Crisis preparedness
HaDEA 2024/OP/0017 – Framework contracts to provide services and supplies to measure pathogens and pollutants of emerging concern in untreated wastewater samples as part of a global sentinel system
2024 P1 07 – Specific Contract for Supply and Delivery Services for Wastewater Infrastructure Samples under Framework Contract HADEA/2024/OP/0017 – Lot 1 Objectives: The contract focuses on two main tasks: (1) providing materials for collecting and packaging wastewater samples, as well as collecting and delivering these samples to designated contractors, analytical facilities, or the JRC as part of the GLOWACON Consortium activities; and (2) supplying equipment for wastewater collection and analysis. Contract value: €1 738 782.99 Contractor: Eurofins Analytico B.V. Contractor’s country: The Netherlands Period: 12 months, signed on 07/05/2025 Status: Ongoing |
2024 P1 09 – 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: € 6 082 903 Contractor: 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) Contractor’s country: Portugal, Italy Period: 12 months, signed on 20/06/2025 Status: Ongoing |
2024 P1 10 – Specific Contract for Measurement of pollutants in untreated wastewater samples under Framework Contract HADEA/2024/OP/0017 – Lot 3 Objectives: The contract focuses on the provision of measurements services by the application of multi-residue extraction and analytical procedures based on mass spectrometric techniques for the detection and quantification of the selected pollutants of emerging concern. Contract value: €178 295.82 Contractor: LABAQUA S.A.U. (leader); CETAQUA Centro Tecnológico Del Agua (partner), Agencia Estatal Consejo Superior De Investigaciones Cientificas (partner), Universidade De Santiago de Compostela (partner) Contractor’s country: Spain Period: 12 months, signed on 24/06/2025 Status: Ongoing |
2024 P1 01 – Specific contract implementing Framework contract HADEA/2022/CPN/009 for the reservation of capacities and a priority right for manufacturing of vaccines (EU FAB) – Lot 1
Objectives:
Reservation of capacities and a priority right for manufacturing of mRNA-based vaccines in case of a future public health emergency.
Contract value: €107 142 000
Contractor: Pfizer Ireland Pharmaceuticals
Contractor’s country: Ireland
Period: 12 months, contract signed on 20/06/2024
Status: Ongoing
2024 P1 02 – Specific contract implementing Framework contract HADEA/2022/CPN/009 for the reservation of capacities and a priority right for manufacturing of vaccines (EU FAB) – Lot 2
Objectives:
Reservation of capacities and a priority right for manufacturing of vector-based vaccines in case of a future public health emergency.
Contract value: €26 250 000
Contractor: Bilthoven Biologicals B.V.
Contractor’s country: The Netherlands
Period: 12 months, contract signed on 14/06/2024
Status: Ongoing
2024 P1 03 - Specific contract implementing Framework contract HADEA/2022/CPN/009 for the reservation of capacities and a priority right for manufacturing of vaccines (EU FAB) – Lot 3
Objectives:
Reservation of capacities and a priority right for manufacturing of protein-based vaccines in case of a future public health emergency.
Contract value: €8 983 200
Contractor: LABORATORIOS HIPRA S.A.
Contractor’s country: Spain
Period: 12 months, contract signed on 04/06/2024
Status: Ongoing
2024 P1 04 – Specific contract implementing Framework contract HADEA/2022/CPN/009 for the reservation of capacities and a priority right for manufacturing of vaccines (EU FAB) – Lot 3
Objectives:
Reservation of capacities and a priority right for manufacturing of protein-based vaccines in case of a future public health emergency
Contract value: €17 600 000
Contractor: CZ Vaccines S.A.U-Reig Jofre S.A.
Contractor’s country: Spain
Period: 12 months, contract signed on 26/06/2024
Status: Ongoing
HADEA/2024/CPN/0021 - Speed up the development of and access to innovative medical countermeasures - Point of care metagenomic sequencing for universal pathogen detection
Objectives:
This procedure supports the development of a metagenomic next-generation sequencing (mNGS)-based test that can detect any respiratory/airborne viral pathogen, including novel and emerging, from any human respiratory sample type.
