European Partnership for Pandemic Preparedness (Phase 2)

Key stakeholders, including relevant EU and national entities, the scientific communities, policymakers and funders enhance their collaboration and coordination to strengthen research on pandemic preparedness and response, forming a strong, structured and comprehensive ecosystem with shared evidence, tools and methodologies cutting across sectors. Research funders, policymakers, relevant EU and national entities, and the research community recognise and rapidly close relevant research and related infrastructure gaps and break existing silos on pandemic preparedness research and response, adopting a One Health approach. Healthcare authorities, regulatory authorities, policymakers and other stakeholders utilise research results to develop evidence-based strategies and policies for pandemic preparedness and response, and deploy good practices to European countries and regions, and beyond whenever relevant. The research community benefits from and uses an improved comprehensive knowledge framework integrating the EU, national/regional data and information infrastructures to improve transnational research in the area of pandemic preparedness and response. The EU is strengthened as an internationally recognised actor for pandemic preparedness research and response, as such substantially contributing to global cooperation and coordination. Scope: This topic targets an action under Article 24(2) HE Regulation aiming to add additional activities to existing grant agreements, together with additional partners (if relevant) that would deliver on those activities. The award of a grant to continue the partnership in accordance with this call should be based on a proposal submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2024-DISEASE-12-01: “European Partnership for Pandemic Preparedness” and the additional activities (which may include additional partners) to be funded by the grant, such as the close coordination with the Clinical Trial Coordination Mechanism (CT-CM) [1] , should be subject to an evaluation. The partnership should be firmly anchored within the framework of the European Health Union package [2] and ensure synergies with the European Health Emergency Preparedness and Response Authority (HERA) and other relevant Commission services. The partnership’s activities are expected to be key enablers of the EU Global Health Strategy [3] . Taking into account that the present action is a continuation of the topic HORIZON-HLTH-2024-DISEASE-12-01: “European Partnership for Pandemic Preparedness” and foresees an amendment to an existing grant agreement, the proposal should present the additional activities (including additional partners) to be covered by the award primarily in terms of grant agreement revisions. The existing action, the “Be Ready Now - European Partnership for Pandemic Preparedness” (BE READY NOW) can only reasonably be enhanced and enlarged on the basis of the existing consortium [4] , as the co-funded framework established cannot simply be replaced without significant disruption, given the top-quality, long-term expertise and wide coverage of the beneficiaries comprising this consortium. The partnership should contribute to the actions proposed in the Joint Communication on the European Preparedness Union Strategy (JOIN(2025) 130 final [5] ) which recognises the essential contribution of research and innovation to allow “continuously adapted, optimised and state-of-the-art responses to crisis”. It should also contribute to the “Strategy for European Life Sciences” [6] . Synergies with EU programmes such as EU4Health Programme (2021-2027) [7] or the Digital Europe Programme [8] are encouraged. The co-funded Partnership for Pandemic Preparedness should enable improved coordination and cooperation on national and European levels (and contributing globally), building on the Strategic Research and Innovation Agenda (SRIA) [9] established in the first phase of the partnership. The partnership’s implementation is grounded in coordinating and jointly funding transnational research, combined with a strong focus on integrative ‘in-house’ activities, ultimately reinforcing the readiness of Europe’s research ecosystem. As a continuation of an existing action, the proposal should present the additional activities (including additional partners) to be covered by the award primarily in terms of grant agreement revisions. The partnership should cover the full scope of preparedness research, ranging from basic and pre-clinical research, to clinical, public health, social sciences and implementation research. The partnership will consider the interplay between environmental, ecological and climatic factors and the emergence and spread of health threats and will adopt a One Health approach to better understand and mitigate the risks of emerging infectious diseases. Of particular interest is the consolidation and further development of the ever-warm clinical research network, comprising both observational and interventional studies, ensuring continuous clinical research activity across diverse sites, and with the in-built capacity to rapidly respond to public health emergencies. In this regard, the partnership should ensure that provisions are in place for the close coordination with the CT-CM, which i) should facilitate providing scientific advice on the clinical research needs in preparedness and response to public health emergencies, and ii) promote a coordinated approach to the national and EU funding of identified clinical research needs. The partnership should strengthen the European Research Area by supporting excellence in innovative research and capacity building, widening the engagement of countries not yet involved. As a demonstration of its added value, the partnership should be able to attract the engagement of a broad range of stakeholders beyond European health authorities and research funders, such as private and philanthropic actors and innovators. The participation of start-ups, micro, small and medium-sized enterprises (SMEs) [10] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation. The relevant European research infrastructures [11] in the area of health should be exploited for available services, expertise and digital tools for dataset creation, standardisation, data discovery, secure access, management, visualization, harmonization, analysis and other functions as appropriate. When defining calls for proposals in the context of jointly funded transnational research, the partnership should consider sex and identity-related differences. If relevant, it also needs to consider the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, to produce meaningful and significant effects enhancing the societal impact of the related research activities. The support and involvement of citizens and civil society should be considered. The partnership will consolidate a suitable health research data ecosystem aligned with the European Health Data Space (EHDS) [12] , and the European Open Science Cloud (EOSC) [13] supporting the harmonisation and standardisation as well as the federated access of FAIR [14] research data in the context of pandemic preparedness and response. The partnership’s work should comply with the appropriate ethical, regulatory and legal frameworks, and should ensure the timely translation of research outcomes into effective clinical and public health policy and innovation. null The total indicative budget for the topic is EUR 63 million committed in annual instalments over the two years, 2026 and 2027 (EUR 30 million from the 2026 budget and EUR 33 million from the 2027 budget). [1] https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupId=104872&fromMeetings=true&meetingId=59543 [2] https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-way-life/european-health-union/health-crisis-preparedness_en [3] EU Global Health Strategy: Better Health for All in a Changing World - European Commission: https://health.ec.europa.eu/publications/eu-global-health-strategy-better-health-all-changing-world_en [4] Consortium which was awarded the grant under topic HORIZON-HLTH-2024-DISEASE-12-01: “European Partnership for Pandemic Preparedness”. [5] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52025JC0130 [6] https://research-and-innovation.ec.europa.eu/strategy/strategy-research-and-innovation/jobs-and-economy/towards-strategy-european-life-sciences_en ; https://ec.europa.eu/commission/presscorner/detail/en/ip_25_1686 [7] https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en , https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R0522 [8] https://digital-strategy.ec.europa.eu/en/activities/digital-programme [9] https://beready4pandemics.eu/sria [10] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361 [11] The catalogue of European Strategy Forum on Research Infrastructures (ESFRI) research infrastructures portfolio can be browsed on the ESFRI website: https://ri-portfolio.esfri.eu [12] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en [13] https://research-and-innovation.ec.europa.eu/strategy/strategy-2020-2024/our-digital-future/open-science/european-open-science-cloud-eosc_en [14] See definition of FAIR data in the introduction to this Work Programme part.

