Innovative healthcare interventions for non-communicable diseases

Scientific and clinical communities can use innovative healthcare interventions to generate meaningful advances in clinical practice and care for patients with NCDs following validation in late-stage clinical trials. Scientific and clinical communities make wide use of relevant databases and/or integrate them with existing infrastructures for storage and sharing of collected data according to FAIR [1] principles, thereby encouraging further use of the data. Policymakers, scientific and clinical communities, developers, patient organisations, regulators, and other relevant bodies are informed of the research advances made and the requirements for a widespread implementation of the innovative therapeutic interventions and complementary approaches. Patients and caregivers are constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefitting from the interventions. Scope: NCDs represent over 80% of the disease burden in Europe and the leading cause of avoidable premature deaths. Innovative and effective healthcare interventions are required to provide treatment and disease management solutions and assure best quality of care for patients suffering from NCDs when prevention strategies have failed. Proposals should address all the following aspects: Perform rigorous early stage [2] clinical trial(s) to validate novel or refined healthcare interventions [3] for treatment and/or disease management solutions for patients suffering from the following specific NCDs: cardiovascular diseases, diabetes, chronic respiratory diseases or chronic kidney diseases [4] . Whenever relevant, existing co- and multimorbidities should be addressed in the trial design. Clinical trial(s) should be supported by completed proof-of-concept [5] of clinical safety and efficacy. Both preclinical research and the draft clinical trial protocol should be completed at the time of submission of the proposal. Proposals should also demonstrate evidence of preliminary consultations with ethics and regulatory authorities at the time of submission. A sound feasibility assessment, including an appropriate patient selection and realistic recruitment plans, justified by publications or preliminary results should be provided. Take into account sex and gender differences in all relevant aspects throughout the research process, and consider stratification criteria such as age, disability, racial or ethnic origin [6] , socio-economic status, genetic and epigenetic variations, etc., where relevant. Use and/or develop technologies, including digital ones (e.g. (generative) Artificial Intelligence, wearable technologies) to help implement and monitor the long-term efficacy of the intervention(s), as well as manage the disease and/or monitor their progression (e.g. with unobtrusive technologies suitable for patient monitoring at home and in real-world conditions), whilst also ensuring they are bias-free, inclusive, and ethically sound. Hardware and software should be interoperable in line with internationally accepted standards [7] . The use of virtual human twins [8] could also be considered, where relevant. Exploit existing data, health data infrastructures [9] , biobanks, registries and/or cohorts, together with the generation of new data that should be managed in line with the FAIR principles and contribute to emerging research infrastructures established in the framework of the European Health Data Space (EHDS) [10] , when relevant. Advance research by leveraging already existing and emerging state-of-the-art research infrastructures as well as results stemming from EU-supported research projects, where applicable. Engage all relevant stakeholders (especially patients and patients’ representatives, caregivers, clinicians, counsellors, regulators, etc.) to design end-user optimised interventions. Engage with national public health authorities and regulators to ensure a robust development pathway and further uptake of the intervention. Present a thorough health-economic assessment and Real-World Data (RWD) [11] analysis to enhance sustainability and scalability of novel interventions. The participation of start-ups, micro, small and medium-sized enterprises (SMEs) [12] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation. This topic requires 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, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities. All projects funded under this topic are encouraged to participate in networking and joint activities, as appropriate [13] and explore potential synergies with projects funded under the EU4Health Programme (2021-2027) [14] in the area of NCDs. Applicants invited to the second stage should provide details of their clinical studies [15] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged. [1] See definition of FAIR data in the introduction to this Work Programme part. [2] For pharmacological interventions: phase 1 and/or phase 2 clinical trials. [3] Applicants may address any mono- or combinatorial pharmacological and/or non-pharmacological interventions. [4] Other diseases are not within the scope of this topic. [5] Comparative effectiveness studies are not within the scope of this topic. [6] The use of the term ‘racial or ethnic origin’ does not imply an acceptance of theories that attempt to determine the existence of separate human races. [7] For digital technologies concerned, appropriate measures for the security of the communications between the intended parties should be considered, in particular based on the use of post-quantum cryptography. [8] https://digital-strategy.ec.europa.eu/en/policies/virtual-human-twins [9] For instance BBMRI, ELIXIR, EU-OPENSCREEN, ECRIN, EATRIS, etc. [10] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en [11] EMA definition: “Real-World Data are routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials (e.g. claims databases, hospital data, electronic health records, registries, mhealth data, etc.)”. [12] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361 [13] Proposals should include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. [14] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en [15] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.

Eligibility and submission conditions

"> General conditions 1. Admissibility Conditions, proposal page limit and layout Applicants submitting a proposal for a blind evaluation (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E). 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 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. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). 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 first-stage proposals of this topic will be evaluated blindly. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. 5b. Evaluation and award: Submission and evaluation processes For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget, and not less than two and a half times the available budget. For the second stage, 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 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. Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [This [decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf ]]. 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 RIA IA Stage 1 BLIND) - the application form specific to this call is available in the Submission System Standard application form (HE RIA, IA) - the application form specific to this call is available in the Submission System Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) - will be used with the necessary adaptations Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations Guidance HE Programme Guide Model Grant Agreement (MGA) Lump Sum MGA Call-specific instructions Information on clinical studies (HE) Detailed budget table (HE LS)   Guidance: "Lump sums - what do I need to know?" 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 [This [decision Standard application form (HE RIA IA Stage 1 BLIND) Standard application form (HE RIA, IA) Standard evaluation form (HE RIA, IA and CSA Stage 1 BLIND) Standard evaluation form (HE RIA, IA) Lump Sum MGA Information on clinical studies (HE) Detailed budget table (HE LS) Guidance: "Lump sums - what do I need to know?" HE Main Work Programme 2026-2027 – 1. General Introduction HE Main Work Programme 2026-2027 – 4. Health Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Terms and Conditions