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Grant Analysis

Purpose & Target

Core objective: To tackle high-burden and under-researched medical conditions by advancing understanding, diagnostics, therapeutics, and preventive strategies through comprehensive research and innovation actions.
Target recipient type and size: Research entities, universities, hospitals, startups, and SMEs, ideally participating in multidisciplinary consortia.
SECTOR-SPECIFIC (Healthcare/Medical Research)
Geographic scope: Eligible countries as defined in Horizon Europe Work Programme General Annexes (Annex B), with explicit eligibility for legal entities established in the United States of America.
Key filtering criteria for initial grant screening:
Focus on specific under-researched medical conditions (myalgic encephalomyelitis/chronic fatigue syndrome, autism, gynaecological diseases, low back pain, or other specified high-burden conditions).
Requirement for multidisciplinary consortia.
Integration of Social Sciences and Humanities (SSH) expertise.
Encouraged patient and patient organization engagement.
Grant frequency and program context: This topic is part of the Horizon Europe Work Programme 2025, specifically Cluster 1 - Health, indicating a recurring framework.

Financial Structure

Min grant amount per project: 6000000.0
Max grant amount per project: 6000000.0
Total budget for this topic (2025): 30000000.0
Expected number of grants: 5
Currency: EUR (implied for Horizon Europe grants).
Funding rate: None (Not explicitly defined in the provided text; generally 100% of eligible costs for non-profit entities and a reduced rate for for-profit entities under Horizon Europe Research and Innovation Actions, as detailed in Annex G of the Work Programme General Annexes).
Eligible and ineligible costs: Not specifically detailed in the provided text; determined by Annex G of the Work Programme General Annexes, typical for Horizon Europe grants.
Matching fund/co-financing requirements: Not explicitly stated as mandatory for this specific topic; standard Horizon Europe RIA typically does not require mandatory co-financing, but contributions from partners are part of the project budget.

Eligibility Requirements

Organizational Type & Structure

Eligible entities are generally those defined in Annex B of the Horizon Europe Work Programme General Annexes.
Any legal entity established in the United States of America is explicitly eligible to receive Union funding.
Participation of startups and Small and Medium-sized Enterprises (SMEs) is strongly encouraged.
Proposals should involve multidisciplinary consortia with a broad representation of stakeholders, including the effective contribution of Social Sciences and Humanities (SSH) disciplines and experts.
Inclusion of patients or patient organizations in the research is strongly encouraged.

Capacity & Expertise

Applicants must demonstrate financial and operational capacity as described in Annex C of the Work Programme General Annexes.
Projects are expected to include clinical studies, thus requiring relevant expertise in conducting clinical research.
Technical expertise in the targeted medical conditions, including pathophysiological mechanisms (e.g., genetic, cellular, and molecular) and potential risk factors (e.g., psychological and environmental), is required.
Expertise in developing diagnostics, therapeutics, and/or preventive strategies is essential.

Geographic & Regulatory

Eligible Countries are described in Annex B of the Work Programme General Annexes.
If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must use Copernicus and/or Galileo/EGNOS.
Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and those they own or control) are not eligible to participate as beneficiaries, affiliated entities, and associated partners for topics identified as 'subject to restrictions for the protection of European communication networks' (refer to Annex B of the General Annexes of this Work Programme for details).

Application Process

Submission Process

Application opening date: 2025-05-22
Application deadline: 2025-09-16 00:00:00+00
Submission method: Proposals must be submitted via the Electronic Submission Service available on the Funding & Tenders Portal.
Submission format: Use the standard application form (HE RIA, IA) specific to this call, available in the Submission System.
Application procedure: Single-stage submission.

Required Documentation

Standard application form (HE RIA, IA).
A dedicated annex providing details of clinical studies, using the template provided in the submission system. This is strongly encouraged as proposals under this topic are expected to include clinical studies.

Evaluation & Selection Timeline

Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
Proposals are evaluated based on award criteria for Excellence, Impact, and Implementation, with specific thresholds for each.
Selection prioritizes both ranking and a balanced portfolio across different targeted medical conditions.

Support and Assistance

Guidance documents: HE Programme Guide, Model Grant Agreements (MGA), and call-specific instructions.
Information on clinical studies (HE).
Assistance is available through:
Funding & Tenders Portal Online Manual.
Funding & Tenders Portal FAQ.
Research Enquiry Service.
National Contact Points (NCPs) in EU and associated countries, and some non-EU/non-associated countries.
Enterprise Europe Network (EEN) for advice to businesses, especially SMEs.
IT Helpdesk for technical submission issues.
European IPR Helpdesk for intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk for standardisation advice.
The European Charter for Researchers and the Code of Conduct for their recruitment.
Partner Search functionality on the portal.

Evaluation Criteria

Evaluation and award criteria, scoring, and thresholds are described in Annex D of the Work Programme General Annexes. Scoring Thresholds

Excellence: 4
Impact: 4
Implementation: 4
Cumulative threshold: 12

Strategic Prioritization

To ensure a balanced project portfolio with regard to the medical condition targeted, grants will be awarded (within available budget) not only in order of ranking but also in function of the highest ranked proposals in different medical conditions, provided that all thresholds are attained.