Eligibility and submission conditions

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form available in the Submission System. 2. Eligible Countries Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide . 3. Other Eligibility Conditions The proposal must be submitted by the coordinator of the consortium funded under topic HORIZON-HLTH-2024-DISEASE-12-01: “European Partnership for Pandemic Preparedness”. This eligibility condition is without prejudice to the possibility to include additional partners. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. Because the US contribution will be considered for the calculation of the EU contribution to the partnership, the concerned consortium of research funders from eligible EU Members States and Associated Countries must expressly agree to this participation. Subject to restrictions for the protection of European communication networks. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. 4. Financial and operational capacity and exclusion Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 5a. Evaluation and award: Award criteria, scoring and thresholds The evaluation will take into account the existing context and the scope of the initial evaluation as relevant, and related obligations enshrined in the grant agreement. If the proposal is successful, the next stage of the procedure will be grant agreement amendment preparations. If the outcome of amendment preparations is an award decision, the coordinator of the consortium funded under topic HORIZON-HLTH-2024-DISEASE-12-01: “European Partnership for Pandemic Preparedness” will be invited to submit an amendment to the grant agreement, on behalf of the beneficiaries. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual . 5c. Evaluation and award: Indicative timeline for evaluation and grant agreement Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 6. Legal and financial set-up of the grants This action is intended to be implemented in the form of an amendment of the grant agreement concluded pursuant to Article 24(2) of the Horizon Europe Regulation. For the additional activities covered by this action: The funding rate is 50% of the eligible costs. This is justified by the pooling of proposers' in-kind contributions and in-house activities and by the nature of activities to be performed: in addition of joint calls, sustain and further develop the EU-wide networks and infrastructures for clinical research, and in particular a network of ever-warm clinical trial sites. Beneficiaries may provide financial support to third parties (FSTP). The support to third parties can only be provided in the form of grants. As a co-funded European Partnership, providing financial support to third parties is a core activity of this action in order to achieve its objectives. Consequently, the EUR 60 000 threshold laid down in Article 207 of Financial Regulation (EU, Euratom) 2024/2509 does not apply. The maximum amount of FSTP that may be awarded to any single third party for the duration of the partnership is set at EUR 3.00 million. This ceiling is justified by the fact that FSTP is a primary activity of this action, by its expected duration of 7-10 years (exceeding a standard project lifespan), and by the extensive experience gained under predecessor partnerships. This ceiling is also justified by the fact that the FSTP will support infectious diseases research involving multi-country research networks and infrastructures as well as their coordination. However, if the objectives of the action would otherwise be impossible or overly difficult (and duly justified in the proposal) the maximum amount may be higher. The starting date of the grant awarded under this topic may be as of the submission date of the application. Applicants must justify the need for a retroactive starting date in their application. Costs incurred from the starting date of the action may be considered eligible (and will be reflected in the entry into force date of the amendment to the grant agreement). The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and evaluation form templates Standard application form (HE COFUND top-up) - the application form specific to this call is available in the Submission System Standard evaluation form (HE COFUND) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreement (MGA) HE MGA Call-specific instructions Information on clinical studies (HE) Information on financial support to third parties (HE) Annual work programme (HE COFUND) Additional documents HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health HE Main Work Programme 2026-2027 – 15. General Annexes HE Programme Guide HE Framework Programme 2021/695 HE Specific Programme Decision 2021/764 EU Financial Regulation 2024/2509 Decision authorising the use of lump sum contributions under the Horizon Europe Programme Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement

