NSF Pharma Biotech’s Executive Director Dr Peter Gough, presented the likely regulatory impact on the trade in medicines between the UK and EU post-Brexit, including: necessary changes to marketing authorisations; the site of QC testing and QP certification; the impact on clinical trials. As a result of measures undertaken at industry, national and EU level, Brexit is not expected to have an immediate impact on the supply of medicines. As uncertainty about Brexit wears on, the head of the British Medical Association (BMA), Dr Chaand Nagpaul, has warned that a no-deal Brexit would be ‘disastrous’ for the NHS, due in part to a predicted exodus of thousands of EU doctors. Brexit has therefore led to further mitigation polices. Until 31 December 2020 a transition period is in place. The past few years have seen increasing concern about drug shortages. The government says that it has analysed the supply chain and is making plans to reduce the risk of disruption. Some things would initially remain the same. Despite this, there have been concerns that there is no guarantee that loss of life due to lack of access to medicines will be avoided if there is a no-deal Brexit. I am. A no deal Brexit is predicted to disrupt ferry ports for at least six months, with capacity halved initially. It says there may be significantly reduced access across the short straits crossings into Dover and Folkestone, which could hamper the movement of vital medicine into the UK. The European Medicines Evaluation Agency, responsible for the licencing of medicines and continued monitoring of their safety after licensing, has already moved from London to Amsterdam. This includes a risk of significant disruption to the supply of medicines and increased instability in the adult social care market. This has made the medicines supply chain more fragile, and production problems, contamination of medicines, a lack of local market responsiveness, and over-concentration of production of raw materials in a small number of medicine manufacturers have all contributed. There will be a transition period until the end of 2020, while the UK and EU negotiate additional arrangements. We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. From atoms to astronomy, computers to cars and robots to robust materials, our goal is to transform our understanding of the world to make life easier, healthier and more sustainable. The University of Birmingham has established a Birmingham Plastics Network, an interdisciplinary team of more than 40 academics working together to shape the fate and sustainable future of plastics. Dr Nagpaul cited BMA figures indicating that 1 in 3 European health professionals intend to leave if a no-deal Brexit happens. The protocol enables pharmacists to supply alternate forms and strengths of medicines without the need to contact the prescriber. The BMA says that EU collaboration on licensing and safety monitoring of medicines, and supply chains for medicines and medical devices, could be disrupted by a no-deal scenario. A Brexit with a ‘no-deal’ outcome was addressed in part by the recent publication of technical notes from the UK Government. EU staff play a vital role in the NHS, and the government says the EU Settlement Scheme (a system by which EU citizens currently living in the UK can apply to stay post-Brexit) means current NHS staff from the EU will be able to stay in the UK. However, the BMA says it is ‘deeply concerned’ about future immigration. At a local patient level, further “Serious Shortage Protocols” could be introduced to deal with Brexit-related shortages, including substitution of alternate medicines. The Brexit impact on Pharma & Life Sciences Top 10 pharmaceutical production in European countries € million 1 Switzerland 33,010 2 Germany 29,010 3 Italy 27,461 ... UK’s Medicines and Healthcare products Regulatory Agency, MHRA, may be equipped with the task of authorising medicines … Restrictions on parallel trading of medicines within the EU have been seen as another way of preventing shortages within individual states, and the UK has already restricted the export of some medicines with known shortages. There are concerns about how a no-deal Brexit scenario might affect medical supplies and healthcare provision in the UK. What could Brexit mean for our access to medicines? The Royal College of Radiologists has recently expressed concern about the lack of logistical detail it has seen on contingency plans for isotope supplies. This previously happened in Greece during the financial crisis. Brexit is already affecting supply and prices of drugs in UK pharmacies, the BBC has reported. We use cookies to allow us and selected partners to improve your experience and our advertising. Around three quarters of medicines and over half of single-use medical products (such as syringes) that the NHS uses come into the UK via the EU, according to the Department of Health and Social Care (DHSC), so there is a risk that if we leave the EU without a deal, border delays could affect this supply. The first step to prepare for Brexit is to identify and analyse the company … United Kingdom, Main Switchboard: However, certain pharmaceuticals, such as orphan medicines, which are used to treat a relatively small number of patients who suffer from rare diseases, are not subject to the decentralised process. Other organisations have raised similar concerns. Pharmacists seem divided on whether enough has been done to mitigate Brexit-related medicine shortages. Below, we outline what we know currently about medicines, medical supplies and healthcare provision in the event of no deal. Whether the UK leaves with or without a deal, Brexit will have a significant impact on the sector, including access to reciprocal healthcare arrangements, protecting public health and the supply of medicines and medical technologies. The rest of … We are working with partners across the globe to understand how to save lives at risk from poor air quality. