2020-2021 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.
The Minister of Health is responsible for this organization.
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.
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 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 Minister's mandate letter.
Operating Context
Health Canada operates in a complex and dynamic environment where many health challenges – such as the COVID-19 pandemic and the opioid overdose crisis – require a multi-jurisdictional approach. Thus, the Department works collaboratively and collectively with federal partners, provinces and territories (P/Ts), Indigenous organizations, industry, and international regulators.
Responding to the COVID-19 pandemic
COVID-19 has challenged Canadians and health systems across the country. The COVID-19 virus has increased the demand and urgency for drugs and health products including vaccines, treatments and medical devices. It has also negatively affected the mental health of many Canadians; disproportionally impacted those living in long-term care homes; worsened the opioid overdose crisis; and intensified the demand for surge capacity for front line workers and scientific experts.
In response, Health Canada mobilized and leveraged all its resources to minimize the impacts of COVID-19 on Canadians' health and safety. The Department, similar to other organizations across the country and the world, had to adapt to working virtually to ensure organizational resilience and agility. Existing programs still had to be delivered while simultaneously responding to an unprecedented health crisis. Health Canada's workforce had to innovate, collaborate and rapidly assess and share information to support informed decision-making in this rapidly changing context.
In 2020-21, the Department approved 5 vaccines (Pfizer-BioNTech, Moderna, AstraZeneca, Serum Institute of India, and Janssen) and the vaccines were rolled out across the country, providing protection to those most at risk. The Department implemented innovative and agile regulatory measures to authorize clinical trials and approve vaccines, treatments and therapies, sanitizers and disinfectants, and medical devices; launched digital tools to support public mental health; developed notification apps to alert Canadians on risk of exposure to control the outbreak; adopted new technologies for collaboration and remote work; and, reinforced comprehensive strategies to protect public servants' mental health and wellness during this challenging time.
Protecting the Canadian health care system
A strong health care system is a cornerstone of good health. Canada's publicly funded health care system is dynamic – it must respond to changes within medicine and throughout society. The basics, however, remain the same – universal coverage for medically necessary health care services provided on the basis of need, rather than the ability to pay.
Improving the quality of care and health outcomes requires close collaboration across jurisdictions, as well as a willingness to leverage resources and technological advances. This is especially so during a pandemic. Health Canada worked closely with P/T governments and stakeholders to develop national approaches to health systems issues and promote the pan-Canadian adoption of best practices in areas such as: sharing medical data; working to establish national standards for long-term care and mental health; and, implementing virtual health services and free digital tools to address challenges posed by mental health and substance use.
Regulating in the context of a global supply chain
The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain is a key challenge for regulators in the 21st century. Effectively regulating new, innovative and complex products, substances, food and emerging product categories in a global marketplace requires a global approach. As such, the Department focused on building and strengthening relationships with its domestic and international partners in order to leverage cooperation and best practices, and accelerate regulatory reviews.
Managing drug and medical device shortages
Although there are benefits to relying on a global marketplace for Canada's supply of drugs and medical devices, some of the risks became more apparent over the course of the pandemic. For example, a shortage of key supplies early on required Health Canada to immediately begin working with industry to develop "made in Canada" capability for producing everything from ventilators to surgical gowns. In addition, shortages in vaccine deliveries due to interruptions in the global supply chain highlighted key gaps in Canada's pandemic response. As a result, the Department is collaborating with Innovation, Science and Economic Development Canada, F/P/T governments, and stakeholders to build a robust domestic bio-manufacturing sector.
Addressing the opioid overdose epidemic
While the pandemic negatively affected the health of many Canadians it especially impacted those in populations at higher risk. It created new barriers and challenges for those already suffering from mental illness and substance use. Pandemic social distancing restrictions resulted in reduced access to health and social services. Closed borders disrupted the supply of opioids and resulted in an increase in contaminated (and toxic) street drugs. These factors contributed to an increased number of deaths due to overdose (up 89% from before the pandemic).
