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European Health and Digital Executive Agency (HaDEA)

Contracts - EU4Health 2024 Annual Work Programme

Crisis preparedness

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. 

Health systems and healthcare workforce

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: 

  1. 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;
  2. 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: €30 million (ceiling)

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 January 2025

Status: Ongoing

Read the contract award notice 

 

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: €497170

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

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:  €496357.00

(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: €797723.75

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:  

  1. The training material to execute the real-time online training sessions; 
  2. An online course for individual learning based on the training material used for the real-time online training sessions; 
  3. 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

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 

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:  EUR 5 670 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