2019-2020 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 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 and Key Risks
Operating Context
Health Canada (HC) operates in a complex and dynamic environment, facing several challenges as it works to deliver results for Canadians. Many of these challenges are beyond the sole control of the Department and involve working collaboratively with a range of partners, including stakeholders, the public and various levels of government, as well as international partners.
The Department monitors and responds to health concerns, identified in Canada and abroad, that affect the health and safety of Canadians. This includes events such as the 2019 novel coronavirus COVID-19 pandemic. The Department is working closely with the Public Health Agency of Canada, Canada’s Chief Public Health Officer, other federal departments and agencies, and provinces and territories to contribute to the Canadian and global response to this public health crisis.
Canada's public health care systems were designed more than half a century ago. All levels of government are aware of the requirement to adjust to the changing needs and expectations of Canadians, and to leverage technological advances in support of improving health outcomes and quality of care. As a partner in the national health care system, the Department works closely with provincial and territorial governments and stakeholders to develop national approaches to health systems issues and to promote the pan-Canadian adoption of best practices.
The increased pace of scientific and technological innovation, globalization, and the complexity of the global supply chain challenges the Department's ability to effectively regulate new, innovative and complex products, substances, food and emerging product categories. Given the evolving and expanding nature of the global marketplace, a key area of focus is on creating and strengthening relationships with domestic and international partners in order to leverage cooperation and best practices.
Canadians continue to expect their Government to be more open and transparent and to effectively engage them in decision-making. The provision of credible and timely information is critical to helping Canadians make informed health decisions for themselves and their families. However, the Department is one of many sources of health information for Canadians. The varying scientific quality and accuracy of information available to the general public can hinder the Department's efforts to reach Canadians, but also provides an opportunity for leadership in the provision of high quality, evidence-based health information.
Key Risks
Health Canada has a well-established integrated 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.
The following table outlines the Department’s three key risks it faced in implementing its core responsibilities, mandate letter commitments and priorities.
Key Risks 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 |
Uphold the Canada Health 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 CHA during the 2019-20 fiscal year.
Key examples of Health Canada's risk responses:
- Implemented new policies
- Worked with the provinces and territories to prepare for the implementation of the Diagnostic Services Policy, which took effect in April 2020.
The Diagnostic Services Policy formalized the longstanding federal position that medically necessary diagnostic services received in private clinics are considered insured health services. - 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.
Key Risk(s) 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: Health Protection and Promotion |
Government priority: Keeping Canadians Safe and Healthy |
| 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 2019-20 fiscal year.
Key examples of Health Canada's risk responses:
- Implemented informative initiatives
Expanded the regulatory, health and safety information made available to Canadians in simple and accessible ways through innovative initiatives and communication activities. For example:
- Provided information to Canadians through an annual surveillance report on health and safety incidents related to consumer products and cosmetics in Canada.
- Delivered 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 continued to expand the interactive map showing locations of opioid-related prevention, harm reduction, treatment and enforcement activities across Canada.
- Implemented a coordinated approach with federal, provincial and territorial partners to messaging on cannabis legalization, regulation, health impacts and drug-impaired driving.
- Published new and updated health warning messages and public education products at the same time as the final regulations for new classes of cannabis to enhance public awareness of the unique health risks associated with edible cannabis and higher strength cannabis extract products, and to promote lower-risk cannabis use.
- Published regular cannabis market data updates, results from the 2019 Canadian Cannabis Survey on the web, and 11 new voluntary recalls conducted by licence holders, which have affected or had the potential to affect Canadians.
- Continued to share intelligence on drug trends and risks with law enforcement agencies and public health organizations, through quarterly summary reports, monthly raw data sets and notifications on newly identified potent drugs.
- Continued to conduct public outreach under the Healthy Home Campaign to help inform Canadians about the potential risks from chemicals and the actions they can take in and around their homes to protect their health. In 2019-20, web visits increased by 295% with search engine marketing.
- Published “Water Talk” documents to help Canadians understand issues related to drinking water.
- Published Hazardous Substance Assessments to help suppliers of workplace products ensure higher quality Safety Data Sheets and product labels to inform workers.
- Published pesticide re-evaluation decision summaries that describe the re-evaluation decision, outcomes of science evaluation, risk mitigation measures, and next steps – including when any changes resulting from the re-evaluation will take effect.
- Delivered public awareness campaign to inform Canadian youth and their parents about the harms and risks of vaping for youth. The campaign used a variety of tactics, including paid advertising, interactive learning events, digital influencers, partnership activities and web resources.
- Informed target populations about formalized peer assistance as a service offering within supervised consumption sites, expanding critical services to people who use drugs, which took effect on March 1, 2020.
- 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 were provided with greater opportunity to be involved in decision-making processes, including the regulatory process throughout its development. For example:
- Engaged with external scientific experts and with Canadians, including patient support groups, to better inform the development of policy and regulations, and to build Heath Canada’s scientific expertise. The scientific advisory committees include the Scientific Advisory Committee on Health Products for Women, the Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System, and the Scientific Advisory Committee on Digital Health Technologies.
- Collaborated with the Canadian Institutes of Health Research, the Canadian Centre on Substance Use and Addiction, and the Mental Health Commission of Canada on cannabis research priorities to gather information and support regulatory actions.
- Continued to publish all correspondences and meetings with stakeholders regarding initiatives under the Healthy Eating Strategy and on the Action Plan on Medical Devices. Through its Action Plan on Medical Devices, Health Canada continued to provide Canadians with information on the medical devices they use. In January 2019, the Department launched an accessible database that contains medical device incident reports in a user-friendly and searchable online format.