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. European Health Insurance Card (EHIC) advice, Best painkillers: aspirin, ibuprofen and paracetamol compared, COVID-19 vaccine explained: what it means for you, Six of the weirdest fitness fads of the past four decades. See our European Health Insurance Card (EHIC) advice, Categories: Bathroom & personal care, Home & garden, Tagged as: brexit Healthcare medicine NHS no deal. As well as the short to medium term logistical and market issues related to Brexit, there are longer term concerns. With more than 1,000 academic staff researchers and around £80 million new research funding per year, we are dedicated to performing world-leading research with the ultimate goal of improving human health. For example, access to radioisotopes that are essential for various types of cancer treatment could be limited. How does stockpiling affect the supply chain and why is it important to continue to prescribe as normal, in view of a possible no deal Brexit? This could lead to patients in the UK facing delays in accessing new medicines and treatments. On 3 August, the government published guidance for commissioners and healthcare providers. There are concerns about how a no-deal Brexit scenario might affect medical supplies and healthcare provision in the UK. GPs, hospitals, and community pharmacies have been told they should not stockpile medicines beyond usual levels. I am suggesting that if you have any up-to-date information it would be very useful to get it out to that group. Wholesalers have been asked to keep rolling six-week stockpiles in case of a no-deal Brexit, and additional warehousing has been bought. Other materials used for medical procedures could be in short supply. UK pharmacists have reported shortages of drugs across most major therapeutic areas. Although the UK media focus has been on the effects in the UK, there are concerns that Brexit may worsen medicine shortages in other member states; for example, in Ireland, where the majority of medicines come from or through the UK. Challenging established views and policy responses to migration and its impact on societies in a rapidly changing world. we operate within the same rules as now) for medicines seems to be the least disruptive option. Tel: +44 (0)121 414 3344. PS: You may ignore at will my more provocative tweets! For blood and organs, if there’s no deal, the current safety and quality standards would be maintained. It would still be an offence to sell or supply unauthorised medicines to anyone in the UK. However, medicine shortages are already widespread in the UK and the EU due to long-standing structural problems in the medicines supply chain. January Brexit and the impact on patient access to medicines and medical technologies 05 Case studies showing potential impact on patients access to medicines and medical devices Availability of medicines for prostate cancer patients Developed in the UK, and manufactured in the UK since 1987, this treatment is used for prostate cancer • • • Media reports of medicine shortages and their causes in the aftermath of Brexit may be influenced by the polarisation seen in the wider Brexit debate. Pharmaceutical companies play a critical role in ensuring continued supply of medicines after Brexit and in minimizing expected disruptions and impact on public health in the UK and the EU. Health union leaders have issued a stark warning that a no-deal Brexit could “devastate” the NHS and cause fatal medicine shortages arguing “no responsible government should take that risk”. In the short-term this disruption at ports could be serious. October 28, 2020. The BMA points out that a no-deal Brexit would lead to uncertainty about the way medicine is regulated in the UK, as it would no longer be part of the broader EU regulatory system. A no-deal Brexit complicates the existing drug shortage problem, with potential border delays. We explore what it means to be human – in historical and cultural contexts, within ethical and legal norms and through languages and communication. Dr Anthony Cox, Senior Lecturer in Clinical Pharmacy and Drug Safety, The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of the University of Birmingham, “A no-deal Brexit complicates the existing drug shortage problem, with potential border delays. Health Secretary Matt Hancock has also said there is no need for clinicians to write longer NHS prescriptions. In October 2018, EMA revised the number down to 31 centrally authorised products (19 human medicines and 12 veterinary medicines) for which it remained concerned about potential Brexit-related supply disruptions. Across the breadth of life and environmental