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The British Generic Manufacturers Association (BGMA) has elected Diane DiGangi Trench to be its new vice-chair. DiGangi Trench takes up the position replacing Xiromed's Peter Ballard and in 12-months' time will assume the association's chair role from Accord's Peter Kelly. With over 25 years of pharmaceutical industry experience, DiGangi Trench has held a number of senior commercial roles including stints with Takeda and Astra Zeneca. She joined Sandoz in 2018 in the US, where she served as Vice-President, Market Access and Patient Services. In 2021, she became the head of Sandoz' UK business and in her two years in role, she has led the organisation through a post-COVID recovery and growth phase to prepare for the proposed spin out of the company from its parent, Novartis, expected later this year. She said: "It's a great honor to take on the role of Vice Chair of the BGMA. The success of the generics and biosimilar industry is essential to the functioning of the NHS. Generic medicines fill four out of five UK prescriptions and biosimilars enable the NHS to expand access to more patients. I am passionate about increasing the sustainability of our industry so we can continue to play our vital part in the health of the nation." Mark Samuels, BGMA chief executive, said: "We are extremely fortunate to be able to call upon the expertise of Diane who has already added significant value through her role on the BGMA board and leadership of a key strategic committee.

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."

he British Generic Manufacturers Association (BGMA) has voted Pete Kelly, managing director of Accord UK, to become its new chair. He replaces Peter Ballard, who has completed his second tenure as the association's chair and will now serve a further year as vice-chair. Pete leads the UK operations of Accord, one of the largest generic and biosimilar manufacturers in Europe. In the UK, the company currently supplies a fifth of all generic medicines. Mark Samuels, chief executive of BGMA, said: "We are very fortunate to have someone of Pete's experience and leadership qualities to take on the mantle of chair of the association. The industry faces a challenging period on many fronts, and Pete's input will be invaluable. "I would also like to record my enormous gratitude to Peter Ballard, our out-going Chair who has been an incredible servant to the association over many, many years. He will continue for another year as vice-chair, and we are pleased to have his continuing advice."

The British Generic Manufacturers Association (BGMA) has elected Matthew Salzmann, UK Country Manager at Viatris, as its new Vice-Chair with immediate effect. He will replace the current chair of the BGMA, Diane DiGangi-Trench, who is the UK country head for Sandoz. Salzman, who is originally from Australia, has served approximately 1 billion patients worldwide last year as the UK Country Manager at Viatris, a global pharmaceutical company operating in 165 countries. In his role as BGMA Vice-Chair, Salzmann would focus on working in partnership with key stakeholders - the NHS, healthcare professionals, policy makers, clinical societies, patient associations, academia - to ensure access to affordable and sustainable medicines for patients and the NHS.

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.

The British Generic Manufacturers Association (BGMA) has warned of the significant implications for future supply as a result of the crippling VPAS rate. The warning comes after the association's judicial review into the Government's decision to bar it from being a full part of the negotiations for the next five-year VPAS period was dismissed. The voluntary scheme for branded medicines pricing and access (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 in 2023 it has soared to 26.5%. All biosimilars and a proportion of the generics market falls into the scheme.

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."

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 British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and are "around double what they were a year ago." BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association is "very concerned" about the current situation. "We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago. We have them at 101 shortages in February this year," said Samuels. Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".

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 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".

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.

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.

Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants, immunosuppressants and drugs to treat type 2 diabetes and ADHD. Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply problems, the highest on record in the UK, and more than double the number recorded at the start of 2022. More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK. The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but Brexit is also cited as another reason for the problem.