Multiple sourcing Framework Contracts to speed up the development of and access to innovative medical countermeasures Next Generation Therapeutics for...

This Pre-Commercial Procurement (PCP) tender (HADEA/2026/CPN/0015) under EU4Health/HaDEA establishes multiple-sourcing framework contracts with a total ceiling budget of €252,000,000 to accelerate development of next-generation therapeutics for viral infections, ARDS and sepsis. It comprises two lots: Lot 1 Highly Innovative Therapeutics (pathogen-targeted solutions excluding small molecules and monoclonal antibodies; estimated €138,000,000; duration 108 months) and Lot 2 Advanced Therapeutics (host-targeted solutions; estimated €114,000,000; duration 69 months). Requests to participate must be submitted electronically via the EU Funding & Tenders Portal by 02 September 2026 at 16:00 CEST. Awards will follow a phased PCP approach and be evaluated on quality (80% weight) and price (20% weight).

What it funds

Scope summary

Pre-Commercial Procurement (PCP) to accelerate competitive phased development and access to innovative therapeutics for infectious diseases, including pathogen-targeted (excluding small molecules and monoclonal antibodies) and host-targeted approaches, direct and indirect antivirals, novel immune modulators, combination therapies, alternative to IV administration, broad-spectrum and pathogen-agnostic solutions and measures to reduce viral resistance.

Estimated total procurement value:Approximately €252,000,000 across the framework (Lot 1 about €138,000,000; Lot 2 about €114,000,000) ¹.

1. 1Who can apply: commercial suppliers, developers and consortia able to deliver R&D and prototyping services under PCP (see tender documents for precise eligibility and selection criteria).
2. 2Procedure: competitive, phased Pre-Commercial Procurement (PCP) with multiple sourcing framework contracts and subsequent service contracts.
3. 3Lots: Lot 1 Highly Innovative Therapeutics (pathogen-targeted and scalable therapies); Lot 2 Advanced Therapeutics (host-targeted and scalable therapies).
4. 4Contract duration examples: Lot 1 planned up to 108 months; Lot 2 planned up to 69 months (see draft contracts).

Access full tender documentation, draft framework contracts, financial offer forms and declaration templates on the official opportunity page Tender details. ¹

Footnotes

1. 1Tender documents published on 02 July 2026 include Invitation to request participation, Tender Specifications, Draft Framework Contracts, Financial Offer Forms and Declaration on Honour. Applicants must consult these documents for detailed eligibility, award criteria and lot-specific requirements.

Basic opportunity details

Call identifier HADEA/2026/CPN/0015. Tender type:Pre-Commercial Procurement (PCP) framework contracts under HaDEA (Health and Digital Executive Agency). Publication date on the Funding & Tenders Portal: 2026-07-02. Two key deadlines are provided: a first deadline timestamp 2026-01-01T14:00:59.000Z (recorded) and the operative submission deadline 2026-09-02T16:00:59+00:00 (end of participation request reception period). Submission method: eSubmission via the EU Funding & Tenders Portal. Estimated total procedure value: €252,000,000 (estimated overall contract amount).

Lead contracting authority:Health and Digital Executive Agency (HaDEA) acting as lead authority for the procurement.

Objective and scope:This PCP tender aims to accelerate the development and access to Next Generation Therapeutics for Infectious Diseases through multiple-sourcing framework contracts and a phased competitive development. The procurement covers development of innovative therapeutics to treat viral infections, acute respiratory distress syndrome (ARDS) or sepsis resulting from infections. It explicitly includes pathogen-targeted therapeutics (excluding small molecules and monoclonal antibodies) and host-targeted therapeutics. Examples of technology classes indicated include, but are not limited to, direct-acting antivirals, indirect-acting antivirals, novel immune modulators, innovative combination therapies, and alternative administration routes to intravenous (IV). Particular interest is expressed for broad-spectrum therapeutics, pathogen-agnostic solutions and therapeutics that reduce or counteract viral resistance.

Detailed extraction and classification

Eligible Applicant Types

Eligible applicants expected to include legal entities competent to deliver advanced therapeutic research, development and demonstration services. Based on the nature of the procurement (PCP) and the tender documentation structure, the following applicant types are applicable and typically eligible: startups, small and medium-sized enterprises (SMEs), large enterprises (pharmaceutical and biotech companies), universities, research institutes, non-profit research organisations, clinical research organisations (CROs), contract development and manufacturing organisations (CDMOs) offering R&D services, hospitals or clinical centres (as project partners), public bodies (where allowed by procurement rules), and consortia of the above. Individual natural persons are not appropriate applicants because the procurement is for complex R&D/service contracts.