Contract value: €23 993 817.65
Contractor: Ginkgo Bioworks Netherlands
Contractor’s country: The Netherlands
Period: 48 months, contract signed on 19/12/2024
Status: Ongoing
2024 P1 05 - Specific Contract under Framework Contract HADEA/2023/OP/0039 - Avian influenza simulation exercise
Objectives
The purpose of the specific contract is to organise a two-day simulation exercise, aimed at exploring public health emergency preparedness and response approaches and countries’ interactions to the topic of the spill-over, cross-border spread and increase in magnitude of avian influenza in humans.
Contract value: €156 000
Contractor: PRICEWATERHOUSECOOPERS EU SERVICES EESV
Contractor’s country: Belgium
Period: 6 months, signed on 11/10/2024
Status: Finalised
Results/achievements:
On 9 and 10 December 2024, the European Commission with the technical support of ECDC (European Centre for Disease Prevention and Control) and EFSA (European Food Safety Authority) delivered a two-day simulation exercise with representatives from EU countries to explore public health emergency preparedness and response approaches and countries’ interactions on the spill-over, cross-border spread and increase in the magnitude of avian influenza in humans.
SC 2023 P3 04 - Support to NCAPR (National Competent Authorities on Pricing and Reimbursement) in implementing the Pharmaceutical Strategy for Europe ’s Affordability Agenda
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 and results
The purpose of the contract is to support the implementation of the Pharmaceutical Strategy for Europe and the Communication on Addressing Shortages in the EU by providing logistic, knowledge and administrative support to the cooperation in the group of National Competent Authorities on Pricing & Reimbursement and public healthcare payers (NCAPR)
This includes the organisation and facilitation of meetings and webinars, the development of a discussion paper as well as the coordination and scientific support to the NCAPR Group.
Contract value: €253 730
Contractor: Intellera Consulting S.P.A. (Leading)
Contractor’s country: Italy
Period: 12 months, contract signed on 19/02/2024
Status: Finalised
Results/achievements:
A consultation conference about the EU guidance on public procurement of medicines was organised fully online on 23 May 2024 with 310 participants from pharmaceutical industries and/or distributors, and from the regulatory/public authority, payer and HTA body.
A multistakeholder event on Biosimilar Medical Products was organised on 5 December 2024 with 146 participants (onsite & online) from 15 EU countries and 2 non-EU-countries.
HADEA/2024/OP/0024 Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Objectives
The aim of this contract is to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up-to-date overview of new and emerging technologies. The contractor will have to screen available sources for identification of novel, emerging technologies, and assess features that may have an impact on medical devices and in vitro diagnostic medical devices, present opportunities, risks or other features related to new and emerging technologies. The need for this horizon scanning has been identified in the context of the implementation of the MDR/IVDR legislation in order to support competitiveness and innovation in the EU market, while ensuring a high level of protection of health for patients and users.
Contract value: €896 400
Contractor: TECHNOPOLIS FRANCE
Contractor’s country: France
Period: 30 months, contract signed on 06/06/2025
Status: Ongoing
Read the contract award notice for more details.
HADEA/2025/OP/013 - Speed up the access to and uptake of an Mpox vaccine
Objectives:
The objective of this contract is to strengthen scientific evidence on the immune response induced by the Modified Vaccinia Ankara–Bavarian Nordic (MVA-BN) vaccine, with a particular focus on the need for and optimal timing of booster doses. The contract covers clinical services for Phase II and/or Phase III trials assessing the immunogenicity of an MVA-BN booster, comparing intradermal and subcutaneous administration. The results are expected to inform vaccination strategies for public health authorities and provide evidence to the European Commission and EU countries to guide policies such as stockpiling and dose-sparing strategies for Mpox vaccination during shortages.