sciences, we discover, apply and translate science to forge major advances in human and environmental health. The effects of Brexit, and consequences of attempts to mitigate those effects, are difficult to predict. Pharmacists are also legally allowed to share medicine stocks between pharmacies, which would help them to manage local stock imbalances. He also expressed ongoing concerns about the movement of specialist drugs that have a short shelf-life, as well as the impact on reciprocal healthcare, which will cost the NHS heavily if UK residents living in or travelling to the EU are no longer covered. These latter issues may overshadow any problems caused by Brexit. Update: 25 June 2019 – BMA chair warns of Brexit’s impact on the NHS. what is likely impact on Prednisolone availability in UK post non deal Brexit? It is still unclear whether there will be an agreement on health-related issues. Patients are worried about essential medication for illnesses such as diabetes being held up by border delays, but there are also wider potential implications for healthcare, from hospital care to supplies and staff. For many organisations in the sector, the future arrangements for regulation of medicines and medical devices post-Brexit is the main concern in their preparations for operating Beyond Brexit. 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Brexit "having impact on EU drug development” EMA and UK regulator both affected In the EMA’s first annual report since its forced move from London to Amsterdam, executive director Guido Rasi pulls no punches about the impact of Brexit on medicines development. As the BBC reports, a vast proportion of prescription medications could be harder to access in the event of a no-deal Brexit. By continuing to browse you consent to our use of cookies. Diabetes UK, along with diabetes research body JDRF, said they are unconvinced that the government’s current plans are robust enough to guarantee no impact on supplies of treatments including insulin. A Brexit where regulatory alignment is achieved with the EU (i.e. However, the government has instructed pharmaceutical companies that supply medicines for NHS patients from, or via, the EU, to make sure there is a minimum of six weeks additional supply in the UK by the revised leave date as a contingency for a no-deal Brexit. Companies can submit Brexit queries to the relevant e-mail address below: Human Medicines – brexit@hpra.ie . Official advice is that plans are being made to prioritise medical supplies and there is no need for patients to stockpile medication. Birmingham academics work on major issues in international ethics and global justice and train the next generation of students to tackle these issues. The Brexit Health Alliance believes that the UK’s approach to the negotiations should provide patients and industry with as much clarity as early as possible, and prioritise: Guaranteeing patients uninterrupted supply of their current treatments and fast access to new medicines and medical devices; For example, a no-deal scenario may discourage EU health professionals from wanting to come and work for the NHS and could lead to a reduction in staff. Pharmaceutical manufacturers and wholesalers have provided assurances that there will be sufficient stocks to bridge any initial issues at … These latter issues may overshadow any problems caused by Brexit. Delegates were concerned that there is a lack of information available for patients about Brexit’s potential impact on healthcare. With a course already set for a fairly “hard” Brexit where the UK entirely leaves the single market, any deal possible at this stage will still cause significant disruption at the border and added costs. No stockpiling is necessary, advises HPRA Veterinary Medicines – vetinfo@hpra.ie The impact of Brexit on medicines is largely unknown. Approximately half a million scans are performed annually using imported radioisotopes. This major new report maps out the health areas that will be affected by this decisive exit from the Union and discusses the dilemmas faced by the health sector in the face of such huge legislative changes. If there’s no deal, the Medicines and Healthcare Regulatory Agency (MHRA) in the UK would take over the regulatory functions currently carried out by the EU for medicine safety and regulation. Building the foundations for a more responsible and sustainable future. Many health economists have written about uncertainty and its impact on HTA [1,2,3], but few have written in the face of uncertainty.Brexit has created one of the most uncertain times in the UK across a number of industries and sectors, including the pharmaceutical industry. After Brexit (2019+) the impact upon the life sciences and healthcare sector largely depends upon what model the UK adopts for its relationship with the EU. Birmingham has been at the forefront of transplants since the pioneering work of Sir Peter Medawar. The Government’s use of non-disclosure agreements in discussions with some pharmaceutical bodies, to enable honest discussions, has led to concerns about a lack of transparency. I am concerned about my blood pressure drugs and I also take colystyramine twice a day since having gall bladder removed 2017. During this period, no changes are expected with regard to the trade in or availability of