Guided by the federal Canadian Drugs and Substances Strategy, Health Canada has developed a public health-focused approach to this crisis. Working alongside other orders of government, Indigenous Peoples, substance use experts, first responders, and people with lived and living experiences, the Department supported community-led initiatives, such as: facilitating access to mental health and addiction support services; setting up supervised injection sites and facilitating access to safer supply; and strengthening prevention efforts, including increased access to naloxone kits.
Building an inclusive workforce
The COVID-19 pandemic and other global events such as the Black Lives Matter movement have highlighted the inequities that persist in communities and workplaces across the country. While COVID-19 affects everyone, the health impacts have been worse for seniors, essential workers, visible minorities, people living with disabilities and women. 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. Increasing diversity and nurturing deeper inclusion across the Public Service is a top priority and is part of Health Canada's core business. 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.
Increasing transparency and privacy protection
Canadians continue to expect their Government to be open and transparent and to effectively engage them in decision-making. As such, Health Canada is committed to openness, transparency, clarity on direction and sharing information as it becomes available to build trust, work in partnership with F/P/Ts and stakeholders, and protect the health and safety of Canadians. Additionally, Canadians expect the Department to provide high quality, scientific and evidence-based health information. This is critical to helping Canadians make informed health decisions for themselves and their families – especially when there is an increasing amount of information available to the general public of varying scientific quality and accuracy.
Throughout the pandemic, Health Canada provided timely and evidence-based information, through a range of online and traditional communication tools and channels. The Department developed a new web portal for Canadians, health professionals and academics with regulatory information on vaccines and treatments for COVID-19. It also created an industry-specific site with up-to-date information on the rapidly changing regulatory context for health products.
Finally, Canadians also expect that their privacy be protected while accessing government sources and apps. Health Canada adhered to privacy provisions and ensured Canadians' personal information was secured.
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 Health Canada's Response to COVID-19
Risk Response | 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: Internal Services |
Mandate Letter Commitment: Government-Wide Priority: |
Authorized clinical trials, and facilitated access to health products |
Core Responsibility 2: |
Mandate Letter Commitment: Government-Wide Priority: |
Fostered engagement and collaboration |
Core Responsibility 1: |
Mandate Letter Commitment: Work with P/Ts and Indigenous leaders to ensure COVID-19 vaccines continue to be distributed to Canadians. Government-Wide Priority: |
Enhanced internal services |
Internal Services |
Mandate Letter Commitment: Government-Wide Priority: |
Delivering on its mandate to ensure Canadians stay safe and healthy during a pandemic
During this unprecedented time, Health Canada used every tool available, leveraged resources and collaborated with F/P/T partners to protect the health of Canadians. The Department immediately implemented risk responses to mitigate the risk to continue delivering on its mandate during 2020-21.
Key examples of Health Canada's risk responses:
Provided timely, trusted and evidence-based information
- Provided Canadians and health care providers with the timely, clear, trusted, accessible, and evidence-based information they need to protect themselves, families, communities and businesses. For example:
- Utilized various communication channels to provide the latest information on vaccine authorizations, safety and efficacy to increase vaccine confidence and encourage uptake.
- Expanded the Canada.ca/coronavirus web site to enable Canadians to access all federal COVID-19 related information, including vaccination, and programs from a single site.
- Kept F/P/T partners, Canadians and health care providers abreast of emerging issues related to COVID-19 nationally and globally.
- Conducted compliance oversight of online advertisements using artificial intelligence tools to scan websites, social media and other online sources for false or misleading information and claims on COVID-19 health products.
- Took prompt actions, in collaboration with the Competition Bureau and e-commerce and social media companies, to remove these ads; and published online the products deemed non-compliant.
- Published advisories and bulletins to alert suppliers and consumers to the risk of using certain substandard or counterfeit products and provided them a means to report incidents relating to these products.
- Developed an online self-assessment tool to help Canadians determine their symptoms and make informed decisions regarding the best actions to take.
- Launched 2 apps: COVID Alert and Canada COVID-19 to support and protect Canadians.
- Promoted and amplified reports from the Testing and Screening Expert Advisory Panel and Industry Advisory Roundtable on COVID-19 Testing, Screening, Tracing and Data Management.
- Launched CanCOVID, an online platform that provides current science advice from academics and experts on issues of concern related to COVID.
- Reached out to visible minority communities by partnering with community leaders.
- Spearheaded the whole-of-government digital response to COVID-19, publishing relevant and timely information for Canadians, including 488 COVID-19-related web pages on Canada.ca/coronavirus.
- Improved web content related to areas of high importance such as vaccines, public health measures, and travel.
Authorized clinical trials, and facilitated access to health products
- Established innovative and agile measures to prioritize and expedite the regulatory review of COVID-related products without compromising standards for safety, efficacy and quality. For example:
- Introduced several Interim Orders to: facilitate the conduct of clinical trials and broaden access for trial participants; establish temporary pathways to expedite the review of medical devices, drugs and clinical trials; allow exceptional importation of drugs, medical devices or foods for a special dietary purpose; and, provide additional tools to help prevent and alleviate shortages of drugs and medical devices that may have been caused or worsened by the pandemic.
- Engaged with F/P/T partners, industry, international partners and healthcare professionals to facilitate access to drugs and devices for the diagnosis and treatment of COVID-19.
- Established the Critical Drug Reserve with P/Ts to ensure future drug supply for medical procedures to support COVID-19 patients, such as drugs needed for ventilators and Intensive Care Units.
- Discussions focused on potential health product solutions, and collaborating with other government departments to address challenges in getting COVID-19 products to market.
- Supported businesses that were ready to mobilize needed products, and provided guidance and advice on regulatory requirements.
- Developed a new web portal for Canadians, health professionals and academics with regulatory information on vaccines and treatments for COVID-19; and created an industry-specific site with up-to-date information on health products.
- Monitored the safety and effectiveness of COVID-19 drugs, vaccines and treatments.
- Prioritized pesticide applications to focus on the highest priorities and offered flexibilities to registrants to facilitate the manufacturing of sanitizers and disinfectants or concentrates to help address shortages and meet product demand.
Fostered engagement and collaboration
- Worked alongside PHAC and the Chief Public Health Officer to lead a whole-of-government approach by engaging and collaborating with partners and stakeholders to adapt to, and meet, the needs of Canadians. For example:
- Worked collaboratively with PHAC and other federal departments to develop a shared understanding on the possible trajectories of the pandemic and facilitate planning and preparedness efforts across government.
- Coordinated with PHAC, Innovation, Science and Economic Development Canada, Canadian Institutes of Health Research (CIHR) and National Research Council to develop key medical countermeasure initiatives needed to respond to the pandemic, including: COVID-19 research (e.g., virus origin and nature, transmission epidemiology, disease impacts, health system impacts, immunity, vaccines, treatments, testing, public health measures, and risk communications); pandemic preparedness and data monitoring; as well as the procurement of safe and effective vaccines and therapies, with corresponding logistics and supplies.
- Supported Public Services and Procurement Canada in the successful negotiation of vaccine agreements, guided by scientific data and expert advice from the Vaccine Task Force.
- Supported PHAC in coordinating the National Emergency Strategic Stockpile Warehouse space initiative to ensure appropriate and secure space for PPE and emergency supply stockpiles.
- Helped to implement travel health measures as well as safety and security assessment processes at points of entry across the country, including at 4 international airports (Vancouver, Calgary, Toronto and Montreal), 16 land borders and 22 Designated Quarantine Facilities.
- Developed a National PPE and Medical Supplies Dashboard to provide accurate, timely information on PPE procurement and deployment to F/P/T decision-makers and a common set of PPE data standards and methodologies for reporting with partners to improve data quality, processing and interpretation of data.
- Engaged with P/Ts to support greater testing and screening in workplaces and provided guidance to facilitate broader use of test kits for screening purposes; supported workplace pilots; and identified best practices.
