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eu drug shortages

Sinopsis

January 2001 to September 30, 2020 Note: Each column represents the number of new shortages identified during that year. The resolution calls on the Commission to address the issue of medicine availability, accessibility and affordability, as well as import dependency in the upcoming EU pharmaceutical strategy. The Covid-19 health crisis has highlighted a growing problem: shortages of medicines and medical equipment that put patients at risk and national health systems under pressure. Some of this legislation has been deemed by the EU Commission to be against Articles 34-36 TFEU, while other restrictions are considered appropriate and proportionate according to Article 36 TFEU. The European Union is looking for firms to supply 24 intensive care drugs, an EU official told Reuters News Agency as it strives to tackle shortages of … University of Utah Drug Information Service Contact: Erin.Fox@hsc.utah.edu, @foxerinr for more information. European patients are safeguarded by the Public Service Obligation enshrined in Directive 2001/83 Article 81, which states that: “The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.”. European patients are safeguarded by the Public Service Obligation enshrined in Directive 2001/83 Article 81, which states that: “. 095858939393, The problems of supply of medicines represent a big concern for health authorities across the continent. Product withdrawal. The problem has received increasing attention in recent years. It called on EU countries to lift export bans and avoid stockpiling; increase and reorganise production; ensure optimal use in hospitals by reallocating stocks; consider alternative medicines; and optimise sales in pharmacies. However, van den Hoven suggested that this poses a risk to the EU market if limited supplies from smaller, weaker countries were transferred to bigger and more powerful ones. Shortages of essential drugs are becoming increasingly frequent globally, burdening health systems with additional costs and posing risks to the health of patients who fail to receive the medicines they need. This platform receives signals from patients who are not able to find a medicine they need, and within 24h the association let you know if the product is available, in which pharmacy and, if the product cannot be found in any pharmacy but a wholesaler has stock of it, they will bring it to the patient. Currently, shortages.eu is focused on the European Economic Area. "As the public health emergency develops, shortages or disruptions cannot be excluded," the European Medicines Agency (EMA) said in a … We use cookies to ensure that we give you the best experience on our website. GIRP (the European Healthcare Distribution Association) have compiled the reasons given in an easy overview. On 17 September, Parliament adopted a resolution calling for the EU to become more self-sufficient in health issues by securing supplies, restoring local drug manufacturing and ensuring better EU coordination of national health strategiess. Given the regulatory procedure that governs marketing authorisation and release of medicinal products in the EU and the potential impacts on the supply chain, shortages of supply of products in the UK in the event of a hard Brexit cannot be excluded. Between 2000 and 2018, shortages in the EU increased 20-fold and according to a note by the European Commission are rising for widely used essential products. Affordable Medicines Europe (signing as EAEPC – former name) have worked intensively with stakeholders from the whole supply chain to identify possible root causes of shortages. Drug shortages are a global issue and the solutions presented in the report can be used also outside the European Union. The global consolidation of manufacturing increases the vulnerability of the supply chain. Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care. Any incident in one of the production facilities might have a big impact on the availability of the medicine in all the markets. Quotas are imposed by manufacturers in many countries to limit the potential for competition. For 12 Member States the causes of shortages are indicated in the lists by the national medicine’s agencies/ministries of health. Medicines to treat cancer, infections and disorders of the nervous system (epilepsy, Parkinson’s) account for more than half of those in short supply. This project has won several awards, including the “Business in Support of a Cause” given by the Federation Bulgarian Patient Forum. The European Union's healthcare regulator said that no drug shortages or supply disruptions have been reported in the region but that an EU steering group had convened to prevent supply bottlenecks due to the coronavirus outbreak. In this document you find our overview of all available official shortages lists from Member States. Problems caused by medicines shortages are serious, threaten patient care in hospitals and require urgent action. Direct access to language menu (press "Enter"), Direct access to search menu (press "Enter"), Medicine shortages in the EU: causes and solutions, Medicines to treat cancer, infections and disorders of the nervous system (epilepsy, Parkinson’s) account for more than half of those in short supply, The geopolitical dimension of medicine shortages, 80% of active pharmaceutical ingredients are sourced from India and China, 40% of finished medicines sold in Europe come from China and India, China and India produce 60% of the world’s paracetamol, 90% of its penicillin and 50% of its ibuprofen, European Medicines Agency: shortages catalogue, Press release: Commission calls on member states to optimise the supply and availability of medicines (8 April 2020), European University Hospital Alliance warned, resolution calling for the EU to become more self-sufficient in health issues, exchange best practices in stock management, increase joint EU procurement of medicines, facilitate the movement of medicines between EU member states. The EU is increasingly dependent on non-EU countries - mainly India and China - when it comes to the production of active pharmaceutical ingredients, chemical raw materials and medicines. Drug shortages are a complex issue, which cannot be attributed to a single factor or manufacturer. As an extra safeguard to ensure that parallel exports do not become a driver of shortages – 11 EU Member States have erected export restriction legislation. Decreased