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 | Strategy to support medical countermeasures against public health threats |
| Lead DG – responsible unit | DG HERA |
| Likely Type of initiative | Communication from the Commission to the European Parliament, the Council,  the European Economic and Social Committee and the Committee of the Regions |
| Indicative Timing | Q2 2025 |
| Additional Information | https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera\_en |
| 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 |
| President von der Leyen set out this initiative in her Political Guidelines for the European Commission 2024-2029 as one of the key initiatives for a more resilient and better prepared EU. The rapid evolution of security risks; the geopolitical landscape and its impact on global health initiatives; and recent health crises (such as the COVID-19 pandemic and the Mpox outbreaks), all demonstrate that the EU needs to reinforce its preparedness and response against public health threats. These include chemical, biological, radiological and nuclear (CBRN) threats – whatever their origin (natural, accidental or deliberate). Health threats are also being triggered by conflict, hybrid threats, humanitarian crises, climate change and extreme weather events. Strengthening the development and availability of crisis-relevant medical countermeasures (MCMs)  [1](#footnote3)  is critical for enhancing the EU’s preparedness and readiness.  Recent high-level reports from Sauli Niinistö and Mario Draghi contain recommendations to strengthen the EU’s crisis preparedness and competitiveness. This strategy will build on these recommendations and the future Preparedness Union Strategy. |
| Problem the initiative aims to tackle |
| The COVID-19 pandemic has shown how essential the development, manufacturing, procurement and equitable distribution of MCMs are to strengthening the EU’s ability to prevent, detect and rapidly respond to cross-border health emergencies. However, despite these trends, gaps remain in terms of availability of MCMs.  ·The research and innovation gap with global competitors is increasing, especially as regards the EU’s ability to bring research from laboratories to patients. The Life Sciences Strategy and other relevant initiatives will also aim at addressing this issue, but specific attention needs to be paid to the challenges in developing crisis-relevant technologies that are essential for our health preparedness and security.  ·The EU’s supply chains dependencies for crisis-relevant countermeasures and their components undermine the EU’s strategic autonomy and ability to withstand shocks. The strategy will also link with the Preparedness Union and Stockpiling Strategies.  ·Uncoordinated and fragmented actions – including lack of coordination across sectors (i.e. insufficient civil and military collaboration) and across regions – undermine access to MCMs and result in unequal access to MCMs and therefore unequal preparedness levels between different Member States. |
| Basis for EU action (legal basis and subsidiarity check) |
| Legal basis |
| Article 168 of the Treaty on the Functioning of the European Union sets out the basis for EU action in the area of public health, including the response to serious cross-border threats to health. The legal basis for EU-level actions in health emergency preparedness and response including in the area of MCMs, is provided by: Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision N 1082/2013/EU; Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority (HERA); Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level. |
| Practical need for EU action |
| The COVID-19 pandemic demonstrated the need to reinforce the EU’s health security framework and the added value of EU-level coordination to prepare and respond to serious cross-border health threats (including to ensure the development, manufacturing, procurement and distribution of MCMs).  Extreme weather events, threats of pandemic such as highly pathogenic avian influenza, antimicrobial resistance and CBRN incidents are concerns for all Member States. EU-level actions will strengthen the efficiency of preparedness and response measures across the EU.  Joined-up action between Member States and the Commission will have more impact and influence at the global, regional and national levels. It will provide opportunities to implement the health objectives of the Preparedness Union Strategy in the new era for European Defence and Security, as called for by the President and building upon the outcome of President Niinistö’s report on European Preparedness and Readiness. |
| B. What does the initiative aim to achieve and how |