- Collaborated with Innovation, Science and Economic Development Canada, the National Research Council, and PHAC and engaged with stakeholders to develop a strategy to fortify and accelerate Canada's domestic biomanufacturing sector.
- Worked with P/Ts to understand their surge human resource needs to respond to the pandemic and assist in developing and deploying surge capacity workforce.
- Worked with F/P/T partners on effective border management.
Enhanced internal services
- Delivered of critical services and commitments during a major health crisis, by focusing on key activities such as:
- Worked closely with Shared Services Canada to expedite the modernization of key infrastructure, by increasing remote capacity by over 300%, and increased bandwidth for the expected growth of over 1,500 new employees.
- Secured networks, equipped employees with mobile devices, and installed virtual and collaborative work applications (e.g. Zoom and M365 tools). By June 2020, all employees were able to access and work on the network simultaneously.
- Enhanced the security of the public cloud by expanding "Protected B" capability to host COVID apps and protect privacy and personnel information.
- Standardized job descriptions to create and staff new positions faster.
- Implemented physical distancing plans, including increased safety measures such as access to PPE and sanitization protocols in all locations nationally particularly where employees are onsite such as laboratories, clinics, and offices conducting critical functions.
- Liaised with building cleaning service providers and PSPC to modify cleaning and disinfecting processes in buildings.
- Adapted programs to the virtual environment, such as: virtual ergonomic assessments; alternative second language evaluations and online training; virtual onboarding/orientation sessions and tools for new employees and students; and equipment allowance to purchase supplies to help set-up remote work locations.
- Implemented innovative mental health tools to support Health Canada employees during the pandemic. Staff can now access counsellors via chat and video conferences.
Key Risk for Core Responsibility 1: Health Care Systems
Risk Response | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
---|---|---|
Implemented new policies |
Core Responsibility 1: |
Mandate letter commitment: Government priority: |
Worked to resolve issues with provinces and territories |
As above |
As above |
Monitored litigation |
As above |
As above |
Monitored changes in health care delivery |
As above |
Mandate letter commitment: Government priority: |
Uphold the Canada Health Act
Health Canada upholds the Canada Health Act(CHA) in an ever-changing environment. The Department's proactive responses have mitigated the risks associated with the CHA during the 2020-21 fiscal year.
Key examples of Health Canada's risk responses:
Implemented new policies
- Worked with provinces (British Columbia, Alberta, Quebec, Ontario, Nova Scotia and New Brunswick) following the implementation of the Diagnostic Services Policy, which took effect in April 2020. Due to the retroactive nature of CHA reporting, P/Ts will report on compliance with the Policy beginning in December 2022.
Worked to resolve issues with provinces and territories
- Evaluated provincial and territorial Reimbursement Action Plans to ensure the elimination of patient charges. For example:
- Worked with British Columbia and Newfoundland and Labrador on their respective Reimbursement Action Plans to eliminate patient charges for insured services. British Columbia received a partial reimbursement for actions taken to reduce the incidence of patient charges in the province. Newfoundland and Labrador received a full reimbursement for successfully eliminating patient charges in their jurisdiction, which were occurring in their jurisdiction.
Monitored litigation
- Monitored litigation that may have impacted the CHA and supported federal involvement as required. For example:
- Monitored the case brought by the Canadian Civil Liberties Association in New Brunswick, claiming the province's policies on coverage for abortion services contravene the CHA.
Monitored changes in health care delivery
- Monitored changes in health care delivery for their effect on access to insured service. For example:
- Monitored and assessed virtual access to primary health care services, which grew rapidly in Canada and around the world.
- Researched, analyzed and conducted policy work on such health care systems issues as: home care; access to sexual and reproductive health services; impacts of health care systems modernization on the health workforce; quality of care; health care systems and service delivery innovation; and health technology.
