2018-2019 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, other federal departments and agencies, non-governmental organizations, other countries, Indigenous partners and the private sector to help achieve our goal of making Canada one of the healthiest countries in the world.

As a partner in health, Health Canada:

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 – these 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 once 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.

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 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.

Canada's public health care systems were designed more than half a century ago. All levels of government are aware of the need to adjust to the changing needs and expectations of Canadians and 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 defining and understanding 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:

1. Health Canada's ability to effectively uphold the Canada Health Act (CHA) could be put at risk by challenges in administering the Act.
Existing risk Risk response strategy and effectiveness Link to the department's core responsibilities Link to mandate letter commitments, government-wide or departmental priorities (as applicable)

The Department identified the following risk elements:

Ability to uphold the CHA.

To facilitate consistent and even-handed administration of the CHA, Health Canada: implemented new policies; worked to resolve issues with provinces and territories in a consistent manner; normalized the internal administration of the CHA through a delegation matrix; and monitored litigation that may impact the CHA and support legal services as required.

Core Responsibility 1: Health Care Systems

Mandate Letter Commitment: Promote and defend the CHA.

Government Priority:
Healthy Canadians

Organizational Priority I: Fostering Sustainable Health Care Systems.

Uphold the Canada Health Act

Health Canada upholds the Canada Health Act (CHA) in an ever changing environment. The Department’s proactive risk responses have mitigated the risk for the 2018 to 2019 fiscal year.

Key examples of Health Canada’s risk responses:

Implemented new policies
Implemented three CHA initiatives via a formal letter from the Minister of Health; the Diagnostic Services Policy; the Reimbursement Policy; and strengthened reporting.
Worked to resolve issues with provinces and territories
Health Canada worked with the provinces and territories to prepare for the implementation of the Diagnostic Services Policy, which takes effect April 2020.
The Department has worked with British Columbia, Newfoundland, and Labrador on their respective Reimbursement Policy Action Plans to eliminate extra-billing and user charges.
Health Canada provided Quebec with the first reimbursement for meeting the requirements of the Reimbursement Policy.
Normalized the internal administration of the CHA
The department continues to work to improve the administration of the CHA.
Monitored litigation
Health Canada continued to monitor litigation that may impact the CHA, and supported the federal case in the British Columbia Charter challenge.
2. Canadians will lose confidence in the safety of health and consumer products if Health Canada is not regarded as a trusted regulator and used as a credible source of information.
Existing risk Risk response strategy and effectiveness Link to the department's core responsibilities Link to mandate letter commitments, government-wide or departmental priorities (as applicable)

The Department identified the following risk elements:

Open and transparent regulatory information to Canadians.

In response to this risk, Health Canada:

1. Expanded the amount of regulatory health and safety information made available to Canadians in a simple and accessible way.

Core Responsibility 2: Health Protection and Promotion

Government Priority: Open and Transparent Government.

Organizational Priority II: Strengthen openness and transparency as modernization of health protection legislation, regulation and service delivery continues.

Involvement of citizens and stakeholders in regulatory decision-making.

2. Increased opportunities for Canadians and stakeholders to provide input to be considered during the regulatory process.

As above

As above

Ability to communicate consistently with sufficient speed.

3. Continued to implement a digital-first approach to inform, communicate and engage Canadians on Canada.ca and on approved Health Canada social media channels.

4. Continued to acquire, develop and improve the tools, processes and resources needed to effectively communicate and engage Canadians on our digital platforms, including on Canada.ca and on official Health Canada social media channels.

5. Made health-related online information easier to find and use from any device, accessible and compliant with Web 2.0 requirements.

As above

As above

Maintain confidence in Health Canada as a trusted regulator

To ensure that Health Canada continued 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 2018-19 fiscal year.

Key examples of Health Canada’s risk responses:

Implemented informative initiatives
Health Canada 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, the Department launched a new Healthy Home Campaign to raise awareness about health risks from chemicals of concern and pollutants that may be found in and around the home. Furthermore, Health Canada modernized the Water Quality Program to increase openness and transparency and further engage the Canadian public.

The Department also established the “Medical Device Action Plan,” including an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada.
Increased communication
Health Canada delivered 147 outreach and stakeholder events related to consumer product safety across the country; provided 28 media interviews (TV, radio, print) on consumer product safety-related topics such as battery safety, household chemicals and toy safety; and responded directly to over 6,000 inquiries from industry and consumers on consumer product safety-related issues.