Contract value: €4 900 000
Contractor: FOLKHALSOMYNDIGHETEN
Contractor’s country: Sweden
Period: 36 months, contract signed on 16/06/2025
Status: Ongoing
HADEA/2025/SC/0020 – Specific contract for HERA’s training programme 2025- 2026 (under Single Framework Contracts to support training programmes and tabletop exercises on preparedness and response to cross border health threats including medical countermeasures)
Objectives:
The present contract aims at developing and implementing specific activities of the HERA’s training and exercise programme. In particular, the contractor is requested to design, develop and implement:
- Nine in-person, hybrid or online thematic workshops;
- Ten eLearning modules;
- Two Communities of practice.
HERA’s training and exercise programme is aimed at:
- Reinforcing EU countries' capacities to prepare and respond to cross border health threats and improve overall EU countries’ preparedness and response capacity to cross-border public health emergencies;
- Strengthen coordination and solidarity at EU level, by ensuring clear and swift decision-making processes, and streamlining communication and information sharing on medical countermeasures (MCM);
- Fostering and developing common and innovative policy approaches to secure equitable access and availability of MCM, including in the medium and long-term.
Contract value: €1 498 143.75
Contractor: ICF SA
Contractor’s country: Belgium
Period: 26 months, contract signed on 19/08/2025
Status: Ongoing
Health systems and healthcare workforce
SC 2024 P4 06 - Support to the technical secretariat for the Notified Bodies Coordination Group and Support to the exchange of experience between authorities responsible for Notified Bodies, 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 both the Notified Bodies Coordination Group (NBCG-Med) referred to in Article 49 of Regulation (EU) 2017/745 on medical devices (MDR) and in Article 45 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), and the designating authorities, and in particular:
- 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 2025 between designating authorities, chaired by DG SANTE.
Contract value: € 579 902
Main Contractor: Intellera Consulting S.P.A.
Contractor’s country: Italy
Period: 19 months, contract signed on 26/02/2025
Status: Ongoing
300115871 Study on quantitative methodology for health impact assessments
Objectives:
Conduct a comprehensive mapping of existing methods for assessing and quantifying health impacts and review their application based on an analysis of IAs and evaluations recently conducted by the European Commission and where relevant, similar exercises by other public administrations (at national or regional level) or other OECD countries. Evaluate their suitability for implementation at the EU level and specifically within DG SANTE and across the wider Commission.
Analyse the prerequisites for the implementation of identified methodologies at DG SANTE and Commission-wide. Identify potential challenges, data requirements and necessary conditions for successful adoption.
Based on the mapping and analysis, propose a decision tree and applicable methods for assessing and quantifying health impacts in different situations, both easily appliable by non-specialists. This should include recommendations for necessary and reliable data sources and analysis tools.
Pilot the proposed methodologies on anonymised impact assessments and evaluations to demonstrate its potential for enhancing the assessment of health impacts. Use real-world cases to showcase the methodology's effectiveness.
Deliver a finalised and implementable decision tree alongside guidelines for applying potential methods when appraising and quantifying health impacts.
Contract value: €400 000
Contractor: Economisti Associati as leader
Contractor’s country: Italy
Period: 12 months, contract signed on May 14, 2025
Status: ongoing
HADEA/2024/OP/0002 - Programme of Continuous Learning within a European Health Union Professional Network
Objectives:
The EU Health Policy Fellowship programme aims to build a strong network of EU health policy professionals who have a comprehensive understanding of the European Health agenda, contribute to it, integrate it into national policies and help build a strong European Health Union. The programme will include an annual in-service fellowship, online and face-to-face workshops, mentored collaborative research projects, an online platform and an annual forum.
