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European Health and Digital Executive Agency (HaDEA)

Contracts - EU4Health 2025 Annual Work Programme

Crisis preparedness

HADEA 2026 SC 0008 – Specific Contract for Measurement of pathogens in untreated wastewater samples under Framework Contract HADEA/2024/OP/0017 – Lot 2

Objectives

The contract focuses on the measurement of pathogens in wastewater samples by polymerase chain reaction (PCR) and by shotgun metagenomics.

Contract value: €6 526 250.00

Contractors: UNINOVA – Instituto de Desenvolvimento de Novas Tecnologia (leader); IDEASSOC Instituto Para O Desenvolvimento E Inovacao Tecnologica (partner), Instituto Superior Técnico (partner), Knowledgebiz Consulting, Lda (partner), STAB VIDA (partner), Investigação e Serviços em Ciências Biológicas LDA (partner), Università Telematica Pegaso s.r.l. (partner)

Contractors' countries: Portugal, Italy        

Period: 12 months, contract signed on 11/03/2026 

Status: Ongoing

 

HADEA/2026/NP/0045 - Supply of RT-PCR diagnostic kits to respond to the Ebola Bundibugyo outbreak

Objectives

Procuring and supplying RT-PCR laboratory kits to scale up high-throughput testing capacity in order to strengthen diagnostic and surveillance capacities in response to the ongoing outbreak of Ebola Bundibugyo virus disease (BDBV) in the Democratic Republic of the Congo (DRC) and Uganda.

Contract value: €2 098 102.00

Contractor: altona Diagnostics GmbH

Contractors country: Germany

Period: 8 months, contract signed on 20/08/2026 

Status: Ongoing

Read the contract award notice to know more.

 

HADEA/2026/NP/0043 - Supply of point of care diagnostic to respond to the Ebola Bundibugyo outbreak

Objectives

This procedure will ensure access to RADIONE POC diagnostic devices and kits used to detect and diagnose BDBV. In particular, this procedure will ensure access to an estimated 40 RADIONE POC diagnostic devices and estimated 4380 RADIONE RP033 kits by a direct contract for the supply and delivery to the African Centre for Disease Control and Prevention (AfCDC) in Kinshasa, Democratic Republic of Congo (the recipient organisation).

Contract value: €2 499 936.00

Contractor: KH Medical Co., Ltd.

Contractors country: South Korea

Period: 8 months, contract signed on 13/08/2026 

Status: Ongoing

Read the contract award notice to know more.

 

HADEA/2026/NP/0035 - Supply of antiviral to respond to the Andes Hantavirus outbreak

Objectives

This procedure will ensure EU access to Favipiravir (200mg tablets) by a direct contract for the supply and delivery to Member States and associated countries. The subject matter of this procedure is the supply of Favipiravir (filmcoated tablets, 200 mg), an antiviral with potential activity against ANDV to interested Members States. Given the high fatality rate of ANDV disease and the uncertainty about the route of transmission, a precautionary approach is warranted when deciding on infection prevention and control (IPC) measures for the care of patients with ANDV disease.

Contract value: €1 672 569.00

Contractor: betapharm Arzneimittel GmbH

Contractors country: Germany

Period: 8 months, contract signed on 13/08/2026 

Status: Ongoing

Read the contract award notice to know more.

 

HADEA 2026 SC 0040 – Specific cobtract for the provision of supplies and delivery services for wastewater surveillance at EU Super-Sites under Framework Contract HADEA/2024/OP/0017 – Lot 1

Objectives

The contract focuses on providing materials for collecting and packaging wastewater samples, as well as collecting and delivering these samples to designated contractors and analytical facilities for analysis.

Contract value: € 174 602.04

Contractor: Eurofins Analytico B.V.

Contractors country: The Netherlands

Period: 6 months, contract signed on 20/07/2026 

Status: Ongoing

 

300166407 - Study on the application of Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices

Objectives

To assess the application of the regulation across the EU/European Economic Area (EEA), focusing on the period from its entry into force on 1 March 2022 to the study month 1 and taking into account the date of application of the relevant provisions. This impact study will cover all aspects related to its extended mandate, examining EMA’s new structures like the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), the Executive Steering Group on Shortages of Medical Devices (MDSSG) and their supporting working parties, the effectiveness of their processes for crisis preparedness and management, as well as the monitoring and management of shortages of medicinal products and medical devices. 

Contract value: € 333 290

Contractor: Ernst & Young Europe

Contractors country: Belgium

Period: 10 months, contract signed on 10/09/2026 

Status: Ongoing

Health systems and health workforce

Specific Contract No 300137712 - CROSS-BORDER CARE scientific background analysis reporting on the Member State yearly data collection related to the Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (implementing framework contract No HADEA/2022/OP/0012)

Objectives 

The service requested is in the context of Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare (hereafter the Directive). The Directive codifies inter alia patients’ rights to reimbursement for healthcare received in another EU country.   

