EU-Wide Advantages & Opportunities under HORIZON-INFRA-2025-01-SERV-01

1. Single Market Access

• Pan-European user base – Trans-national/virtual access rules allow infrastructures to attract researchers, SMEs and industry from all 27 Member States plus Associated Countries, instantly opening a market of 450 + million citizens for any resulting health solutions (vaccines, paediatric devices, exposome tools).

• Simplified service procurement – Frameworks such as the Public Procurement of Innovative Solutions (PPI) Directive enable beneficiaries to commercialise new RI services or data products EU-wide without duplicative national tenders.

• Demand aggregation – Pooling requests for specialised services (e.g. BSL-4 facilities, paediatric trial platforms) across countries drives utilisation rates, lowers unit costs and accelerates time-to-market for health technologies.

2. Cross-Border Collaboration & Knowledge Exchange

• Mandatory multinational consortia guarantee inclusion of at least one ESFRI Landmark/ERIC, forcing genuine scientific integration (e.g. EMBL, BBMRI-ERIC, ECRIN, EIRENE).

• Mobility & skills transfer – On-site access budgets finance researcher exchanges, harmonising protocols for epidemic-response assays, adaptive paediatric trial designs and exposome measurements.

• One-Health integration – Linking veterinary, environmental and clinical nodes in different countries operationalises the One-Health concept at scale, something unattainable in purely national schemes.

• Shared governance models – Joint steering committees across institutions pilot new EU-level governance structures that can later feed into the Pandemic Preparedness Partnership or the European Health Data Space.

3. Alignment with EU Flagship Policies

| EU Policy | Direct Contribution of the Call |

|-----------|---------------------------------|

| European Health Union & HERA | Builds EU-wide countermeasure capacity; aligns ISIDORe network with future Pandemic Preparedness Partnership. |

| EU Children’s Rights Strategy | Accelerates safe medicines & devices for children; supports EU Paediatric Regulation aims. |

| European Green Deal / Zero-Pollution | Area 3 delivers exposome data to guide pollution-reduction legislation. |

| Digital Europe & European Open Science Cloud (EOSC) | All areas generate FAIR, GDPR-compliant datasets feeding into EOSC and upcoming European Health Data Space. |

| Industrial Strategy / SME scale-up | Access for biotech SMEs and med-tech start-ups to RIs lowers CAPEX, de-risks innovation and boosts EU competitiveness. |

4. Regulatory Harmonisation Benefits

• GDPR & EHDS readiness – EU-wide data governance blueprints created by the project will facilitate pan-European secondary use of health and exposome data.

• Ethics & paediatric trials – Harmonised ethics review templates reduce redundant national approvals, shortening paediatric study set-up by up to 6 months.

• Standards leadership – Adoption of open, global standards (HL7-FHIR, InChI, MIxS, ISA-Tab, etc.) positions EU players as rule setters in international fora (WHO, OECD).

5. Access to the EU Innovation Ecosystem

• Synergies with existing ESFRI/ERIC assets – Seamless plug-in to infrastructures such as ECRIN (clinical trials), BBMRI-ERIC (biobanks), ELIXIR (life-science data), ERINHA (high-containment labs), EIRENE (exposome).

• Talent pipeline – Training work packages cultivate next-gen data stewards and lab specialists, addressing EU-wide skills shortages in BSL-3/4 operations, paediatric pharmacometrics, and multi-omics exposome analytics.

• Industry testbeds – Open calls allow SMEs to validate prototypes (e.g., rapid diagnostics, wearables for children, AI-based exposure models) in certified environments accepted by EMA and notified bodies.

6. Funding Synergies & Leverage

• Blending with other EU instruments

- EU4Health & EU-HERA: coordination of laboratory capacities and data registries.

- Digital Europe: HPC/AI vouchers for data processing pipelines developed under the grant.

- European Regional Development Fund (ERDF): upgrades of regional RI nodes can be co-funded for long-term sustainability.

- Innovative Health Initiative (IHI) & ERA4Health: downstream clinical validation studies.

• Cascade funding – Up to 20 % of the project budget may be redistributed via open calls, multiplying the number of beneficiaries and aligning with Widening participation goals.

7. Scale & Societal Impact

• Rapid scalability – Harmonised SOPs and data models allow any additional EU laboratory or clinic to join the network with minimal onboarding, essential during health emergencies.

• Economies of scope – Shared platforms (e.g., federated data lakes, harmonised monitoring stations) allow simultaneous research on multiple diseases or pollutants, maximising ROI.

• Policy uptake – Pan-EU evidence bases (catalogues of RI services, exposome datasets, paediatric trial master files) directly feed into ECDC risk assessments, EMA guidelines and Environmental Action Plan indicators.

8. Strategic Value Unique to EU-Level Operation

1. Critical Mass – Only an EU-wide consortium can aggregate the diversity of pathogens, paediatric sub-populations, and environmental exposures needed for statistically robust research.

2. Resilience & Redundancy – Distributed RI nodes across climates and regulatory contexts ensure uninterrupted service provision during local outages or outbreaks.

3. Global Leadership – By coordinating with WHO, WOAH, FDA, and LMIC partners under a single EU framework, the project positions Europe as the standard-setter for epidemic readiness, paediatric therapeutics and exposome science.

4. Long-Term Sustainability – Embedding at least one ESFRI Landmark/ERIC guarantees post-grant maintenance of services via membership fees and national RI roadmaps—an assurance difficult to secure in national calls.

9. Actionable Opportunities for Applicants

• Area 1 – Create a "FastTrack Pathogen Service" linking ERINHA BSL-4 labs, EMBL structural biology beamlines and ELIXIR data hubs; offer 72-hour rapid access vouchers during outbreaks.

• Area 2 – Establish a "Paed-Trial-as-a-Service" platform combining ECRIN nodes, big-data synthetic control arms (from EP PerMed), and remote e-consent tools; target rare-disease SMEs.

• Area 3 – Deploy a "European Exposome Observatory" federating EIRENE sampling sites, JRC HTT toxicology pipelines and IPCHEM; provide open APIs to environmental agencies and green-tech firms.

10. Key Take-Away

Leveraging the regulatory coherence, scientific excellence and market scale unique to the European Union, HORIZON-INFRA-2025-01-SERV-01 offers unmatched opportunities to build sustainable, world-class research-infrastructure service networks that no single Member State could realise alone. Applicants that strategically integrate cross-border assets, align with EU flagship policies and plan for long-term EU-level exploitation stand to maximise impact and secure funding success.