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The British Generic Manufacturers Association has backed the UK government's proposed changes to the Statutory Scheme for branded medicines, which includes a 'Life Cycle Adjustment' (LCA) mechanism to permit a lower rebate rate for medicines sold in competitive markets. The association underscored the necessity for crucial amendments to forestall unintended consequences and ensure a practical alignment with market operations. A precisely tailored approach is crucial in ensuring sustainability and growth in this sector, the BGMA said in a statement on Oct. 11. The Department of Health and Social Care is currently working on the successor to the 2019 voluntary scheme for branded medicines and pricing access (VPAS) agreement, slated to end in 2023. Negotiations for this successor, scheduled to begin on January 1, 2024, are already underway. "We are pleased that the Statutory Scheme consultation recognises that branded generic and biosimilar medicines are subject to different market dynamics and competitive pressures," said Mark Samuels, Chief Executive of BGMA. "As such, a one-size-fits-all approach across all branded products is not suitable for the next five years. It is crucial to adopt a precisely tailored approach to this sector, ensuring both sustainability and growth."

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A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market, revealing significant issues impacting patient care. The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives, posing substantial hurdles to ensuring continuous patient care. Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market. A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management. The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility nationwide.

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The NHS claims that it's been able to save taxpayers £1.2 billion in just three years by procuring hundreds of hospital medicines at a better price. The adoption of cheaper versions of a single drug - adalimumab - which is used to treat more than 45,000 patients with rheumatoid arthritis, inflammatory bowel disease and psoriasis, has accounted for about one third of the savings. After the exclusive patent on the drug - originally known as its brand name Humira - expired in 2018, the NHS struck cost-saving deals to bulk-buy generic versions, which have the same quality, safety and efficacy of a branded one. Since then, tens of millions of pounds have been saved by buying cheaper generic versions of other medicines for conditions ranging from severe skin infections to aggressive blood cancers. Four in five medicines prescribed in the NHS are now non-branded, helping the NHS to achieve significant savings while ensuring the continuity of high-quality patient care. NHS chief executive Amanda Pritchard said: "Smart deals by the NHS mean patients are getting the best medicines and taxpayers are getting best value.

The NHS is on track to miss out on savings of over a billion pounds as patents for a new lineup of 85 biologics are set to expire within the next five years, the British Generic Manufacturers Association has revealed in its new study. The government's Voluntary Scheme for Branded Medicines Pricing and Access is expected to lead to a cost of more than £1 billion for the NHS in the coming years. The BGMA research found that more than 85 biological medicines will experience loss of exclusivity during the upcoming VPAS Scheme period from 2024 to 2028. "This includes blockbuster products like the cancer medicine Keytruda and wet macular product Eylea, which together generate approximately $25 billion in global sales," BGMA said. "The molecules coming off-patent also cover other disease areas including oncology, diabetes, arthritis, and asthma." While biological medicines dominate the medicines budget, constituting the largest cost and cost growth sectors, NHS England aims to expedite biosimilar availability, yielding substantial savings and expanding patient access to vital treatments. Yet, the report found that "this is jeopardised by the influence of the VPAS Scheme".

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The British Generic Medicines Association (BGMA) has called for exemption from the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), an agreement between the UK Government, NHS England, and the pharmaceutical industry for branded generics and biosimilars. "Due to the rising rate of VPAS on top of existing competition, manufacturers are finding the additional levy economically unviable given their already low prices," the association said. According to research by the Office of Health Economics OHE and Professor Alistair McGuire (LSE) the rising rate of VPAS will force manufacturers pull out of the market which may lead to prices rise due to a lack of competition and critical savings to the NHS will be lost. The new study stated that Government levy on medicines designed to increase access to new treatments and promote affordability could actually be denying the NHS billions of pounds of annual savings due to the impact it is having on branded generics and biosimilars.

The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI). Mark Samuels, Chief Executive of BGMA said: "The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS). "We are deeply concerned by this decision. It has left us no choice but to take legal action." "While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028." "The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS. The association had raised its full participation in the negotiations with the Government last November.

The High Court has dismissed the British Generic Manufacturers Association (BGMA)'s claim on being excluded from ongoing negotiations between the government and industry to agree a new Voluntary Scheme for medicine pricing and access (VPAS). The association had sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI) in April. Commenting on the result of the case, Richard Torbett, Chief Executive of the ABPI said: "For over 60 years the ABPI has acted as the representative industry body for negotiations on the Voluntary Scheme for branded medicines - a responsibility we take extremely seriously - and one which has been reaffirmed by today's judgment. "While we were disappointed that the BGMA decided to take this action - we recognise their decision was driven by the extreme challenge placed on all parts of the industry from the surge in the branded medicine payment rates. "The solution to these problems must be a completely new and sustainable approach to medicines provision in the UK which rapidly brings industry revenue payments in line with comparator countries to unlock investment and growth."