Programme context

Topics under this destination are directed towards the Key Strategic Orientation 3 “ A more resilient, competitive, inclusive, and democratic Europe ” of Horizon Europe’s strategic plan 2025-2027 [1] . Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “ healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety ” . Communicable and non-communicable diseases pose a significant health, societal, and economic threat worldwide, causing premature deaths and disabilities. Despite being largely preventable, only 6% of healthcare budgets are spent on prevention [2] . To address this, there is an urgent need to develop new public health interventions, preventive, diagnostic, and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, considering sex/gender-related issues. To address these challenges, Research and Innovation will require international cooperation to leverage global expertise, access world-class research infrastructures and invest in priority needs, aligning with other funders of international cooperation in health Research and Innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases and respond to public health needs, including rare diseases and the global burden of non-communicable diseases. In this Work Programme part, Destination “ Tackling diseases and reducing disease burden ” will focus on major societal challenges linked to the Commission's Political Guidelines for 2024-2029 [3] , such as the fight against non-communicable and communicable diseases, mental health, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment, of Antimicrobial-Resistant (AMR) infections, coherent also with wider EU initiatives such as the European Medical Countermeasures Strategy [4] and the forthcoming Critical Medicines Act [5] . In particular, the topics under this destination will support activities aiming at: i) new treatment and disease management options to reduce burden on non-communicable diseases and long-term conditions after post-bacterial and post-viral infections; ii) improve and protect mental health of children and young adults; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) innovative therapies for AMR critical pathogens; and v) support to second phases of the co-funded European Partnership on Rare Diseases [6] and the co-funded European Partnership for Pandemic Preparedness [7] . To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities, such as participating in joint workshops, exchanging knowledge, developing and adopting best practices, or undertaking joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic, as well as between projects funded under different topics, Clusters, or Pillars of Horizon Europe. For example, synergies could be sought with projects funded under the European health research infrastructures (Pillar I of Horizon Europe), the EIC [8] strategic challenges on health (Pillar III of Horizon Europe), or with projects on themes that cut across the Clusters under Pillar II of Horizon Europe, such as health security/emergencies under Cluster “Civil Security for Society”, Artificial Intelligence (AI)-based tools and technologies under Cluster “Digital, Industry and Space”, or antimicrobial resistance under Cluster “Food, Bioeconomy, Natural Resources, Agriculture and Environment”. The Commission aims to foster synergies between Horizon Europe and other EU programmes. To this end, applicants are encouraged to explore the funding opportunities available through the EU4Health Programme (2021-2027) [9] , the EU's public health programme, as a means of capitalising on potential collaborations and maximising impact. Expected impacts : Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts: Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare. Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases [10] , [11] are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs) [12] . Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide [13] , [14] , [15] . Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies). Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme. The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers [16] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details. [1] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en [2] Preventive healthcare expenditure as a share of the current expenditure on healthcare: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png [3] https://commission.europa.eu/about/commission-2024-2029_en [4] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [5] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en [6] https://cordis.europa.eu/project/id/101156595 , https://erdera.org [7] https://cordis.europa.eu/project/id/101226682 , https://beready4pandemics.eu [8] https://eic.ec.europa.eu [9] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en [10] https://www.who.int/publications/i/item/9789241506236 [11] https://www.who.int/publications/m/item/implementation-roadmap-2023-2030-for-the-who-global-action-plan-for-the-prevention-and-control-of-ncds-2023-2030 [12] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death. [13] WHO global action plan on antimicrobial resistance, 2015 [14] EU One Health Action Plan against AMR, 2017 [15] https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies [16] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

Hivatkozott dokumentumok

Annex A Horizon Europe Programme Guide Online Manual Standard application form (HE COFUND top-up) Standard evaluation form (HE COFUND) HE MGA Information on clinical studies (HE) Information on financial support to third parties (HE) Annual work programme (HE COFUND) HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health Decision authorising the use of lump sum contributions under the Horizon Europe Programme Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions