2022-2023 Raison d'être, mandate and role: who we are and what we do - Health Canada

Raison d'être

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

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, other countries, Indigenous partners 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; and,
• informs Canadians to make healthy choices.

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

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

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

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

For more information on the Department's organizational mandate letter commitments, see the 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 the overdose crisis, public health events like the COVID-19 pandemic, global supply chain issues, and climate change – are beyond the sole control of the Department and involve working collaboratively with federal partners, provinces and territories (P/Ts), Indigenous organizations, industry and international regulators.

Strengthening and modernizing the health care system

Canada’s health care system continued to face numerous challenges in terms of sustainability, access to services, and service delivery. This was exacerbated by the COVID-19 pandemic. High patient workloads, challenging work conditions and concerns for personal safety led to high levels of burnout, absences and turnover amongst health professionals. Canadians felt the impact in overflowing or temporarily closed emergency rooms, long wait times for surgeries and other procedures, and the lack of family health teams, including family doctors and nurse practitioners. Health Canada undertook a wide range of engagement sessions with P/Ts and other key health partners to identify and advance potential solutions for this crisis.

Health care delivery is primarily under P/T jurisdiction with funding administered by the Department of Finance 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 health care system with standardized health data and digital tools; and helping Canadians age with dignity and closer to home.

Addressing the overdose crisis

The overdose crisis is one of the most serious public health threats in Canada's recent history, and is having devastating impacts on individuals, friends and families, and communities across the country. During the pandemic, the crisis worsened and became more complex. For example, the illegal drug supply became increasingly toxic and unpredictable in Canada and those seeking life-saving harm reduction and treatment services experienced reduced access to health and social services.

Addressing these challenges and facilitating access to mental health and substance use support services required collaboration between all levels of government and partners to deliver on a range of activities. Guided by the federal Canadian Drugs and Substances Strategy, Health Canada continued to lead a comprehensive, collaborative, compassionate and evidence-based approach to the overdose crisis and substance use related harms.

Managing the impacts of the COVID-19 pandemic

In 2022-23, the COVID-19 pandemic continued to challenge Canadians and health systems across the country. The pandemic negatively affected the mental health of many Canadians, disproportionally impacted those living in long-term care homes and worsened the overdose crisis.

Health Canada leveraged its resources to minimize the impact of COVID-19 on Canadians’ health and safety. Throughout the pandemic, the Department procured and distributed rapid tests and self-tests, authorized new vaccines, therapeutics and diagnostics, including boosters and vaccines for children, and supported P/Ts through targeted investments in mental health, virtual care, and long-term care. It also supported digital platforms in areas ranging from mental health to delivering critical information to the public and working closely with partners to protect Canadians from non-compliant advertising of COVID-19 vaccines and treatments. The Federal supply of rapid tests helped enable P/Ts to develop a significant reserve, allowing them to sustain rapid testing programs throughout 2022 and 2023.

Regulation and supply chain challenges in the context of increased globalization

The increased pace of scientific and technological innovation, globalization and the complexity of the global supply chain have been key challenges for regulators and manufacturers. Geopolitical issues, inflation, rises in commodity prices and supply chain challenges (e.g., extreme weather events due to climate change) impacted manufacturers' ability to meet Canadian market demand for necessary food and health products, drugs and medical devices. Effectively regulating new, innovative and complex products, substances, food and emerging product categories in a global marketplace requires novel and flexible regulatory approaches. Health Canada has responded to these challenges by strengthening oversight of foreign manufacturing sites, collaborating internationally, and adapting to changing business models in the supply chain. Activities included sharing information with stakeholders, advancing the Department's Forward Regulatory Plan, and supporting the advancement of international standards.

Health Canada also increased surveillance and data collection to improve supply and demand analysis for critical shortages and supported approaches to develop a more resilient drug supply for Canada.