Contract value: €5 million (maximum ceiling)
Contractor: Boston Consulting Group
Contractor’s country: Belgium
Period: 21/08/2024 – 20/08/2028 (48 months)
Status: Ongoing
Read the contract award notice
Specific contract 2024 P4 04 – EU health policy fellowship programme launch – first cohort (Specific contract under framework contract HADEA/2024/OP/0002)
Objectives:
The specific contract aims at:
- Preparing and validating the content of the fellowship programme, organising networking activities, developing workshops content and material, running the workshops and managing an existing online platform to support training, communication and collaborative work;
- Enrolling and supervising, up to one fellow per EU country in the training programme (indicatively 27 fellows).
Contract value: €809 570
Contractor: Boston Consulting Group
Contractor’s country: Belgium
Period: 08/10/2024 – 07/10/2025 (12 months)
Status: Ongoing
Specific contract COM0021/HADEA/2024/079 2024 P4 05 - HTAR Conference 2025
Objectives:
The organisation of a one-day hybrid conference to mark the beginning of the application phase of the HTA Regulation, which will come into force on 12 January 2025.
Contract value: €149 954.32
Contractor: Intrasoft
Contractor’s country: Luxembourg
Period: 10 months, contract signed on 18 December 2024
Contract award notice: N/A
Status: Ongoing
HADEA/2024/OP/0031 - Single Framework contract for joint clinical assessments and joint scientific consultations under Regulation (EU) 2021/2282 on health technology assessment
Objectives
The contracting authority purchases services related to conducting joint clinical assessments and joint scientific consultations in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts referred to in Articles 7(4), 15(1), 20(1), 25(1) and 26(1) of the HTA Regulation, guidance, detailed procedural steps and the timeframe and templates adopted by the HTACG pursuant to Article 3(7), points (d)-(g), and Article 21 of the HTA Regulation.
Contract value: €35
Contractor: Consortium HTA led by the Rijksinstituut voor ziekte- en invaliditeitsverzekering, Institut national d'assurance maladie-invalidité (RIZIV-INAMI)
Contractor’s country: Belgium
Period: 48 months, contract signed on 22/01/2025
Status: Ongoing
Read the contract award notice
Contract reference: 300127488 – 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 (FWCHTAREG-35515) aims to support the conduct of joint clinical assessments (henceforth ‘JCA’) in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on Health Technology Assessment. This action focuses on the implementation of two JCAs for two different medicinal products undergoing evaluation according to the standard centralised procedure in the European Medicines Agency.
Contract value: €700 000
Contractor: RIZIV-INAMI
Contractor’s country: Belgium
Period: 15 months, purchase order signed on 23/05/2025
Status: ongoing
Contract reference: 300128298 – 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 (FWCHTAREG-35810) aims to support the conduct of joint scientific consultations (henceforth ‘JSC’) in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on Health Technology Assessment. This action focuses on the implementation of two JSCs of a medicinal product conducted as a JSC HTA only process and one JSC of a medicinal product in parallel with the scientific advice procedure at the European Medicines Agency.
Contract value: €138 000
Contractor: RIZIV-INAMI
Contractor’s country: Belgium
Period: 8 months, purchase order signed on 23/05/2025
Status: Ongoing
300116620 - Action in Support of Regulatory Coherence Across Substances of Human Origin Based Therapies with Other Legal Frameworks implementing framework Contract No HADEA/2022/OP/0012
Objectives
This action aims at supporting the implementation of new Substances of Human Origins (SoHO) Regulation (Regulation (EU) 2024/1938) and its coherence with other EU legal frameworks. The action will focus on improving interaction and coherence across SoHO and related frameworks through a series of meetings aiming to enhance coordination in scenarios where a SoHO's regulatory status changes or it is combined with technologies from other frameworks.
