Source: EURLEX
Language: en
Format: md

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| CALL FOR EVIDENCE  FOR AN INITIATIVE (without an impact assessment) | |
| This document aims to inform the public and stakeholders about the Commission’s work, so they can provide feedback and participate effectively in consultation activities.  We ask these groups to provide views on the Commission’s understanding of the problem and possible solutions, and to give us any relevant information they may have. | |
| Title of the initiative | Proposal for a Critical Medicines Act |
| Lead DG – responsible unit | DG SANTE – Unit D.2 (Medical Products: Quality, Safety, Innovation) |
| Likely Type of initiative | Proposal for a Regulation |
| Indicative Timing | Q1-2025 |
| Additional Information | - |
| This document is for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described by this document, including its timing, are subject to change. | |

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| A. Political context, problem definition and subsidiarity check |
| Political context |
| The European Union has been facing an increasing number of medicine shortages, posing a significant risk to public health and patient care across Member States. This is in particular true for critical medicines, where limited or no alternatives exist, and where insufficient supply could result in serious harm or risk of harm to patients. Recent global events such as the COVID-19 pandemic and Russia’s military aggression against Ukraine have further exposed vulnerabilities in pharmaceutical supply chains. Shortages of critical medicines threaten public health, disrupt healthcare systems and can reduce trust in healthcare across EU Member States.  In response, Member States, the European Parliament and other stakeholders have consistently called on the European Commission to address these vulnerabilities, including by strengthening the supply chains for these critical medicines. Some of the actions already taken include:  ·the Structured Dialogue on the security of medicines supply;   ·the extended mandate of the European Medicines Agency (EMA) so as to establish a framework to address the issue of shortages during and before public health emergencies and major events;   ·the proposed reform of the EU pharmaceutical legislation;  ·the adoption of a Communication on addressing medicine shortages in the EU;   ·the publication of a Union List of Critical Medicines (‘the List’); and  ·the establishment and work of the Critical Medicines Alliance. |
| Problem the initiative aims to tackle |
| The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems to industry’s competitiveness. In particular, shortages of medicines can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components.  A supply chain vulnerability may exist when there is a dependency on a supplier that is the only source of that raw material, intermediate or active pharmaceutical ingredient (API) globally. A vulnerability could also exist when there is dependency on a number of suppliers located in only one geographical location.  In 2023, the European Commission, the EMA and Member States’ Heads of Medicines Agencies published a first Union List of Critical Medicines. This list was updated in December 2024 and includes over 270 active substances. It covers treatments for various illnesses such as infections, heart disease, mental health conditions and cancer. Most of these critical medicines are ‘off-patent’, i.e. they are medicines no longer covered by intellectual property rights or other regulatory data protection.  Even for off-patent medicines, it can happen that only one or two manufacturers supply the EU market. Suppliers often operate in a highly competitive environment, where procurements may focus on the lowest price as the main criterion. In that context, companies have moved production or outsourced the supply of key ingredients to outside the EU. As a result, the EU has become increasingly dependent on a limited number of suppliers or manufacturers for many critical medicines, with many being located outside the EU, especially in Asia.  This heavy reliance on a handful of suppliers and production sites has made the supply chains for critical medicines particularly vulnerable to increases in demand, market withdrawals by suppliers, manufacturing and quality problems, or disruptions of supply from specific regions or countries.  Furthermore, for certain critical medicines and other medicines of common interest, access can vary considerably from Member State to Member States. Due to various factors, including the size of the markets, companies market medicines differently across Europe. As a result, patients across the EU may not have equal access to the medicines they need. |
| Basis for EU action (legal basis and subsidiarity check) |
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| Legal basis |
| The proposal is expected to be based on Articles 114(1) and 168(4), point (c), of the Treaty on the Functioning of the European Union (TFEU). This ensures a comprehensive approach that addresses both the internal market and public health aspects of the initiative. Article 114(1) TFEU serves as the legal basis for measures aiming to ensure the establishment and functioning of the internal market. Article 168(4), point (c) TFEU enables the EU to adopt measures to ensure high standards of quality and safety for medicinal products. Finally, the expected choice of the legal basis is consistent with the legal basis of existing EU pharmaceutical legislation. |
| Practical need for EU action |
| Medicine shortages have hit every Member State in the EU over the last decade. While an individual Member State can act to improve its supply of certain medicines, these efforts are fragmented and insufficient to address the broader, cross-border supply chain problems, including dependency on certain non-EU countries. To address these challenges and to achieve a secure and reliable supply of critical medicines, a common effort at EU level is needed through this new initiative, i.e. the proposed act. |
| B. What does the initiative aim to achieve and how |