Responding to Climate Change

The effects of climate change and extreme weather events such as wildfires, heat waves, floods and droughts, continued across Canada, affecting the health of Canadians, and adding pressure on health care resources and Health Canada's services, operations and assets. To better understand the current, medium and long-term risks from climate change to the Department’s services, operations and custodial facilities, Health Canada completed a Climate Change Risk Assessment in 2022-23, and initiated work to develop measures to mitigate, address and prioritize risks that were identified in the assessment.

Building a diverse, agile and inclusive workforce

Inequities persist in healthcare, communities and workplaces across the country. Diversifying the healthcare and public workforce increases access to quality health care for all populations, reduces health disparities, improves cross-cultural communication, and contributes to health equity. 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 – formed the foundation of who we are, what we do, and how we do our work.

The Department addressed systemic racism, harassment, and discrimination and improved hiring, onboarding, and retention processes in line with the Clerk’s Call to Action on Anti-Racism, Equity, and Inclusion in the Federal Public Service. As well, it provided training and program to ensure that underrepresented employees were supported and provided growth opportunities throughout their employment.

In 2022, Health Canada also established a new Addressing Racism and Discrimination in Canada’s Health System Program to foster health systems free from racism and discrimination. The program funds projects that address systemic racism and discrimination in Canada’s health system in a way that is informed by the lived experience of Indigenous, racialized and marginalized communities.

Providing timely, trusted and evidence-based information

Canadians expect the Department to provide high quality, scientific and evidence-based health information. However, Health Canada's reputation as a source of credible information is threatened by the increasing misinformation and disinformation regarding health products and other regulated substances from a wide range of sources easily accessible to the public. This poses a challenge for the Department to respond 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. A continuing focus on sharing clear, accurate and timely information with stakeholders and the public will help 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 continues to provide high quality, scientific and evidence-based health information through a range of online and traditional communication tools and channels.

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 could be put at risk by challenges in administering the Act.

Health Canada upholds the Canada Health Act in an ever-changing environment. The Department's proactive responses have mitigated the risks associated with the administration of the Canada Health Act during the 2022-23 fiscal year. Specifically, Health Canada undertook the following:

Upholding the Canada Health Act Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Monitored and report on compliance	Core Responsibility 1: Health Care System	Mandate letter commitment: Strengthening compliance with and modernizing the interpretation of the Canada Health Act on matters of extra billing for publicly insured services.
Implemented new policies	As above	Mandate letter commitment: As above.
Worked to resolve issues with P/Ts	As above	Mandate letter commitment: As above.
Monitored litigation	As above	Mandate letter commitment: As above.
Monitored changes in health care delivery	As above	Mandate letter commitment: As above.

Monitored and reported on compliance:

Monitored and reported on compliance with the Canada Health Act. For example:

• Monitored P/T reports on their patient charges as per the Extra-billing and User Charges Information Regulations.
• Reported to Parliamentarians in February on the administration and operation of the Canada Health Act.

Implemented new policies:

Worked with P/Ts to ensure reporting on patient charges for diagnostic services as per the Diagnostic Services Policy, specifically:

• Reported first deductions taken under the Diagnostic Services Policy, totaling over $76 million, for patient charges levied for medically necessary diagnostic imaging services.
• Administered the Canada Health Act's Reimbursement Policy. Under the policy, mandatory Canada Health Transfer deductions may be reimbursed provided the province or territory implicated carries out a Reimbursement Action Plan to eliminate patient charges and the circumstances that led to them. For example, the Government of British Columbia (BC) qualified for a reimbursement of approximately $15.5 million in recognition of its progress in eliminating patient charges.

Worked to resolve issues with P/Ts:

Worked with P/Ts to resolve issues when deductions to health transfers were necessary and ensured reimbursements were distributed as stipulated in the Reimbursement Policy. For example:

• Deducted $6 million from BC, Ontario and New Brunswick for insured services provided at private surgical clinics and for access to insured abortion clinics.

Monitored litigation:

Monitored litigation that may implicate the Canada Health Act and supported federal involvement as required. For example:

• Supported British Columbia during the appeal stage of the Cambie Charter challenge.
• Continued to monitor the case brought by the Canadian Civil Liberties Association in New Brunswick, which alleges the province’s policies on coverage for abortion services contravene the Canada Health Act.

