Health Canada (HC; )
[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 (), formally His Majesty's Government (), is the body responsible for the federation, federal administration of Canada. The term ''Government of Canada'' refers specifically to the executive, which includes Minister of t ...
responsible for national
health policy
Health policy can be defined as the "decisions, plans, and actions that are undertaken to achieve specific healthcare goals within a society".World Health Organization''Health Policy'' accessed 22 March 2011(archived 5 February 2011) According ...
. The department itself is also responsible for numerous federal health-related agencies, including the
Canadian Food Inspection Agency
The Canadian Food Inspection Agency (CFIA; ) is a regulatory agency that is dedicated to the safeguarding of food, plants, and animals (FPA) in Canada, thus enhancing the health and well-being of Canada's people, environment and economy. The age ...
(CFIA) and the
Public Health Agency of Canada
The Public Health Agency of Canada (PHAC; ) is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.
History
The PHAC was f ...
(PHAC), among others. These organizations help to ensure compliance with federal law in a variety of
healthcare
Health care, or healthcare, is the improvement or maintenance of health via the preventive healthcare, prevention, diagnosis, therapy, treatment, wikt:amelioration, amelioration or cure of disease, illness, injury, and other disability, physic ...
,
agricultural
Agriculture encompasses crop and livestock production, aquaculture, and forestry for food and non-food products. Agriculture was a key factor in the rise of sedentary human civilization, whereby farming of domesticated species created f ...
, and
pharmaceutical
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, 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 ...
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
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, 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 ...
products—including the regulation of health research and
pharmaceutical manufacturing/
testing 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: Representation (politics), representing the Election#Suffrage, electorate, making laws, and overseeing ...
through the
minister of health as part of the federal health portfolio. The
deputy minister of health, the senior most
civil servant
The civil service is a collective term for a sector of government composed mainly of career civil service personnel hired rather than elected, whose institutional tenure typically survives transitions of political leadership. A civil service offic ...
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 flu pandemic, also known as the Great Influenza epidemic or by the common misnomer Spanish flu, was an exceptionally deadly global influenza pandemic caused by the H1N1 subtype of the influenza A virus. The earliest docum ...
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
A chief financial officer (CFO) is an officer of a company or organization who is assigned the primary responsibility for making decisions for the company for projects and its finances; i.a.: financial planning, management of financial risks, ...
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 ) is a government employee who investigates and tries to resolve complaints, usually through recommendations (binding or not) or mediation. They are usually appointed by the government or by parliament (often with a sign ...
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
***
Biologic and Radiopharmaceutical Drugs 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 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:
*
Public Health Agency of Canada
The Public Health Agency of Canada (PHAC; ) is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.
History
The PHAC was f ...
;
*
Canadian Institutes of Health Research
The Canadian Institutes of Health Research (CIHR; ; IRSC) is a federal agency responsible for funding health and medical research in Canada. Comprising 13 institutes, it is the successor to the Medical Research Council of Canada.
CIHR supports ...
;
* the
Patented Medicine Prices Review Board; and
* the
Canadian Food Inspection Agency
The Canadian Food Inspection Agency (CFIA; ) is a regulatory agency that is dedicated to the safeguarding of food, plants, and animals (FPA) in Canada, thus enhancing the health and well-being of Canada's people, environment and economy. The age ...
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 CA ...
(CAEP).
International collaboration
In December 2016, Health Canada approved the purchase of a new
botulism
Botulism is a rare and potentially fatal illness caused by botulinum toxin, which is produced by the bacterium ''Clostridium botulinum''. The disease begins with weakness, blurred vision, Fatigue (medical), feeling tired, and trouble speaking. ...
antitoxin
An antitoxin is an antibody with the ability to neutralize a specific toxin. Antitoxins are produced by certain animals, plants, and bacterium, bacteria in response to toxin exposure. Although they are most effective in neutralizing toxins, the ...
called ''
heptavalent botulism antitoxin'' (BAT) from the American-based company
Emergent Biosolutions, a global specialty
biopharmaceutical
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, t ...
