 | The examples and perspective in this article may not represent a worldwide view of the subject.(April 2021) |
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.
The largest pharmaceutical companies and their two trade groups, Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization, lobbied on at least 1,600 pieces of legislation between 1998 and 2004. According to the non-partisan OpenSecrets, pharmaceutical companies spent $900 million on lobbying between 1998 and 2005, more than any other industry. During the same period, they donated $89.9 million to federal candidates and political parties, giving approximately three times as much to Republicans as to Democrats. [1] According to the Center for Public Integrity, from January 2005 through June 2006 alone, the pharmaceutical industry spent approximately $182 million on federal lobbying in the United States. [2] In 2005, the industry had 1,274 registered lobbyists in Washington, D.C. [3]
A 2020 study found that, from 1999 to 2018, the pharmaceutical industry and health product industry together spent $4.7 billion lobbying the United States federal government, an average of $233 million per year. [4]
Critics of the pharmaceutical lobby argue that the drug industry's influence allows it to promote legislation friendly to drug manufacturers at the expense of patients. [5] [ failed verification ] The lobby's influence in securing the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 was considered a major and controversial[ according to whom? ] victory for the industry, as it prevents the government from directly negotiating prices with drug companies who provide those prescription drugs covered by Medicare. Price negotiations are instead conducted between manufacturers and the pharmacy benefit managers providing Medicare Part D benefits under contract with Medicare. In 2010 the Congressional Budget Office estimated the average discount negotiated by pharmacy benefit managers at 14%. [6]
The high price of U.S. prescription drugs has been a source of ongoing controversy. Pharmaceutical companies state that the high costs are the result of pricey research and development programs. Critics point to the development of drugs having only small incremental benefit. [5] [7] According to Marcia Angell, former editor-in-chief of the New England Journal of Medicine , "The United States is the only advanced country that permits the pharmaceutical industry to charge exactly what the market will bear." [8] In contrast, the RAND Corporation and authors from the National Bureau of Economic Research have argued that price controls stifle innovation and are economically counterproductive in the long term. [9] [10]
In 2021, during the height of COVID-19, vaccine makers increased lobbying and public-relations efforts to oppose a proposal that would temporarily waive their patents in Germany, Japan and other countries. This proposal would allow COVID-19 vaccine patents to be licensed to international vaccine makers or otherwise sold entirely. The Biden presidential administration in the U.S. supported the waiver proposal; however, pharmaceutical industry trade groups supported Germany, Japan, and other countries that expressed opposition. Pharmaceutical industry representatives have been lobbying members of Congress to pressure the Biden administration to reverse its support of the waiver, arguing that the patents protect its innovations. However, proponents of the proposal see the patent as giving companies a monopoly over sales of vaccines during a world crisis. [11]
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
Pharmaceutical Research and Manufacturers of America, formerly known as the Pharmaceutical Manufacturers Association, is a trade group representing companies in the pharmaceutical industry in the United States. Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. PhRMA is headquartered in Washington, DC.
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.
Prescription drug list prices in the United States continually rank among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices and that the American payer ends up subsidizing the world's R&D spending on drugs.
The Medicare Prescription Drug, Improvement, and Modernization Act, also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health program's 38-year history.
Wilbert Joseph Tauzin II is an American lobbyist and politician. He was President and CEO of PhRMA, a pharmaceutical company lobby group. Tauzin was also a member of the United States House of Representatives from 1980 to 2005, representing Louisiana's 3rd congressional district.
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, 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%.
Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Under the program, drug benefits are provided by private insurance plans that receive premiums from both enrollees and the government. Part D plans typically pay most of the cost for prescriptions filled by their enrollees. However, plans are later reimbursed for much of this cost through rebates paid by manufacturers and pharmacies.
The pharmaceutical industry is one of the leading industries in the People's Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical machinery. China has the second-largest pharmaceutical market in the world as of 2017 which is worth US$110 billion. China accounts for 20% of the world's population but only a small fraction of the global drug market. China's changing health-care environment is designed to extend basic health insurance to a larger portion of the population and give individuals greater access to products and services. Following the period of change, the pharmaceutical industry is expected to continue its expansion.
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 pharmaceutical industry in India was valued at an estimated US$42 billion in 2021. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 50% of all vaccines manufactured in the world. With industry standards compliant mega production capabilities and large number of skilled domestic workforce, Indian exports meet the standards and requirements of highly regulated markets of USA, UK, European Union and Canada. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, domestic pharmaceutical market turnover reached Rs 129,015 crore in 2018, growing 9.4 per cent year-on-year and exports revenue was US$17.28 billion in FY18 and US$19.14 billion in FY19.
The Association of the British Pharmaceutical Industry (ABPI) is the trade association for over 120 companies in the UK producing prescription medicines for humans, founded in 1891. It is the British equivalent of America's PhRMA; however, the member companies research, develop, manufacture and supply 80% of the medicines prescribed through the National Health Service.
In the United States, a pharmacy benefit manager (PBM) is a third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans. According to the American Pharmacists Association, "PBMs are primarily responsible for developing and maintaining the formulary, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims." PBMs operate inside of integrated healthcare systems, as part of retail pharmacies, and as part of insurance companies.
Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.
The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.
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.
Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, in the mid-1990s there were fewer than 30, by 2008 there were 200, and by 2015 there were 300. Drugs are often defined as specialty because their price is much higher than that of non-specialty drugs. Medicare defines any drug for which the negotiated price is $670 per month or more, as a specialty drug which is placed in a specialty tier that requires a higher patient cost sharing. Drugs are also identified as specialty when there is a special handling requirement or the drug is only available via a limited distributions network. By 2015 "specialty medications accounted for one-third of all spending on drugs in the United States, up from 19 percent in 2004 and heading toward 50 percent in the next 10 years", according to IMS Health, which tracks prescriptions. According to a 2010 article in Forbes, specialty drugs for rare diseases became more expensive "than anyone imagined" and their success came "at a time when the traditional drug business of selling medicines to the masses" was "in decline". In 2015 analysis by The Wall Street Journal suggested the large premium was due to the perceived value of rare disease treatments which usually are very expensive when compared to treatments for more common diseases.
The Association for Accessible Medicines (AAM), Washington, D.C., is a trade association representing the manufacturers and distributors of generic prescription drugs, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the U.S. generic drug industry. As the primary lobby for makers of generic drugs, AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.
Albert Bourla is a Greek-American veterinarian and the chairman and chief executive officer of Pfizer, an American pharmaceutical company. He joined the company in 1993 and has held several executive roles across Pfizer's divisions. Prior to becoming chief executive officer, Bourla served as chief operating officer.
Waiver from certain provisions of the TRIPS Agreement for the Prevention, Containment and Treatment of COVID-19 is a joint intervention communication by South Africa and India to the TRIPS council of the World Trade Organization (WTO) on 2 October 2020.
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