Contract value: €497 170
Contractor: INTELLERA CONSULTING SPA
Contractor’s country: Italy
Period: 15 months, contract signed on 07/04/2025
Status: ongoing
HaDEA/2024/OP/0029 - Framework contract in cascade for the implementation of pharmaceutical legislation and data-driven policy for medical products
Objectives
This contract aims to support the European Commission in its activities to inform and shape policy making related to the medical products sector (mainly medicinal products and medical devices). The work will involve data gathering and economic analysis of large data sets as well as relevant contextual and sectoral/company account data. The work will aim to provide insight to the contracting authority on the medical products sector such as on how well relevant policies/legislation are performing and how changes in the regulatory framework affect the functioning and structure of the markets including market actors as well as products on the market and their use. Relying on both quantitative and qualitative data, the work will include economic and other analysis of the market development including factors that influence pricing, competition, and market structure and the interaction of key healthcare actors (including patients, healthcare providers, public payers and industry), and the actors within supply chains.
Contract value: €6 000 000 (max. ceiling)
Contractor:
Framework contract in cascade with three contractors ranked as follows:
1. TECHNOPOLIS CONSULTING GROUP BELGIUM
2. KPMG ADVISORY SPA
KPMG ADVISORY NV
OPEN EVIDENCE, SL
3. THE BOSTON CONSULTING GROUP BV/SRL
Period: 48 months, contract signed 24/03/2025
Status: Ongoing
Read the contract award notice.
HADEA/2024/OP/0024 Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Objectives:
The aim of this contract is to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up-to-date overview of new and emerging technologies. The contractor will have to screen available sources for identification of novel, emerging technologies, and assess features that may have an impact on medical devices and in vitro diagnostic medical devices, present opportunities, risks or other features related to new and emerging technologies. The need for this horizon scanning has been identified in the context of the implementation of the MDR/IVDR legislation in order to support competitiveness and innovation in the EU market, while ensuring a high level of protection of health for patients and users.
Contract value: €896 400
Contractor: TECHNOPOLIS FRANCE
Contractor’s country: France
Period: 30 months, contract signed on 6/6/2025
Status: Ongoing
Read the contract award notice.
HADEA/2024/OP/0057 - Organisational support to competent authorities in Member States for the implementation of Regulation 1938/2024 on Substances of Human Origin (SoHO)
Objectives
This call for tenders aims to increase the capacities of EU countries to carry out the necessary activities for the implementation of the Regulation on standards of quality and safety for substances of human origin intended for human application (Regulation (EU) 2024/1938), (henceforth "SoHO Regulation").
More specifically, and to achieve its main objective, the subject of this call for tenders is:
- To assess the current oversight situation in the national/competent authorities and to perform the analysis of the gaps that need to be addressed, to be able to implement the Regulation by EU countries in a harmonised way;
- To give guidance and training to the national/competent authorities within EU countires on the implementation of the Regulation in a harmonised way and to facilitate the future collaboration between the national/competent authorities of the countries. Specifically, this collaboration will lead to benefits such as joint assessments of SoHO preparation authorisations and joint inspections, which could be advantageous for EU countries.
Contract value: €4.620.577,07
Contractor: KPMG Advisory S.p.A.
Contractor’s country: Italy
Period: 30 months, contract signed on 25/08/2025
Status: Ongoing
Contract reference: 300132815 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 (FWCHTAREG-36828) aims to support the conduct of joint clinical assessments (henceforth ‘JCA’) in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on Health Technology Assessment. This action focuses on the implementation of one JCA for one medicinal product undergoing evaluation according to the standard centralised procedure in the European Medicines Agency.
Contract value: €350 000
Contractor: RIZIV-INAMI
Contractor’s country: Belgium
Period: 15 months, contract signed on 25 June 2025
Status: Ongoing
Contract reference: 300141645 – 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 (FWCHTAREG- 40327) aims to support the conduct of joint scientific consultations (henceforth ‘JSC’) in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on Health Technology Assessment. This action focuses on the implementation of one JSCs of a medicinal product conducted as a JSC HTA only process and three 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: 8 months, contract signed on 19/09/2025
Status: Ongoing
300141964 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 (FWCHTAREG - 40541) aims to support the conduct of joint clinical assessments (henceforth ‘JCA’) in accordance with the conditions and procedures set out in the HTA Regulation, Commission implementing acts and guidance, detailed procedural steps and the timeframe and templates adopted by the Member State Coordination Group on Health Technology Assessment. This action focuses on the implementation of six JCAs for five different medicinal products undergoing evaluation according to the standard centralised procedure in the European Medicines Agency.
