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.

Mark Samuels is the Chief Executive of the association and also of the British Biosimilars Association [1] . The current Chair is Diane DiGangi Trench, head of Sandoz UK [2] . The Vice-Chair is Paul Burden, who is the Vice President of Rx UK for Thornton & Ross [3] .

The association is concerned that a no-deal Brexit could force up the price of generic drugs because it would increase regulatory complexity. [4]

It is a member of the AMR Industry Alliance, a European organization dedicated to combatting antimicrobial resistance. [5]

In 2023, ahead of the UK General Election, the association published its Manifesto outlining the key policy priorities for whichever party was to form the next Government. [6]

In 2017, it said it was working with the Department of Health and Social Care to deal with problems caused by generic drug shortages, [7] 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. [8]

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. [9]

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. [10]

Related Research Articles

<i>British National Formulary</i> Pharmaceutical reference book for the UK

The British National Formulary (BNF) is a United Kingdom (UK) pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicines available on the UK National Health Service (NHS). Information within the BNF includes indication(s), contraindications, side effects, doses, legal classification, names and prices of available proprietary and generic formulations, and any other notable points. Though it is a national formulary, it nevertheless also includes entries for some medicines which are not available under the NHS, and must be prescribed and/or purchased privately. A symbol clearly denotes such drugs in their entry.

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 compared to their performance at the time when they were patented drugs. 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 are 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 the American 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 is permitted to be dispensed only to those with a medical prescription. 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 and others, is a disease-modifying antirheumatic drug and monoclonal antibody used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. It is administered by subcutaneous injection. It works by inactivating tumor necrosis factor-alpha (TNFα).

<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$2.5 billion. By 2023, Apotex employed close to 8,000 people as Canada's largest drug manufacturer, with over 300 products selling in over 115 countries. 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.

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.

The Drug Tariff, also known as Drug Tariff price, is that amount that the NHS repays pharmacies for generic prescription medications. It differs from prescription charges which are £9.90 per item/drug as of April 2024 unless exemptions apply.

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. PBMs operate inside of integrated healthcare systems, as part of retail pharmacies, and as part of insurance companies.

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 Law SF 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 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.

A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication. Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.

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.

<span class="mw-page-title-main">Food and Drug Administration Safety and Innovation Act</span> Piece of American regulatory legislation

The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.

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. "BGMA appoints Mark Samuels as CEO, as Warwick Smith retires". C+D. 2021-02-18. Retrieved 2024-09-23.
  2. "BGMA Lines Up New Leadership With Change Of Vice-Chair". Generics Bulletin. 2023-05-22. Retrieved 2024-09-23.
  3. "Paul Burden elected BGMA Vice-Chair, bringing 25 years of industry leadership - Latest Pharmacy News | Business | Magazine - Pharmacy Business". 2024-06-17. Retrieved 2024-09-23.
  4. "No-deal Brexit 'will force up price of generic drugs'". Health Service Journal. 26 September 2018. Retrieved 4 November 2018.
  5. "Our Members". AMR Industry Alliance. 2017. Retrieved 4 November 2018.
  6. "UK risks becoming a medicines supply backwater claims BGMA". www.pharmacymagazine.co.uk. Retrieved 2024-09-23.
  7. "BGMA: WE ARE WORKING WITH DEPARTMENT OF HEALTH TO COUNTER GENERIC SHORTAGES". Pharmacy Biz. 29 October 2017. Retrieved 4 November 2018.
  8. "Drugs firms are accused of putting cancer patients at risk over price hikes". 2017-01-28. Retrieved 2022-05-15.
  9. "NHS pays twice the price for generic medicines that manufacturers charge, finds report". Pharmaceutical Journal. 26 June 2019. Retrieved 23 August 2019.
  10. "UK rebate mechanism could force market withdrawals, warns BGMA". Chemist and Druggist. 25 October 2022. Retrieved 10 November 2022.