Health Canada

Last updated
Health Canada
Santé Canada
Health Canada logo.gif
Department overview
TypeDepartment responsible for federal health policy in Canada
Jurisdiction Canada
Employees11,223 (March 2020) [1]
Annual budget$3.9 billion (2021–22) [2]
Ministers responsible
Department executives
  • Dr. Stephen Lucas, Deputy Minister
  • Heather Jeffrey, Associate Deputy Minister
Website www.hc-sc.gc.ca

Health Canada (HC; French : Santé Canada, SC) [NB 1] 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.

Contents

The department is responsible to Parliament through the minister of health—presently Jean-Yves Duclos—as part of the federal health portfolio. [3] The minister is assisted by the associate minister of health, and minister of mental health and addictions—presently Carolyn Bennett. 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 [4] —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. [5]

Organization

Health Canada's leadership consists of: [6]

Branches

The following branches, offices, and bureaus (and their respective services) fall under the jurisdiction of Health Canada: [6]

  • 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
    • 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:

Additionally, Health Canada is a corporate partner of the Canadian Association of Emergency Physicians (CAEP). [7]

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. [8]

Labs and offices

Offices

Laboratories

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: [9]

Acts for which Health Canada has total or partial responsibility: [10]

Acts which Health Canada is involved or has special interest in:

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. [11]

COVID-19 response

The chief medical advisor of Health Canada, Supriya Sharma, [12] [13] as of April 2021, oversees the COVID-19 vaccine approval process in Canada. [12] [14] On 29 March 2021, 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. [13] [15]

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. [16]

On 10 September 2012, a report on CBC television questioned the safety of drugs sold in North America. [17] 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. [18]

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. [19]

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. [19]

See also

International counterparts

Notes

  1. Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (French : Ministère de la Santé).

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<span class="mw-page-title-main">Botulism</span> Human and animal disease

Botulism is a rare and potentially fatal illness caused by a toxin produced by the bacterium Clostridium botulinum. The disease begins with weakness, blurred vision, feeling tired, and trouble speaking. This may then be followed by weakness of the arms, chest muscles, and legs. Vomiting, swelling of the abdomen, and diarrhea may also occur. The disease does not usually affect consciousness or cause a fever.

<span class="mw-page-title-main">Minister of Health (Canada)</span>

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The Canadian Food Inspection Agency 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 agency is governed by the Minister of Agriculture and Agri-Food and Minister of Health.

<span class="mw-page-title-main">Good manufacturing practice</span> Manufacturing quality standards

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<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

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The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods.

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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 to Canadians so they can make healthy, informed decisions about their health.

<span class="mw-page-title-main">Food safety</span> Scientific discipline

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The Pest Management Regulatory Agency (PMRA) is the Canadian government agency responsible for the regulation of pest control products in Canada under the federal authority of the Pest Control Products Act and Regulations. The agency is a branch that reports to Parliament through Health Canada. The PMRA is responsible for providing access to pest management tools while minimizing the risks to human health and the environment by “using modern evidence-based scientific approaches to pesticide regulation, in an open and transparent manner”. Their main activity areas include: new product evaluation, post market review and compliance and enforcement.

The following outline is provided as an overview of and topical guide to clinical research:

Adulteration is a legal term meaning that a food product fails to meet the legal standards. One form of adulteration is an addition of another substance to a food item in order to increase the quantity of the food item in raw form or prepared form, which results in the loss of actual quality of food item. These substances may be either available food items or non-food items. Among meat and meat products some of the items used to adulterate are water or ice, carcasses, or carcasses of animals other than the animal meant to be consumed.

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The Botulism Antitoxin Heptavalent - (Equine) – BAT, made by Emergent BioSolutions Canada Inc. – is a licensed, commercially available botulism anti-toxin that effectively neutralizes all seven known botulinum nerve toxin serotypes. It is indicated for sporadic cases of life-threatening botulism and is also stockpiled for the eventuality of botulinum nerve toxins being used in a future bioterrorist attack.

The Veterinary Drugs Directorate is the Canadian body responsible for putting all "veterinary products, such antimicrobials, growth promotion drugs and feed additives, through a rigorous approval process before they are licensed and sold for use" in Canada. It is part of the Health Products and Food Branch of Health Canada, and exists by virtue of the Food and Drugs Act. Its goal is "to protect human and animal health and the safety of Canada's food supply."

References

  1. "GC InfoBase". www.tbs-sct.gc.ca. Retrieved Mar 5, 2021.
  2. "GC InfoBase". www.tbs-sct.gc.ca. Retrieved April 15, 2021.
  3. "Health Portfolio". Canada.ca. Government of Canada (2017). Retrieved 29 April 2020.
  4. "Influenza, 1918-1919 | Canada and the First World War". Canadian War Museum. Canadian Heritage. 2017 [2008]. Retrieved 29 April 2020.
  5. Cheung-gertler, Jasmin H. (2014) [2008]. "Health Canada". The Canadian Encyclopedia . Historica Canada . Retrieved 29 April 2020.
  6. 1 2 "Health Canada's organizational structure". Health Canada. Government of Canada. 15 April 2020. Archived from the original on 2010-10-16. Retrieved 29 April 2020.
  7. "Annual Report 2018-2019" (PDF). Canadian Association of Emergency Physicians . 2019. Archived (PDF) from the original on 2022-04-20. Retrieved 2022-06-18.
  8. "Emergent BioSolutions Receives Health Canada Approval for Botulism Antitoxin". Yahoo Finance. 2016-12-12. Archived from the original on 2017-01-13. Retrieved 2017-01-11.
  9. "About Health Canada - Ontario Region - Compliance and Enforcement". Health Canada. Archived from the original on 2013-10-29.
  10. "About Health Canada - Legislation & Guidelines - Acts". Archived from the original on 2007-05-19. Retrieved 2007-04-15.
  11. Canada, Health (23 December 2002). "Health Canada's special access programs: Request a drug". www.canada.ca. Retrieved 13 September 2021.
  12. 1 2 Rabson, Mia (March 28, 2021). "'Unprecedented': How Canada approved five vaccines for COVID-19 in under a year". The Canadian Press. The National Post. Retrieved 28 April 2021.
  13. 1 2 Cochrane, David; Tasker, John Paul (29 March 2021). "Immunization committee to recommend provinces stop giving AstraZeneca vaccine to those under 55: sources". CBC.
  14. Ritchot, Mélanie (23 December 2020). "Nunavut to get 6,000 doses of Moderna vaccine in first shipment". Nortext Publishing Corporation (Iqaluit). Nunavut News.
  15. Gillies, Rob (29 March 2021). "Canada pauses AstraZeneca vaccine for under 55". Chicago Daily Herald. Associated Press.
  16. Gauntlet Editorial Board. "Editorial: Mis-informed consent". Editorial. The Gauntlet. Archived from the original on 7 March 2012. Retrieved 18 December 2011.
  17. "Drug safety expert questions medications made overseas". 10 September 2012. Archived from the original on 2013-03-29. Retrieved 2012-09-11.
  18. Bains, Camille (10 September 2012). "Health Canada mum on plant inspections: researcher". via BC - CTV News.ca. The Canadian Press . Retrieved 24 July 2022.
  19. 1 2 Post, Special to Financial (2021-06-16). "Opinion: Let's have permanently quicker drug approvals". Financial Post. Retrieved 2021-10-18.