Monitored changes in health care delivery:

Monitored the evolution in the delivery of health care to ensure that insured services under the Canada Health Act remain covered regardless of changes in how the care is provided or who is providing the care. For example, Health Canada held an F/P/T Forum on Emerging Challenges to Plan Coverage Management to discuss challenges related to the integration of virtual care delivery of insured services, as well as the delivery of physician-equivalent services by other health care practitioners.

Key Risks for Core Responsibility 2: Health Protection and Promotion

2. Public Trust Risk: Canadians may lose confidence in Health Canada’s ability to help protect their health if the Department is not regarded as a trusted regulator and used as a credible source of information.

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 2022-23 fiscal year. Specifically, Health Canada undertook the following:

Public Trust Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Implemented informative initiatives	Core Responsibility 2: Health Protection and Promotion	Mandate letter commitment: Safe and sustainable use of effective pesticide products in Canada. Government priority: Keeping Canadians Safe and Healthy
Offered engagement opportunities to Canadians and stakeholders	As above	As above
Modernized communications about Health Canada’s role as a regulator	As above	As above
Advanced regulatory modernization initiatives	As above	As above

Implemented informative initiatives:

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

• Implemented the Department’s Open Science Action Plan and Framework for Science and Research Excellence to ensure federal science is transparent and accessible;
• Modernized the Workplace Hazardous Products Program web presence on Canada.ca with new, clear and concise external-facing information and distributed the latest news and information through newsletters;
• Promoted Radon Action Guides to help municipalities and P/Ts address radon in their communities;
• Consulted on a draft Guidance document which included examples of a search portal to improve transparency of Canadian clinical trial information.
• Updated information and communication products to support Canadians in making informed decisions about their health, such as information on: medical devices and clinical trials; health product risk; cannabis health risks, adverse reaction reports, market data and research; risks of substance use including vaping and tobacco; where to seek help for substance use, for example men working in the trades through the Ease the Burden campaign; and, cosmetics reports and recalls. 
• Issued communication products to provide healthcare professionals with safety information concerning marketed health products, including monthly Health Product InfoWatch newsletters, and Health Product Risk Communications for new and clinically significant risks.
• Implemented new front-of-package labelling regulations that will enable Canadians to identify foods high in -nutrients of concern (e.g., saturated fat, sodium and/or sugars) in prepackaged foods.

Offered engagement opportunities to Canadians and stakeholders:

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

• Consulted stakeholders, including consumer and patient groups, health partners, industry, academia, and non-governmental organizations, on regulatory modernization initiatives, supply chain transparency, options for addressing the consumer products exclusion in the Hazardous Products Act, labelling of chemicals in consumer products, and amendments to the Hazardous Products Regulations.
• Engaged with stakeholders on modernizing the regulation of natural health products (NHPs) including improved NHP labelling and a modernized regulatory framework for biocides and the use of the Drug Establishment Licensing and Good Manufacturing Practices regulatory flexibilities introduced during the pandemic, including exploring their future use and availability during times of emergency as part of safeguarding drug supply chains.
• Co-chaired multi-stakeholder steering committee meetings on Drug Shortages, with Provincial partners, offering industry and health care stakeholders the opportunity to shape the approach for improving drug shortage mitigation and prevention in Canada.
• Ensured Canadians had convenient access to information and opportunity to provide input on current regulatory consultations through the Consulting with Canadians and Canada Gazette website.

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

Continued to acquire, develop and improve the tools, processes and resources for effective communication and engagement with Canadians on Health Canada’s digital platforms, including Canada.ca and Health Canada social media channels. Specifically, Health Canada:

• Continued to innovate, leverage and optimize content and digital tools for Canadians, and automate data publishing to Canada.ca which allowed information to be published and updated in real time. This improved coordination between the web publishing, technical, strategic communications, and social media teams to quickly post information on many files including vaccine authorizations, provide real time information on drug and health product shortages, and update over 100 web pages for the COVID-19 Interim Orders.
• Improved transparency on pesticide regulatory decisions through plain language, increased access to information and data, and simplified tools and approaches to engaging stakeholders.
• Launched a new online application form to streamline requests for exemptions due to confidential business information for workplace hazardous products labels and safety data sheets.