The Department maintained transparency by publishing all correspondences and meetings with stakeholders regarding initiatives under the Healthy Eating Strategy. In addition, Medical Device Quarterly and Annual Performance Reports are now publically available. Finally, 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.

Expanded the Submissions Under Review List initiative to include a list of generic submissions and released additional datasets (i.e., Regulatory Decisions Summaries) for all new Class III medical device licenses (e.g., orthopedic implants or blood glucose monitors) as well as for final positive decisions for new Class III medical device applications that are issued on or after January 31, 2019 in the Drug and Health Product Register. The Regulatory Decisions Summary initiative was also expanded, to include supplemental new drug submissions for new routes of administration, new dosage forms, and new strengths.
Provided more engagement opportunities with Canadians and stakeholders
Canadians and stakeholders were given more opportunities to provide input for consideration during the regulatory processes. For example, the Department consulted stakeholders on a proposal to ‘Pause-the-Clock’ for Drug and Medical Device Establishment Licence applications. Feedback received during the consultation was taken into consideration and the Pause-the-Clock policy was revised and will be implemented in 2020. Health Canada also conducted a 60-day public consultation on proposed regulations to minimize the risks posed by edible cannabis, cannabis extracts and cannabis topicals, which were published in the Canada Gazette.

The Department conducted consultations to gather ideas on potential next steps under the Canadian Drugs and Substances Strategy, and published the What We Heard: Strengthening Canada’s Approach to Substance Use Issues report.

Health Canada consulted specific stakeholders on the draft Compliance Approach for the Reimbursement Regulations under the Assisted Human Reproduction Act (AHRA) in February 2019. These consultations were an additional opportunity for targeted stakeholders to provide their input on the draft compliance approach for the proposed AHRA Reimbursement Regulations. This was in addition to public consultations on the overall regulatory package.

The Department also consulted the Canadian clinical trial industry and stakeholders on the first Guidance Document on Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”. This guidance document will help those involved in conducting clinical trials of drugs in human subjects in Canada to comply with the Regulations and to understand the International Council for Harmonisation Guidance Document in the Canadian context. Finally, the Department completed consultations for the new Infant Formula Good Manufacturing Practices document.
Implemented a digital-first approach
Health Canada continued to implement a digital-first approach to inform, communicate to and engage with Canadians on Canada.ca and on approved Health Canada social media channels. The Department provided information and tools to help Canadians make informed health and safety decisions related to consumer products and cosmetics. For example, Health Canada conducted 27 social media campaigns, communicated 236 recalls to Canadians due to health or safety concerns affecting 5.5 million consumer product units, ranging from USB chargers to bassinets, as well as published annual and quarterly reports related to consumer products and cosmetics.
Improved communication tools
Health Canada continued to develop and improve the tools, processes and resources needed to effectively communicate and engage Canadians through digital platforms, including Canada.ca and Health Canada social media channels. Content on Canada.ca was rewritten to be more mobile-friendly and accessible. To remain a credible source of information in a digital first environment, Health Canada improved navigation on Canada.ca, making online information easier to find for Canadians and removed redundant and outdated web content.
Fulfilled Web 2.0 requirements for online information
Health Canada made its online information compliant with Web 2.0 requirements, and made it more accessible and easier to find from any device. The Department completed seven large-scale web optimization and content renewal projects, including: cannabis, Canada’s Food Guide, responding to Canada's opioid crisis, safe internal cooking temperatures, and food safety.

Social media plans were developed and implemented on priority files including: opioids, cannabis, and Canada’s Food Guide. Other major social media plans included healthy eating and food safety (for example, how to safely cook frozen raw breaded chicken products). Although these were individual plans, they contained many posts spanning several months to increase awareness of each issue. Health Canada also launched the Healthy Canadians Instagram account to inspire young Canadians to make healthy choices.
3. Health Canada's ability to protect Canadians from the risks of products may be weakened due to the changing integrity of the global supply chain and the rapid pace of innovation.
Existing risk Risk response strategy and effectiveness Link to the department's core responsibilities Link to mandate letter commitments, government-wide or departmental priorities (as applicable)

The Department identified the following risk elements:

Efficiency gains can be realized through information and work sharing with other regulatory organizations in the global market.

In response to this risk, Health Canada:

1. Collaborated with international regulatory organizations, and aligned where appropriate with foreign regulators.

Core Responsibility 2 : Health Protection and Promotion 

Organizational Priority II: Strengthen openness and transparency as modernization of health protection legislation, regulation and service delivery continues.

