EU-wide Advantages and Opportunities for the grant "Understanding how infections foster and induce non-communicable diseases" (HORIZON-JU-IHI-2025-11-02-two-stage)

1. Single Market Access

- Immediate reach to 450+ million citizens through a single regulatory, commercial and reimbursement area.

- One EU-wide conformity pathway (EMA centralised procedure / CE-mark under IVDR), avoiding up to 27 parallel national filings and shortening time-to-market by an estimated 18-24 months.

- Favourable conditions for joint cross-border procurement (HERA, EU4Health tenders), accelerating first adoption of diagnostics, early-intervention therapeutics and prophylactic vaccines once developed.

2. Cross-Border Collaboration

- Direct use of pan-European cohorts & biobanks (e.g. BBMRI-ERIC, EGA, FinnGen, UK Biobank, Luxembourg Parkinson cohort, European Prospective Investigation into Cancer (EPIC), European Heart Failure Registry) that individually lack critical mass but collectively provide >40 million longitudinal samples.

- Built-in multinational consortia model fostered by IHI JU encourages participation of SMEs, pharma, diagnostics companies and academic centres from at least three Member States/Associated Countries, unlocking complementary expertise (multi-omics, AI, translational models) not available in a single country.

- Facilitation of data interoperability via European Health Data Space (EHDS) and European Open Science Cloud (EOSC) reduces legal friction, enabling federated analysis across borders while maintaining GDPR compliance.

3. EU Policy Alignment

- Delivers on EU Beating Cancer Plan, Pharmaceutical Strategy for Europe, and EU NCD Initiative by targeting early prevention and personalised medicine.

- Leverages Digital Europe Programme and the forthcoming AI Act by embedding trustworthy AI models for causal inference and biomarker discovery.

- Contributes to the Green Deal through reduced disease burden (lower healthcare resource use, greener manufacturing) and to the European Research Area (ERA) Policy Agenda Action 7 on common research infrastructures.

4. Regulatory Harmonisation Benefits

- Early scientific advice from EMA, HMA and national competent authorities under one coordinated framework; parallel EMA-HTA joint scientific consultations streamline evidence requirements for future reimbursement dossiers.

- Uniform application of GDPR, IVDR, Clinical Trials Regulation and forthcoming EHDS Regulation simplifies multi-country sample/data transfer and secondary-use permissions.

5. Access to Europe’s Innovation Ecosystem

- Direct linkage with 1,700+ organisations in EIT Health, 9 KIC hubs and 15 Digital Innovation Hubs specialised in health data and AI.

- Synergies with High-Performance Computing (EuroHPC JU) for large-scale multi-omics and AI workloads; access to supercomputers LUMI, Leonardo, MareNostrum5.

- Talent pipeline via MSCA Doctoral Networks and Erasmus Mundus programmes enhances workforce mobility and upskilling.

6. Funding Synergies

- Blending opportunities with

• EIC Pathfinder/Transition for follow-on validation of vaccine strategies;

• EU4Health for early uptake and joint procurement;

• ERDF / Recovery & Resilience Facility for scaling manufacturing or clinical infrastructure in less-developed regions;

• COST Actions to widen participation from Widening Countries and Western Balkans.

- Complementarity with Horizon-HLTH-2023-DISEASE-03-07 and IHI Call 11 brain-dysfunction platform maximises knowledge spill-over and avoids duplication.

7. Scale and Societal Impact

- Potential to define pan-European prevention guidelines reducing incidence of neurodegenerative and cardiometabolic NCDs—diseases responsible for >60 % of EU mortality.

- Harmonised biomarker panels unlock EU-wide screening programmes, estimated to avert €20 bn/year in long-term healthcare costs by enabling earlier intervention.

- Contributes to strategic autonomy in vaccine R&D and manufacturing, strengthening EU preparedness for future outbreaks.

8. Data & Infrastructure Advantages

- Use of federated learning within EHDS enables privacy-preserving analysis of insurance, transplant and immunosuppressed patient datasets covering >100 million life-years.

- Alignment with FAIR principles ensures assets feed into ELIXIR, BBMRI-ERIC and JRC data catalogues, guaranteeing post-project sustainability.

9. Market Uptake & Sustainability

- Horizon Europe results ownership rules support rapid licensing across Member States, while the Unitary Patent and UPC provide cost-effective IP protection in up to 25 jurisdictions.

- Pre-Commercial Procurement (PCP) and Public Procurement of Innovative Solutions (PPI) instruments can be triggered after project end to secure first-buyer reference sites.

10. Strategic Value of Operating at EU Scale

- Combines genetic, environmental and socio-economic diversity unavailable in single-country studies, enhancing external validity and accelerating regulatory acceptance.

- Critical mass of patients, data and expertise increases probability of establishing causal links that meet Hill’s criteria within five-year horizon.

- Strengthens Europe’s global competitiveness by positioning the EU as the first jurisdiction to systematically translate infection-NCD links into preventative vaccines and precision diagnostics.