Key Risks for Core Responsibility 2: Health Protection and Promotion
Risk Response | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
---|---|---|
Implemented informative initiatives |
Core Responsibility 2: |
Government priority: |
Provided more engagement opportunities with Canadians and stakeholders |
As above |
As above |
Improved communication tools |
As above |
As above |
Maintain confidence in Health Canada as a trusted regulator
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 2020-21 fiscal year.
Key examples of Health Canada's risk responses:
Implemented informative initiatives
- Expanded the amount of regulatory health and safety information made available to Canadians in a simple and accessible way through innovative initiatives and communication activities. For example:
- Published a summary table of complaints identifying/listing companies and corresponding pharmaceuticals, biologics (including vaccines), medical devices, and natural health products linked to fraudulent advertising claims.
- Provided information and guidance on food safety during the pandemic, such as safe food handling and cooking practices; tips for safe grocery shopping and food delivery; and, publishing research findings in relation to spread of the virus through food safety.
- Launched a web page to update and inform Canadians on nitrosamines. Nitrosamines are compounds that can form in certain drugs during manufacturing. Some nitrosamines may increase the risk of cancer if people are exposed to them over long periods of time.
- Provided new and updated information to Canadians on a number of food chemical and allergen topics.
- Provided information to Canadians through quarterly and annual surveillance reports on health and safety incidents related to consumer products and cosmetics in Canada.
- Published Consumer Product Enforcement Summary Reports to provide information to industry and consumers on products verified for compliance by Health Canada.
- Informed regulated parties on the Enforcement Approach for the General Prohibitions under the Canada Consumer Product Safety Act. This document describes Health Canada's approach and expectations in enforcing the general prohibitions against manufacturing, importing, advertising or selling a consumer product that is a danger to human health or safety.
- Promoted awareness of potentially unsafe consumer products through various social media postings and campaigns such as a first-person testimonial video on the risks associated with flame jetting in firepots.
- Participated in internationally-coordinated consumer product awareness campaigns, including the Organisation for Economic Co-operation and Development's 2020 Global Awareness Campaign on the safety of toys sold online, which Canada co-led with Australia, as well as a joint campaign with the European Union on toy recalls.
- Continued to promote the Healthy Home Campaign through Health Canada's social media channels to inform Canadians about the potential risks from chemicals and the actions they can take in and around their homes to protect their health. In 2020-21, web visits increased by 161% as result of paid social media and search engine marketing campaigns.
- Shared monthly and quarterly drug analysis data reports by Health Canada with F/P/T partners, stakeholders and law enforcement. Continued Drug Notifications to Canadian law enforcement agencies and public health partners. In addition fulfilled international reporting requirements for the narcotics and psychoactive substances to the United Nations Office on Drugs and Crime.
- Continued to engage openly and transparently with international partners to provide factual information about Canada's experience with legalizing and regulating cannabis.
- Delivered public education campaigns to inform and educate Canadians about potential harms associated with the use of cannabis, opioids, and other controlled substances, and to reduce stigma related to substance use and mental health. For example, launched a digital advertising campaign to engage youth and young adults on the facts related to cannabis use on mental health.
- Published cannabis market data updates that include: non-binding service standards regarding the issuance of licences, permits and personal registrations under the Cannabis Act and its regulations; results from the Canadian Cannabis Survey 2020 and the Canadian Cannabis Vaping Survey; 18 voluntary recalls conducted by licence holders; and the Compliance and enforcement report: Cannabis inspection data summary (2018-19).
- Published data on cannabis for medical purposes to include additional elements such as the number of health care practitioners authorizing cannabis use for medical purposes.
- Published an advisory on accidental ingestion of cannabis in pediatrics, reminding readers about safe storage of products after receiving adverse reaction reports of accidental ingestion in pediatrics with illicit products.
- Monitored and assessed case reports of adverse reactions involving legal cannabis products to identify potential safety signals and issue 2 risk communications linked to adverse reactions. For example:
- Published new safety information on cannabis related to adverse reaction in the InfoWatch newsletter on the MedEffect Canada Web page, such as the review article on cannabis-warfarin interactions in October 2020.