Existing legislative and regulatory frameworks are challenged by the pace of innovative new substances, technologies, products, pesticides, food and emerging product categories, along with new business models, fraudulent activities and healthcare service delivery strategies.

2. Developed oversight strategies and tools to strengthen market surveillance and oversight of emerging products.

As above

As above

Pace of innovations in supply chains and manufacturing activities occurring at a multitude of foreign sites.

3. Increased the use of regulatory and non- regulatory activities that address changing business models in the supply chain, specifically for foreign sites.

As above

As above

Protect Canadians from the risks of products

To ensure that Health Canada is able to 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 with international regulatory organizations
Health Canada collaborated with international regulatory organizations and aligned where appropriate with foreign regulators. For example, Health Canada participated in the Active Pharmaceutical Ingredients and Finished Dosage Inspections Coordination Programme, coordinated by the European Medicines Agency and U.S. Food and Drug Administration, which fosters greater international collaboration and information-sharing for identifying sites of common interest, better distribution of inspection capacity, reducing unnecessary duplication, as well as sharing of inspection outcomes.

The Department improved international regulatory cooperation to facilitate ongoing information sharing. For example, 61 recalls were conducted jointly with the United States and/or Mexico regarding unsafe consumer products and cosmetics. This ensured increased consumer awareness and reduced the likelihood of confusion. Also, Health Canada signed an information-sharing agreement with the European Commission under the Comprehensive Economic and Trade Agreement, which will allow Canada and Europe to react quicker to potential risks posed by consumer products and share information on new products entering the market. Health Canada also took a leadership role in facilitating coordination of regulatory responses to the global recall of sartan drugs, working closely with the US FDA, the European Medicines Agency, Swiss Medic, and other regulators.

Health Canada strengthened international partnerships for the benefit of Canadians. For example, Health Canada approved a new drug for the treatment of prostate cancer though a joint review with the Therapeutic Goods Administration of Australia. This work-sharing initiative strengthens international partnerships in submission review and accelerates the approval of drugs for the benefit of Canadians.
The Department expanded the scope of a Mutual Recognition Agreement with the Therapeutics Goods Administration of Australia to include active pharmaceutical ingredients. The agreement allows for the recognition of Australian regulatory oversight of drug production facilities, reducing the burden for industry as oversight by one of the countries is accepted by both.
Strengthened oversight
Health Canada developed oversight strategies and tools to strengthen market surveillance and oversight of emerging products. The Department took additional steps to address the opioid crisis, by further restricting the marketing and advertising of prescription opioids to health care professionals and added requirements under the Food and Drug Regulations for a warning sticker and patient information handout to be provided with all prescription Class A opioids at the time of dispensing, in order to provide better information for patients on the safe use of opioid medications. Furthermore, Health Canada worked with provincial/territorial/municipal partners, health experts and practitioners, and law enforcement officials to understand how best to implement a comprehensive response to the current opioid crisis.

Health Canada implemented the Tobacco and Vaping Products Act, which was enacted in May 2018, to regulate the manufacture, sale, labeling and promotion of vaping products (along with tobacco products) sold in Canada. The Department further implemented new compliance monitoring activities of vaping on the Internet and social media. This has allowed the department to react quickly to emerging youth vaping issues and repeat non-compliant advertising and promotion complaints.

Health Canada introduced the Compliance and Enforcement Policy for the Cannabis Act to outline the department’s consistent and transparent approach to promoting and enforcing compliance with the Cannabis Act and its Regulations. The Department also developed a national Cannabis Tracking System to monitor cannabis production and supply levels, and help prevent cannabis from being diverted to, or inverted from, the illegal market.

As part of a Pesticides Program Transformation initiative, Health Canada is conducting a review of activities relating to the Post-Market Pesticide Re-Evaluation Program. The goal is to create a sustainable post-market review program that first continues to protect health and the environment, but is also efficient and streamlined from a stakeholder and regulator perspective.

The Department further established a 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.
Increased use of regulatory and non-regulatory activities
Health Canada increased the use of regulatory and non-regulatory activities, which address changing business models in the supply chain, specifically for foreign sites. Health Canada carried out 45 foreign on-site Good Manufacturing Practices inspections in 2018-19. These foreign site inspections increase Health Canada’s oversight of drug production earlier in the supply chain.

As a new initiative in 2018-19, Health Canada carried out thirteen on-site foreign medical device inspections.
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