| Santé Canada | |
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| Department overview | |
|---|---|
| Type | Department responsible for federal health policy in Canada |
| Jurisdiction | Canada |
| Headquarters | Ottawa,Ontario |
| Employees | 9,848 (2023–24)[1] |
| Annual budget | C$6.842 billion (2023–24)[2] |
| Minister responsible | |
| Deputy Ministers responsible |
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| Website | health |
Health Canada (HC;French:Santé Canada, SC)[a] is thedepartment of theGovernment of Canada responsible for nationalhealth policy. The department itself is also responsible for numerous federal health-related agencies, including theCanadian Food Inspection Agency (CFIA) and thePublic Health Agency of Canada (PHAC), among others. Since 2012, the CFIA has operated as a separate agency but continues to report to the Minister of Health for food safety matters.[3] These organizations help to ensure compliance with federal law in a variety ofhealthcare,agricultural, andpharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, andpharmaceutical products—including the regulation of health research andpharmaceutical manufacturing/testing facilities.
The department isresponsible toParliament through theminister of health as part of the federal health portfolio.[4] Thedeputy minister of health, the senior mostcivil servant within the department, is responsible for the day-to-day leadership and operations of the department and reports directly to the minister.
Originally created as the "Department of Health" in 1919—in the wake of theSpanish flu crisis[5]—what is known asHealth Canada today was formed in 1993 from the formerHealth and Welfare Canada department (established in 1944), which split into two separate units; the other department beingHuman Resources and Labour Canada.[6]
Health Canada's leadership consists of:[7]
The following branches, offices, and bureaus (and their respective services) fall under the jurisdiction of Health Canada:[7]
In their responsibility of maintaining and improving the health of Canadians, the Minister of Health is supported by the Health Portfolio, which comprises Health Canada as well as:[8]
Additionally, Health Canada is a corporate partner of theCanadian Association of Emergency Physicians (CAEP).[9]
In December 2016, Health Canada approved the purchase of a newbotulismantitoxin calledheptavalent botulism antitoxin (BAT) from the American-based companyEmergent Biosolutions, a global specialtybiopharmaceutical company. The PHAC has identified botulism as a likelybiological terrorist threat.[10]
The Compliance and Enforcement Directorate provides support to Health Canada by enforcing the laws and regulations pertaining to the production, distribution, importation, sale, and/or use of consumer products, including but not limited to:tobacco,pest control materials, drugs andmedical devices,biologics, andnatural health products.[11]
The Directorate conducts inspections and investigations to ensure that products are safe, of good quality, and properly labelled and distributed, in order to better protect Canadians from potentially harmful products and consumables.[12]
Compliance and Enforcement Directorate is divided into six distinct programs:[13]
Health Canada's Canada Vigilance Program (CVP) "collects and assesses reports of suspected adverse reactions to health products marketed in Canada," includingprescription andover-the-counter medications,natural health products,biotechnology products,vaccines,blood products,human cell products,human tissue products,human organs,disinfectants andradiopharmaceuticals. The program has been in effect since 1965.[14]
Pharmacovigilance related toAdverse Events Following Immunization (AEFI) is a shared responsibility between Health Canada and thePublic Health Agency of Canada.[15]
Acts for which Health Canada has total or partial responsibility:[16]
Acts which Health Canada is involved or has special interest in:
Health Canada has a special access program that health care providers may use to request medications that are not currently commercially available in Canada.[17]
The chief medical advisor of Health Canada, Supriya Sharma,[18][19] as of April 2021, oversaw theCOVID-19 vaccine approval process in Canada.[18][20]
In March 2021, theNational Advisory Committee on Immunization made a declaration of a pause for the administration of the AstraZeneca vaccine to Canadians under the age of 55.[19][21]
By 2023, Health Canada had authorized multiple vaccines and boosters, including Pfizer-BioNTech, Moderna, AstraZeneca, Novavax, and bivalent boosters, under both regular and rolling submissions.[22]
An editorial published by theCanadian Medical Association Journal has called for Health Canada to more strictly regulatenatural health products. The editorial cited weaknesses in current legislation that allow natural health products to make baseless health claims, to neglect side-effects research prior to products reaching market, and to be sold without being evaluated by Health Canada.[23]
On 10 September 2012, a report onCBC Television questioned the safety of drugs sold inNorth America.[24]The Canadian Press reported that Health Canada is secretive regarding inspections about drugs manufactured overseas, leaving the public unsure about the safety of these drugs.[25]
Health Canada aims to provide responses to pharmaceutical innovators within 300 days of submitting a drug for review. However, for submissions filed between 2015 and 2019, only 33 percent received a response within that target. Fully 18 percent waited over a year, and almost 5 percent over two years. The average delay for a standard review was 335 days. Health Canada's accelerated pathway for approval dubbed "conditional compliance" reduces its target timeline to 200 days, but its actual average delay was still 302 days, and only 8 percent of applicants received responses within the 200-day target.[26]
Since 2022, Health Canada has implemented "Agile Regulations," expanding the use of rolling submissions and greater reliance on trusted foreign regulators to accelerate market approvals.[27][28]
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