production, logistical problems, export bans and stockpiling due to the health crisis further increased the risk of bottlenecks. Affordable Medicines Europe (signing as EAEPC – former name) have worked intensively with stakeholders from the whole supply chain to identify possible root causes of shortages. However, short-term, parallel imports is the most efficient and readily available tool in the fight against shortages. Medicines Agencies across the EU confirm this finding in their official shortages’ lists (see above). These medicines are 100% safe, as parallel traders are subject to the same regulatory requirements as manufacturers of the branded or generic pharmaceuticals, and they have to undergo regular inspections by the competent authorities. In our policy section, you can read much more on how shortages can be mitigated in the medium- to long-term. Drugs in short supply often include sterile injectables and potentially life-saving oncology (cancer) treatments. In April 2020, the European University Hospital Alliance warned that rising demand in intensive care units for certain anaesthetics, antibiotics, muscle relaxants and medicines used in a way they were not originally approved for to treat Covid-19 could mean stocks run out. More than 50% As a consequence, the supply chain becomes very rigid and less reactive to fluctuations of the medicines demand, creating shortages when they occur. Copyright – AffordableMedicines- created by Adgrafics, Transparency Register Number: This is more and more common around Europe – especially for generics. Drug Shortages in Europe is a non-profit project created for hospital pharmacists and other healthcare workers. In the occurrence of a shortage or supply constraint, van den Hoven proposed that the EC should co-ordinate national strategies to reduce any impacts. Find out why there is a shortage of medicines, the impact of the coronavirus pandemic and how Parliament wants to improve the situation. An erroneous preconception must be dispelled: parallel trade does not bring medicines from poor countries to sell them in richer countries to the detriment of the former and the benefit of the latter. In addition to this, the concentration of the industries and the reduction of the costs might have had an effect on quality, as increasing recalls of medicines have provoked shortages. See more at www.accesstomedicine.eu and follow the campaign @FillTheGap_EU on Twitter. The EU’s health policy aims to foster good health, provide protection from health threats and harmonise strategies between member states. Medicines Agencies across the EU confirm this finding in their official shortages’ lists (see above). Furthermore, Affordable Medicines Europe monitor closely the development of shortages across the EU. Parallel traders’ capacity to repackage and relabel products, in addition with their knowledge of the different markets and distribution network, gives them the chance to swiftly introduce a medicine in the market with supply problems will full safety assurance for the patient. For 12 Member States the causes of shortages are indicated in the lists by the national medicine’s agencies/ministries of health. Quota systems. They are an acute threat to the correct functioning of health systems and to the wellbeing of patients in Europe.  Despite the efforts to secure access to medicines, shortages have multiplied their incidence in recent years. Below are the newest and most recently updated Shortage and Discontinuation reports. In the Single Market parallel traders can buy pharmaceuticals in any EU/EEA country, repackage them to comply with national legislation and linguistic needs, and sell them at a lower price than the standard local price, in competition with that same identical product sold by the manufacturer or its local licensee. The results have been published in this joint stakeholder paper. Parallel imports are original European supply sourced in another country of the EU/EEA and totally adapted to the destination market. The main causes of shortages worldwide are well-known. Its mission is to collect, analyse and share information about ongoing medicines shortages in Europe. In the resolution MEPs welcome the new EU health programme EU4Health aiming to make medicines and medical equipment more available and call for boosting pharmaceutical production in Europe and setting minimum quality standards for healthcare. National Drug Shortages: New Shortages by Year. Production and quality problems. The main causes globally are acknowledged to be fuelled by: Affordable Medicines Europe has initiated the campaign #FillTheGap. Furthermore, Affordable Medicines Europe monitor closely the development of shortages across the EU. One explanation for Europe’s rising shortages is that drugs and their ingredients are increasingly manufactured by only a handful of companies, mostly located in Asia. This creates sizable savings for public health insurance systems, pharmacies and, ultimately, patients. Medicine shortages, stockpile drugs and medical crisis as result of no deal brexit concept theme with doctor wearing latex gloves holding a … If European supply chains are disrupted, there could be shortages Several EU countries, including the UK, have imposed stockpiling policies due to Brexit concerns, and France and Germany are considering similar actions. There are direct and indirect savings. EU Prepares for Drug Shortages Due to COVID-19 Friday, March 13, 2020 As COVID-19 (coronavirus) disruptions delay drug and medical supply shipments from Asia, health-care officials in Europe are preparing to handle escalating drug shortages. Belgium Imposes Selective Export Ban As COVID-19 Threatens Stocks A shortage means, in respect of a drug, a situation in which the manufacturer to whom a document was issued under subsection C.01.014.2 (1) that sets out the drug identification number assigned for the drug is unable to meet the demand for the drug. