Modernising the EU pharmaceutical legislationAffordable, accessible, and innovative medicines Access to medicine varies across Europe. Some Europeans have to wait for 4 months on average to find for a medicine in their nearest pharmacy, while others have to wait more than 2 years for the same medicine. There is also growing concern about possible shortages of medicines, such as antibiotics and painkillers.In 2023, the Commission has presented the largest reform of the EU’s pharmaceutical sector in over 20 years. It aims at modernising the pharmaceutical sector with a patient-centred approach, that also fully supports an innovative and competitive industry. It will make this sector more agile, flexible, and adapted to the needs of the 21st century, while preserving the EU's high standards for the authorisation of safe, effective, and quality medicines.Since then, the Commission has published a list of critical medicines, that helps to identify and monitor critical medicines, and a Communication on addressing medicine shortages in the EU.To complement these measures, the Commission proposed the Critical Medicines Act in March 2025. It aims to enhance manufacturing capabilities within the EU. It provides measures to address supply chain vulnerabilities for critical medicines and reduce dependency on single suppliers and third countries. It also proposes measures to address market failures, whereby certain EU countries do not have access to medicines of common interest. What will the pharmaceutical sector reform change? Single Marketcreating a Single Market for medicinesRegulatory frameworkreducing the administrative burden for medicines to reach patients fasterMedicines for allensuring better access to affordable medicinesMedicine supplyaddressing shortages of medicines and ensuring security of supplyInnovationpromoting innovation and competitivenessEnvironmentally friendlymaking medicines more environmentally sustainable Saving livestackling antimicrobial resistance (AMR)Transparencyinforming better about public funding used to develop medicines Putting patients at the centre ©mixettoAll patients should have the same access to medicine in Europe. Medicine should reach patients when they need it, and all Member States should receive the medicine at the same time. This legislative proposal aims to give a better access to effective and affordable medicines to all. In practice, this means making sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines. To this end, new incentives encourage companies to make their medicines available to patients in all EU countries, while EU legislation on medicines for children and rare diseases will also be revised.Putting patients first also means enhancing security of supply and ensuring medicines are always available to patients, regardless of where they live in the EU. How will I benefit from a patient-centred approach? Better access to effective and affordable medicines Reduced shortages and increased availability of medicines Earlier market entry of biosimilar medicines to reduce medicine pricesMore medicines for children and rare diseases Increased representations of patients in the approval of medicinesEasier access to product information More environmentally sustainable medicines Reducing the of shortages of critical medicines In 2023, the Commission took steps to prevent and reduce critical shortages of medicines in the EU. Recent critical medicine shortages, including of certain antibiotics, show that continued coordinated action is needed to address supply challenges and to make Europe’s medicine supply chains more resilient in the long run.Actions to address medicine shortages in the EU are structured around three pillars:immediate and short-term actions to mitigate critical shortagesstructural measures to support long-term security of supplyinternational partnerships for supplyShort-term actionsThe Commission launched a European Voluntary Solidarity Mechanism for medicines in October 2023. This allows EU countries to flag their needs for a given medicine to other Member States, that can respond by indicating the medicines available for redistribution. To help identify medicines which are critical for the proper functioning of our healthcare systems, the European Medicines Agency (EMA) and all EU countries developed and published in December 2023 the first Union list of Critical Medicines. Lastly updated in 2024, it contains over 270 active substances, covering treatments for illnesses such as infections, cardiovascular diseases, mental health conditions and cancer.Supporting long-term security of supplyTo encourage production of more diverse critical medicines, the Commission set up a Critical Medicines Alliance in April 2024. This Alliance allows national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at EU level against long-standing shortages of medicines and to address supply chain vulnerabilities. It focuses on medicines with the highest risk of shortages and whose shortages have the highest impact on healthcare systems and patients. Over 300 stakeholders took part in the process, which resulted in a series of recommendations published in February 2025.Building on the recommendations of the Critical Medicines Alliance and other consultation activities, the Commission presented in March 2025 the Critical Medicines Act, a regulation to support manufacturing and improving the availability of critical medicines in the EU.Te key elements of the Critical Medicines Act include:Increase and modernisation of manufacturing capacity for critical medicines or their ingredients in the EU, through strategic projectsPublic procurement to encourage reliable supply chains of critical medicines and improve access to other medicines in the EUSupporting collaborative procurement among EU countries to reduce disparities throughout the EUExploring international partnerships to broaden supply chains and reduce dependencies on single suppliers Driving innovation for a competitive pharmaceutical industry European Union/Getty ImagesThe EU aims to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe. The EU will create this environment by promoting world-class innovation, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs.It will seek to ensure faster authorisation of innovative medicines by implementing simpler rules and procedures and through more patient involvement in the medicines assessment processes without compromising safety.And in terms of research and development in unmet medical needs, innovation which benefits patients will be rewarded through a globally-competitive incentives system. To establish this system, the Commission proposed a directive outlining the requirements for authorisation, monitoring, labelling, regulatory protection, market placement, and other procedures for all medicines authorised at both EU and national levels, while also harmonising the authorisation