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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.

Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is "not in shape" to help Europe meet its public health priorities. In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data. Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022). These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause "significant harm to patients and pose important challenges to health systems." While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted. Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.

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".

Community Pharmacy England (CPE) has explained MPs on instability that puts operational pressures on pharmacies, financial pressures on businesses at a Parliamentary drop-in event held on Monday (10 July). The association has been in Parliament today alongside patient representatives and others to highlight our ongoing concerns about medicines supply to MPs. It said: "Medicines supply remains a critical issue for community pharmacies with disruption causing problems both accessing medicines and procuring them cost effectively." In CPE's recent sector polling, community pharmacy owners rated medicines supply instability as being the most severe pressure facing their businesses. This echoed the results of CPE's Pressures Survey which found 97% of pharmacy owners survey are facing significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued. During the Parliamentary drop-in event, CPE talked MPs through the issues and set out what it believe needs to happen to resolve them, calling for- Reform of Serious Shortage Protocols; Allowing generic substitution; An overhaul of the concessions system; and a strategic Government review of medicine supply and pricing with a shift to focusing on how to improve the functioning of the supply chain rather than solely on the drive to depress prices and margins.

The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

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.

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.

Community pharmacy bodies have said that the current crippling financial pressures and severe staff shortages will limit the sector from fully supporting the new health secretary's ambition to improve patient care in England. Thérèse Coffey announced her plans on Thursday (September 22) which would be looking to reduce the country's reliance on general practice by expanding the range of services available from community pharmacies and allowing pharmacists more "prescribing powers". "Pharmacists will be able to manage and supply more medicines, without a prescription from a GP. We will look to go further on enabling pharmacists with more prescribing powers and making more simple diagnostic tests available in community pharmacy," she said in her foreword to Our Plan for Patients. However, the National Pharmacy Association has lamented that the plan stops short of promising any fresh funding for community pharmacies to deliver patient care and develop clinical services. NPA vice-chair, Nick Kaye, said: "The life is being choked out of independent pharmacy businesses by the continuation of a fundamentally under-resourced contract in England.

The Department of Health and Social Care (DHSC) has issued Serious Shortage Protocols (SSPs) on three HRT medicines to limit dispensing supply to three months. To ensure women across the UK will be able to more reliably access HRT products SSPs has been issued on the supply of Oestrogel, Ovestin cream and Premique Low Dose. DHSC stated, "Women who have a prescription for more than three months but are only able to access three months' supply will not have to pay an additional prescription charge." "This means women will not incur any additional costs. Imposing a three month limit will mean more women are able to access the medication they want. Any woman who is worried about access to HRT or is unable to access HRT should speak to her GP." Recently, Vaccine Taskforce Director General Madelaine McTernan has been appointed to spearhead a new HRT Supply Taskforce, applying lessons learned from the successful procurement seen during the Covid vaccination programme to identify ways to support the HRT supply chain ensuring it can meet both short and long term demand. The move will save time for patients as well as pharmacists and prescribers who are working tirelessly to tackle the covid backlog.

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.

Department of Health and Social Care (DHSC) has issued a medicine supply notification for Oxcarbazepine (Trileptal) 300mg and 600mg tablets on Wednesday (14 June). It has notified that the Oxcarbazepine (Trileptal) 300mg tablets will be out of stock from late June 2023 until mid-July 2023 and Oxcarbazepine (Trileptal) 600mg tablets are out of stock until mid-July 2023. However, generic oxcarbazepine 300mg and 600mg tablets remain available and will be able to support increased demand. "Oxcarbazepine (Trileptal) 150mg tablets and generic oxcarbazepine 150mg tablets remain available but cannot support the increase in demand," said DHSC. "Oxcarbazepine (Trileptal) 60mg/ml oral suspension remains available but cannot meet an increase in demand."

Atorvastatin, a medicine to treat high blood cholesterol, is the most dispensed drug with 59 million items in England in 2022/23, revealed the NHS Business Services Authority (NHSBSA) on Thursday (8 June). While Apixaban (an anticoagulant) was the drug with the highest costs of £430 million. Apixaban 5mg tablets had the largest increase in cost between 2021/22 and 2022/23 in England, with an increase of £280 million. NHSBSA's annual statistics report 'Prescription Cost Analysis-England 2022/23' published also has revealed an eight per cent rise in the prescription items that were dispensed in the community in England. The report highlighted that in 2022/23, 1.18 billion prescription items were dispensed at a cost of £10.4 billion in the community in England, witnessing an increase of eight per cent from £9.69 billion in 2021/22.

Instability in the supply chain network is frequently undermining the profit margins in community pharmacies, former Pharmacy Minister and Chair of the Health and Social Care Committee Steve Brine has said. Brine emphasised that community pharmacies often lack information about the prices wholesalers charge for essential generic medications. "They lack visibility into scarcity, and the pricing of these products is often significantly higher compared to other European countries," the former minister remarked during a parliamentary debate focused on the future of community pharmacies on September 14. From financial pressures to workforce crisis and pharmacy closures, the debate delved into critical challenges faced by pharmacies, aiming to propose tangible solutions for a sustainable future in the sector. Chaired by Sir Mark Hendrik, the debate was initiated by Conservative MP Peter Aldous and featured contributions from a host of participants including Labour MPs Taiwo Owatemi and George Howarth among others.