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued guidance for pharmaceutical marketing authorisation holders (MAHs) and regulators to mitigate drug shortages in the EU.. Here you will find examples of solutions to shortages. Published 2013, 24 pages. This is possible because prices of individual drugs vary between Member States. Several initiatives have been undertaken by our members to help patients to get the medicines they need via parallel imports. Manufacturers decide to withdraw pharmaceutical products from the market because in certain conditions they are no longer profitable. In fact, more than 50% of the parallel imports are sourced in high income countries, and the distribution of the trade flows is fairly balanced between southern, northern and eastern countries of Europe. The Commission issued guidelines to tackle shortages due to the coronavirus outbreak in April. Our industry has the ability to mitigate shortages by bringing medicinal products that are suffering from problems of supply in one country from another market in which there is a surplus. The problems of supply of medicines represent a big concern for health authorities across the continent. Are suggestions of Brexit drug shortages over exaggerated? Whereas only the EU has parallel trade, also the US, Canada, Japan, and Australia face shortages. The reasons are complex, ranging from manufacturing problems, industry quotas, legal parallel trade and unexpected peaks in demand following epidemics or natural disasters to pricing, which is decided at national level. Both parallel importers and parallel exporters are committed to reduce the incidence of medicines shortages problem and improve the access to these key pharmaceuticals. Find out the latest news on the EU-coordinated response to the coronavirus outbreak and the European Parliament's actions. If the product has been withdrawn in Bulgaria, they will recommend the patient to go back to the doctor to ask for an alternative treatment and ask the authorities if an emergency parallel import can be arranged. National Drug Shortages: New Shortages by Year - Percent Injectable ASHP and its partners keep the … Past EAHP Medicines Shortages Reports have highlighted the increasing burden of medicines shortages in European hospitals. GIRP (the European Healthcare Distribution Association) have compiled the reasons given in an. The results have been published, For 12 Member States the causes of shortages are indicated in the lists by the national medicine’s agencies/ministries of health. Drug Shortages International By Thomas Sullivan Last updated May 6, 2018 The European Medicines Agency (EMA) recently released a proposal for how it can help mitigate potential and real drug shortages stemming from manufacturing problems, reported FiercePharmaManufacturing. He is especially concern… A number of European countries are experiencing shortages of the drug amid a surge of Covid-19 infections. This is particularly the case for patients taking medicines which have a significant clinical consequence when doses are missed, such as anti-psy… The documents released by the EMA explain to pharmaceutical industry stakeholders the actions they should undertake when faced with potential or expected … The savings stem from the price differences of manufacturers’ prices for the same medicine between countries of the EEA. Medicines shortages cause serious problems for patients, health professionals and health systems. “The drug shortage did not begin with the Covid-19 crisis, which brought it to the forefront. In this document you find our overview of all available official shortages lists from Member States. Combatting EU drug shortages New guidelines to be issued after EMA report Later this year, the European Medicines Agency (EMA) will issue new guidance, following a report on shortages (the EMA Report), to provide more transparency and to assist national agencies in dealing with this shortage of … Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on the European Union’s planned transition from the EU Clinical Trials Register to the EU portal and database system for the submission of clinical trial information. Drug shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors. Drug shortages can have a significant impact on patient care and public health. They are an acute threat to the correct functioning of health systems and to the wellbeing of patients in Europe.  Despite the efforts to secure access to medicines, shortages have multiplied their incidence in recent years. These are the main findings of a study based on extensive data provided by the members of Affordable Medicines Europe in 14 countries, that represent around 85% of the parallel import sales in the continent. The European Union is planning a sweeping change in its rules governing generic drugs, Reuters reports, a move that could cut into the bottom lines of global pharmaceutical firms. The EU and Drug Shortages By Patricia Van Arnum - DCAT Editorial Director The European Medicines Agency (EMA) has issued two guidance documents, respectively to pharmaceutical companies and national regulators in the European Union (EU), to develop and coordinate actions to better prevent, identify, manage, and communicate drug shortages. Between 2000 and 2018, shortages in the EU increased 20-fold and according to a note by the European Commission are rising for widely used essential products. European Medicines Agency (EMA) publishes information on specific medicine shortages that affect or are likely to affect more than one European Union (EU) Member State, where EMA has assessed the shortage and provided recommendations to … The Heads of Medicines Agencies have the task of informing the patients in cases of public concern or which affect the health care system. “It is true that medicines and the required raw materials are increasingly being produced outside of Europe. Affordable Medicines Europe are fully committed to ensure that parallel exports never cause a shortage and work proactively with the EU Commission and Member States to ensure this is the case. More than 50% Medicines to treat cancer, infections and disorders of the nervous system (epilepsy, Parkinson’s) account for more than half of those in short supply Medicines are not simple items of commerce, they are an essential component of patient care and in the hospital sector they must be administered to the patient in a timely manner. Parliament had already called for better traceability of research and development costs, public funding and market expenditure to make medicines more affordable in a resolution adopted in 2017. According to a senior official from the European Union (EU) Commission, the EU is assessing the delays. Moreover, the solution requires collaboration and joint action. In the EU, most medicine shortages are dealt with at national level by national competent authorities. The objective of parallel trade is to offer Europeans original supply of medicines at a lower price. 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