EU-Wide Advantages & Opportunities for HORIZON-HLTH-2025-01-DISEASE-03

1. Single Market Access & Joint Procurement

• Direct pathway to a 450-million-citizen market governed by one central authorisation (EMA) rather than 27 national files.

• Eligibility for the EU Joint Procurement Agreement and HERA stockpiling, which can transform innovative antibodies into guaranteed purchase contracts during crises.

• Common VAT & customs rules simplify cross-border delivery of GMP batches and ancillary materials.

2. Cross-Border Collaboration & Knowledge Exchange

• Mandatory multi-country consortia unlock complementary BSL-3/4 infrastructure (e.g. INSERM–Jean-Mérieux, RKI, IRTA-CReSA) and humanised animal models scattered across MS.

• Possibility to add endemic-country partners (e.g. Argentina for Junín, West Africa for Lassa) under Article 19 exceptions, widening epitope diversity and sample access.

• Alignment with pan-European infrastructure initiatives (ISIDORe, EATRIS, Instruct-ERIC) reduces duplication of assays and accelerates SOP convergence.

3. Alignment with Key EU Strategies

• Health Union & HERA: contributes directly to ‘priority countermeasures’ list and HERA incubator.

• Pharmaceutical Strategy for Europe: supports advanced-therapy medicinal products (ATMP) roadmap and encourages sustainable manufacturing.

• Digital Europe & European Health Data Space: facilitates federated sharing of pre-clinical and early-phase data using common FAIR standards.

• Green Deal: antibody-derived proteins can be produced in plant or yeast platforms with lower carbon footprints, aligning with EU sustainable biomanufacturing ambitions.

4. Regulatory Harmonisation Benefits

• EMA centralised procedure, PRIME & accelerated assessment shorten time-to-market by ±12–18 months vs. fragmented approaches.

• Parallel EMA/HTA scientific advice now possible under new HTA Regulation, easing post-2025 joint clinical assessment.

• GDPR/CTR/IVDR provide one legal framework for clinical data handling across Member States, lowering compliance costs.

5. Leveraging the EU Innovation Ecosystem

• Access to >2 000 entities in the European Research Infrastructure landscape plus 400+ hospitals in ECRIN for FIH trials.

• Seamless hand-off to downstream EIC Accelerator, IHI joint undertakings, EIB venture debt and IPCEI-Health for late-stage scale-up.

• Utilisation of Horizon Europe’s ‘unit-cost’ model for access to trans-national services (e.g., synchrotrons, cryo-EM) at zero cash outlay.

6. Funding Synergies & Blended Finance

• EU4Health can finance regulatory science, training and stockpiling once FIH data are positive.

• EDCTP3 & Global Health EDCTP to sponsor Phase II trials in endemic LMIC regions, leveraging Horizon results.

• InvestEU & EIB Bio-Manufacturing Guarantee Facility available for building EU-based GMP plants compliant with greener processes.

7. Scale & Impact Potential

• Centralised pandemic procurement could cover 27+ states within weeks, delivering equitable access and avoiding ‘vaccine nationalism’ repeat.

• EU crisis-response budget (Emergency Support Instrument) can rapidly convert project outputs into deployable antibody cocktails.

• Harmonised pharmacovigilance via EudraVigilance allows real-time safety signal detection across the continent.

8. SME & Start-Up Upscaling Advantages

• 25 % budget bonus when coordinating SMEs helps de-risk small-company participation.

• EU IP Helpdesk & Unitary Patent reduce IP management costs; fast-track path to EU-wide SPC protection for biologics.

• Participation opens doors to Enterprise Europe Network for partnering and out-licensing.

9. Concrete Action Points for Applicants

• Map consortium assets to ESFRI/ISIDORe service catalogue on Day 1 to justify ‘EU value added’.

• Schedule early parallel scientific advice sessions with EMA + national agencies under HERA support.

• Include a work package on sustainable, low-carbon bio-manufacturing to align with Green Deal indicators.

• Plan data deposition in ELIXIR nodes using EOSC interoperability layers to meet Open Science obligations and enhance EU reuse.

Bottom Line: Leveraging the EU’s integrated regulatory, financing and research landscape gives applicants faster development timelines, larger guaranteed markets, lower compliance overheads and a unique springboard for global deployment—advantages impossible to replicate at a purely national level.