Health Canada

Health Canada (HC) is the department of the Government of Canada 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, agricultural, and pharmaceutical 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 products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.
The department is responsible to Parliament through the minister of health—presently Mark Holland—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 Ya'ara Saks. 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 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 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 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
Assistant Deputy Minister's Office
Biologics 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; and
the Canadian Food Inspection Agency
Additionally, Health Canada is a corporate partner of the Canadian Association of Emergency Physicians (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, pest control materials, drugs and medical devices, 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, vaccines, blood products, human cell products, human tissue products, human organs, disinfectants and radiopharmaceuticals. 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.
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
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
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
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 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 questioned the safety of drugs sold in North America. 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.
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
U.S. Department of Health and Human Services (HHS)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
European Medicines Agency (EMA)
Japanese Ministry of Health, Labour and Welfare (MHLW)
National Centre for Disease Control (NCDC)
Notes
References
External links
Medical and health organizations based in Canada
Federal departments and agencies of Canada
Canada
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