medicines as all EU agreements and rules will still apply to the UK. As part of trying to plan for possible delays at the major ports, the DHSC is establishing a dedicated shipment hub in Belgium for suppliers of urgently required medicines (those that are usually delivered from the EU to the UK with short lead times of 24 to 72 hours). Concerns have been expressed over possible new customs delays in a no-deal scenario. Academia partnering with business, investigating, developing and co-creating robust and innovative solutions to achieve responsible business success. The already available framework for shortages of medicines will be used to manage emerging issues. Is there any likelihood of these type of drugs being hard to get hold of. I take, Amlodipine, Furosemide, Atenolol, Losartan, Sertraline, Omeprazole, Levothyroxine and Vit D. Would appreciate your feedback. Germany has been discussing the repatriation of antibiotic production. Impact of Brexit on the Pharmaceutical Industry. How will the money be allocated for SSP arrangement, for the prescriptions of a country with a population of almost 68 million? The UK’s exit from the EU could have wide-ranging implications for medicine supply, science and research and the health and care workforce. The recent Queen’s speech had proposals to try to maintain access to innovative medicines for patients and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) plans for a no-deal Brexit are in the public domain. Birmingham B15 2TT Brexit, particularly a no-deal Brexit, has potentially serious consequences for the supply of medicines in the UK. To be able to achieve this, the Medicines Authority will provide any support necessary to its stakeholders. We’ll update this page when we know more. How much difference any agreement makes will depend on how ambitious it is for the drugs and devices sector. Could you explain the reasons why the letter by Keith Ridge was sent out only 3 weeks before the transition? If manufacturers decide to focus on the EU market, the UK may have reduced access to new innovative medicines. You can understand more and change your cookies preferences here. Decarbonisation is one of two railway grand challenges (along with digitalisation) that requires a strategic, whole-sector approach with government, industry and academia working together. They must be authorised centrally by the EMA. Hi, there has been a "black dot" campaign on twitter (people put blacks dots against their names) about shortages of drugs under brexit. The government announced this week that supplies could be disrupted for up to six months, in a ‘worst-case’ no-deal scenario, and said that it is adjusting plans to account for this. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties. Updated page titles and the summary to clarify that this guidance is about importing medicines from EEA countries if there's a no-deal Brexit. A £25 million express freight service, using both air and road, has also been created, allowing next-day delivery for small consignments, including temperature-controlled or hazardous products, 48 hr deliveries for large orders, and specialist hand deliver if required. EMA, together with its scientific committees, assessed how critical these products are for the treatment of the disease they target. Increasing the local production of medicines is one proposed solution. However, some organisations, including the Royal College of Radiologists and Diabetes UK, have raised concerns about the robustness of these plans. The UK government has also introduced a “Serious Shortage Protocol” for drugs with known supply problems. Irish regulatory authorities have prepared detailed contingency plans to face the possible impact of hard Brexit on medicines supply in Ireland. How will Brexit affect my consumer rights? The UK relies on importing nuclear radioisotopes and these come mainly from the Netherlands, France and Belgium. The government is continuing to evaluate the situation and plans are constantly evolving. A globalised procurement process focussed on reducing costs has led to the manufacture of many drugs outside Europe, mainly China and India. EMVO has been working to manage the implications of Brexit (the UK’s departure from the EU Internal Market rules) for the EMVS and its users. The first such protocol was issued on 3rd October to alleviate the shortages of fluoxetine capsules, unrelated to Brexit; it allows pharmacists to dispense different forms and strengths to fill patients’ prescriptions. The pharmaceutical industry is one of the most important industries that will be directly impacted by Brexit. Brexit, particularly a no-deal Brexit, has potentially serious consequences for the supply of medicines in the UK. In September 2017, the BMA patient liaison group convened a meeting to explore what Brexit means for patients. These can’t be stockpiled as they decay quickly. Our researchers are continuing his legacy. Developing the use of sensors and clocks in innovative, ground-breaking technologies to change the future landscapes of healthcare, transport, defence, civil engineering and more. In the event of a no deal Brexit, the political will to ensure the continued movement of medicines into, out of, and across the UK should exist. There is concern over other current shortages include hormone replacement