Contract value: €2 100 000
Contractor: RIZIV-INAMI
Contractor’s country: Belgium
Period: 15 months, contract signed on 26/09/2025
Status: Ongoing
300128878 (under FWC HaDEA/2022/OP/0012) - Services for administrative, logistic and communication support to the Secretariat of the Member State Coordination Group on Health Technology Assessment and HTA Stakeholder network ('HTA Secretariat 3')
Objectives
The purpose of this specific contract is to organise meetings with authorities and stakeholders from EU countries.
Contract value: €249 993.25
Contractors: Intellera Consulting S.P.A.; consortium including Predictby Research and Consulting S.L.U, CECOFORMA SA - Conception, Etudes et Coopération de Formation, and Empirica Gesellschaft für Kommunikations- und Technologieforschung mbH
Main contractor’s country: Italy
Period: 14 months (entry into force: 5/8/2025; implementation: 1/10/2025 - 13/12/2026)
Status: Ongoing
Cancer
SC 2024 P3 01 (Specific Contract under the Framework Contract HADEA/2022/OP/0012) - Administrative, logistic, and scientific support for the Sub-group on Cancer under the PHEG and for the EU-US Health Task Force (Cancer)
Objectives
The purpose of this specific contract is to support the organisation of meetings of the Subgroup on Cancer under the Public Health Expert Group and its thematic groups, as well as the EU-US Health Task Force in the area of cancer. In addition, the contractor will complete scientific papers to help with the implementation of the Cancer Plan as well as manage and animate the expert groups in the Health Policy Platform and scientific webinars.
Contract value: €496 357
(Main) contractor: Intellera Consulting Spa
Contractor’s country: Italy
Period: 24 months, contract signed on 22/07/2024
Status: Ongoing
HADEA/2024/OP/0027 Exploratory study on the provision of care for Adolescent and Young Adult (AYA) cancer patients in the Union
Objectives:
The aim of this study is to map the provision of healthcare to Adolescent and Young Adults (AYA) cancer patients and survivors in all EU countries, Norway and Iceland. Based on the evidence collected, the study will document and analyse the major barriers and enabling factors for the design and provision of quality care before, during and after cancer treatment, but also highlight best practices and innovative approaches. Recommendations for future actions directed at EU countries, Norway and Iceland will be developed by the contractor, with relevant strategies to improve the provision of targeted healthcare to AYA cancer patients and survivors.
Contract value: €797 723.75
Contractor: ICF SA (lead); SPARK LEGAL AND POLICY CONSULTING BV (group member)
Contractor’s country: Belgium
Period: 18 months, contract signed on 2/04/2025
Status: Ongoing
Read the contract award notice.
Digital
SC 2024 P5 01 - Specific contract implemented under the Inter-institutional Multiple Framework Contract in Cascade EASME/2019/OP/0021 - Communication and information activities to support the rollout and use of the planned European Health Data Space (EHDS)
Objectives:
Under this specific contract, the contractor will:
- Prepare a target audience analysis for each stakeholder group, including identifying their needs, interests, and preferred communication channels;
- Define the overall strategy for EHDS communication and information campaigns for each audience group, including key messages, channels and visual ideas;
- Prepare toolkits for each stakeholder group which reflects the communications strategy, in line with the European Health Union visual identity rules of the European Commission's Directorate-General for Communication;
- Test/Pilot the toolkits with each stakeholder group in six counties and adapt based on the feedback received;
- Organise a one-day hybrid high-level conference to raise awareness on the EHDS.
Contract value: €996 164.75
Contractor: NETCOMPANY - INTRASOFT S.A.