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, 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
Canada Vigilance Program
Health Canada's Canada Vigilance Program (CVP) "collects and assesses reports of suspected adverse reactions to health products marketed in Canada," including
prescription and
over-the-counter medications,
natural health products,
biotechnology products,
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...
s,
blood products,
human cell products,
human tissue products,
human organs,
disinfectant
A disinfectant is a chemical substance or compound used to inactivate or destroy microorganisms on inert surfaces. Disinfection does not necessarily kill all microorganisms, especially resistant bacterial spores; it is less effective than ...
s and
radiopharmaceutical
Radiopharmaceuticals, or medicinal radiocompounds, are a group of pharmaceutical drugs containing radioactive isotopes. Radiopharmaceuticals can be used as diagnostic and therapeutic agents. Radiopharmaceuticals emit radiation themselves, which ...
s. The program has been in effect since 1965.
Pharmacovigilance related to
Adverse Events Following Immunization (AEFI) is a shared responsibility between Health Canada and the
Public Health Agency of Canada
The Public Health Agency of Canada (PHAC; ) is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.
History
The PHAC was f ...
.
Related legislation
Acts for which Health Canada has total or partial responsibility:
* ''
Assisted Human Reproduction Act''
* ''
Canada Health Act''
* ''
Canadian Centre on Substance Abuse Act''
* ''
Canadian Environmental Protection Act''
* ''Canadian Institutes of Health Research Act''
* ''Cannabis Act''
* ''
Controlled Drugs and Substances Act
Control may refer to:
Basic meanings Economics and business
* Control (management), an element of management
* Control, an element of management accounting
* Comptroller (or controller), a senior financial officer in an organization
* Controll ...
''
* ''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
Patent Act and Patents Act (with their variations) are stock short titles used in Canada, India, Malaysia, New Zealand, the United Kingdom and the United States for legislation relating to patents.
A Patent Act is a country's legislation that con ...
''
* ''
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''
* ''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
The ''Immigration and Refugee Protection Act'' (IRPA) (, LIPR) is an Act of the Parliament of Canada, administered by Immigration, Refugees and Citizenship Canada (IRCC) and Canada Border Services Agency (CBSA), that replaced the '' Immigration A ...
''
* ''
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, 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).
Knowledge about the structure and fun ...
approval process in Canada.
In March 2021, the National Advisory Committee on Immunization made a 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 term natural health product (NHP) is used in Canada to describe substances such as vitamins and minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines. A 2010 survey sho ...
. 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, or simply CBC) is a Television in Canada, Canadian English-language terrestrial television, broadcast television network owned by the Canadian Broadcasting Corporation, the national public broadcasting, p ...
questioned the safety of drugs sold in North America
North America is a continent in the Northern Hemisphere, Northern and Western Hemisphere, Western hemispheres. North America is bordered to the north by the Arctic Ocean, to the east by the Atlantic Ocean, to the southeast by South Ameri ...
. The Canadian Press
The Canadian Press (CP; , ) is a Canadian national news agency headquartered in Toronto, Ontario. Established in 1917 as a vehicle for Canadian newspapers to exchange news and information, The Canadian Press has been a privately-held company, pr ...
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
The Public Health Agency of Canada (PHAC; ) is an agency of the Government of Canada that is responsible for public health, emergency preparedness and response, and infectious and chronic disease control and prevention.
History
The PHAC was f ...
* First Nations Health Authority
* U.S. Department of Health and Human Services (HHS)
* Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the National public health institutes, national public health agency of the United States. It is a Federal agencies of the United States, United States federal agency under the United S ...
(CDC)
* Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(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 pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
(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 Provinces and territories of Canada, ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, making it the world's List of coun ...
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
Government health agencies in Canada