Advanced regulatory modernization initiatives:

Continued to advance Health Canada’s regulatory modernization commitments to make Canada’s science-based regulatory system more agile and internationally aligned, including proposed agile regulations for drugs and medical devices. This would enhance the Department’s ability to provide comprehensive drug oversight, ensure safety, and maintain position as a top-tier regulator. Specifically, Health Canada: 

• Worked towards enabling the use of terms and conditions on the drug identification number of all drugs and broadened the scope of its use for Class II, III, and IV medical devices. 
• Proposed managing potential risks of human drug products by implementing risk management plans as appropriate, and by taking into consideration sex and gender-based analysis into the risk management plan review. 
• Advanced the work to allow sponsors to file rolling review drug submissions with some, but not all, of the information necessary to assess their safety, efficacy and quality. As with all other drug submissions, a decision to authorize these drugs can only be made once all the required information has been provided, reviewed, and found to be acceptable. The option for a rolling review would include submissions for drugs intended to address public health emergencies, such as COVID-19 drugs.
• Proposed new requirements for manufacturers to submit human clinical trial data broken down by population subgroups for new and supplemental human drug submissions, in line with submission requirements to the United States Food and Drug Administration or the European Medicines Agency. 
• Consulted on a regulatory proposal to create a pathway to authorize biocides based on decisions from other foreign regulators, starting with the United States Environmental Protection Agency. 

3. 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:

Regulatory Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Strengthened oversight	Core Responsibility 2: Health Protection and Promotion	Government priority: Keeping Canadians Safe and Healthy
Collaborated internationally	As above	Government priority: As above
Addressed changing business models in the supply chain	As above	Government priority: As above

Strengthened oversight:

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

• Inspected 80 vaping manufacturers to verify industry compliance with packaging, labelling, promotion, nicotine concentration, and child-resistant container requirements.
• Worked with regulated parties, health care partners and industry stakeholders to enhance early signal detection, monitoring, and data-sharing to help prevent health product shortages where possible, mitigating their impacts when they occur, and improving supply/demand analysis for certain critical shortages.
• Explored, developed, and implemented strategies and digital and administrative tools to strengthen oversight of e-commerce and online marketplace domains.
• Enhanced supply chain transparency to strengthen mandatory labelling of chemicals in consumer products, including proposed requirements to disclose certain fragrance allergens on labels for cosmetics under the Cosmetic Regulations, and new requirements to address consumer product exclusions under the Hazardous Products Act.
• Published amendments to the Natural Health Products Regulations in the Canada Gazette, Part II to improve natural health product labelling, along with updated guidance.

Collaborated internationally:

Collaborated with international regulatory and/or multilateral organizations and aligned where appropriate with foreign regulators. For example, Health Canada:

• Collaborated with international partners such as the United States Occupational Safety and Health Administration, United States Consumer Product Safety Commission, Mexico’s Consumer Protection Agency, European Commission, and World Health Organization on various international issues, such as updates to hazard communication, health impacts of hazardous chemicals, air pollution, water quality, climate change, consumer product safety, regulatory reviews, market authorizations, increased diversity in clinical trials, post-market safety surveillance and product shortages.
• Participated in international forums, the United Nations Sub-Committee of Experts, Project Orbis and utilized the G7 Clinical Trials Charter to build and leverage international relationships, develop global regulatory standards, and share best practices to ensure better health outcomes for Canadians through timely access and safer development of health products such as vaccines, therapeutics and cancer drugs.
• Communicated joint recalls of products, including 216 consumer product and cosmetic recalls, of which 82 were joint recalls with the United States and/or Mexico.
• Contributed to the global sound management of chemicals through the Strategic Approach to International Chemicals Management and participated in negotiations on the new ambitious global framework (SAICM Beyond 2020) on chemicals and waste, to protect human health and the environment.