- Updated cannabis adverse reaction data continued through the Canada Vigilance Adverse Reaction Online Database.
- Conducted ongoing education and outreach presentations on adverse reaction reporting to licence holders and other stakeholders to increase awareness on the Vigilance Framework for Cannabis and the importance of reporting adverse reactions.
- Continued public awareness campaigns to inform youth and their parents on the harms and risks of vaping and tobacco use, through a variety of virtual and interactive learning events, such as Consider the Consequences of Vaping, and web content, such as breakitoff.ca and canada.ca/quit-smoking.
- Published guidance documents about substances under the CDSA to increase decision-making transparency, such as the status determination of benzodiazepine, a drug that slows down brain activity.
- Published a total of 18 pesticide re-evaluation and special review decision summaries that describe the decision, outcomes of science evaluation, risk mitigation measures, and next steps - including when any changes resulting from the re-evaluation will take effect.
Provided more engagement opportunities to Canadians and stakeholders
- In line with the Government of Canada's Open Government initiative and Health Canada's Forward Regulatory Plan, Canadians and stakeholders had greater opportunity to be involved in decision-making processes, including the regulatory process throughout its development. For example:
- Continued to publish all correspondence and meetings with stakeholders, such as industry and advocates, regarding Healthy Eating Strategy initiatives to inform the development of policies, guidance or regulations.
- Consulted with health products stakeholders, including pharmaceutical associations and representatives, manufacturers, importers and distributors, in response to shortages of prescription drugs, biocides, and medical devices.
- Led the work of the Multi-Stakeholder Steering Committee on Drug Shortages and the Tier Assignment Committee, to improve the communication of drug shortage information to the public and prevent/alleviate drug shortages in Canada.
- Consulted with health and industry stakeholders and developed a regulatory framework for the sale of human milk fortifiers. The final regulations were published in the Canada Gazette Part II in April 2021.
- Consulted with Canadians and stakeholders on the proposed modernization of the Radiation Emitting Devices Act, which focuses on radiation safety risks and governs the sale, lease, advertising and importation of radiation emitting devices in Canada.
- Published Regulatory Decision Summaries for amendments to Class III and IV medical devices on the Drug and Health Product Register.
- Held webinars to present to stakeholders the revised sodium reduction targets for processed foods and provide them with an opportunity to ask questions.
- Consulted with health and industry stakeholders on the development of a Food Labelling Coordination Strategy which will provide greater predictability and enhanced interdepartmental coordination for mandatory food labelling changes required by Health Canada and the Canadian Food Inspection Agency.
- Discussed the regulatory requirements regarding the assessment and reporting of nitrosamines with industry, domestic and international regulators, and stakeholders, such as the U.S. FDA, Europe, Australia, Singapore, Japan and the United Kingdom.
- Published 69 datasets on chemical contaminant surveillance results, including targeted surveys for melamine, mycotoxins and other toxins as well as nutrition surveillance data (Usual Intakes from Food) on the Open Government Portal.
- Engaged with partners and stakeholders on the issuance and reissuance of COVID-19 related interim orders for health products.
- Engaged patients represented by the Scientific Advisory Committee on Health Products for Women who had been adversely impacted by implanted urinary meshes and breast implants. The patient representatives advised Health Canada on considerations to improve pre-market review and post-market surveillance of medical devices used in women.
- Engaged stakeholders from patient safety organizations, academic researchers, medical professional groups, and industry on a proposal to reduce the retention period for clinical trial records from 25 to 15 years.
- Engaged with CIHR, the Canadian Association of Research Ethics Boards and regional ethical boards across the country as well as collaborated with policy makers, regulators, funders and oversight bodies on the clinical trials for COVID-19 therapeutic products to ensure timely access for consumers.
- Engaged with F/P/T partners, industry and healthcare professionals of the actions taken by Health Canada to facilitate access to drugs and medical devices for the diagnosis and treatment of COVID-19.