therapy, anti-epileptic drugs, statins, anti-psychotics, eye-drops, and anti-depressants. This article outlines the delivered and predicted impact of Brexit, the withdrawal of the United Kingdom (UK) from the European Union (EU) and the European Atomic Energy Community (EAEC or Euratom).. Impact of Brexit on the EU Regulatory Network. The lack of clarity on a future immigration system is also hindering the ability of the healthcare industry to plan future staff, according to the BMA. The Malta Medicines Authority’s (MMA) main priority is the protection of public health and ensuring continuity of supply of medicinal products for the patients. The HPRA continues to advise companies to engage with us at the earliest opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market. Health Secretary Matt Hancock has said that this means the six-week stockpiling activities already advised will need to be supplemented by additional measures, and has instructed companies to review their supply chains to prepare for any disruptions. We address the challenges facing society and the economy, from shedding light on the refugee crisis, to character education in schools, through to developing leaders in the NHS. This was undertaken in close collaboration with concerned authorities and stakeholders, including the European Commission, as well as the most impacted National Medicines Verification Organisations (NMVOs). The report of the symposium is available here . GPs, hospitals and pharmacies are also being told not to stockpile medicine, but pharmaceutical companies have been advised to do so. Any evaluation is complicated by the baseline rates of drug shortages caused by other factors. We are leading the way in decarbonising the railway in the UK and across the world. What is clear though, is that even if government attempts to avoid medicine shortages are entirely successful, and supply chains adapt rapidly to post-Brexit changes, the underlying structural causes of medicine shortages will affect the supply of medicines for years to come. The government has also published the Operation Yellowhammer documents, which set out the ‘reasonable worst case scenario’ impact of a no-deal Brexit. Regulatory requirements have been communicated to companies to ensure they can still sell their medicines in the UK in the event of a no deal Brexit, and support has been given to companies to ensure they can meet new custom and border requirements. The UK government has indicated that stockpiling of six weeks supply of medicines will take place. Brexit and the impact on patient access to medicines and medical technologies Publication date: 01 Jan 2018 The UK’s plans to leave the European Union (EU) and the EU’s single market could have serious implications for patients’ access to medicines and medical technologies. In the short-term this disruption at ports could be serious.”. With the prospect of a deal still very much hanging in the balance, the UK's transition period for leaving the European Union ends in a matter of days on 31 December 2020. According to a BMA survey, 45% of EEA doctors said they were considering leaving the UK following the referendum vote. What impact will Brexit have on the supply of and access to medicines, for example? Edgbaston If the UK remains in the European Economic Area (EEA), then the changes may be minimal. For example, France has argued for the creation of public drug manufacturers to supply the EU. Worried about healthcare abroad? Patients are worried about essential medication for illnesses such as diabetes being held up by border delays, but there are also wider potential implications for healthcare, from hospital care to supplies and staff. by Impact of Brexit on medicines. Unless there are special agreements put in place post-Brexit, the implications would be serious. They could still be bought from some non-EU countries but supplies may more expensive and not be as reliable. This fragility is well illustrated by a 2017 explosion at a Chinese factory, which left only one other global supplier of an important antibiotic (piperacillin-tazobactam). Brexit: NHS managers warn about impact of no deal The organisation that negotiates drug pricing on behalf of pharmacies told BBC Radio 5 Live's Wake up … Playing a full, active role in European regulatory procedures for medicines remains a priority. Given the highly regulated nature of the Pharmaceutical and Life Sciences sector, it’s no surprise that the separation of the UK from the EU could have major ramifications for the industry. Ireland: The impact of Brexit on medicines supply in Ireland. When it comes to medicines that have a short shelf life and can’t be stockpiled, pharmaceutical suppliers have been asked to ensure they have air-freighting plans in place to avoid border delays for importation. These contingency plans cover prescription-only and pharmacy-only products. As of 31 January 2020 the UK is no longer an EU country. International ethics and global justice and train the next generation of students to tackle these issues, difficult... From some non-EU countries but supplies may more expensive and not be as reliable scenario’ impact of country! Some non-EU countries but supplies may more expensive and not be as reliable we operate the... 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