rules across the EU.How will a competitive pharmaceutical sector be achieved? Promoting world-class innovation Reducing administration and speeding up authorisation of innovative medicines Incentivising research and development Tackling antimicrobial resistance Tackling antimicrobial resistance Antimicrobials are medicines used to prevent and treat infections in humans, animals and plants. Antimicrobial resistance (AMR) occurs when microbes stop responding to medicines designed to kill them and is caused by overuse or misuse of antimicrobials such as antibiotics.A silent pandemic When you consider that, without action, the death toll from AMR could rise to as many as 10 million deaths globally per year by 2050, it is clear why tackling it is a key focus of the proposal. Between 2016 and 2020 the number of infections and deaths due to AMR in in the EU/EEA increased significantly. It causes 35,000 deaths every year in the EU and leads to high costs, including €1.5 billion annually for our healthcare systems.The European Commission put forward a Recommendation on stepping up EU actions to combat AMR to provide solutions for human, animal, and environmental health. The Council adopted the proposed Recommendation on 13 June 2023. The Recommendation addresses the following:1. Marketing authorisation and surveillance of antimicrobialsMarketing authorisation of antimicrobials to include prudent use measuresAdditional surveillance and monitoring of the consumption of antimicrobials, better infection prevention and control; more awareness of the public, education and training of professionals.2. Prudent use of antimicrobialsOnly half of EU citizens are aware that antibiotics are ineffective against viruses. The overuse and misuse of antimicrobials such as antibiotics means AMR is increasing.The Recommendation advocates for a more prudent use of antimicrobials setting itself a target for reduced use of antibiotics and is recommending Member States set corresponding national targets:- 20% in consumption of antibiotics in the EU by 2030recommend national-level targets in addition3. Ensuring the availability of antibioticsPrudent use of antibiotics is essential to tackle AMR, but this also affects sales volumes and return on investment for medicine developers.We therefore need to encourage the development of innovative antimicrobials and to ensure access to and availability of antimicrobials.The Recommendation foresees procurement mechanisms to provide access to antimicrobials, including those under development.In addition, the Commission proposed, as part of the pharmaceutical legislation reform, a transferable data exclusivity voucher giving developers of new antimicrobials an extra year of market protection, making it more attractive to develop innovative antimicrobials without direct financial contributions from Member States.4. Fighting AMR globallyAMR cannot be tackled by one sector, one country or one continent in isolation. This means:Keeping AMR at the centre of the EU’s Global Health StrategyPushing for more global cooperation for example by addressing AMR in a potential WHO international agreement on pandemic prevention, preparedness and response. Documents 22 MAY 2024Factsheet Pharma - Putting patients in the centre Related links Reform of the EU pharmaceutical legislation, including documentsPharmaceutical Strategy for EuropeEU Action on Antimicrobial ResistanceEuropean Centre for Disease Prevention and ControlEuropean Medicines AgencyEuropean Critical Medicines Alliance
Access to medicine varies across Europe. Some Europeans have to wait for 4 months on average to find for a medicine in their nearest pharmacy, while others have to wait more than 2 years for the same medicine. There is also growing concern about possible shortages of medicines, such as antibiotics and painkillers.In 2023, the Commission has presented the largest reform of the EU’s pharmaceutical sector in over 20 years. It aims at modernising the pharmaceutical sector with a patient-centred approach, that also fully supports an innovative and competitive industry. It will make this sector more agile, flexible, and adapted to the needs of the 21st century, while preserving the EU's high standards for the authorisation of safe, effective, and quality medicines.Since then, the Commission has published a list of critical medicines, that helps to identify and monitor critical medicines, and a Communication on addressing medicine shortages in the EU.To complement these measures, the Commission proposed the Critical Medicines Act in March 2025. It aims to enhance manufacturing capabilities within the EU. It provides measures to address supply chain vulnerabilities for critical medicines and reduce dependency on single suppliers and third countries. It also proposes measures to address market failures, whereby certain EU countries do not have access to medicines of common interest.
©mixettoAll patients should have the same access to medicine in Europe. Medicine should reach patients when they need it, and all Member States should receive the medicine at the same time. This legislative proposal aims to give a better access to effective and affordable medicines to all. In practice, this means making sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines. To this end, new incentives encourage companies to make their medicines available to patients in all EU countries, while EU legislation on medicines for children and rare diseases will also be revised.Putting patients first also means enhancing security of supply and ensuring medicines are always available to patients, regardless of where they live in the EU.
European Union/Getty ImagesThe EU aims to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe. The EU will create this environment by promoting world-class innovation, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs.It will seek to ensure faster authorisation of innovative medicines by implementing simpler rules and procedures and through more patient involvement in the medicines assessment processes without compromising safety.And in terms of research and development in unmet medical needs, innovation which benefits patients will be rewarded through a globally-competitive incentives system.
When you consider that, without action, the death toll from AMR could rise to as many as 10 million deaths globally per year by 2050, it is clear why tackling it is a key focus of the proposal. Between 2016 and 2020 the number of infections and deaths due to AMR in in the EU/EEA increased significantly. It causes 35,000 deaths every year in the EU and leads to high costs, including €1.5 billion annually for our healthcare systems.The European Commission put forward a Recommendation on stepping up EU actions to combat AMR to provide solutions for human, animal, and environmental health. The Council adopted the proposed Recommendation on 13 June 2023.