Excellence Criteria

Scientific and clinical communities' effective use of state-of-the-art information, data, technologies, tools, and best practices to understand the condition and underpin development of diagnostics, therapeutics, and/or preventive strategies.
Identification of pathophysiological mechanisms (e.g., genetic, cellular, molecular) and potential risk factors (e.g., psychological and environmental).
Demonstration that the targeted medical condition is insufficiently understood, inaccurately diagnosed, or inadequately treated, representing a high burden for patients and society.
Consideration of sex and gender-related aspects, age, ethnicity, socio-economic, lifestyle, and behavioural factors.
Addressing emotional and societal long-term effects of chronic disorders for affected individuals.
Where applicable, sound development of biomarkers, technologies for diagnosis, monitoring, and patient group stratification.
Where applicable, sound development of clinically relevant (non-)human model systems that complement clinical investigations.
Effective exploitation of existing data, biobanks, registries, and cohorts, coupled with generation of new data (e.g., genomics, epigenomics, transcriptomics, proteomics) following FAIR principles.
Multidisciplinary approaches and broad representation of stakeholders in the consortia.

Impact Criteria

Contribution to reducing disease burden in the EU and worldwide through effective disease management and innovative approaches.
Reduction of premature mortality from non-communicable diseases, promotion of mental health and wellbeing, and attainment of WHO Global Action Plan targets.
Strengthening of Research and Innovation expertise, human capacities, and know-how for combatting diseases.
Reduction of (cross-border) health threat from epidemics and antimicrobial resistance (AMR) pathogens.
Empowerment of patients and citizens in health decisions and adherence to knowledge-based disease management strategies.
Informing policymakers and funders about research advances to ensure sustainability of studies.
Access for health professionals to improved clinical guidelines on diagnosis and/or treatment.
Strengthening collaboration and building knowledge and care networks in Europe and beyond through data and knowledge exchange.
Wide use of newly established and/or integrated open-access databases following FAIR principles.

Quality and Efficiency of the Implementation (Implementation)

Coherence and effectiveness of the work plan, including tasks, resources, and risk management.
Quality and capacity of the consortium, ensuring the effective contribution of all partners.
Soundness of the management and coordination structure.
Appropriateness of efforts to ensure data management and sharing in line with FAIR principles.

Compliance & Special Requirements

Regulatory & Legal Compliance

General conditions regarding Admissibility Conditions, Eligible Countries, Financial and Operational Capacity, Evaluation and Award, and Legal and Financial Set-up of grants are described in the respective Annexes of the Horizon Europe Work Programme General Annexes (A, B, C, D, F, G).
Compliance with EU Financial Regulation 2024/2509.
Rules for Legal Entity Validation, LEAR Appointment, and Financial Capacity Assessment apply.
Adherence to the EU Grants AGA — Annotated Model Grant Agreement.
If projects involve satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS.

Ethical & Data Standards

Research activities involving clinical studies must adhere to all relevant ethical standards and regulations.
Exploitation of existing data, biobanks, registries, and cohorts is expected.
Generation of new data (e.g., genomics, epigenomics, transcriptomics, proteomics) is expected.
Collected data should follow FAIR principles (Findable, Accessible, Interoperable, Reusable).
Sharing of samples, quality data, and advanced analytical tools should, where possible, make use of existing infrastructures developed at European or national level (e.g., BBMRI-ERIC).
Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and those they own or control) are not eligible if the topic is identified as 'subject to restrictions for the protection of European communication networks'.

Cross-Cutting Themes & Strategic Alignment

Required effective contribution of Social Sciences and Humanities (SSH) disciplines and involvement of SSH experts to enhance societal impact.
Sex and gender-related aspects, age, ethnicity, socio-economic, lifestyle, and behavioural factors must be considered.
The emotional and societal long-term effects of chronic disorders for affected individuals should be addressed.
Patient and patient organization involvement in the research is strongly encouraged.
Cooperation between EU-funded projects is welcomed for cross-fertilisation and synergies (e.g., networking, joint workshops, knowledge exchange).
Synergies with European health research infrastructures, EIC strategic challenges on health, EIT-KIC Health, and other Horizon Europe Clusters (e.g., Civil security, Digital, Food/Bioeconomy) are encouraged.
Research and Innovation actions under this destination should support the mission of the European Health Emergency and Response Authority (HERA) where applicable.
Synergies with the EU4Health Programme (2021-2027) are sought, especially for implementing research results into policy and clinical practice.

Specific Focus & Exclusions

The grant targets specific high-burden, under-researched medical conditions, explicitly including: myalgic encephalomyelitis/chronic fatigue syndrome, autism, gynaecological diseases, and low back pain. Other conditions identified by an independent scoping study may also be targeted.
Proposals must explicitly state which of the above medical conditions is targeted, and the proposed work should address only this specific condition.
Excluded medical conditions: Rare diseases (including rare cancers) and under-researched medical conditions already addressed by projects funded under topic HORIZON-HLTH-2024-DISEASE-03-14-two-stage.

Grant Details