Funding Type

Primary financial mechanism:Tender / Procurement under Pre-Commercial Procurement (PCP). This is not a grant, loan or equity instrument; it is a procurement procedure that awards framework contracts for R&D and pre-commercial development activities. The procurement will remunerate contractors according to the framework contract and call-off procedures.

Consortium Requirement

The procurement documentation and framework contract drafts indicate that applicants may form consortia. The tendering terms reference selection criteria and detailed procurement documents that typically allow single legal entities or groups (consortia) to submit requests to participate and tenders. Therefore the requirement is: consortium allowed and likely encouraged for complex offers, but single legal entities may also apply where able to meet the technical and capacity requirements. Specific lot rules and selection criteria in the tender specifications must be consulted for mandatory consortium composition elements.

Beneficiary Scope (Geographic Eligibility)

Geographic eligibility:EU-wide procurement managed by HaDEA. The Funding & Tenders Portal posting and HaDEA implementation indicate that participants from EU Member States are eligible. As an EU public procurement, standard rules allow economic operators established in EU Member States and possibly in EEA countries, and other countries specified in the procurement documents or covered by the WTO Government Procurement Agreement or EU procurement rules. Applicants should consult the Tender Specifications and Invitation to Submit a Request to Participate for precise eligible country lists and domicile requirements. The procurement is not labelled as exclusively limited to SMEs or widening countries.

Target Sector

Primary sector:health / biotech / advanced therapeutics. Target thematic areas include infectious diseases, antiviral therapeutics, host-directed therapies, immunomodulators, combination therapies, alternative administration routes (non-IV), and broad-spectrum or pathogen-agnostic therapeutics. Secondary sectors: pharmaceuticals development, clinical development, biologics and advanced therapeutic platforms, medical countermeasures and biodefense preparedness.

Mentioned Countries

No individual countries are explicitly listed in the scraped description beyond references to EU programmes and HaDEA. Regionally the opportunity targets EU / EU-funded participants; the contracting authority is HaDEA (European Union agency).

Project Stage and Expected Maturity

Expected project maturity:from research and development through validation and demonstration. As a PCP, the procurement funds pre-commercial R&D phases, typically including concept refinement, prototyping, development, validation and demonstration phases prior to full commercial procurement. The planned durations for the lots indicate multi-year development: Lot 1 planned duration 108 months (9 years) and Lot 2 planned duration 69 months (approx. 5 years), which implies staged development pathways from earlier R&D into advanced validation/demonstration steps.

Funding Amount and Financial Scale

Estimated overall contract amount:€252,000,000 distributed across two lots. Lot 1 (Highly Innovative Therapeutics) estimated overall contract amount: €138,000,000. Lot 2 (Advanced Therapeutics) estimated overall contract amount: €114,000,000. These values are the estimated total procedure values for the procurement and indicate the scale available for framework contracts and subsequent call-offs.

Application Type and Submission Method

Application method:open call via the EU Funding & Tenders Portal. The process requires electronic submission (eSubmission) of requests to participate and tenders via the Portal. The Invitation to Submit a Request to Participate and related tender specification documents are provided on the Portal and must be used.

Nature of Support

Support is financial remuneration under a public procurement contract for the performance of R&D and pre-commercial activities. Beneficiaries will receive monetary payments under contract terms (service/R&D payments), not grants. The procurement will also include contractual obligations, deliverables, milestones, reporting requirements and possibly non-financial support such as coordination with HaDEA, access to EU stakeholder networks and regulatory dialogue as stipulated in the tender documents.

Application Stages

The procurement is indicated as a phased competitive development under PCP. Typical PCP processes include multiple stages: 1) Request to participate and selection; 2) Submission of full tenders; 3) Award of framework contracts and phased R&D (competitive phases with down-selection); 4) Call-offs for further phases and demonstration. The documentation explicitly references a two-stage deadline date and phased development. Therefore applicants should expect at least 3 to 4 stages: expression of interest / request to participate, selection to tender, award of framework contract, then successive competitive R&D phases with evaluations and possible down-selection. Exact stage count and gating criteria are defined in the tender specifications and draft framework contracts.