As part of the ongoing monitoring linked to the reporting obligation of the Commission, it was agreed with EU countries that the Commission would initiate a yearly data collection exercise related to the operation of the National Contact Points and on patients’ mobility.   

The purpose of the contract is to assist the Commission in obtaining and processing the data collection questionnaires, collect the data and produce yearly reports of reference years 2024 and 2025 for its publication including an overview on trends (for years 2023 to 2025) and conclusions for the next Commission report on the operation of the Directive. 

Contract value: €66 400

Contractor: Intellera 

Contractor’s country: Italy                                     

Period: September 2025 - May 2027  

Status: Ongoing 

 

HADEA/2025/OP/0043 - Support the implementation of the new Substances of Human Origin (SoHO) Regulation 1938/2024, including dissemination and training of SoHO professionals to comply with the new technical and regulatory requirements

Objectives

The scope of the call for tenders is to prepare SoHO professionals across the EU for the 2027 implementation of the Regulation (EU) 2024/1938 on Substances of Human Origin. The objectives of this call are to develop training programmes, awareness and capacity building activities, technical assistance and supporting measures to facilitate the implementation of the new SoHO Regulation by the professional sector (scientific societies and associations).

This action implements the EU4Health programme’s general objective of strengthening health systems by improving their resilience and resource efficiency.

Contract value: €3 499 828.50

Contractors: PredictBy Research and Consulting S.L., European Blood Alliance, European Eye Bank Association, The European Society of Human Reproduction and Embryology, European Hematology Association, Stichting European Society for Blood and Marrow Transplantation, European Helicobacter and Microbiota Study Group, European Association of Tissue and Cell Banks e.V., European Milk Bank Association

Contractors' countries: Spain, the Netherlands, Italy, Belgium, Austria, Germany

Period: Signed on 20/03/2026 for 30 months

Status: Ongoing

Read the contract award notice to know more.

 

HADEA/2025/OP/0045 - Single Framework contract for supporting joint work of Member States in the field of Substances of Human Origin

Objectives

The subject of this call for tenders is to support the joint work of Member States in the field of Substances of Human Origin (SoHO) in accordance with the conditions and procedures set out in the SoHO Regulation, the Commission implementing and delegated acts to be adopted, as well as the guidance, detailed procedural steps and the timeframe and templates to be adopted by the SoHO Coordination Board (SCB). 

Contract value: €4 000 000

Contractors: Agence de la Biomedicine (ABM)

Contractor's country: France

Period: Signed on 06/03/2026 for 48 months

Status: Ongoing

Read the contract award notice to know more.

 

Specific contract 2025 SC 0055 – Health Union Fellowship – second cohort (Specific contract under framework contract HADEA/2024/OP/0002)

Objectives: 

The specific contract aims at implementing the following objectives of the Framework contract: 

  1. preparing and validating the content of the fellowship programme, networking activities, developing workshops and forum content and material, running the workshops and forum and managing an existing online platform to support training, communication and collaborative work.Some of the training material will be re-used from the previous cohort.
  2. Supervising 33 fellows in the training programme. (the enrolment of the fellows for this cohort was already completed under the short contract HADEA 2025 SC 0035).

Contract value: €808 850    

Contractor: Boston Consulting Group

Contractor’s country: Belgium                 

Period: signed on 19/12/2025 (14 months)

Status: Ongoing 

 

Contract 300160890- Technical assistance to support the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 on medical devices and in vitro diagnostic medical devices, implementing the framework contract for services HADEA/2022/OP/0012 (Multiple Framework Contracts in cascade for support services to manage expert groups in the field of health 2023-2025)

Objectives:

The purpose of this contract is to provide logistic, knowledge and administrative support services in relation to the Medical Device Coordination Group (MDCG), the Notified Bodies Coordination Group (NBCG-Med) and authorities responsible for notified bodies (designating authorities) to support the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and in particular:

- To provide services to the MDCG in its tasks to contribute to the development of the guidance aimed at ensuring effective and harmonised implementation of Article 105 c), d), e) of the MDR and IVDR, to the continuous monitoring of the technical progress, and to the development of device standards, common specifications and scientific guidelines;

- To provide services to the NBCG-Med and assist the Chairpersons of the NBCG-Med in carrying out technical-related duties;

- To organise one exchange of experience session in 2026 between designating authorities, in hybrid format, chaired by DG SANTE.

Contract value: € 1,249,806

Main Contractor: Intellera Consulting S.P.A.

Contractor’s country: Italy

Period: 18 months, contract signed on 16/04/2026

Status: Ongoing

 

Contract 300159687 - Purchase order in support of joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on health technology assessment

Objectives: 

This purchase order 01-2026 aims to support the conduct of joint scientific consultations (henceforth ‘JSC’) in accordance with the conditions and procedures set out in the Health Technology Assessment (HTA) Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on HTA. This action focuses on the implementation of 2 JSCs of a medicinal product conducted as a JSC HTA only process and 2 JSC of a medicinal product in parallel with the scientific advice procedure at the European Medicines Agency.

