Innovative healthcare interventions for non-communicable diseases

The call for proposals HORIZON-HLTH-2027-02-DISEASE-01-two-stage is part of the Horizon Europe program aimed at funding innovative healthcare interventions for non-communicable diseases (NCDs) such as cardiovascular diseases, diabetes, chronic respiratory diseases, and chronic kidney diseases. The total budget for this topic is €63.8 million, with the expectation of funding approximately eight grants ranging from €7 million to €8 million each.

The submission process consists of two stages. The first stage begins on February 10, 2027, with a deadline of April 13, 2027, where proposals will be submitted with a blind evaluation focused on excellence and impact. The second stage requires a full proposal from selected candidates by September 22, 2027, evaluated on excellence, impact, and implementation.

Eligible applicants include a broad range of entities such as research institutions, universities, healthcare providers, SMEs, and patient organizations. The call encourages consortium formation, emphasizing the need for multi-disciplinary collaborations that include clinical trial coordinators, pharmaceutical developers, academic researchers, and patient representatives.

Geographically, the opportunity is open to entities in EU member states, EEA countries, associated countries, and legally established organizations in the United States. Eligibility for support is extended to other countries that have made specific provisions for funding under Horizon Europe.

The call highlights the importance of using digital technologies, ensuring FAIR data principles, and engaging patient and caregiver perspectives to enhance healthcare interventions. Successful proposals should include thorough evaluations of clinical protocols already developed and must engage with ethical and regulatory authorities.

The application logistics employ a two-stage blind evaluation process designed to filter the strongest proposals while alleviating the administrative burden for those not selected in the first stage. The funding mechanics are structured as lump-sum grants, allowing for budgetary flexibility.

In summary, this initiative aims to address the significant burden of NCDs in Europe through innovative, evidence-based healthcare interventions, leveraging collaborations across various sectors and ensuring wide-scale implementation that meets patient needs and societal impacts. The emphasis on integrating technology and careful consideration of gender and other diverse factors positions this call as a comprehensive approach to improving health outcomes for patients suffering from NCDs.

This is a Horizon Europe (HORIZON) call, specifically Cluster 1 Health (Two stage 2027) (HORIZON HLTH 2027 02 two stage). The call is for HORIZON RIA HORIZON Research and Innovation Actions. The Model Grant Agreement is a HORIZON Lump Sum Grant [HORIZON AG LS]. It is a forthcoming call with a two stage deadline model. The planned opening date is 10 February 2027. The deadline dates are 13 April 2027 17:00:00 Brussels time and 22 September 2027 17:00:00 Brussels time.

The topic is Innovative healthcare interventions for non communicable diseases HORIZON HLTH 2027 02 DISEASE 01 two stage. The expected outcome of this topic is to support activities that enable or contribute to several expected impacts of destination “Tackling diseases and reducing disease burden”. Proposals should aim to deliver results directed at, tailored towards, and contributing to the following expected outcomes: Researchers, developers, and clinical practitioners having access to state of the art knowledge, data, technologies, tools, methods, best practices, and training to develop innovative healthcare interventions aimed at reducing the burden of specific Non Communicable Diseases (NCDs) such as cardiovascular diseases, diabetes, chronic respiratory diseases, or chronic kidney diseases. Scientific and clinical communities using 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 making wide use of relevant databases and/or integrating them with existing infrastructures for storage and sharing of collected data according to FAIR principles, thereby encouraging further use of the data. Policymakers, scientific and clinical communities, developers, patient organizations, regulators, and other relevant bodies being informed of the research advances made and the requirements for widespread implementation of innovative therapeutic interventions and complementary approaches. Patients and caregivers being constructively engaged with the research, ensuring that their needs are catered for, with the aim of tangibly benefiting from the interventions.

The scope of this topic is that NCDs represent over 80% of the disease burden in Europe and are the leading cause of avoidable premature deaths. Innovative and effective healthcare interventions are required to provide treatment and disease management solutions and assure the 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 clinical trial(s) to validate novel or refined healthcare interventions for treatment and/or disease management solutions for patients suffering from specific NCDs such as cardiovascular diseases, diabetes, chronic respiratory diseases, or chronic kidney diseases. Existing co and multimorbidities should be addressed in the trial design. Clinical trial(s) should be supported by completed proof of concept 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 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, 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. The use of virtual human twins could also be considered, where relevant. Exploit existing data, health data infrastructures, 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), 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, counselors, regulators, etc.) to design end user optimized 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) analysis to enhance sustainability and scalability of novel interventions. The participation of start ups, micro, small and medium sized enterprises (SMEs) 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 and explore potential synergies with projects funded under the EU4Health Programme (2021 2027) in the area of NCDs. Applicants invited to the second stage should provide details of their clinical studies 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.