| The initiative will cover critical medicines. These are medicines for which insufficient supply results in serious harm, or risk of serious harm, to patients. In addition, certain measures will also apply to other medicinal products of common interest, where the functioning of the market does not sufficiently ensure that these products are available and accessible to patients in the different Member States.  The main goal of the act will be to support the security of supply and the availability of critical medicinal products, and to support the availability and accessibility of other medicinal products of common interest. To achieve this objective, the act will propose measures to:  1)facilitate investments to diversify manufacturing capacities for critical medicinal products, in particular investments addressing a supply chain vulnerability;   2)lower the risk of supply disruptions by incentivising and rewarding the resilience of the supply chains in public procurements of critical medicines;   3)leverage the aggregated demand of the interested Member States through collaborative procurement of critical medicines and certain other medicines of common interest.  The measures that will be proposed in the act will further address the specific concerns related to critical medicines. This will complement the proposed revision of the rules on pharmaceuticals under the EU Pharma Package.  The proposed act would aim to create a more favourable framework for establishing or expanding manufacturing facilities of critical medicines in the EU. One way of achieving this is to identify strategic projects which may benefit from faster administrative procedures, regulatory and scientific support, and access to financial support, thus improving the supply resilience of critical medicines.  The proposed act would also introduce measures that incentivise the use of criteria other than the lowest price when purchasing critical medicines. This could include criteria related to security and diversity of supply. |
| Likely impacts |
| The proposed act is expected to strengthen the resilience of the EU's medicines supply chains, contributing to improved security of supply. It should also reduce shortages of critical medicines and enhance public health and trust. Economically, the proposal is expected to strengthen the manufacturing base of critical medicines and make the pharmaceutical sector more competitive, including through diversification. On a social level, the proposed act should improve access to critical medicines and certain other medicines for EU patients. These outcomes will directly contribute to achieving Sustainable Development Goal (SDG) 3, ‘Good health and well-being’. Besides the public health-related benefits, the proposal is expected to mostly affect the pharmaceutical industry involved in the supply of critical medicinal products, as the industry may benefit from administrative and regulatory support and access to funding for certain strategic projects. In addition, the proposed act will likely affect national administrative authorities and procurers active in the public procurement of critical medicines. |
| Future monitoring |
| Implementation of the proposed act will be monitored using key indicators that relate to the vulnerabilities of the critical medicines supply chain. These include: how often and how long shortages of critical medicines happen, changes in practices for the public procurement of medicines, and an increase in EU-based production of critical medicines and their components. Data collection and analysis are expected to be carried out, with the support of Member States and the EMA, to monitor the availability and analyse the vulnerability of medicines on the Union Critical Medicines List. The Commission will also consider input from stakeholders, including industry representatives, healthcare organisations and patient groups. |
| C. Better regulation |
| Impact assessment |
| As there is pressing urgency to address the policy problem identified, the act will be adopted without an impact assessment. A staff working document will be published within three months of the proposal’s adoption and will provide the evidence and analysis on the act’s expected impacts. The analysis will be supported by an external contractor study, which includes targeted consultations with various stakeholders.  Extensive evidence and stakeholder input on medicine shortages have been gathered in recent years.  The consultation on the revision of the pharmaceutical legislation showed that stakeholders, especially civil society and healthcare professionals, view shortages as a major issue and feel that current laws have been shown to be ineffective. During that consultation, positive feedback was given on proposed measures like shortage prevention and monitoring systems.  The Study on best practices in the public procurement of medicines, published in 2022, demonstrated that public procurement can be a useful tool to support the security of supply of medicines.  In October 2022, the Commission published a report on vulnerabilities in global medicine supply chains. The report was based on the Structured Dialogue on medicine supply security with various stakeholders, including public authorities, NGOs and researchers.  In 2024, the Critical Medicines Alliance was established, bringing together Member States, civil society and patients, the pharmaceutical industry, and healthcare payers. In February 2025, the Alliance will publish strategic recommendations to address vulnerabilities in the manufacturing of critical medicines. These recommendations will inform the development of the Critical Medicines Act.  Together with the ongoing preparatory study, the feedback on this call for evidence will help to shape effective and well-informed policy measures for the act. |
| Consultation strategy |
| This call for evidence will run for four weeks. Its goal is to gather insights and input from a diverse group of stakeholders to support the development of the proposed act. By incorporating feedback from a broad range of perspectives and expertise, this consultation will help draft effective and well-informed policy measures for the act.  The main stakeholders identified include:  ·EU Member States and EEA countries (national ministries, authorities responsible for public health and healthcare/pharmaceuticals/industrial policy);  ·civil society and patient organisations with a focus on access to medicines;  ·businesses and trade associations operating in the EU, particularly in the pharmaceutical sector;  ·healthcare professionals and their associations;  ·public procurers active in the health sector, hospitals, central purchasing bodies;  ·the general public, including EU citizens, patients and consumers;  ·academic and research institutions involved in medicines;  ·international organisations and associations working in the field of medicines and industrial policy;  ·non-EU/EEA countries.    The feedback given in response to this call for evidence will be considered during the preparation and negotiation of the proposed act, along with the results of previous consultations. A summary report covering the input received in this call for evidence will be included in the act’s explanatory memorandum and in the staff working document that will be published within three months after the proposal’s adoption. |

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