British Generic Manufacturers Association

Last updated

The British Generic Manufacturers Association is a trade association for the British generic drug industry. It has offices in the City of London.

Warwick Smith is the director general of the association and also of the British Biosimilars Association. [1] Tim de Gavre, head of Sandoz UK is the chair from 2018. [2]

The association is concerned that a no-deal Brexit could force up the price of generic drugs because it would increase regulatory complexity. [3]

It is a member of the AMR Industry Alliance, a European organization dedicated to combatting antimicrobial resistance. [4]

In 2017, it said it was working with the Department of Health and Social Care to deal with problems caused by generic drug shortages, [5] to address price gauging through a "Health Services Medical Supplies Bill". It explained that some generic drugs were produced by only one supplier "because the total market size is too small to be attractive for generic companies to enter, since they would not recoup the million-pound plus costs of developing, testing and registering a new generic medicine". This has been countered by Andrew Hill from the department of pharmacology and therapeutics at the University of Liverpool. [6]

In June 2019 it reported that the NHS was, on average, paying 193% of the manufacturers' selling price for Category M products, more than 500 medicines which are readily available with wholesalers receiving half of the profit and pharmacies receiving the other half. [7]

In 2022 it called for branded generics and biosimilars to be exempted from the Voluntary Scheme for Branded Medicines Pricing and Access that was introduced in 2019 because the rising rebate rate “is forcing manufacturers to shun the UK market, further reducing price competition”. This is based on a new analysis conducted by the Office of Health Economics. [8]

Related Research Articles

An epinephrine autoinjector is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The first epinephrine autoinjector was brought to market in 1983.

<span class="mw-page-title-main">Generic drug</span> Pharmaceutical equivalent to a brand-name product

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 U.S. 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 U.S. health care sector to use their bargaining power to negotiate lower prices and that the US payer ends up subsidizing the world's R&D spending on drugs.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis. It is administered by injection under the skin.

Mylan N.V. was a global generic and specialty pharmaceuticals company. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris. Previously, the company was domiciled in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and a "Global Center" in Canonsburg, Pennsylvania, US.

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.

<span class="mw-page-title-main">Apotex</span> Canadian pharmaceutical company

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.

<span class="mw-page-title-main">Teva Pharmaceuticals</span> Israeli pharmaceutical company

Teva Pharmaceutical Industries Ltd. is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include active pharmaceutical ingredients and, to a lesser extent, proprietary pharmaceuticals. Teva Pharmaceuticals was the largest generic drug manufacturer, when it was surpassed briefly by US-based Pfizer. Teva regained its market leader position once Pfizer spun off its generic drug division in a merger with Mylan, forming the new company Viatris at the end of 2020. Overall, Teva is the 18th largest pharmaceutical company in the world.

An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.

<span class="mw-page-title-main">Actavis</span> Global pharmaceutical company

Actavis Generics is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States.

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.

A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.

Evergreening is any of various legal, business, and technological strategies by which producers extend the lifetime of their patents that are about to expire in order to retain revenues from them. Often the practice includes taking out new patents, or by buying out or frustrating competitors, for longer periods of time than would normally be permissible under the law. Robin Feldman, a law professor at UC Hastings and a leading researcher in intellectual property and patents, defines evergreening as "artificially extending the life of a patent or other exclusivity by obtaining additional protections to extend the monopoly period."

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.

The Pharmaceutical Price Regulation Scheme (PPRS) is the mechanism used by the UK Department of Health to ensure that the NHS has access to good quality branded medicines at reasonable prices. It involves a non-contractual agreement between the UK Department of Health and The Association of the British Pharmaceutical Industry (ABPI). The scheme applies to all branded, licensed medicines available on the NHS. The purpose of the scheme is to achieve a balance between reasonable prices for the NHS and a fair return for the pharmaceutical industry.

The term "me-too drug" or "follow-on drug" refers to a medication that is similar to a pre-existing drug, usually by making minor modifications to the prototype, reflected in slight changes in the profiles of side effects or activity, and used to treat conditions for which drugs already exist. While pharmaceutical companies have justified the development of me-toos as offering incremental improvements in efficacy, side-effects, compliance and cost, critics have questioned the increasing marketing of me-toos, their absorption of research and development resources and their impact on the innovation of new treatments.

Pharmacy in the United Kingdom has been an integral part of the National Health Service since it was established in 1948. Unlike the rest of the NHS, pharmacies are largely privately provided apart from those in hospitals, and even these are now often privately run.

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.

The Healthcare Distribution Association is a trade association for wholesalers in the British pharmaceutical industry.

References

  1. ↑ "Proposals to include biologics in price controls could threaten NHS savings, says biosimilars head". Pharmaceutical Journal. 8 August 2018. Retrieved 4 November 2018.
  2. ↑ "Tim de Gavre takes up BGMA Chair role". Pharma Times. 29 May 2018. Retrieved 4 November 2018.
  3. ↑ "No-deal Brexit 'will force up price of generic drugs'". Health Service Journal. 26 September 2018. Retrieved 4 November 2018.
  4. ↑ "Our Members". AMR Industry Alliance. 2017. Retrieved 4 November 2018.
  5. ↑ "BGMA: WE ARE WORKING WITH DEPARTMENT OF HEALTH TO COUNTER GENERIC SHORTAGES". Pharmacy Biz. 29 October 2017. Retrieved 4 November 2018.
  6. ↑ "Drugs firms are accused of putting cancer patients at risk over price hikes". 2017-01-28. Retrieved 2022-05-15.
  7. ↑ "NHS pays twice the price for generic medicines that manufacturers charge, finds report". Pharmaceutical Journal. 26 June 2019. Retrieved 23 August 2019.
  8. ↑ "UK rebate mechanism could force market withdrawals, warns BGMA". Chemist and Druggist. 25 October 2022. Retrieved 10 November 2022.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.