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Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the
Government of Canada The government of Canada (french: gouvernement du Canada) is the body responsible for the federal administration of Canada. A constitutional monarchy, the Crown is the corporation sole, assuming distinct roles: the executive, as the ''Crown-i ...
responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of
healthcare Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health pro ...
, agricultural, and
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and
pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
products—including the regulation of health research and
pharmaceutical manufacturing Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations, such as milling, gra ...
/
testing An examination (exam or evaluation) or test is an educational assessment intended to measure a test-taker's knowledge, skill, aptitude, physical fitness, or classification in many other topics (e.g., beliefs). A test may be administered verba ...
facilities. The department is responsible to
Parliament In modern politics, and history, a parliament is a legislative body of government. Generally, a modern parliament has three functions: representing the electorate, making laws, and overseeing the government via hearings and inquiries. Th ...
through the minister of health—presently Jean-Yves Duclos—as part of the federal health portfolio. The minister is assisted by the associate minister of health, and minister of mental health and addictions—presently
Carolyn Bennett Carolyn Ann Bennett (born December 20, 1950) is a Canadian physician and politician who has served as minister of mental health and addictions, and associate minister of health since October 26, 2021. A member of the Liberal Party, she has rep ...
. The deputy minister of health, the senior most civil 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 the
Spanish flu The 1918–1920 influenza pandemic, commonly known by the misnomer Spanish flu or as the Great Influenza epidemic, was an exceptionally deadly global influenza pandemic caused by the H1N1 influenza A virus. The earliest documented case wa ...
crisis—what is known as ''Health Canada'' today was formed in 1993 from the former Health and Welfare Canada department (established in 1944), which split into two separate units; the other department being Human Resources and Labour Canada.


Organization

Health Canada's leadership consists of: * Minister of Health * Deputy Minister * Associate Deputy Minister


Branches

The following branches, offices, and bureaus (and their respective services) fall under the jurisdiction of Health Canada: *Health Canada **Office of Audit and Evaluation ***Departmental Audit Committee ***Director General / Chief Audit Executive's Office ***Internal Audit and Special Examinations ***Program Evaluation Division ***Performance Measurement Planning and Integration ***Practice Management **
Chief Financial Officer The chief financial officer (CFO) is an officer of a company or organization that is assigned the primary responsibility for managing the company's finances, including financial planning, management of financial risks, record-keeping, and fina ...
Branch ***Departmental Performance Measurement and Evaluation Directorate ***Departmental Resource Management Directorate ***Financial Operations Directorate ***Internal Control Division ***Materiel and Assets Management Directorate ***Planning and Corporate Management Practices Directorate **Communications and Public Affairs Branch ***Ethics and Internal
Ombudsman An ombudsman (, also ,), ombud, ombuds, ombudswoman, ombudsperson or public advocate is an official who is usually appointed by the government or by parliament (usually with a significant degree of independence) to investigate complaints and at ...
Services ***Marketing and Communications Services Directorate ***Planning and Operations Division ***Public Affairs and Strategic Communications Directorate ***Stakeholder Relations and Consultation Directorate **Controlled Substances and Cannabis Branch **Corporate Services Branch **Departmental Secretariat **
Health Products and Food Branch The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information ...
***Assistant Deputy Minister’s Office ***
Biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
and Genetic Therapies Directorate ***Food Directorate *** Marketed Health Products Directorate ***Medical Devices Directorate ***Natural and Non-prescription Health Products Directorate ***Office of Nutrition Policy and Promotion ***Policy, Planning and International Affairs Directorate ***Resource Management and Operations Directorate *** Therapeutic Products Directorate *** Veterinary Drugs Directorate **Healthy Environments and Consumer Safety Branch ***Consumer and Hazardous Products Safety Directorate ***Environmental and Radiation Health Sciences Directorate ***Policy Planning and Integration Directorate ***Safe Environments Directorate ****Climate Change and Innovation Bureau ****Water and Air Quality Bureau ****New Substances Assessment and Control Bureau ****Existing Substances Risk Assessment Bureau **Legal Services **Opioid Response Team ***Controlled Substances Directorate ***Opioid Response Team Directorate ** Pest Management Regulatory Agency **Regulatory Operations and Enforcement Branch **Strategic Policy Branch


Partner agencies

In their responsible 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: * Public Health Agency of Canada; * Canadian Institutes of Health Research; * the
Patented Medicine Prices Review Board The Patented Medicine Prices Review Board () is a federal quasi-judicial regulatory and reporting agency in Canada with a mandate to protect consumers by ensuring that the prices of patented medication charged by manufacturers of patented drugs ...
; and * the Canadian Food Inspection Agency Additionally, Health Canada is a corporate partner of the
Canadian Association of Emergency Physicians The Canadian Association of Emergency Physicians (CAEP) is the professional association of emergency physicians in Canada. It is also known in French as ''Association Canadienne des Médecins d'Urgence'' (''ACMU''). The official journal of the ...
(CAEP).


International collaboration

In December 2016, Health Canada approved the purchase of a new botulism antitoxin called '' heptavalent botulism antitoxin'' (BAT) from the American-based company Emergent Biosolutions, a global specialty biopharmaceutical company. The PHAC has identified botulism as a likely biological terrorist threat.


