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.
The Senate of Canada is the upper house of the Parliament of Canada. The Senate is modelled after the British House of Lords and consists of 105 members appointed by the governor general on the advice of the prime minister. Seats are assigned on a regional basis: four regions—defined as Ontario, Quebec, the Maritime provinces, and the Western provinces—each receives 24 seats, with the last nine seats allocated to the remaining portions of the country: six to Newfoundland and Labrador and one each to the three northern territories. Senators serve until they reach the mandatory retirement age of 75.
A statutory instrument (SI) is the principal form in which delegated legislation is made in Great Britain.
Health Canada 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.
Environment and Climate Change Canada is the department of the Government of Canada responsible for coordinating environmental policies and programs, as well as preserving and enhancing the natural environment and renewable resources. Prior to 2015, it was known as Environment Canada (EC).
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.
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 Access to Information Act or Information Act is a Canadian Act providing the right of access to information under the control of a federal government institution. As of 2020, the Act allowed "people who pay $5 to request an array of federal files". Paragraph 2. (1) of the Act ("Purpose") declares that government information should be available to the public, but with necessary exceptions to the right of access that should be limited and specific, and that decisions on the disclosure of government information should be reviewed independently of government. Later paragraphs assign responsibility for this review to an Information Commissioner, who reports directly to parliament rather than the government in power. However, the Act provides the commissioner the power only to recommend rather than compel the release of requested information that the commissioner judges to be not subject to any exception specified in the Act.
The Pledge to Africa Act (long title: An Act to amend the Patent Act and the Food and Drugs Act is an Act of the Parliament of Canada. It was Bill C-9 of the third session of the 37th Canadian Parliament. The legislation amends the Patent Act and the Food and Drugs Act to implement Canada's Access to Medicines Regime. It represented the first implementation of the TRIPS flexibilities declared in the August 30, 2003, General Council decision. Enacted in May 2004, it allows Canada to enact compulsory licenses to export essential medicines to countries without the capacity to manufacture their own. Other countries that have since enacted similar legislation include Norway and India.
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$1 billion. By 2016, Apotex employed over 10,000 people as one of Canada's largest drug manufacturers, with over 300 products selling in over 115 countries. Revenues were about CA$1.19 billion annually. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.
The Financial Transactions and Reports Analysis Centre of Canada is the national financial intelligence agency of Canada. FINTRAC was established in 2000 under the Proceeds of Crime Act to facilitate detection and investigation of money laundering, FINTRAC's mandate was expanded in December 2001 following amendments to the Proceeds of Crime Act to also disclose financial intelligence to other Canadian intelligence and law enforcement agencies with respect to suspected terrorist financing. FINTRAC's mandate was further expanded in 2006 under Bill C-25 to enhance the client identification, record-keeping and reporting measures, established a registration regime for money services businesses and foreign exchange dealers, and created new offences for not registering.
Insite is the first legal supervised drug injection site in North America, located at 139 East Hastings Street, in the Downtown Eastside (DTES) neighbourhood of Vancouver, British Columbia. The DTES had 4700 chronic drug users in 2000 and has been considered to be the centre of an "injection drug epidemic". The site provides a supervised and health-focused location for injection drug use, primarily heroin. The clinic does not supply any drugs. Medical staff are present to provide addiction treatment, mental health assistance, and first aid in the event of an overdose or wound. In 2017, the site recorded 175,464 visits by 7,301 unique users; 2,151 overdoses occurred with no fatalities, due to intervention by medical staff. The site also offers a free checking service so clients can check their substances for fentanyl and carfentanil. Health Canada has provided $500,000 per year to operate the site, and the BC Ministry of Health contributed $1,200,000 to renovate the site and cover operating costs. Insite also serves as a resource for those seeking to use a harm reduction approach for people who inject drugs around the world. In recent months and years, delegations from a number of countries are on record touring the facility, including various U.S. states, Colombia and Brazil. 95% of drug addicts who use Insite also shoot up on the street according to a British Columbia health official.
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 are not excessive. The board does this through its role as a regulator, and through its reporting on trends, research and development in the Canadian pharmaceutical industry.
Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brasil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.
Crown copyright is a form of copyright claim used by the governments of a number of Commonwealth realms. It provides special copyright rules for the Crown, i.e. government departments and (generally) state entities. Each single Commonwealth realm has its own distinct Crown copyright regulations. There are therefore no common regulations that apply to all or a number of those countries. There are some considerations being made in Canada, UK, Australia and New Zealand regarding the "reuse of Crown-copyrighted material, through new licences".
Canada's drug regulations are measures of the Food and Drug Act and the Controlled Drugs and Substances Act. In relation to controlled and restricted drug products, the Controlled Drugs and Substances Act establishes eight schedules. of drugs and new penalties for the possession, trafficking, exportation and production of controlled substances as defined by the Governor-in-Council. Drug policy of Canada has traditionally favoured punishment of the smallest of offenders, but this convention was partially broken in 1996 with the passing of the Controlled Drugs and Substances Act.
In Canadian patent law, only “inventions” are patentable. Under the Patent Act, only certain categories of things may be considered and defined as inventions. Therefore, if a patent discloses an item that fulfills the requirements of novelty, non-obviousness and utility, it may nonetheless be found invalid on the grounds that it does not fall within one of the statutory categories of “invention”. Since the Patent Act, the categories of patentable subject matter have been defined and interpreted by Canadian courts.
Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 is a leading Supreme Court of Canada decision on the disclosure requirements for a patent in Canada.
A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate.
Access to medicines refers to the reasonable ability for people to get needed medicines required to achieve health. Such access is deemed to be part of the right to health as supported by international law since 1946.