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.
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy that depends on the legislation of the country.
The pharmaceutical industry discovers, develops, produces, and markets pharmaceutical drugs for the use as medications to be administered to patients, with the aim to cure and prevent diseases, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%.
Pressure ulcers, also known as pressure sores, bed sores or pressure injuries, are localised damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of usually long-term pressure, or pressure in combination with shear or friction. The most common sites are the skin overlying the sacrum, coccyx, heels, and hips, though other sites can be affected, such as the elbows, knees, ankles, back of shoulders, or the back of the cranium.
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two" and sponsored by Senator Richard Burr, aims to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005, is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk in the event of a declared public health emergency. The part of PREPA that actually affords such protection is now codified at 42 U.S.C. § 247d-6d. The act specifically affords to drug makers immunity from actions related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies under the purview of the secretary of Health and Human Services (HHS). PREPA provides $3.8 billion for pandemic influenza preparedness to protect public health in the case of a pandemic disease outbreak.
Neglected tropical diseases (NTDs) are a diverse group of tropical infections that are common in low-income populations in developing regions of Africa, Asia, and the Americas. They are caused by a variety of pathogens, such as viruses, bacteria, protozoa, and parasitic worms (helminths). These diseases are contrasted with the "big three" infectious diseases, which generally receive greater treatment and research funding. In sub-Saharan Africa, the effect of neglected tropical diseases as a group is comparable to that of malaria and tuberculosis. NTD co-infection can also make HIV/AIDS and tuberculosis more deadly.
Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. It is a sub-discipline of health economics. A pharmacoeconomic study evaluates the cost and effects of a pharmaceutical product. Pharmacoeconomic studies serve to guide optimal healthcare resource allocation, in a standardized and scientifically grounded manner.
Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs, biologics, vaccines and natural health products.
The pharmaceutical lobby refers to the representatives of pharmaceutical drug and biomedicine companies who engage in lobbying in favour of pharmaceutical companies and their products.
Peter J. Pronovost is Chief Quality and Transformation Officer at University Hospitals Cleveland Medical Center, the main affiliate of the Case Western Reserve University School of Medicine. At UH, Pronovost is responsible for improving value across the health system, helping people stay well, get well and manage their most acute medical conditions. He is the clinical lead for population health and the lead for high-reliability medicine, with direct responsibility for the UH employee accountable care organization. He is also responsible for telehealth and virtual health programs serving patient and provider communities.
Dana Paul Goldman is the dean of the USC Price School of Public Policy, Leonard D. Schaeffer Chair and director of the University of Southern California Leonard D. Schaeffer Center for Health Policy and Economics, and Professor of Public Policy, Pharmacy, and Economics at the Price School and USC School of Pharmacy. He is also an adjunct professor of health services and radiology at UCLA, and a managing director and founding partner, along with Darius Lakdawalla and Tomas J. Philipson, at Precision Heath Economics, a health care consulting firm. Previously held positions include the director of the Bing Center for Health Economics, RAND Royal Center for Health Policy Simulation, and UCLA/RAND Health Services Research Postdoctoral Training Program.
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 Brazil 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.
David Hemenway is a Professor of Health Policy at the Harvard School of Public Health. He has a B.A. (1966) and Ph.D. (1974) from Harvard University in economics. He is the director of the Harvard Injury Control Research Center and the Harvard Youth Violence Prevention Center. He is also currently a James Marsh Visiting Professor-at-Large at the University of Vermont. Hemenway has written over 130 articles and five books in the fields of economics and public health.
The Health Impact Fund is a proposed pay-for-performance mechanism that would provide a market-based solution to problems concerning the development and distribution of medicines globally. It would incentivize the research and development of new pharmaceutical products that make substantial reductions in the global burden of disease. The Health Impact Fund is the creation of a team of researchers led by the Yale philosopher Thomas Pogge and the University of Calgary economist Aidan Hollis, and is promoted by the non-profit organization Incentives for Global Health (IGH).
KV Pharmaceutical Company (KV) was an American drug company that brought generic and non-branded pharmaceutical products to the market. Headquartered in St. Louis, Missouri, it had research and manufacturing facilities, as well as marketing and sales operations, the latter activities conducted through its subsidiaries, Ther-Rx Corporation and Nesher Pharmaceuticals Inc.
Martin Adel Makary is a British-American surgeon, professor, author and medical commentator. He practices surgical oncology and gastrointestinal laparoscopic surgery at the Johns Hopkins Hospital, is Mark Ravitch Chair in Gastrointestinal Surgery at Johns Hopkins School of Medicine, and teaches public health policy as Professor of Surgery and Public Health at the Johns Hopkins Bloomberg School of Public Health.
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.
The Indonesian Food and Drug Authority, Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicine and cosmetics. The task and purposes of this agency is similar to the USFDA.
Rick Arthur Bright is an American immunologist, vaccine researcher, and public health official. He was the director of the Biomedical Advanced Research and Development Authority (BARDA) from 2016 to 2020. In May 2020, he filed a whistleblower complaint, alleging that the Trump administration ignored his early warnings about the COVID-19 pandemic and illegally retaliated against him by ousting him from his role and demoting him to a position at the National Institutes of Health. On October 6, 2020, Bright resigned from the government. On November 9 he was named a member of President-elect Joe Biden's coronavirus advisory board.
