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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.

Thornton & Ross is all set to expand its consumer healthcare offering by acquiring the well-established Opticrom eye-drops brand from Sanofi in the UK. Opticrom forms part of a wider transaction between Thornton & Ross' parent group, STADA, and Sanofi for eight local consumer healthcare brands across several countries, including Belgium, Germany, Hungary, Spain and the UK. The transaction will be financed with a combination of cash on balance sheet and existing facilities, and is scheduled to close in the fourth quarter of 2023, subject to customary approvals of relevant regulatory authorities. Opticrom Allergy 10ml bottle and 20 single doses for itchy, watery, red and inflamed eyes can be found behind the pharmacy counter, while Opticrom Hayfever 10ml bottle is available to purchase via self-selection to soothe and relieve eye symptoms of hayfever. These non-prescription medicines contain 20 mg/1ml sodium cromoglicate (2.0% w/v) and offer relief within 2 minutes.

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.

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

The Royal Pharmaceutical Society (RPS) is seeking views of pharmacists to help shape the future of pharmacy practice in England over the next decade. The RPS's project with The King's Fund, transforming pharmacy practice, aims to develop a vision for the role of pharmacists and pharmacy teams working across systems, providing patient care and NHS services. It's due to be published at the end of the year. "From 15 August to 30 September we are asking people to respond to our consultation on six key themes," the RPS said. "We'll also be holding face-to-face and virtual events in September to hear your views." The King's Fund has completed a literature review which has helped inform the initial six themes which will be the focus of the consultation, all of which can be downloaded and read before responding.

Lack of appropriate funding is making survival a massive challenge for community pharmacy, a sector relied upon as a vital support system by both primary and secondary care in England. The Telegraph newspaper ran a story on Monday (August 22) which highlighted the dire straits community pharmacy finds itself in. Seasoned pharmacist Ian Strachan told the paper: "Our four pharmacies were the only point of call that was open (during Covid). We were there every single day, even when the virus was prevalent and people were dying." Describing the current situation, he said: "What is happening is we're facing a system that's just not working at all in our favour." Strachan says the issue is that pharmacists are "just not getting the help we need to be able to do this job properly". The sector is hugely dependent on funding from the NHS. The government had agreed in 2019 to set £2.6bn as annual funding for the sector. However, according to a report from EY that amount was already down £200m on the 2016 levels of government funding. "We've been starved of appropriate funding since 2016," Dr Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies told The Telegraph. "It looks grim for businesses. The fees pharmacists get are going nowhere, but now, there's higher utility bills, higher staff fees and higher drug costs."

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 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.

Professional leadership bodies from around the world discussed workforce shortages in community pharmacy and other challenges affecting the sector at a global meeting held in Paris last month. Delegated from Denmark, Australia, Ireland, New Zealand, Portugal, Spain, US and the UK updated the conference on how the profession was progressing in practice, technology and workforce development in their respective countries. The UK was represented at World Pharmacy Council meeting by National Pharmacy Association chair Andrew Lane and chief executive at the Pharmaceutical Services Negotiating Committee Janet Morrison. Lane said: "It's very useful to be part of a global network of pharmacy bodies who are all going through similar challenges as we are in the UK. Sharing intelligence on other pharmacy systems around the world helps us to prepare the right strategy for engaging with the NHS at home. "Hearing some of the strides in services and digital technology in the profession gives us hope for the future of the sector. It's clear however that key challenges such as workforce shortages are starting to have an effect in other parts of the world too."

Britain's competition watchdog has fined pharmaceutical companies Pfizer and Flynn £63 million and £6.7 million respectively for allegedly breaking competition law and illegally profiting from the sale of an anti-epilepsy drug. The Competition and Markets Authority (CMA) found that the two companies colluded to sell phenytoin sodium capsules, previously known as Epanutin, at "unfairly high prices" for over four over years between 2012 and 2016. The annual costs of the capsules for the NHS increased from £2 million in 2012 to approximately £50 million the following year. CMA has accused Pfizer of charging, over four years, prices between 780 per cent and 1,600 per cent higher than what was fixed previously for the medicine used to prevent life-threatening epileptic seizures. Pfizer supplied the drug to Flynn, which then sold the capsules on to wholesalers and pharmacies at a price between 2,300 per cent and 2,600 per cent higher than the prices previously charged by Pfizer.

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 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.

Covid-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they could over the last 18 months. Executives at the biggest Covid vaccine makers including Pfizer and Moderna said they believe most people who wanted to get vaccinated against Covid have already done so - more than five billion people worldwide. In the coming year, most Covid vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said. Pfizer, which makes its shot with Germany's BioNTech and Moderna still see a major role for themselves in the vaccine market even as overall demand declines. Upstart US vaccine maker Novavax and Germany's CureVac, which is working with GlaxoSmithKline, are developing vaccines they hope to target at the booster market. The roles of AstraZeneca and Johnson & Johnson, whose shots have been less popular or effective, are expected to decline in this market.

