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The government has launched a consultation into radically changing the Statutory Scheme for branded medicines (known as the Statutory Scheme). The consultation comes as delicate negotiations for replacing the alternative Voluntary Scheme are underway, potentially undermining these talks, while also further damaging industry confidence in the UK as a viable place to research, launch and supply medicine. The government proposals seek to hold average revenue clawback rates under the Statutory Scheme at historic highs of between 21-27%, compared to the pre-pandemic averages of 9.4% for the Statutory Scheme (2019-2021), and 6.88% for the Voluntary Scheme (2014-2021). The accompanying cost-benefit analysis ignores any negative impact this may have on medicine supply and wrongly claims it will boost investment. The consultation comes on the heels of government data last week showing UK life sciences foreign direct investment (FDI) fell by 47% between 2021 and 2022, down by £900m year on year. This large fall in investment coincided with a rise in the main UK clawback rate under the Voluntary Scheme from 5% to 15%, and led to the UK falling from 2nd to 9th out of 18 comparator countries for life sciences FDI in 2022. The Voluntary Scheme clawback rate now sits at a record 26.5% in 2023.

The Department of Health and Social Care (DHSC) has published the full text of the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The 2024 VPAG agreement text sets out the detailed terms of the agreement reached between DHSC, NHS England and the Association of the British Pharmaceutical Industry (ABPI) to support patient access to medicines, the financial sustainability of the NHS and the UK life sciences sector. The new voluntary scheme will come into force on 1 January 2024, following expiry of the 2019 Voluntary Scheme and shall remain in force for a period of five years, until 31 December 2028. Manufacturers or suppliers of branded medicines to the NHS have been given time till 15 January 2024 to decide whether to join the new 2024 Voluntary Scheme, or default to the updated Statutory Scheme.

The government, NHS England and the Association of the British Pharmaceutical Industry (ABPI) has begun the negotiations for a new voluntary scheme for branded medicines pricing on Thursday (4 May). A new voluntary scheme is expected to take effect from 1 January 2024, replacing the current scheme which came into force in 2019 and ends on 31 December 2023 In their first meeting, the government, NHS England and industry - represented by the ABPI -expected to agree to a shared negotiation aim of working toward a mutually beneficial agreement that supports better patient outcomes and a healthier population, a financially sustainable NHS, and UK economic growth. Health Minister, Will Quince, said: "These negotiations will ensure a new scheme continues to deliver value for money by providing significant savings for our health services, securing access to innovative lifesaving drugs for NHS patients, and helping to reduce waiting times - one of the Prime Minister's 5 priorities. The current voluntary scheme supports investment in NHS services and saves billions of pounds for the NHS, while also promoting innovations and a successful life sciences sector.

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 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 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."

The Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI) have reached an agreement on the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). The landmark deal will save the NHS £14 billion over 5 years in medicines costs, boost the nation's health, and support research investment. The new VPAG scheme, which will be a non-contractual voluntary agreement between DHSC and ABPI, will run for 5 years from 1 January 2024 until 31 December 2028. It will double the annual allowed growth of sales of branded medicines from two per cent per year in 2024 to four per cent per year by 2027.

The Association of the British Pharmaceutical Industry (ABPI) has proposed a Voluntary Scheme for Pricing, Access and Growth (VPAG) that aims to deliver a sustainable approach to medicines provision and maximise the growth potential of the UK life sciences industry. It has published the industry's vision for a new agreement with the government which will deliver for patients, the NHS and the economy. VPAG also includes measures to ensure rapid patient access and adoption of new medicines, as well as opportunities to improve health outcomes and productivity for the whole country. The association's proposals consist of four key areas: restoring an internationally competitive commercial environment for life sciences; supporting UK clinical research and R&D; ensuring rapid patient access and uptake of new medicines; and improving population health and productivity through health innovation. The proposal would deliver over £1bn a year to the NHS - around £300m more than the average delivered under the old scheme before 2023, and comfortably more than the highest contributions ever made before the pandemic.

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 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.

Pharmaceutical companies AbbVie and Eli Lilly have withdrawn from Britain's voluntary medicines pricing agreement, an industry body said on Monday. Companies are increasingly arguing that it is no longer possible to justify the UK's "voluntary scheme" to global boardrooms and investors as repayment rates in 2023 have surged to 26.5 per cent of revenue, the Association of the British Pharmaceutical Industry (ABPI) said in a statement. "The current scheme has harmed innovation, with costs spiralling out of control, and the UK falling behind other major countries to be left as a global outlier," said Laura Steele, president and general manager for Eli Lilly's Northern Europe division. ABPI said it was seeking early talks with the government to set out a new future settlement. In December, the industry body had said the government raised the amount manufacturers of branded medicines within the voluntary scheme will be required to return to almost £3.3 billion in sales revenue from an earlier amount of £1.8 billion.

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 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 (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 Association of the British Pharmaceutical Industry (ABPI) on Thursday (February 2) called for the government to scrap its plans to raise the repayment rates for drugmakers, to avoid possible setbacks in the sector. Drugmakers that are part of the government's voluntary scheme agreement, which makes branded medicines affordable for people, are required to pay a part of their drug revenue to the government. The Department of Health and Social Care plans to raise the revenue clawback rate to 27.5 per cent from 24.5 per cent. The country's ongoing attempt to raise rates is likely to send the "worst possible signal" to global investors and boardrooms, said the ABPI. "Hiking these clawbacks to such uncompetitive levels risks undermining the UK's offer to global life sciences companies," Richard Torbett, chief executive of the ABPI, said in a statement. Pharmaceuticals giants AbbVie and Eli Lilly withdrew from the UK's voluntary drug pricing agreement in January after the repayment rates surged to 26.5 per cent.

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.

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.

Susan Rienow, UK Managing Director and Country President of Pfizer is all set to take up her role as President of the Association of the British Pharmaceutical Industry (ABPI). The association had announced her appointment in March. Last year in September she was appointed as the vice-president of ABPI. In her new role, she will oversee the ABPI, the ABPI Board, and the ABPI's Code of Practice, which is administered by the Prescription Medicines Code of Practice Authority (PMCPA). Susan takes up the Presidency as negotiations begin for a new Voluntary Scheme for branded medicines pricing between the government, NHS England and the ABPI. All parties are looking to secure a new agreement that will help improve patient outcomes, support a healthier population and a financially sustainable NHS, while also supporting economic growth for the UK.

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.