Addressed changing business models in the supply chain:

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

• Shared information with trusted regulators to strengthen inspection reliance and, as part of the Mutual Recognition Agreements, on the suspension of Drug Establishment Licenses in Canada.
• Carried out foreign on-site Good Manufacturing Practices inspections to increase Health Canada’s oversight of drug production earlier in the supply chain.
• Implemented regulatory initiatives and plans, such as the Health Canada Forward Regulatory Plan, and the Regulatory Cooperation Council Joint Action Plan.
• Initiated discussions with the U.S. FDA on topics such as: medical devices shortages, supply chain challenges, general regulatory oversight, signal gathering and assessment.

Key Risks for Internal Services

4. 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, diverse, and agile workforce within a healthy workplace.

To ensure the Department continued building a healthy, diverse, and inclusive workforce; enabling a safe and productive workforce with access to modern tools and facilities; and communicating with Canadians the Department successfully implemented effective risk responses in the 2022-23 fiscal year. Specifically, Health Canada undertook the following:

People Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Supported workplace wellness initiatives	Internal services	Building a healthy, diverse, and inclusive workforce
Promoted diversity, bilingualism and inclusion	As above	As above
Attracted and retained skilled and talented employees	As above	As above

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; strategies that align with the National Standard for Psychological Health and Safety in the Workplace; the Employee Assistance Program and its resources; LifeSpeak, and the Mental Health Workplace Wellness Joint Sub-Committee, which sets mental health and workplace wellness organizational priorities and initiatives based on workplace assessments, results from the Public Service Employee Survey and the identification of psychological risk factors.
• Provided guidance, support, a safe space, and tools and resources to resolve issues of individual and organizational wellbeing through the Center for Ombuds, Resolution, and Ethics so employees can maintain a healthy and respectful workplace.
• Continued to implement the Workplace Harassment and Violence Prevention Regulations and Program as per the Canada Labour Code Part II, which included the development and launch of the Mandatory Learning Paths for managers and employees.

Promoted diversity, bilingualism and inclusion:

Encouraged diversity, bilingualism and inclusion and supported the Clerk’s Call to Action on Anti-Racism, Equity, and Inclusion in the Federal Public Service. For example:

• Continued implementation of the Department’s Multi-Year Diversity and Employment Equity Plan for 2022-25 and the Department’s 2018-2022 Official Languages Action Plan and expanding access to standardized language training through the Department’s Single Window Access to Languages Training and the Equitable Access to Language Training Program.
• Addressed racism and discrimination through the Leadership Council on Diversity and Inclusion and Employee Networks.
• Provided services to help employees at all levels address racism and discrimination through the Centre for Ombuds, Resolution and Ethics.
• Implemented strong employee networks with the support of their respective Champions and the commitments in Health Canada’s first Accessibility Plan.

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 and training.
• Incorporated accessibility, diversity, and inclusivity 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 and intentional recruitment approaches tailored to each Employment Equity hiring group.
• Began and continued work on staffing strategies/approaches for increasing Indigenous Peoples representation (e.g., launched an external advertised inventory open to indigenous communities).
• Successfully implemented collective staffing processes and inventory callouts for ongoing staffing needs across the Department were to respond to high volume staffing demands and to achieve greater efficiencies in the staffing process. As well, initiated work to manage staffing pools effectively and efficiently.
• Offered training through Managers Technical Briefings and mandatory training to increase awareness and understanding of flexibilities and address potential barriers.