Contractor’s country: Luxembourg
Period: 17 months, contract signed on 4/11/2024
Status: Ongoing
Results/achievements:
Contract award notice: N/A
HADEA/2024/OP/0003 - Organisation and implementation of online training activities on the legal framework, deployment, functioning and future development of MyHealth@EU (eHealth Digital Service Infrastructure)
Objectives
The aim of this contract is to organise and implement trainings for MyHealth@EU (formerly known as eHealth Digital Service Infrastructure, eHDSI) on the legal framework, deployment, functioning and future development of the MyHealth@EU infrastructure.
The main objectives of this service contract are to develop:
- The training material to execute the real-time online training sessions;
- An online course for individual learning based on the training material used for the real-time online training sessions;
- The eLearning materials on the legal framework, deployment, functioning and future development of MyHealth@EU for the Foundation, as well as the Practitioner Level.
The training programme and eLearning materials are essential tools to improve knowledge-transfer and raise awareness on MyHealth@EU, as well as to promote a harmonised approach to the deployment and operation of National Contact Points for eHealth (NCPeH).
Contract value: €450 000
Contractor: PRICEWATERHOUSECOOPERS (group leader), INTEGRATING THE HEALTHCARE ENTERPRISE CATALYST (group member)
Contractor’s country: Luxembourg
Period: 36 months, contract signed on 10/10/2024
Status: Ongoing
Read the contract award notice.
300110828 - Compliance checks for HealthData@EU and Secure Processing Environments in the European Health Data Space (Specific contract under DIGIT/2020/OP/0005 BEACON FWC)
Objectives:
This contract supports the Commission to better understand how to conduct the compliance checks of the participants in the secondary use of health data within the European Health Data Space. This implies analysis of requirements, analysis of candidate methodologies, design of compliance frameworks and piloting of compliance check activities. The actual performance of the compliance checks will be carried out under another action.
The specific objectives of the contract are:
- Objective 1: Design compliance check frameworks for participants of HealthData@EU and operators of Secure Processing Environments;
- Objective 2: Increase Commission’s and stakeholders’ understanding and capacity to conduct compliance checks of participants of HealthData@EU and Secure Processing Environments;
- Objective 3: Ensure sound project management, by adopting PM2 project management methodology and adjust it to the project specific needs and ensure business continuity, namely by designing and executing a structured handover plan.
Contract value: €1 092 516.24
Contractor: ERNST & YOUNG CONSULTING
Contractor’s country: Belgium
Period: 18 months, contract signed on 07/04/2025
Status: Ongoing
Specific contract No 300137710 under FWC HADEA/2022/OP/0012 ‘Technical and administrative support for groups and communities on digital health and the European Health Data Space’
Objectives
This specific contract aims to provide administrative and secretarial support in managing the groups and governance bodies contributing to the implementation and operation of the European Health Data Space (EHDS) Regulation and other digital health initiatives.
Contract value: € 497 277.50
Contractor: INTELLERA CONSULTING SPA
Contractor’s country: Italy
Period: 6 months, contract signed on 1/9/2025
Status: Ongoing
HADEA/2024/OP/0014 Support centre for the European electronic health record exchange Format (EEHRxF) and for the interoperability and security of electronic health record systems
Objectives
The objective of this action is to set up and operate a support centre to advance the adoption of the European electronic health record exchange Format (EEHRxF) and key aspects such as the interoperability and security of EHR systems towards the implementation of the European health data space (EHDS). The support centre will provide services to implementers intending to ensure compatibility of their systems with the EHDS requirements.
Contract value: €4 095 000.97
Contractor: ERNST & YOUNG CONSULTING BV
Contractor’s country: Belgium
Period: 36 months, contract signed on 19/08/2025
Status: Ongoing
Telemedicine
HADEA 2024 P4 01 - Study on the applicability of existing Union legislation to telemedicine services
Objectives
The general objective is to explore the dynamics of telemedicine, with an emphasis on legal frameworks, its general role, its role in mental health care and psychological support, and its impact on the health workforce.