- Conducted technical briefings and compliance promotion sessions with health system stakeholders on Canada's response to emerging issues, including the planned response to address concerns about bulk importation of drugs that could threaten the national supply of key health products.
- Consulted with Canadians and stakeholders on the Instrument Choice Framework for the Canada Consumer Product Safety Act. The Framework outlines the approach to decision-making when addressing consumer product risks and the guiding principles to determine the appropriate instrument to help protect the health and safety of Canadians.
- Published the Safety Data Sheet (SDS) Compliance Promotion Tool on whmis.org. The tool assists suppliers in preparing an SDS for workplace hazardous products by providing information about regulatory requirements and best practices to address common safety non-compliances.
- Advanced cannabis research priorities in collaboration with CIHR, the Canadian Centre on Substance Use and Addiction, and the Mental Health Commission of Canada.
- Conducted public consultations for changes to the regulatory framework of the cannabis program.
- Established the F/P/T Working Group on Alcohol following increased alcohol consumption and resulting harms exacerbated by the pandemic. The group identified collaborative actions taken to strengthen and better implement evidence-based policies to reduce and prevent problematic alcohol use.
- Conducted public online consultations and delivered workshops, through the Canadian Pain Task Force, capturing the perspectives of over 2,000 people living with and affected by chronic pain across the country.
- Continued to conduct semi-annual stakeholder webinars to provide regular updates on the Pesticide Program.
- Conducted a series of consultations with employees, domestic and international stakeholders and regulatory counterparts receiving broad support for the integrated lifecycle approach to pesticide regulation.
- Extended consultation periods for certain post-market pesticide reviews to provide adequate opportunities for stakeholders impacted by the pandemic to provide comments.
Improved communication tools
- Continued to acquire, develop and improve the tools, processes and resources needed to effectively communicate to, and engage, Canadians on Health Canada's digital platforms, including Canada.ca and on approved Health Canada social media channels. For example:
- Continued to deliver public awareness campaigns to inform Canadians about opioids and their related health risks, and to address the stigma that creates barriers for those seeking treatment. For example, Health Canada expanded the interactive map showing locations of opioid-related prevention, harm reduction, treatment and enforcement activities across Canada.
- Implemented strategies to build new, user-focused recalls and safety alerts systems, improving the ability of Canadians to take actions to protect themselves from unsafe products.
- Improved collection of relevant SGBA Plus information from the medical device incident reporting form facilitated by the Scientific Advisory Committee on Health Products for Women. This supported user-focused digital content that is findable and accessible.
- Collaborated with other government departments to create travel tools for the public to access information regarding requirements related to travel during the pandemic and quarantine.
Risk Response | Link to the Department's Core Responsibilities | Link to Mandate Letter Commitments or Government-Wide Priorities |
---|---|---|
Strengthened oversight |
Core Responsibility 2: |
Mandate letter commitment: Government priority: |
Collaborated internationally |
As above |
Government priority: |
Increased the use of regulatory and non-regulatory activities |
As above |
Government priority: |
Protect Canadians from the risks of products
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.
Key examples of Health Canada's risk responses:
Strengthened oversight
- Developed strategies and tools to further strengthen market surveillance and oversight of emerging products. For example:
- Expanded regulatory oversight of online vaping product retailers by increasing capacity to conduct online compliance and enforcement activities.
- Launched the first Compliance Promotion and Sampling Project for cannabis edibles products. In total, 96% of license holders that had reported sale of cannabis edible products were inspected and 144 edible cannabis samples were collected to monitor and verify compliance with regulatory and legislative requirements.
- Continued the Cannabis Vaping Sampling Project. To date, 63% of license holders producing / selling vaping products have been inspected and 81 vaping products have been sampled, of which, 93% of the samples were found to be satisfactory.
- Continued to promote, verify and enforce the Compliance Promotion Strategy on cannabis regulations. Overall, Health Canada reviewed 23,905 notices of new cannabis products in 2020-21 to help protect Canadians from the risks associated with these products. Additionally, the Department monitored and assessed adverse reaction reports and conducted health risk assessments upon request.
