Tackling high-burden for patients and under-researched medical conditions
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Funding Description – HORIZON-HLTH-2025-01-DISEASE-07
1. Grant Snapshot
* Title: Tackling high-burden for patients and under-researched medical conditions
* Call ID: HORIZON-HLTH-2025-01-DISEASE-07
* Programme / Destination: Horizon Europe – Cluster 1 Health / “Tackling diseases and reducing disease burden”
* Type of Action: Research & Innovation Action (RIA) – 100 % funding rate
* Indicative EU contribution per project: €8 – 15 million (no formal cap, but the overall topic budget is €80 million and evaluators will scrutinise cost-efficiency)
* Opening date: 22 May 2025
* Deadline (single stage): 16 Sept 2025, 17:00 CET (Brussels time)
* Project duration (typical): 48–60 months
2. What the Grant Funds
The call finances the full research‐innovation continuum from basic discovery to clinical validation and guideline development for *one* high-prevalence, high-burden yet under-researched condition:
• Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS)
• Autism (neurodevelopmental disorder)
• Gynaecological diseases (e.g. endometriosis, adenomyosis, PCOS)
• Low back pain
• “Other” conditions identified in the 2023 EC scoping study and not covered by previous 2024 call
Fundable activities include (non-exhaustive):
* Multi-omics, imaging, molecular and psychosocial *pathophysiology* studies
* Identification/validation of *biomarkers* for diagnosis, monitoring, stratification
* Development of *clinically relevant models* (in-vitro, in-silico, animal, organ-on-chip, AI)
* *Exploratory or confirmatory clinical studies* (interventional or observational) – template annex mandatory
* Integration of existing *registries, cohorts, biobanks*; generation of FAIR-compliant new data
* *SSH* investigations (stigma, quality-of-life, health-economics, gender, ethics)
* Creation/upgrade of *clinical guidelines*, decision-support tools & policy briefs
* Stakeholder engagement: patients, caregivers, SMEs, regulators, payers
3. Who Is Eligible?
* Minimum consortium: 3 independent legal entities from 3 different EU Member States or Associated Countries
* Typical actors: universities, research institutes, hospitals, ERICs, SMEs/start-ups, patient organisations, public health bodies, social science centres
* US participants, international partners, and UK entities are eligible for funding under HE rules
* Exclusions: projects focusing on rare diseases/rare cancers or on medical conditions already funded under HORIZON-HLTH-2024-DISEASE-03-14 (two-stage)
4. Budget & Cost Rules
* Funding rate: 100 % of eligible direct costs + 25 % flat-rate indirect costs
* Equipment depreciation, clinical trial insurance, data management, open access fees, patient compensation, exploitation/dissemination and ethics costs are eligible
* No co-funding obligation, but in-kind contributions and national co-financing strengthen sustainability
5. Evaluation Particularities
* Standard Horizon Europe criteria (Excellence, Impact, Quality & Efficiency of Implementation) – threshold 4/5 for each; overall 12/15
* EC will ensure a balanced portfolio across medical conditions; the highest-ranked proposal per condition is prioritised if thresholds are met
* Clinical studies ethics, sex-and-gender analysis, data management plan and patient involvement are scrutinised
6. Key Compliance Requirements
* Focus on one eligible medical condition only
* Demonstrate high societal burden + research gap (DALY, QoL, cost-of-illness data)
* Apply FAIR & open-science principles; deposit data in EU infrastructures (BBMRI-ERIC, EGA, etc.)
* Provide Clinical Study Annex (if any human study)
* Address SSH integration, sex/gender, age, ethnicity, socio-economic factors
* Include patient organisations meaningfully (co-creation, governance, dissemination)
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*Failure to comply with any of the above may render the proposal ineligible or non-fundable.*
📊 At a Glance
🇪🇺 Strategic Advantages
EU-Wide Advantages & Opportunities for HORIZON-HLTH-2025-01-DISEASE-07
1. Single Market Access
Unique Value: The EU’s single market of 450 + million citizens and >10 000 hospitals offers an unparalleled test-bed and launchpad for novel diagnostics, therapeutics and preventive solutions targeting high-burden, under-researched conditions.
• Harmonised CE-marking (IVDR/MDR) enables one regulatory clearance for all 27 Member States.
• Scalable reimbursement via EU Joint Clinical Assessment (JCA) under the new HTA Regulation (2025→) for rapid market uptake.
• Unified public-procurement frameworks (e.g., Big Buyers for Health) open large cross-country tenders once clinical evidence is produced in the project.