DE Group, one of the UK's leading independent pharmaceutical wholesalers, has gone into administration. Pharmacy Business has learnt that the group was put into administration on Monday (May 9), putting hundreds of jobs at risk and stoking fears of a "sudden shock" to pharmaceutical supply chain. A community pharmacy contractor who has done business with the wholesaler for over 20 years told Pharmacy Business: "I fear for the worst. I don't think there will be enough supply of medicines to cope up with a surge at such a short notice." Bharat Shah, founder and CEO of Sigma Pharmaceuticals, another leading short-line wholesaler, said the news will send shock-waves and have "a massive impact on the market" because DE Group enjoyed a "substantial coverage and market share" in the independent pharmacy sector. "It won't be easy for anyone to take on the extra volume as it could jeopardise their own business," he said, adding that Sigma was actively looking into expanding its own operations in the foreseeable future.

The Pharmacists' Defence Association raised concerns over the practice of firing and rehiring employees, which often leads to denial of individuals' rights to redundancy, forcing them to face cuts to their terms and conditions. It noted that some employers may use the 'fire and rehire' practice to force staff to accept lower wages, different hours, or other changes in working conditions. It cited an example of a lawsuit in which Tesco lost a High Court battle when Usdaw won a case to protect workers from unfair tactics. The PDA said although the trade union won the case, the practice of firing and rehiring can still be legal in some circumstances. However, it believes the practice is both immoral and unethical.

Generic and over-the-counter drugs company Stada has asked the German government to seek assurances from Ukraine that the company can continue operations there even though it also does business in Russia. In a March 21 letter to German Economy Minister Robert Habeck, Stada CEO Peter Goldschmidt said there was a risk Kyiv might withdraw the company's market authorisation. Stada "still has no longer-term certainty that we will be able to sell our products in Ukraine in the future," the letter said, with the subject line: "Please prevent the exclusion of international pharmaceutical companies from the Ukrainian market." The Economy Ministry did not have an immediate comment on the letter. Habeck promised investment guarantees for German companies during a trip to Ukraine on Tuesday (April 4) as part of his goal to speed up reconstruction in the war-torn country. Goldschmidt said restricting Stada's operations would be bad for Ukraine.

The UK GDP Association has been established as a non-profit organisation, operating as a Community Interest Company (CIC), with a focus on providing a broader support network, particularly for small and medium business enterprises and pharmacy wholesalers. In addition to delivering commercially viable Good Distribution Practice (GDP) consultancy services for simple models with smaller budgets, the association aims to function as a networking platform for Responsible Persons in the UK. As members of the association, companies and individuals can gain multiple benefits that will add value to their business through access to knowledge, discounted training, consultancy services, audit and inspection support, as well as resources like document templates for risk assessments, CAPA, deviations, and more. Moreover, members can enjoy the benefit of a like-minded support network via a dedicated GDP community hub, providing a platform for discussions, seeking advice, and fostering new relationships. "Our mission is to ensure that patient safety, GDP compliance, and excellent quality is paramount in all organisations, regardless of budget," the company said.

Since 1990, Glendale Pharmacy in Wooler, Northumberland, has been under the ownership of Andrew Booth, who recently decided to sell it to pursue a well-earned retirement. According to Christie & Co, the community pharmacy has been acquired by Jagraj Randeva, who owns a small portfolio of pharmacies in Ashington and Newcastle upon Tyne. Jagraj was particularly drawn to this pharmacy because of its advantageous, unchallenged location and its strong historical performance. Located near the Cheviot Hills and 17 miles south of Berwick-upon-Tweed, Glendale Pharmacy dispenses an average of 6,600 items per month. Karl Clezy, Director - Pharmacy at Christie & Co, noted that Glendale Pharmacy has seen an improvement in its trading performance since the start of the marketing process, increasing its prescription numbers and providing more additional/enhanced services.

The 14th Annual Community Pharmacy Conference by Sigma Pharmaceuticals began on Monday, 25 February at Sun City, South Africa. Dr. Bharat Shah, Manish Shah, and Kamal Shah, co-founders of the company, extended a warm welcome to the delegates in attendance at the event. In a written message, Prime Minister Rishi Sunak extended his best wishes to all the participants attending the conference. The message read: "This conference is timely as it coincides with the launch of the Pharmacy First, a new initiative launched across England that will enable patients to receive treatments for seven common conditions directly from a pharmacist without the need for a GP appointment or prescription." "We are all grateful for the tremendous contributions that pharmacists make to our NHS. The fantastic work you do is critical to the success of Pharmacy First and many other initiatives."