- Implemented new operational tools in response to the COVID-19 pandemic, to remotely inspect tobacco and vaping product manufacturers and importers in accordance with the Tobacco and Vaping Products Act and the Canada Consumer Product Safety Act.
- Redefined the program's risk-based approach and supporting tools to cannabis-related compliance and enforcement activities to more accurately identify and target activities and products within the cannabis industry that represented the highest risk to public health and safety of Canadians.
- Published final regulations on the post-market surveillance of medical devices in December 2020. The regulations give Health Canada powers to request tests, studies, and new assessments from manufacturers and to require manufacturers to inform the Department within 72 hours if there are new warnings abroad about serious risks related to their medical device allowing the Department to act quickly on problematic medical devices that may pose a serious risk to the health and safety of Canadians.
- Developed a digital tool to enhance monitoring of the nutritional quality in the food supply by automating the extraction of nutrient and ingredient label information from Canadian grocery and food business websites.
Collaborated internationally
- Collaborated with international regulatory organizations, and aligned where appropriate with foreign regulators, including on joint recalls where appropriate. For example:
- Issued a collective statement with Australia-Canada-Singapore-Switzerland-United Kingdom (Access) partners, pledging support to tackle COVID-19 by collaborating and sharing vital information. This partnership resulted in the publishing of a COVID-19 vaccines evidence statement and guidance on COVID-19 vaccines modifications to address new variants.
- Increased international collaboration (e.g., Access Consortium, Orbis, ICH, vaccine and therapeutics reviews, post-market surveillance).
- Joined the European Medicines Agency's OPEN pilot initiative in December 2020. The initiative makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to collaborate with the Agency. It will provide additional opportunities for collaborative work on the safety and effectiveness of health products, particularly for emerging COVID-19 therapeutics and vaccines.
- Met with U.S. FDA to discuss regulatory flexibilities to facilitate access to PPE, ventilators and diagnostic testing devices.
- Engaged with the U.S. FDA, the U.K.'s Medicines and Healthcare products Regulatory Agency and Australia's Department of Health to share best practices and information on medical device and drug shortages, in the context of the COVID-19 pandemic.
- Promoted the global implementation and adoption of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through active participation in the United Nations Sub-Committee of Experts on the GHS.
- Facilitated information sharing internationally. For example:
- Communicated 171 consumer product recalls, including 50 joint recalls with the U.S. and/or Mexico, regarding unsafe consumer products and cosmetics.
- Finalized a commitment with the U.S. FDA to facilitate the sharing of information related to cannabis, specifically quality standards, supporting methodologies, and clinical research of safety standard for regulated cannabis products, health products containing cannabis and drugs containing cannabis.
- Shared with the European Commission industry and product information and the corrective actions taken on consumer products and cosmetics that may present a risk to Canadians.
- Led the International Coalition of Medicines Regulatory Authorities (ICMRA) Real World Evidence (RWE) initiative to tackle real-world evidence issues on COVID-19. This included the initiation of 3 Drug Safety and Effectiveness Network (DSEN) COVID-19 research projects to address steroid use, coagulopathy and pregnancy, with additional research studies forthcoming.
- Expanded networks and enhanced relationships with international regulators in various post-market surveillance activities including monitoring COVID-19 health products. This expansion enhanced trust, confidence, cooperation and collaboration with international partners on issues of mutual priority.
Increased the use of regulatory and non-regulatory activities
- Increased the use of regulatory and non-regulatory activities that address changing business models in the supply chain, specifically for foreign sites. For example:
- Participated in the International Coalition of Medicines Regulatory Authorities' Digital Transformation Working Group to share knowledge and experiences on digital changes made to the Good Manufacturing Practices and Good Clinical Practices inspections conducted during the COVID-19 pandemic. A focus on remote inspection techniques and technologies informed an International White Paper.
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