With Novo Nordisk's patent protection for liraglutide now expired, the UK is set to welcome the first wave of generic weight loss medicines. The British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, believes these generic versions could "provide could provide much-needed capacity to meet growing demand and alleviate shortages." Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is primarily used to treat type 2 diabetes and obesity. Novo Nordisk markets liraglutide under the brand names Victoza (for type 2 diabetes and Saxenda (for weight loss). In a statement released on 20 November 2024, the BGMA confirmed that "liraglutide's patent protection was no longer in force, marking the first time generic versions of diabetes and weight loss treatments can be available in the UK." The BGMA anticipates that at least four companies will obtain UK marketing authorisations for generics targeting type 2 diabetes and obesity. However, it remains uncertain how many will launch immediately.

The British Generic Manufacturers Association (BGMA) has raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. The Department of Health Social Care (DHSC) today announced that the 2019 voluntary scheme payment percentage for 2023 will be 26.5%. The 2019 voluntary scheme for branded medicines pricing and access is an agreement between the Department of Health and Social Care, NHS England and the Association of the British Pharmaceutical Industry. BGMA believes that the high VPAS tax for 2023 risks more medicines shortages, rising prices for the NHS via reduced competition, and new medicine launches to the UK being deferred. Mark Samuels, Chief Executive of BGMA, said: "Raising the VPAS tax to 26.5% will damage the UK's medicines supply because it will make some products lossmaking. It is more than a five-fold tax increase from 2021, and no industry can cope with this unpredictable and exceptional tax volatility.

Recently launched generic version of Apixaban by Teva UK is said to bring savings to the NHS drug bill while making sure patients get the medicine they need. The generic apixaban is available for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA) and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Previously there was only a 'branded' product available, but Castleford-based Teva UK succeeded in invalidating the apixaban patent and SPC (supplementary protection certificate) in the UK High Court and so is now able to launch its own 'generic' version - which will bring savings for the NHS while making sure patients get the medicine they need. "We've always said that we stand up for the patient", said Kim Innes, General Manager of Teva UK and Ireland. "The launch of generic apixaban emphasises Teva's commitment to doing the right thing by putting patients at the heart of everything we do by giving them and the NHS access to affordable treatments." Apixaban is an anticoagulant which directly inhibits factor X (factor Xa), inhibiting thrombin formation and the development of thrombi (blood clots). For at-risk patients, such as those with, or at risk for DVT, or NVAF, the risk of stroke related to blood clots forming in the body and traveling to the brain is a serious concern. Each year, DVT affects around 1 person in every 1,000 in the UK and if left untreated, about 1 in 10 people with a DVT will develop a PE.

Loughborough-based generic and branded pharmaceutical manufacturer Morningside Pharmaceuticals has donated almost 60,000 packs of essential medicines to communities impacted by the war in Ukraine. The donation, which includes 1.29 million doses, was made after the company's founder and chairman, Dr Nik Kotecha OBE, spoke with the Ukrainian ambassador to the United Kingdom, Vadym Prystaiko, at a business event in London. Dr Kotecha, who was also recently appointed a deputy lieutenant of Leicestershire, said: "The heartbreaking situation in Ukraine has touched us all, and like so many people in the United Kingdom, we've been keen to do everything we can to help the victims of this terrible conflict." The large shipment of medicines has been transported in a secure and temperature controlled environment via Morningside's logistics partner to the embassy's distribution hub in Poland. From there the medicines will be supplied to hospitals, healthcare centres and patients throughout Ukraine including the regions hardest hit by the Russian invasion.

The British Generic Manufacturers Association (BGMA) has warned that England's 42 integrated care boards (ICBs) may need to allocate an extra £37 million from their budgets annually for the next five years due to the spiralling tax rates. The government's Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) rebate rate increased more than five-fold in the past two years, the BGMA said in its white paper released on Monday (October 30). The report, conducted by consultancy firm Conclusio in consultation with local NHS leaders, examined the potential effects of the VPAS on ICB budgets. BGMA said that due to the elevated VPAS rate, each ICB in England will experience significant increases in expenses for branded generics and biosimilars annually - a consequence of reduced competition.

The Department of Health and Social Care (DHSC) has introduced new arrangements for the application of discount deduction to community pharmacy payments which will be implemented in six financial quarters beginning in October 2022 and concluding in January 2024. Under the new discount deduction system, the current single scale will be split into three groups: one each for generic medicines, branded medicines, and appliances. Separate fixed deduction rates have been determined for each group. This will provide all pharmacies the same rates of deduction applied to their reimbursement for the three different groups, regardless of the total value of that reimbursement. Fin McCaul, PSNC member and independent community pharmacy contractor, said: "The discount deduction scale has been a point of contention for contractors for many years, and PSNC has long been pushing to remedy this. "The incoming changes are designed to both improve equity of access to margin and manage the distortions presented by branded medicines, which just don't have the same level of discount available as generics.

The British Generic Manufacturers Association (BGMA) has published a positioning paper which sets out the objectives that need to be delivered through the next Voluntary Pricing and Access Scheme (VPAS) on Thursday (15 June). The paper details how a financially sustainable VPAS can support widened medicines access to patients. VPAS is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1% but for 2023 it has soared to 26.5%. Last year, the association had raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. "The rocketing rate is in large part due to the growth in spend in on-patent medicines since 2019. Looking at the four completed years of the current VPAS scheme, data shows that the average annual growth rate for on-patent medicine sales value from 2019-22 was 18% compared to just 2% for off-patent products," said the association.