Specific objectives include:
- Assessing the legal bases for telemedicine in the EU and in MSs and EEA countries and investigating the potential impact of newly adopted Union legislation, such as the European Health Data Space Regulation;
- Evaluating the effectiveness of telemedicine in delivering mental health care and psychological support;
- Investigating the impact of telemedicine on the health workforce, including training needs and opportunities, role adjustments, administerial adjustment and professional satisfaction;
- Mapping the currently available technological solutions with their different functions and their availability in the EU and EEA countries.
Contract value: €163 962.50 EUR
Contractor: ICF SA
Contractor’s country: Belgium
Duration of the contract 12 months
Start date: 06/11/2024
Status: Ongoing
Health promotion and disease prevention
HADEA/2025/SC/0021 - Operation of the Technical Group for the assessment of tobacco characterising flavours, including maintenance of the group of sensory assessors - 2025-2026 (under the 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 impart a characterising flavour other than tobacco.
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. In view of the substantial change of circumstances regarding heated tobacco products, Article 7(12) of Directive 2014/40/EU has been amended in order to extend the prohibition of the placing on the market of tobacco products with a characterising flavour that already exists for cigarettes and roll-your-own tobacco, to heated tobacco products.
Contract value: €607 200
Contractor: University of Crete
Contractor’s country: Greece
Period: 12 months, contract signed on 04/06/2025
Status: Ongoing
Specific Contract 300137711 - EU-level event on patients’ rights in CBHC and ERNs implementing SuSerMEG - HADEA/2022/OP/0012 - FWC for support services
Objectives
This specific contract aims to organise a one-day EU-level event to present the outcome of national workshops on cross-border healthcare provision and newly prepared communication material. The event aims to further raise awareness on patients’ rights in the field, promote active participation, bridge the gap between policy efforts and public understanding, and foster a more inclusive approach for the implementation of the cross-border health care Directive (2011/24/EU), including the European Reference Networks.
Contract value: €146,414.50
Contractor: INTELLERA CONSULTING SPA (group leader) + 3 group members
Contractor’s country: Italy (leader)
Period: 7 months, contract signed on 5/9/2025
Status: Ongoing
Recurrent, horizontal, IT and communication activities
HADEA/2025/OP/0012 - Multiple framework contracts in cascade for legal support services for the compliance assessment of national transposing measures in the health and food safety areas, in the context of the enlargement
Objectives
The subject of this call for tenders is the conclusion of multiple framework contracts in cascade for the provision of legal support services in the field of compliance assessment of national transposing measures, in the health and food safety areas, in the context of the enlargement.
Contract value: €5 67 0 00
(Main) contractor: To be decided
Contractor’s country: N/A
Period: 48 months, invitation will be launched on 25/03/2025
Status: Pre-launching
HADEA/2025/VLVP/0027 - Data elaboration and development of reports on Emerging Health Technologies (EHT) in accordance with Article 22 and Article 30 of Regulation (EU) 2021/2282 on Health Technology Assessment (‘HTA EHT Subgroup: data & reporting’)
Objectives
Article 22 of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (HTA Regulation) provides for the preparation of reports on the emerging health technologies expected to have major impact on patients, public health or healthcare systems. Those reports shall address, in particular, the estimated clinical impact and the potential organisational and financial consequences of Emerging Health Technologies (EHT) for national healthcare systems. Those reports cover medicinal products, medical devices (MDs) and in vitro diagnostic medical devices (IVDs).
The EHT subgroup of the HTA Coordination Group needs support for carrying-on tasks in the context of triangulation of data coming from different sources and drafting the EHT annual reports, referred to in Article 22 of the HTA Regulation.
Contract value: €14 999
Contractor: ST. JAMES'S HOSPITAL BOARD
Contractor’s country: Ireland
Period: 6 months, contract signed on 25/08/2025
Status: Ongoing