Success Rates

Success rates are not published on the portal. As a multiple-sourcing PCP framework, the awarding approach typically selects a limited number of suppliers per lot to be included in the framework. Success rate depends on number of applicants vs number of framework places; no explicit number of contracts to be awarded is provided in the scraped text. Applicants should consult the Invitation to Submit a Request to Participate and the Tender Specifications for the number of suppliers to be selected per lot and to estimate probability of award.

Co-funding Requirement

Co-funding:The procurement documents should be consulted for financial arrangements. PCPs normally pay contractors for R&D activities per agreed unit costs/milestones; contractors typically bear part of development risk and do not necessarily need to contribute co-funding, but resource contributions (in-kind, third-party funding, subcontracting) may be allowed or required to demonstrate capacity. No direct co-funding percentage is stated in the scraped content; bidders should check the Tender Specifications and Financial Offer Form (Lot-specific) documents for precise contractual payment schedules, eligible costs and co-funding expectations.

Templates and Application Forms

The portal provides the following procurement documents (published 2026-07-02):Invitation to Submit a Request to Participate (document 1), Draft Framework Contract for Lot 1 and Lot 2 (documents 2 and 2), Draft contract annex Appendix 1 Security requirements (2a), Tender Specifications (document 3) and Tender Specifications Annexes in Word (3a), Declaration on Honour (document 4), Financial Offer Forms for Lot 1 and Lot 2 (5.a and 5.b). The documents include native-format templates: Word and Excel forms. Key form types available: request-to-participate package, declaration on honour template, tender specifications annexes, draft contract and draft annexes, and financial offer spreadsheets per lot. Bidders must complete the Financial Offer Form corresponding to the lot and submit electronically via the Portal. Exact structure and fields are in the provided annexes; applicants must download and complete those templates.

1. 1Documents published and template filenames include: 1. HADEA 2026 CPN 0015_Therapeutics for Infectious Diseases_Invitation Request to Participate_V1.pdf
2. 22. HADEA 2026 CPN 0015_Draft Framework Contract_Therapeutics_Lot 1_V1.pdf and Lot 2_V1.pdf
3. 32a. HADEA 2026 CPN 0015_Appendix 1 Security requirements_V1.pdf
4. 43. HaDEA 2026 CPN 0015_Tender Specifications_V1.pdf and 3a. Annexes in Word_V1.docx
5. 54. HADEA 2026 CPN 0015_Declaration on Honour_V1.docx
6. 65.a and 5.b HADEA 2026 CPN 0015_Financial Offer Form_Lot 1_V1.xlsx and Lot 2_V1.xlsx

Lots and Specific Lot Focus

Procurement and Award Criteria

Awarding terms in the tendering metadata show a primary split of quality (80 weight) and price (20 weight). The tendering documents instruct bidders to consult the procurement documents for detailed evaluation criteria, sub-criteria, weighting and scoring methods. Selection criteria and tenderer qualification requests are included in the tender specifications; a Declaration on Honour is required as part of requests to participate. Appeal terms and procurement rules are defined in the call documentation.

Key compliance and contractual aspects

The Draft Framework Contract and Appendix 1 Security Requirements are published and must be accepted by successful applicants. The draft contract will govern framework terms, call-offs, intellectual property arrangements consistent with PCP rules, confidentiality, data protection, security requirements, liability and deliverables. Bidders must review draft contractual clauses carefully because PCPs often define ownership and exploitation rules for pre-commercial results, including potential rights for the contracting authority to use results for public interest or further procurement.

How to apply and important procedural notes

Use the EU Funding & Tenders Portal eSubmission route. Download the Invitation to Submit a Request to Participate and all tender specification annexes and templates (including Declaration on Honour and the Financial Offer Form for the relevant lot). Complete all requested templates, upload them via the Portal before the deadline 2026-09-02 at 16:00:59 (Brussels time). Ensure compliance with submission format (native Word/Excel and PDF where requested) and meet all selection and exclusion criteria in the Tender Specifications. Requests to participate are subject to examination against qualification requirements prior to invitation to tender, as typical in a PCP two-stage procedure.

For legal and procedural clarifications, applicants should consult the procurement documents and the HaDEA contact channels listed in the tender dossier. The tender documents include contact and appeal information and provide an Access Tools URI to the tender page for further instructions and updates.

Reference links and where to find the tender documentation:The main tender page on the EU Funding & Tenders Portal contains the full set of documents and templates: Tender page. HaDEA information is available at HaDEA website ¹.

