EU-Wide Advantages and Opportunities for the Phage-Therapy RIA (HORIZON-HLTH-2025-01-DISEASE-01)

1. Single Market Access (450+ million citizens)

• Centralised EMA marketing authorisation – one dossier → 30+ national markets; removes duplicate regulatory/HTA filings and accelerates revenue generation by ~2-3 years compared with sequential national approvals.

• Freedom to operate under EU Intellectual Property regime (unitary patent & SPC reform) lowers patenting costs (~35 %) and prevents market fragmentation for personalised or cocktail phage products.

• Pan-EU procurement channels (Joint Procurement Agreement, EU FAB/HERA) enable rapid uptake in hospitals and preparedness stockpiles, creating early demand and price stability.

2. Cross-Border Collaboration & Trial Efficiency

• Access to ECRIN-facilitated multi-country clinical trial infrastructure – harmonised ethics submission (CTIS) cuts approval timelines by 30-40 %.

• Larger, genetically diverse AMR patient pools across Member States increase statistical power and accelerate recruitment (≈ 1 patient/site/week vs 0.3 nationally).

• Alignment with European Reference Networks for rare infections and burns improves patient referral and long-term follow-up.

• Shared phage biobanking (e.g. Phage Directory EU, Microbially-derived Biological Resource Centres, BBMRI-ERIC) ensures rapid sourcing & matching of personalised phages.

3. EU Policy Alignment

| EU Strategy | Grant Contribution |

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

| European One-Health AMR Action Plan | Demonstrates tangible alternative to antibiotics, directly addressing flagship action 2.3 (new therapeutics). |

| Pharmaceutical Strategy for Europe | Generates real-world evidence and supports adaptive pathways & novel evidence framework for personalised biologics. |

| EU Health Union & HERA | Builds clinical-grade phage manufacturing capacity regarded as a strategic medical countermeasure. |

| Digital Europe / EHDS | FAIR, GDPR-compliant multi-country phage & resistance data sets feed the European Health Data Space and AI initiatives. |

| Green Deal / Circular Bioeconomy | Bio-based therapy with low environmental impact compared with small-molecule antibiotics; supports sustainable healthcare. |

4. Regulatory Harmonisation Benefits

• EU Clinical Trials Regulation (CTR 536/2014): Single decision per Member State group, simplified safety reporting → lower admin burden (~€0.5–1 m saving).

• EMA scientific advice fee reductions & PRIME access for SMEs performing high-unmet-need trials (AMR qualifies).

• Ongoing EDQM & Ph. Eur. monograph on phage therapy: consortium can co-shape quality standards, ensuring future compliance and market readiness.

5. Access to EU Innovation Ecosystem

• 5 of the global top-10 phage research centres are in the EU (Pasteur, KU Leuven, Tbilisi, University of Copenhagen, Max Planck). Grant allows formalised network building.

• Use of ERICs: ELIXIR (sequence/AI), EATRIS (translational services), EU-OPENSCREEN (compound-phage combos).

• SME participation incentive: Lump-sum model reduces cash-flow risk; eligible for concurrent EIC Accelerator (€2.5 m) for scale-up.

6. Funding Synergies & Leveraging

• Cascade funding windows: IHI AMR Flagship, ERA4Health IICS, EIT Health Bridgehead can finance post-trial market launch activities.

• Combining with EU4Health (€5.3 bn) for stewardship training and procurement pilots.

• Cohesion Policy & Recovery funds may co-invest in GMP phage manufacturing plants in Convergence Regions (up to 50 % capex support).

7. Scale & Impact Potential

• Establishment of a European Phage Therapy Platform (EPTP) hosting a living phage-bacteria interaction atlas; scalable to veterinary and environmental applications (One-Health).

• Projected health-economic benefit: reducing AMR infections by 5 % saves €1.5 bn/year in EU hospital costs and 27,000 DALYs.

• Creation of standardised AI-enabled phagogram pipeline exportable to at least 24 National Reference Labs within 3 years.

8. Strategic Value vs National-Level Efforts

1. Critical mass – Only EU-wide network can enrol >1,000 patients needed for definitive efficacy signals across multiple pathogens.

2. Risk sharing – Distributes scientific, financial, and manufacturing risk across ≥3 Member States, meeting Horizon lump-sum robustness tests.

3. Market pull – Joint HTA (Regulation 2021/2282) ensures simultaneous reimbursement decisions, impossible at single-country scale.

Bottom line: Leveraging EU integration multiplies the scientific power, regulatory speed, market reach and socio-economic return of phage-therapy development far beyond what any national programme could achieve.