 Data Strategy for the Federal Public Service, the Government of Canada Digital Standards, and the Policy on Results by improving business processes through the adoption of digital tools such as automating Conflicts of Interest declarations, and working to optimize Performance Information Profiles data collection.
• Developed and delivered a digital literacy education pilot series on Digital Product Management and Agile practices.
• Established an Enterprise Robotic Process Automation platform and Center of Expertise to enable Department programs to benefit from this new technology.
• Launched an Artificial Intelligence Community of Practice to build artificial intelligence literacy and skills.
• Strengthened digital oversight and governance by implementing a Director General-level architecture governance table chaired by the Chief Information Officer, with members from Health Canada and Public Health Agency of Canada.

Promoted training and awareness:

Ensured Department vigilance and raised employee awareness. For example:

• Communicated with employees on security requirements.
• Implemented employee training on new applications and technology.
• Provided training to all employees on safeguarding information and security. For example, various cyber-security training and awareness products were used leveraging events such as Cyber-Security Awareness Month to improve coverage, including a Phishing campaign to address one of the biggest cyber threats to Health Canada's networks. Refined and delivered mandatory training regarding the management of personal information.
• Conducted internal privacy risk assessments to ensure employees understand and are aware of privacy risks and privacy advisory resources.
• Clarified the roles of Contracting, Digital Transformation Client Services, Shared Services Canada, and Security through the identification of an internal process for procuring IT professional services.
• Developed security tools and continued implementation of the Security Awareness Working Group action plan.

Strengthened oversight:

Implemented oversight strategies and fostered both remote and on-site security. For example:

• Updated policies and tools to safeguard and protect people, information and assets in compliance with Treasury Board policies, directives and standards such as the Treasury Board Standard on Security Screening.
• Implemented new protocols on managing IT security incidents to ensure effective collaboration and communication when an issue, event, or incident is first detected.
• Continued to implement the revised Privacy Management Framework with a focus on further expanding a risk-based approach for initiatives with personal information.
• Continued Privacy Impact Assessments and Privacy Breach Process and Reporting.
• Updated Business Continuity Plans regularly.

Key risk for strengthening emergency preparedness

7. Major Health Events Risk: Health Canada's ability to achieve its mandate may be at risk due to challenges posed by major disruptive events such as extreme weather and pandemics.

Health Canada used every tool available, leveraged resources and collaborated with F/P/T partners to protect the health of Canadians. The Department sustained a high level of activity to respond to and mitigate risks associated with major health events while continuing to deliver on its mandate in 2023-24. Specifically, Health Canada undertook the following:

Provided timely, trusted, and evidence-based information:

• Continued providing P/Ts, health care providers and residents of Canada with the timely, clear, and evidence-based information they need to protect themselves.
• Published clinical information used to support regulatory decisions and the basis for those decisions to foster public trust and solidify the Department's commitment to greater openness and transparency. For example, through the newly launched Drug and Health Product Portal.

Facilitated access to health products:

Supported the prevention and treatment of novel diseases via clinical trials and flexible measures. For example:

• Authorized clinical trials for health products under transition regulations and existing regulatory frameworks.
• Implemented innovative and flexible measures to help prioritize and expedite the regulatory review of health products of greatest need without compromising Canada's high standard for quality, safety, and efficacy.

Fostered engagement and collaboration:

Worked alongside other government departments (e.g., PHAC, PSPC) to advance a whole-of-government approach to adapt to and meet the needs of Canadians. For example:

• Worked toward enhancing the Government-wide ability to monitor the evolution of major health events.
• Collaborated with P/Ts to strengthen the healthcare system's capacity to protect priority communities through funding.
• Supported the timely deployment of high quality and safe emergency health products to Canadians through incorporating agile regulations and ensuring an adequate supply of health products.
• Engaged and collaborated with international regulatory partners (e.g., the International Coalition of Medicines Regulatory Authorities).
• Continued to engage internationally to better prevent, prepare for and respond to future health emergencies including the process to amend and modernize International Health Regulations (2005) and working with the Intergovernmental Negotiating Body to draft and negotiate a Pandemic Agreement.

Enhanced internal services:

Delivered services and commitments during major crises. For example:

• Worked with Shared Services Canada to ensure network infrastructure can support business needs, to minimize the risk of network outages, and improve regional user experience by implementing Wide Area Network redundancy at some regional hub sites. Also worked with Shared Services Canada to align device configuration for Government of Canada Wi-Fi Whole Building Approach.
• Supported platforms and tools for enabling collaboration and remote work such as M365 collaboration tools and features.
• Conducted a thorough environmental scan of the Cyber/IT Security environment and developed a comprehensive cyber strategy, aligned with the Departmental Security Plan, Health Canada's Corporate Risk Profile and Government of Canada best practices to address gaps and identify areas of improvement.
• Provided additional oversight for technology operations and projects by implementing and enhancing the Information Technology Service Delivery's work oversight committee, which oversees all work and provides senior leadership guidance to project and operational teams.
• Maintained robust and resilient governance frameworks and processes across the Department and the Health Portfolio to effectively address horizontal initiatives and issues in times of crisis.
• Maintained detailed, tested, and high-profile emergency preparedness, crisis management, communications, business continuity, and business resumption plans, mapped against best practices and lessons learned.
• Developed comprehensive, practical strategies to protect and promote employees' health, accommodate and support staff and their family members (where applicable), and assess and promote occupational health and safety.
• Maintained a health emergency coordination office to support readiness for health emergencies.
• Finalized Health Canada's Climate Change Adaptation Plan to manage and mitigate departmental climate change risks to services, operations, and assets.