2. Cross-Border Collaboration & Knowledge Exchange
• Patient recruitment & diversity: Multi-country consortia can access heterogeneous populations (age, ethnicity, socio-economic) improving statistical power and external validity.
• Existing EU infrastructures: Easy connection to BBMRI-ERIC biobanks, ELIXIR genomics nodes, ECRIN trial support, ERN clinics for autism or gynaecological diseases, ensuring instant data/sample exchange.
• Shared research assets: FAIR data lakes, common SOPs and GDPR-compliant cloud frameworks (e.g., EOSC, European Health Data Space sandbox) reduce duplication and speed discoveries.
• Mobility schemes: Marie-Skłodowska-Curie and COST Actions allow secondments and short-term scientific missions, embedding skills across borders.
3. Alignment with Key EU Policies
• European Health Union & EU4Health: Results feed directly into EU-level guideline development, disease registries and prevention programmes.
• Digital Europe & Europe’s Digital Decade: Integration of AI/omics pipelines leverages EU investments in HPC, GAIA-X and cross-border 5G/6G health connectivity.
• European Green Deal/Zero-Pollution: Development of non-invasive, low-waste diagnostics and tele-health follow-up contribute to sustainable healthcare.
• Gender Equality Strategy 2020-25: Addressing sex- and gender-specific gaps (critical for gynaecological diseases & ME/CFS) shows direct policy coherence.
4. Regulatory Harmonisation Benefits
• Single ethics opinion pathway via Voluntary Harmonisation Procedure (VHP) for multi-site trials saves 6-12 months.
• GDPR one-stop-shop: A single Lead Supervisory Authority eases pan-EU data transfer once appropriate safeguards are in place.
• EMA PRIME & Orphan procedures (if applicable for sub-groups) provide scientific advice and accelerated assessment.
5. Access to Europe’s Innovation Ecosystem
• 3000 + universities & 40 000 + SMEs active in health can be tapped through EIT Health Nodes, facilitating spin-outs and commercial pathways.
• Living Labs in the Vanguard Initiative or EIT Health testbeds allow real-world validation in multiple healthcare settings.
• InvestEU & EIC Accelerator can scale successful prototypes post-project, de-risked by Horizon evidence.
6. Funding Synergies & Leverage
• Structural Funds / ERDF: Regional authorities co-invest in pilot facilities or biobank upgrades that the project needs.
• Digital Europe Programme (DEP): Additional grants for cloud, AI, cyber-security layers of health data platforms.
• EU4Health joint actions to disseminate new clinical guidelines EU-wide after project end.
• National Recovery & Resilience Plans (RRF): Many Member States earmark money for health data infrastructures—aligning project deliverables unlocks co-financing.
7. Scale & Societal Impact Potential
• EU Guidelines & ERNs: Evidence generated can be channelled into European professional societies (EFIC, EBC, ESGE, etc.) and European Reference Networks, guaranteeing continent-wide practice change.
• Public health indicators: Project outcomes directly support WHO NCD targets and EU Disability-Adjusted Life Year reduction goals, demonstrating measurable impact.
• Economic savings: Earlier diagnosis and targeted therapies for high-burden conditions could cut EU healthcare costs by billions (e.g., low-back pain alone costs €240 bn/year).
8. Actionable Recommendations for Applicants
1. Form a geographically balanced consortium (≥12 countries, incl. EU13 & associated) to maximise patient diversity and evaluation scores.
2. Embed EU infrastructures (BBMRI + ECRIN + ELIXIR nodes) as partners or service providers—this scores on excellence & impact.
3. Plan for HTA & regulatory alignment from day one; include an EMA scientific advice work package.
4. Connect with EU4Health Policy DG-SANTE units to co-create dissemination pathways for new guidelines.
5. Budget for FAIR data stewardship using EOSC rules to meet mandatory open-science criteria and enable future meta-analyses.
6. Leverage EIT Health or national innovation agencies for commercialisation mentoring parallel to research WP.
Conclusion
Applying under HORIZON-HLTH-2025-01-DISEASE-07 at EU level unlocks integrated regulatory, financial, scientific and market advantages that no single Member State can offer. A well-structured, pan-European proposal can accelerate breakthroughs against under-researched, high-burden conditions, deliver rapid patient benefit and cement Europe’s leadership in precision health.
🏷️ Keywords
Ready to Apply?
Get a personalized assessment of your eligibility and application strategy
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