Contract value: €184 000  

Contractor: RIZIV-INAMI

Contractor’s country: Belgium                 

Period: signed on 27/05/2026, end date 31/01/2027 (8 months)

Status: Ongoing

 

Contract 300164995 - Purchase order in support of joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on health technology assessment

Objectives:

This purchase order 02-2026 aims to support the conduct of joint scientific consultations (henceforth ‘JSC’) in accordance with the conditions and procedures set out in the Health Technology Assessment (HTA) Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on HTA. This action focuses on the implementation of 3 JSCs of a medicinal product conducted as a JSC HTA only process.

Contract value: €138 000  

Contractor: RIZIV-INAMI

Contractor’s country: Belgium                 

Period: signed on 29/05/2026, end date 31/05/2027

Status: Ongoing

 

Contract 300170967 - Purchase order in support of joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on health technology assessment

Objectives:

This purchase order 03-2026 aims to support the conduct of joint clinical assessments (henceforth ‘JCA’) in accordance with the conditions and procedures set out in the Health Technology Assessment (HTA) Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on HTA. This action focuses on the implementation of 2 JCA of a medical device or in vitro diagnostic medical device.

Contract value: €700 000  

Contractor: RIZIV-INAMI

Contractor’s country: Belgium                 

Period: signed on 22/07/2026, end date 31/05/2027 (15 months)

Status: Ongoing

 

Contract 300169225: Reflection paper on the future of ERNs

Objectives:

The objective of this contract is to obtain an independent, evidence-based, forward-looking reflection paper. Based on an assessment of the efficiency and sustainability of the current functioning and structure of the ERNs, the paper will evaluate three distinct scenarios for restructuring the ERN system.

Contract value: €128 400  

Contractor: Intellera (empirica)

Contractor’s country: Italy/Germany

Period: entered into force on 15/09/2026 for 12 months

Status: Ongoing

 

HaDEA/2025/OP/0052 - Strengthening national implementation of organ transplant practices, in particular through cooperation between national authorities and professional sector associations

Objectives 

The objective of this contract is to strengthen the national implementation of organ transplant practices, in particular through cooperation between national authorities and professional sector associations. The contractor will develop and provide training to professionals and staff from competent authorities or delegated bodies regarding organ transplant practices to strengthen their organ donation and transplantation systems. The contractor will also develop conclusions stemming from these trainings and recommendations for follow-up work in the field.

Contract value: €1 989 139,32

Contractor: KPMG Advisory Ltd. (KPMG Tanácsadó Kft.)

Contractor’s country: Hungary                                

Period: 36 months, signed on 31/08/2026

Status: Ongoing 

 

Digital

HADEA/2025/OP/0034 - Specific Contract N. 300143622 - Administrative and secretarial support for the implementation of initiatives on digital health and the European Health Data Space (EHDS)

Objectives: 

The objective of this service contract is to provide administrative and secretarial support to DG SANTE in implementing the European Health Data Space and other initiatives such as the Biotech Act and the cybersecurity of hospitals, as well as others that may be defined in the future. 

This includes providing support to manage the groups and subgroups working on primary and secondary uses of data, for instance the eHealth Network (eHN), eHealth Member State Expert Group (eHMSEG), eHealth Stakeholder Group (eHSG), EHDS2 Community of Practice, and any groups or subgroups that may be created in the future, like the European Health Data Space (EHDS) Board, the two steering groups for EHDS infrastructures (MyHealth@EU and HealthData@EU), and Stakeholder Forum.

Contract value: €900 250.00

Contractor: Verian Group Belgium SA

Contractor’s country: Belgium        

Period: 36 months, contract signed on 23/02/2026 

Status: Ongoing

 

Health promotion and disease prevention

HaDEA/2026/SC/0014 - Operation of the Technical Group for the assessment of tobacco characterising flavours, including maintenance of the group of sensory assessors - 2026-2027 (under Single Framework Contract No HADEA/2023/OP/0001)

Objectives

The general objective of this specific contract is to provide HaDEA and the European Commission with scientific, economic and technical expertise to facilitate the implementation of the current tobacco control policies.

More specifically, it should provide input to the assessment of sensory profiles and, where appropriate, chemical properties of tobacco products with a view to assist in decisions on whether tobacco products (e.g. cigarettes and heated tobacco products) impart a characterising flavour other than tobacco. For this, the implementation of the Tobacco Products Directive (2014/40/EU) of the European Parliament and of the Council entails the operation of a Technical Group of sensory and chemical assessors. 

This project was launched in the context of the implementation of the Tobacco Products Directive of the European Parliament and of the Council which provides that Member States shall prohibit the placing on the market of tobacco products with characterising flavours.

Contract value: €607 200

Contractor: University of Crete

Contractor's country: Greece

Period: Contract signed on 19/06/2026 for 12 months

Status: contract to start on 21/09/2026