5. 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 2022-23 fiscal year. Specifically, Health Canada undertook the following:

Technology and Infrastructure Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Continued to update IT and lab infrastructure	Internal services	Support the modernization and security of the workforce
Promoted digital transformation	As above	As above
Promoted training and awareness	As above	As above
Strengthened oversight	As above	As above

Continued to update IT and lab infrastructure:

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

• Continued to modernize workplace facilities, provided novel and secure tools, and implemented the Departmental Security Plan and use of M365 collaboration tools/features.
• Invested $6.5 million to address aging base building systems through major investments to upgrade and modernize the ventilation, heating, and cooling infrastructure in Health Canada’s Scarborough and Sir Frederick Banting laboratories, as systems reached the end of their useful life. 
• Participated in Labs Canada to explore opportunities for creating world-class, innovative, and collaborative science research centers across Canada. 
• Drafted a Real Property Portfolio Strategy to better align real property investments with Health Canada priorities and inform, where required, retention versus divestiture decisions.
• Developed and/or implemented business applications to address the risks of aged technology, including technology that does not meet business needs by assessing the over 200 HC portfolio business applications and developing plans to address those at highest risk.
• Investigated modern, reliable and robust security enterprise solutions that meet the Department’s needs.
• Created a systematic approach to capital investment planning and management by centralizing the Department’s capital budget and prioritizing investments.

Promoted digital transformation:

Leveraged data as an asset to inform decision-making and improve programs and services. For example:

• Continued to advance the Department’s digital-data transformation outlined in the Data Strategy.
• Worked towards aligning with the 2023 – 26 Data Strategy for the Federal Public Service, the Government of Canada Directive on Service and Digital, and the Policy on Results through the implementation of the Health Canada’s Data Strategy.

Promoted training and awareness:

Ensured Department vigilance and raised employee awareness. For example:

• Educated employees on security requirements and provided training on new applications and technology as well as on personal information management.
• Conducted branch-level privacy risk assessments to ensure branches understand privacy risks and allocate privacy advisory resources to the areas of highest need.
• Identified an internal process for procuring IT professional services to clarify the roles of Contracting, Digital Transformation Client Services, Shared Services Canada, and Security.
• Developed security tools and continued implementation of the Security Awareness Working Group action plan.

Strengthened oversight:

Implemented oversight strategies and fostered a security culture remotely and onsite. For example:

• Updated Business Continuity Plans, 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.
• Continued Privacy Impact Assessments, Privacy Breach Process and Reporting and implemented the revised Privacy Management Framework focusing on further expansion of a risk-based approach for initiatives with personal information.
• Managed and protected the personal information of Canadians through appropriate policies and safeguard measures, processes and tools.

Key Risk for Strengthening Emergency Preparedness

6. Major Disruptive Events Risk: Health Canada's ability to achieve its mandate may be at risk due to challenges posed by major disruptive events (such as the COVID-19 pandemic or impacts of climate change).

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 disruptive events while continuing to deliver on its mandate in 2022-23. Specifically, Health Canada undertook the following:

Major Disruptive Events Risk Response

Risk Responses	Link to the Department's Core Responsibilities	Link to Mandate Letter Commitments or Government-Wide Priorities
Provided timely, trusted and evidence-based information	Core Responsibility 2: Health Protection and Promotion Internal Services	Mandate Letter Commitment: Support openness, effectiveness and transparency in government. Improve digital capacity and services for Canadians. Ensure the Government of Canada continues to be prepared to proactively mitigate, and respond to, emerging incidents and hazards Government-Wide Priority: Keeping Canadians Safe and Healthy
Facilitated access to health products	Core Responsibility 2: Health Protection and Promotion	Government-Wide Priority: As above
Fostered engagement and collaboration	Core Responsibility 1: Health Care Systems	Mandate Letter Commitment: Continue to work in close collaboration with P/Ts, municipalities, Indigenous communities and other partners to increase COVID-19 testing and tracking; support the availability of rapid tests and self-tests; and meet surge capacity needs, including in remote and isolated communities. Government-Wide Priority: As above
Enhanced internal services	Internal Services	Mandate Letter Commitment: Ensure a safe, respectful, rewarding and welcoming place of work. Government-Wide Priority: Commit to implementing Government plans aimed at protecting and supporting Canadians through challenging times.