Summary

This HaDEA Pre-Commercial Procurement (PCP) tender (HADEA/2026/CPN/0015) establishes multiple-sourcing framework contracts totalling an estimated €252 million to accelerate development of next-generation therapeutics for infectious diseases. It targets innovative pathogen-targeted (excluding small molecules and monoclonal antibodies) and host-targeted therapeutics, including novel antivirals, immune modulators, combination therapies and solutions enabling non-IV administration. Two lots split focus between Highly Innovative Therapeutics (Lot 1) and Advanced Therapeutics (Lot 2) with distinct planned durations and estimated contract amounts. Applications must be submitted electronically through the EU Funding & Tenders Portal by 2 September 2026 16:00:59 (Brussels time) using the published request-to-participate, tender specification annexes, draft contract and financial offer templates. The award will be based primarily on quality (80) and price (20) criteria; the procurement will follow a phased competitive PCP approach with multiple stages and possible down-selection during R&D phases. Interested parties should download and complete the specified templates, carefully review draft contractual clauses (including security and IP provisions), and verify country eligibility and selection rules in the tender specifications before submission.

Footnotes

1. 1Applicants must consult the Invitation to Submit a Request to Participate and the Tender Specifications (documents 1 and 3) available on the Funding & Tenders Portal for full procurement rules, eligibility, exclusion and selection criteria, detailed award criteria, contractual terms and the exact list of eligible countries.

Opportunity Summary and Strategic Goal

This Pre-Commercial Procurement (PCP) tender aims to accelerate the development of innovative Next Generation Therapeutics for Infectious Diseases by adopting a competitive, phased development model ¹. The initiative targets therapeutics for viral infections, Acute Respiratory Distress Syndrome (ARDS), and sepsis resulting from infections, with a total estimated budget of €252,000,000 ².

Scope of Therapeutics and Exclusions

The scope includes pathogen-targeted therapeutics (excluding small molecules and monoclonal antibodies) and host-targeted therapeutics, such as direct-acting antivirals, indirect-acting antivirals, and novel immune modulators ³. Broad-spectrum, pathogen-agnostic therapeutics, and those reducing viral resistance emergence are of particular interest ⁴.

Key Exclusions:Small molecules and monoclonal antibodies are explicitly excluded from this call ³.

Lot Structure and Allocation

Eligibility and Application Process

Interested economic operators must submit a request to participate via the EU Funding and Tenders Portal ⁵. The procedure is an open call for tenders under a Framework Contract with reopen of competition ⁶.

1. 1Submit request to participate by 02 September 2026, 16:00 CEST ⁵
2. 2Ensure capability to deliver R&D services for solutions not yet on the market ⁷
3. 3Prepare technical and financial offers using the provided forms for specific lots ⁸

Award Criteria and Contract Details

Contracts will be awarded based on quality (80% weight) and price (20% weight) ⁹. The framework contract is expected to run for up to 108 months, allowing for comprehensive development and potential regulatory preparation ⁷.

Total Budget:The total ceiling budget for the entire framework is €252,000,000 ².

Key Deadlines and Documents

The deadline for the request to participate is 02 September 2026, 16:00 CEST ⁵. Essential documents include the Tender Specifications, Draft Framework Contracts for both lots, and Financial Offer Forms ⁸.

Footnotes

1. 1HaDEA Call for Tenders: HADEA/2026/OP/0015, Framework contracts to speed up the development of and access to next-generation therapeutics for infectious diseases HaDEA Official Page.
2. 2Total budget indicated as €252,000,000 in the official HaDEA call summary HaDEA Official Page.
3. 3Scope explicitly excludes small molecules and monoclonal antibodies, focusing on pathogen-targeted and host-targeted therapeutics EU Funding Portal Description.
4. 4Broad spectrum, pathogen-agnostic therapeutics, and those reducing viral resistance are of particular interest EU Funding Portal Description.
5. 5Deadline for request to participate: 02 September 2026, 16:00 CEST via EU Funding and Tenders Portal HaDEA Official Page.
6. 6Indicative type of procedure: Open call for tenders; Contract type: Framework Contract with reopen of competition NCP Brussels PIN Summary.
7. 7PCP is designed to buy R&D services for solutions not yet available on the market; indicative duration is 108 months NCP Brussels PIN Summary.
8. 8Available documents include Tender Specifications, Draft Framework Contracts (Lot 1 & 2), and Financial Offer Forms EU Funding Portal Documents.
9. 9Award criteria: Quality (80%) and Price (20%) EU Funding Portal Lots Data.