|Type||Department responsible for federal health policy in Canada|
|Employees||11,223 (March 2020)|
|Annual budget||$3.9 billion (2021–22)|
Health Canada (HC; French : Santé Canada, SC) 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 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. 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.
Health Canada's leadership consists of:
The following branches, offices, and bureaus (and their respective services) fall under the jurisdiction of Health Canada:
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).
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.
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:
Acts for which Health Canada has total or partial responsibility:
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.
The chief medical advisor of Health Canada, Supriya Sharma,as of April 2021, oversees the COVID-19 vaccine approval process in Canada. 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.
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.
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.
The United States Food and Drug Administration 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 safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
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.
The minister of health is the minister of the Crown in the Canadian Cabinet who is responsible for overseeing health-focused government agencies including Health Canada and the Public Health Agency of Canada, as well as enforcing the Canada Health Act, the law governing Canada's universal health care system. The current minister is Jean-Yves Duclos.
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.
Current Good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The Food and Drugs Act is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics. It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for disease listed in Schedule A, cannot be advertised to the general public.
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.
A food safety agency or food administration is a kind of agency found in various countries and international organizations with responsibilities related to food, primarily with ensuring the safety of food sold or distributed to the population, and with ensuring that food sellers inform the population of the origins and health qualities and risks associated with food being sold.
Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.
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.
Food safety is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. This includes a number of routines that should be followed to avoid potential health hazards. In this way, food safety often overlaps with food defense to prevent harm to consumers. The tracks within this line of thought are safety between industry and the market and then between the market and the consumer. In considering industry to market practices, food safety considerations include the origins of food including the practices relating to food labeling, food hygiene, food additives and pesticide residues, as well as policies on biotechnology and food and guidelines for the management of governmental import and export inspection and certification systems for foods. In considering market to consumer practices, the usual thought is that food ought to be safe in the market and the concern is safe delivery and preparation of the food for the consumer.
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
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.
The use of pesticides in Canada is regulated by the Pest Management Regulatory Agency, a division of Health Canada via the Pest Control Products Act. Pesticides are used predominantly by the agricultural sector. In 2016, 20% of reported pesticide sales were non-agricultural sector products, and just under 5% were domestic sector products.
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."