Labs and offices


Offices

*Office of the Cameron Visiting Chair *Office of the Chief Dental Officer *The National Office of WHMIS *Nurse Recruitment *Public Services Health Medical Centre


Laboratories

*Laboratory Centre for Disease Control *Sir Frederick G Banting Research Centre


Compliance and Enforcement Directorate

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 Tobacco is the common name of several plants in the genus '' Nicotiana'' of the family Solanaceae, and the general term for any product prepared from the cured leaves of these plants. More than 70 species of tobacco are known, but the ...
, pest control materials, drugs and
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s,
biologics A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, th ...
, and natural health products. 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. Compliance and Enforcement Directorate is divided into six distinct programs: *Canada Vigilance Program *Controlled Substances Program *Inspectorate Program *Pesticide Compliance Program *Product Safety Program *Tobacco Control Program


Related legislation

Acts for which Health Canada has total or partial responsibility: * ''
Assisted Human Reproduction Act The ''Assisted Human Reproduction Act'' (the ''Act'') is law enacted by the Parliament of Canada. Its purpose is to regulate assisted human reproduction (AHR) and related research. It is one of the most comprehensive pieces of legislation in the ...
'' * '' Canada Health Act'' * '' Canadian Centre on Substance Abuse Act'' * ''
Canadian Environmental Protection Act The ''Canadian Environmental Protection Act, 1999'' (''CEPA, 1999''; french: Loi canadienne sur la protection de l'environnement (1999)) is an act of the 36th Parliament of Canada, whose goal is to contribute to sustainable development through p ...
'' * ''Canadian Institutes of Health Research Act'' * ''Cannabis Act'' * ''
Controlled Drugs and Substances Act The ''Controlled Drugs and Substances Act'' (french: Loi réglementant certaines drogues et autres substances) (the ''Act'') is Canada's federal drug control statute. Passed in 1996 under Prime Minister Jean Chrétien's government, it repeal ...
'' * ''Comprehensive Nuclear Test-Ban Treaty Implementation Act'' * ''Department of Health Act'' * ''Financial Administration Act'' * ''Fitness and Amateur Sport Act'' * '' Food and Drugs Act'' * ''Hazardous Materials Information Review Act'' * ''Hazardous Products Act'' * '' Patent Act'' * '' Pest Control Products Act'' * ''Pesticide Residue Compensation Act'' * ''Quarantine Act'' * ''Radiation Emitting Devices Act'' * ''Tobacco Act'' & ''Act to Amend the Tobacco Act'' (sponsorship) Acts which Health Canada is involved or has special interest in: * ''
Broadcasting Act Broadcasting Act (with its variations) is a stock short title used for legislation in Canada, Hong Kong, Malaysia, the Republic of Ireland and the United Kingdom that relates to broadcasting. The Bill for an Act with this short title will usually h ...
'' * ''
Canada Labour Code The ''Canada Labour Code'' (french: Code canadien du travail) (the Code) is an Act of the Parliament of Canada to consolidate certain statutes respecting labour. The objective of the Code is to facilitate production by controlling strikes & lo ...
'' * ''Canada Medical Act'' * ''Canada Shipping Act'' * ''Canadian Food Inspection Agency Act'' * ''Emergency Preparedness Act'' * ''Energy Supplies Emergency Act'' * ''Excise Tax Act'' * ''Federal-Provincial Fiscal Arrangements Act'' * ''Feeds Act'' * '' Immigration and Refugee Protection Act'' * '' National Parks Act'' * '' Nuclear Safety and Control Act'' * ''Non-Smokers Health Act'' * ''Queen Elizabeth II Canadian Research Fund Act'' * ''Trade Marks Act''


Special access program

Health Canada has a special access program that health care providers may use to request medications that are not currently commercially available in Canada.


COVID-19 response

The chief medical advisor of Health Canada, Dr. Supriya Sharma, as of April 2021, oversees the
COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID19). Prior to the COVID19 pandemic, an e ...
approval process in Canada. On 29 March 2021, Dr. Sharma supported the National Advisory Committee on Immunization's declaration of a pause for the administration of the AstraZeneca vaccine to Canadians under the age of 55.


Criticisms

An editorial published by the Canadian Medical Association Journal has called for Health Canada to more strictly regulate natural 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. On 10 September 2012, a report on
CBC television CBC Television (also known as CBC TV) is a Canadian English-language broadcast television network owned by the Canadian Broadcasting Corporation, the national public broadcaster. The network began operations on September 6, 1952. Its French- ...
questioned the safety of drugs sold in
North America North America is a continent in the Northern Hemisphere and almost entirely within the Western Hemisphere. It is bordered to the north by the Arctic Ocean, to the east by the Atlantic Ocean, to the southeast by South America and th ...
.
The Canadian Press The Canadian Press (CP; french: La Presse canadienne, ) is a Canadian national news agency headquartered in Toronto, Ontario. Established in 1917 as a vehicle for the time's Canadian newspapers to exchange news and information, The Canadian Pre ...
reported that Health Canada is secretive regarding inspections about drugs manufactured overseas, leaving the public unsure about the safety of these drugs.


Drug approvals process

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. It has been suggested that government entities should make use of rolling submissions, as was done for COVID-19 vaccines, to proceed with the examination of partially complete submissions and accept new information as it becomes available, and also that drugs already approved in other jurisdictions should be approved more rapidly to avoid redundancy.


See also

* Health care in Canada * Public Health Agency of Canada *
First Nations Health Authority The First Nations Health Authority (FNHA) is a health service delivery organization responsible for administering a variety of health programs and service for First Nations people living in BC. Overview The FNHA is part of a First Nations Health ...


International counterparts

*
U.S. Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
(HHS) *
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georg ...
(CDC) *
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) *
European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Eur ...
(EMA) * Japanese Ministry of Health, Labour and Welfare (MHLW) * National Centre for Disease Control (NCDC)


Notes


References


External links

* * {{authority control Medical and health organizations based in Canada Federal departments and agencies of Canada
Canada Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by to ...
Public health organizations Regulators of biotechnology products Ministries established in 1996 Regulation of medical devices Federal law enforcement agencies of Canada 1996 establishments in Canada