The admissibility conditions, proposal page limit and layout are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form available in the Submission System. Applicants submitting a proposal for a blind evaluation must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first stage application. 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. 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. There are subject to restrictions for the protection of European communication networks. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. 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. 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. The indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. 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). Legal and financial set up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

The application and evaluation form templates include the Standard application form (HE RIA IA Stage 1 BLIND) and the Standard application form (HE RIA, IA), both available in the Submission System. The Standard evaluation forms (HE RIA, IA and CSA Stage 1 BLIND) and (HE RIA, IA) will be used with the necessary adaptations. Guidance documents include the HE Programme Guide, Model Grant Agreement (MGA), Lump Sum MGA, Call specific instructions, Information on clinical studies (HE), Detailed budget table (HE LS), and Guidance: "Lump sums what do I need to know?". Additional documents include the 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, and Funding & Tenders Portal Privacy Statement.

The budget overview for the year 2027 includes the following topics: HORIZON HLTH 2027 02 DISEASE 01 two stage HORIZON RIA HORIZON Research and Innovation Actions with a budget of EUR 63,800,000, a two stage process, opening on 2027 02 10, deadlines on 2027 04 13 and 2027 09 22, contributions ranging from EUR 7,000,000 to EUR 8,000,000, and an indicative number of 8 grants. HORIZON HLTH 2027 02 DISEASE 14 two stage HORIZON RIA HORIZON Research and Innovation Actions with a budget of EUR 39,300,000, a two stage process, opening on 2027 02 10, deadlines on 2027 04 13 and 2027 09 22, a contribution of around EUR 10,000,000, and an indicative number of 4 grants. HORIZON HLTH 2027 02 IND 02 two stage HORIZON IA HORIZON Innovation Actions with a budget of EUR 39,300,000, a two stage process, opening on 2027 02 10, deadlines on 2027 04 13 and 2027 09 22, contributions ranging from EUR 5,000,000 to EUR 7,000,000, and an indicative number of 6 grants. HORIZON HLTH 2027 02 TOOL 01 two stage HORIZON RIA HORIZON Research and Innovation Actions with a budget of EUR 44,200,000, a two stage process, opening on 2027 02 10, deadlines on 2027 04 13 and 2027 09 22, contributions ranging from EUR 6,000,000 to EUR 8,000,000, and an indicative number of 6 grants.

There is one partner search announcement available. LEARs, Account Administrators or self registrants can publish partner requests for open and forthcoming topics after logging into this Portal, as well as any user having an active public Person profile. The submission system is planned to be opened on the date stated on the topic header. There are 0 item(s) found in the Topic Q&As.

For support, carefully read all provisions before preparing the application. The Online Manual is a guide on the procedures from proposal submission to managing the grant. The Horizon Europe Programme Guide contains detailed guidance to the structure, budget and political priorities of Horizon Europe. The Funding & Tenders Portal FAQ provides answers to frequently asked questions on submission of proposals, evaluation and grant management. The Research Enquiry Service can answer questions about any aspect of European research in general and the EU Research Framework Programmes in particular. National Contact Points (NCPs) can provide guidance, practical information and assistance on participation in Horizon Europe, including NCPs in many non EU and non associated countries (‘third countries’). The Enterprise Europe Network can provide advice to businesses with special focus on SMEs. The IT Helpdesk can answer questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc. The European IPR Helpdesk assists on intellectual property issues. The CEN CENELEC Research Helpdesk and ETSI Research Helpdesk advise on how to tackle standardisation in the project proposal. The European Charter for Researchers and the Code of Conduct for their recruitment outlines the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers. Partner Search can help find a partner organisation for the proposal.

In summary, this Horizon Europe call aims to fund research and innovation actions focused on developing innovative healthcare interventions for non communicable diseases (NCDs). The call encourages the use of digital technologies, FAIR data principles, and engagement with relevant stakeholders, including patients, caregivers, and regulatory bodies. The call is structured in two stages, with specific deadlines for each stage, and utilizes a lump sum grant approach. The call encourages the participation of SMEs and requires the effective contribution of social sciences and humanities (SSH) disciplines. The overall goal is to reduce the burden of NCDs in Europe by supporting the development and implementation of effective healthcare interventions.

Eligible Applicant Types: The eligible applicant types include start-ups, micro enterprises, small and medium-sized enterprises (SMEs), researchers, developers, clinical practitioners, scientific communities, clinical communities, policymakers, patient organizations, regulators, and other relevant bodies. Any legal entity established in the United States of America is also eligible to receive Union funding.

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant, under the HORIZON Research and Innovation Actions (HORIZON-RIA) and HORIZON Innovation Actions (HORIZON-IA).

Consortium Requirement: The opportunity appears to support both single applicants and consortia, as it encourages the participation of various entities, including SMEs, and promotes networking and joint activities.

Beneficiary Scope (Geographic Eligibility): 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. 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.

Target Sector: The target sector is health, specifically innovative healthcare interventions for non-communicable diseases (NCDs). This includes cardiovascular diseases, diabetes, chronic respiratory diseases, and chronic kidney diseases. The program also targets social sciences and humanities (SSH) disciplines, artificial intelligence, wearable technologies, and data infrastructures.

Mentioned Countries: The United States of America is explicitly mentioned as eligible for Union funding. The opportunity is broadly available to entities in EU member states and associated countries, as described in Annex B of the Work Programme General Annexes.

Project Stage: The project stage targets early-stage clinical trials (phase 1 and/or phase 2 for pharmacological interventions) and validation in late-stage clinical trials. Projects should have completed proof-of-concept of clinical safety and efficacy, with both preclinical research and a draft clinical trial protocol completed at the time of proposal submission.

Funding Amount: The funding amounts vary depending on the specific topic:
HORIZON-HLTH-2027-02-DISEASE-01-two-stage: €7,000,000 to €8,000,000 (indicative number of grants: 8)
HORIZON-HLTH-2027-02-DISEASE-14-two-stage: Around €10,000,000 (indicative number of grants: 4)
HORIZON-HLTH-2027-02-IND-02-two-stage: €5,000,000 to €7,000,000 (indicative number of grants: 6)
HORIZON-HLTH-2027-02-TOOL-01-two-stage: €6,000,000 to €8,000,000 (indicative number of grants: 6)

Application Type: The application type is an open call with a two-stage submission process. The first stage proposals of this topic will be evaluated blindly.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves two stages. In the first stage, proposals are evaluated based on Excellence and Impact. In the second stage, proposals are evaluated based on Excellence, Impact, and Implementation.

Success Rates: The success rates are not explicitly mentioned, but the evaluation process indicates that the total requested budget of proposals admitted to stage 2 should be as close as possible to three times the available budget, and not less than two and a half times the available budget.

Co-funding Requirement: The need for co-funding is not explicitly mentioned; however, the lump sum funding mechanism implies that the total project costs should be well-justified and aligned with the expected outcomes.

Summary:
This Horizon Europe call focuses on funding innovative healthcare interventions for non-communicable diseases (NCDs), including cardiovascular diseases, diabetes, chronic respiratory diseases, and chronic kidney diseases. The call aims to support activities that contribute to reducing the disease burden and improving the quality of care for patients with NCDs. The funding is provided as a lump sum grant, and the application process involves two stages. Eligible applicants include researchers, developers, clinical practitioners, SMEs, patient organizations, and other relevant stakeholders from EU member states, associated countries, and the United States. Projects should focus on validating novel or refined healthcare interventions through rigorous clinical trials, leveraging digital technologies, and engaging with relevant stakeholders to ensure the widespread implementation and sustainability of the interventions. The call encourages the use of FAIR data principles and the integration of data with emerging research infrastructures, such as the European Health Data Space. The indicative budget for each topic varies, with individual grants ranging from approximately €5 million to €10 million. The call emphasizes the importance of addressing sex and gender differences, considering stratification criteria, and conducting health-economic assessments to enhance the scalability of novel interventions.