- Published two quarterly reports for summer and fall 2019 outlining the summary results of vaping retail inspections. The list identifies establishments inspected and found to be non-compliant with the Tobacco and Vaping Products Act and/or the Canada Consumer Product Safety Act.
- Continued to conduct semi-annual stakeholder webinars to provide regular updates on the Pesticide Program.
- Engaged various stakeholders throughout the country to seek input for the continued improvement of the pesticide regulatory system.
- Improved communication tools
Acquired, developed and improved 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:
- Worked with social media influencers to reach niche audiences, promote events and amplify campaign messaging on important health issues, including the risk of substance use (tobacco, vaping and opioids).
- Continued to publish Drug Establishment Licensing Bulletins on the Government of Canada’s digital collaboration platform, GCcollab. These bulletins communicate drug inspection and establishment licensing updates to stakeholders.
- Identified and began working to remove redundant, outdated and trivial content on Canada.ca and to prioritize content to make it easier for Canadians to find and understand important health and safety information online.
| Risk response | Link to the department's core responsibilities | Link to mandate letter commitments or government-wide priorities |
|---|---|---|
Collaborated internationally |
Core Responsibility 2: |
Government priority: |
Strengthened oversight |
As above |
Mandate letter commitment: 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:
- Collaborated internationally
Collaborated with international regulatory organizations, and aligned where appropriate with foreign regulators. For example:
- Participated in the International Pharmaceutical Regulators Programme, held in Singapore in November 2019, aimed to foster greater international collaboration and information-sharing on regional pharmaceutical regulations.
- Improved international regulatory cooperation to facilitate ongoing information sharing. For example, Health Canada communicated 69 joint recalls regarding unsafe consumer products and cosmetics with the United States of America and/or Mexico. Joint recalls improve the coverage of a recall, leading to increased consumer awareness and reduced likelihood of confusion.
- Strengthened partnership with the U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). In 2019-20, Health Canada was formally invited to join the U.S. FDA/MHRA collaboration and formed a trilateral partnership that meets regularly to collaborate, share best practices and work together in the globalized clinical trial industry.
- Exchanged information with the European Commission through an administrative arrangement between the European Union and Canada under the Comprehensive Economic and Trade Agreement. Information exchanged included industry and product information, in addition to details of any corrective action taken on consumer products and cosmetics that may present a risk to consumers. Also, consistent with the Global Chemicals Outlook, Health Canada continued to play a leadership role in negotiations of an international policy framework to enhance the sound management of chemicals globally.
- Began information sharing, in March 2020, regarding companies found to have non-compliant medical device inspections with multiple countries – including Australia, Singapore, Japan, Brazil, Ireland, the United Kingdom, and France – as well as the World Health Organization, and the European Commission.
- Strengthened oversight
Developed strategies and tools to further strengthen market surveillance and oversight of emerging products. For example:
- Worked with partners from Toxicovigilance Canada and the Canadian Surveillance System for Poison Information (CSSPI) to enhance surveillance of possible poisoning risks associated with pharmaceuticals, controlled substances, pesticides, consumer products, industrial chemicals, health products and other chemical substances.
- Established the Scientific Advisory Committee on Health Products for Women to provide patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women’s health and the regulation of medical devices and drugs. The Advisory committee met twice in 2019-20 in order to consider issues related to medical devices, such as lifecycle management of medical devices (using mesh implants as a case study).
- Completed transition to an audit system, the Medical Device Single Audit Program, in December 2019. The program improves Health Canada's oversight of the medical devices sold in Canada, and ensures that the medical devices Canadians use meet higher quality standards. A quality manufacturing system helps to ensure that medical devices are produced in a manner that meets regulatory requirements.
- Initiated the first foreign on-site inspections of Medical Device Establishment Licence holders supplying the Canadian market, including the inspection of 14 establishments in 2019-2020.
- Advanced regulatory oversight through the Action Plan on Medical Devices by improving safeguards for Canadian participants of medical device testing, aligning Canadian approaches with international best practices, proposing regulations to improve post-market surveillance of medical devices, increasing inspections, and setting higher standards of evidence required before pre-market approval of medical devices.
- Implemented in October 2019 amendments to the Cannabis Regulations, which set out the rules governing the legal production and sale of edible cannabis, cannabis extracts and cannabis topicals.
- Developed and implemented a Compliance Promotion Strategy to increase awareness, improve understanding and foster ongoing compliance for the amended Regulations among regulated parties, federal partners, and provinces and territories. Overall, the Department reviewed a total of 2,190 notices of new cannabis products in 2019-20 to help protect Canadians from the risks associated with these products.
- Facilitated access to medications used in the treatment of substance use disorder and provided a safer supply. In April 2019, upon the recommendations of Canada’s Chief Public Health Officer, diacetylmorphine (prescription-grade heroin) was added to the List of Drugs for an Urgent Public Health Need, making it possible for all provinces and territories to import this drug for the treatment of opioid use disorder. In May 2019, the Department approved the use of injectable hydromorphone by qualified health care practitioners as a treatment for adults with severe opioid use disorder.
- Increased use of regulatory and non-regulatory activities
Increased the use of regulatory and non-regulatory activities to strengthen international collaboration and harmonization on Good Manufacturing Practices inspections for drugs. For example:
- Issued the first Certificate of Compliance under a revised Mutual Recognition Agreement with Australia for active pharmaceutical ingredients and successfully completed the re-assessment as a participating authority of the Pharmaceutical Inspection Co-operation Scheme.
- Conducted consultations on proposed amendments to the Food and Drug Regulations to improve access to generic drugs for Canadians, in spring 2019.
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