| The strategy’s purpose is to fortify the EU’s health security; enhance the EU’s strategic autonomy in health; and contribute to reinforcing the competitiveness of strategic sectors for the EU economy and security. It will do so by providing a framework to strengthen equitable access to, and supply of, crisis-relevant MCMs; as well as by boosting the EU’s competitiveness and innovation in this field.  The strategy will consolidate the Commission’s work in that field over the past five years, leveraging the close work carried out with Member States and international partners. It will aim at bridging the gaps in the availability of MCMs to address current and future health threats. It will be based on HERA’s health threats prioritisation. It will identify actions to support and accelerate R&D for MCMs; strengthen their supply chains and production capacity; and ensure their availability and equitable access. The strategy will harness tools such as joint procurement, stockpiling and innovative financial instruments.  The strategy will cover MCMs such as medicines (i.e. vaccines, antimicrobials and antibodies); substances of human origin (blood products); medical devices (i.e. diagnostics and respirators); personal protective equipment; and other relevant goods or services that are necessary for preparing for and responding to serious cross-border threats to health. The strategy will propose a package of actions; set policy priorities and guiding principles to shape MCM preparedness; and identify concrete flagship initiatives and lines of action at the EU, national and international levels. Until 2027, to support actions on MCMs, the Commission will rely on the earmarked budget under the EU4Health, Horizon Europe and RescEU programmes and any other relevant instruments supporting MCMs’ development and availability.  To ensure coherence and consistency from a policy perspective, the strategy will build on the Preparedness Union Strategy and the Global Health Strategy. It could also draw on relevant parts of the European Life Sciences Strategy, the White Paper on European Defence and the Strategy on Internal Security. It will also ensure complementarities with the Critical Medicines Act, the EU Stockpiling Strategy and the Union Prevention Preparedness and Response Plan to be developed in 2025. It will take into account the findings of the HERA Review and the mid-term evaluation of the Regulation on serious cross-border threats to health. |
| Likely impacts |
| The likely impact of the strategy at EU-level is an increased coherence and complementarity of MCMs preparedness and response measures; as well as a stronger commitment to health emergency preparedness and response. The strategy should bridge the gaps in the availability of MCMs in order to strengthen citizens’ protection against cross-border threats.  It will contribute to the development of a strong Preparedness Union, strengthen the European Health Union and complement the Global Health Strategy – thus reinforcing the EU’s leadership in this area.  It will also contribute to boosting the EU’s competitiveness in life sciences; attracting investments and reinforcing the competitiveness of EU innovators and SMEs; and converting preparedness investments into growth opportunities within the EU and in partner countries, thus benefiting businesses and citizens. |
| Future monitoring |
| Monitoring of implementation will be ensured primarily through existing mechanisms, with no additional reporting from Member States and businesses. The Commission will formally update the Parliament and Council on the state of play of the strategy’s implementation by means of a mid-term review and a final review. It will also include exchanges with relevant Council working parties and relevant European Parliament Committees. Monitoring will also take place in the context of the monitoring of the EU Preparedness Union Strategy. |
| C. Better regulation |
| Impact assessment |
| The strategy will take the form of a Commission Communication. Therefore, it does not require a dedicated impact assessment. However, legislative or other proposals that are likely to have a significant impact and policy options that are announced in the Strategy should be accompanied by impact assessments where appropriate |
| Consultation strategy |
| The consultation comprises:  ·a call for evidence;  ·targeted stakeholder consultations (starting in April 2025).  The consultation will gather all relevant inputs particularly on the scope of the strategy; challenges and gaps identified; and possible instruments to address them. These inputs will be considered in order to lay a solid and evidence-based foundation for the strategy. In particular, the consultation will seek to obtain information on challenges faced in the development and supply of MCMs, including on:  -Types of MCMs and new emerging technologies relevant to facing health threats;  -Types of public and private support needed for the development of MCMs;  -Challenges in the supply and deployment of MCMs;  -Challenges in the innovation landscape of MCMs;  -Opportunities to strengthen development and access to MCMs, in preparedness and crisis times;  -Opportunities for cross-sectoral coordination and collaboration.    The consultation’s outcome will complement evidence from other reliable sources. Targeted consultations will also be organised with relevant stakeholders.  Response to the consultation can be made in all official EU languages. The consultation will be promoted via press releases, webpages, social media, etc. A summary of the consultation activities will be published on the ‘Have Your Say’ portal. The Communication will report on the results of the consultation. |

:   [(1)](#footnoteref3)
     Medical countermeasures are products used in response to a public health emergency. They include medicinal products for human use as defined in Directive 2001/83/EC of the European Parliament and of the Council; medical devices as defined in point 12 of Article 3 of Regulation 2022/2371; and other goods or services that are necessary for the purpose of preparedness for and response to serious cross-border threats to health.

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