Provided timely, trusted, and evidence-based information:

Continued to provide P/Ts, health care providers, and Canadians with timely, clear, and evidence-based information and labelling to protect themselves on topics such as COVID-19 and critical drug shortages, increase awareness of vaccine safety and effectiveness, and demonstrate COVID-19's impact on higher-risk populations. For example:

• Published information on the number of COVID-19 rapid tests purchased and distributed to P/Ts, COVID-19 related clinical trial information used to support regulatory decisions to foster public trust, and a joint white paper with the United States titled Substance use and harms during the COVID-19 pandemic and approaches to federal surveillance and response, which studied approaches to surveillance and applied research, evaluating the impacts of COVID-19 measures on the opioid crisis.
• Continued use of Health Product Risk Communications and monthly Health Product Infowatch newsletter as a tool to increase healthcare professionals’ and Canadian awareness of vaccine safety and effectiveness as well as treatment and product information.

Facilitated access to health products:

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

• Introduced amendments to the Medical Devices Regulations to create a permanent regulatory framework for COVID-19 medical devices, which maintained many of the flexibilities provided under the medical devices interim orders while maintaining safety, effectiveness, and quality.
• Authorized clinical trials for health products which allowed for the authorization of an additional 27 COVID-19 testing devices, introduced amendments to COVID-19 testing devices, and reviewed responses to conditions from authorization holders. In particular, the Department authorized 7 new COVID-19 products, including four new bivalent booster vaccines.
• Reported to Parliament quarterly regarding how Bill C-10 funds were used to purchase rapid tests in 2021 and 2022.

Fostered engagement and collaboration:

Continued to work alongside other government departments (e.g., Public Health Agency of Canada, Public Services and Procurement Canada), P/Ts, and international regulatory partners (e.g., International Coalition of Medicines Regulatory Authorities) to coordinate Canada’s response to major health events such as the COVID-19 pandemic to meet and adapt to the needs of Canadians. For example:

• Worked with P/Ts to strengthen the healthcare system’s capacity to protect underserved communities, such as the commitment of $25 billion in bilateral agreement funding for P/Ts for shared health priorities, including increasing access and integration of mental health and substance use and establishing the Addressing Racism and Discrimination in Canada’s Health System Program to foster health systems free from racism and discrimination, including a focus on addressing needs of rural and remote areas.
• Enhanced the Government of Canada’s ability to monitor the evolution of major health events and worked with federal partners, P/Ts and the Canadian Red Cross to provide surge capacity for contact tracing, nursing, and outbreak management.
• Supported the timely deployment of safe and high-quality emergency health products throughout Canada such as the distribution of the 682 million rapid tests to Canadians.
• Provided funding and guidance through the Safe Restart Agreement Contribution Program to programs and P/Ts for: surge support to healthcare systems under stress; COVID-19 testing and the creation of 22 wastewater surveillance programs across Canada; strengthening data management for P/Ts and Indigenous organizations; and, distributing over 11 million rapid antigen tests to small and medium sized business, non-profits, and charities to support workers, volunteers, and individuals in vulnerable groups.
• Exchanged knowledge and best practices through interjurisdictional committees and forums such as the F/P/T Assistant Deputy Minister’s Committee on COVID-19 Testing, Contact Tracing, and Data Management and Infrastructure, as well as the Testing and Screening Knowledge Exchange Session.
• Led and supported multiple COVID-related intergovernmental and external advisory committees including the Variants of Concern Leadership Group and the Federal Pandemic Science Coordination and Action Group.

Enhanced internal services:

Continued to deliver services and commitments to prioritize, mitigate and manage risks to services, operations and assets major health events. For example:

• Developed practical strategies to promote employees’ health, and occupational health and safety.
• Established a health emergency coordination office and maintained detailed, high-profile plans, processes and governance frameworks for emergency preparedness, crisis management, business continuity, business resumption and horizontal initiatives, mapped against best practices and past lessons learned.
• Worked with Shared Services Canada to ensure network infrastructure supported business needs and minimized the risk of network outages.
• Supported platforms and tools for collaboration and remote work, such as the Microsoft 365 suite of tools.