Contracts - EU4Health 2023 Annual Work Programme

Crisis preparedness

HADEA/2023/P1/01 (Specific contract under the Framework contract CHAFEA/2018/HEALTH/03) - EU reference laboratories (I): support the set-up and operation of the EU reference laboratories for the Diagnostics of Human Pathogens Network (Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU)   

Objectives:

The objective of this contract is to support the designation and implementation of the future EU reference laboratories (EURLs) in the area of public health/human pathogens.

The main tasks are to support the European Commission and ECDC in their on-going mapping of existing networks and ongoing activities in the EU, from which learning can be extracted on how to set up and implement EURLs for human pathogens as well as to identify gaps and potential for overlap. And to also support the European Commission and ECDC with stakeholder consultations on issues related to the implementation of EURLs. This may include the collection of information on activities carried out under existing laboratory networks (including those operated by ECDC and other relevant EU actions) as well as on future laboratory networks (including those to now operated by DG HERA).

Contract value:   €295 000

Contractor: Stichting Nederlands Instituut voor Onderzoek van de Gezondheidszorg (Netherlands Institute for Health Services Research - NIVEL)

Contractor’s country: The Netherlands

Period: 20/04/2023 - 19/11/2023 (7 months)

Status: Finalised

HADEA/2023/P1/02 (Specific Contract under Framework Contract CHAFEA/2018/HEALTH/03) - Training on management of medical countermeasures: public procurement in times of crisis

Objectives:

The purpose of this contract is to organise advanced training workshops on public procurement of medical countermeasures, and on medical countermeasures’ stockpiling management and operations, with the aim of strengthening knowledge and skills on preparedness and response to medical countermeasures. The workshops’ programmes expose participants to the different aspects of medical countermeasures’ procurement and stockpiling, covering preparedness and response, using case studies and best practices, with a hands-on and interactive approach.

Contract value: €  332 022

Contractor: Stichting Nederlands Instituut voor Onderzoek van de Gezondheidszorg (Netherlands Institute for Health Services Research - NIVEL)

Contractor’s country: The Netherlands          

Period:  20/04/2023 - 19/11/2023 (7 months)

Status: Finalised

SC 2023 P1 04 - Setting up of an advisory committee (ad-hoc operation in case of potential emergencies) (Regulation (EU) 2022/2371 of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU) - Advisory Committee for Public Health Emergencies - implementing the framework contract for services number - HADEA/2022/OP/0012

Objectives:

The purpose of this contract is to provide logistic, knowledge and administrative support services to Directorate General for Health and Food Safety (DG SANTE) in its role as the Secretariat of the Advisory Committee for Public Health Emergencies.

Contract value: €438 131      

Main contractor: Intellera Consulting S.P.A.

Contractor’s country: Italy       

Period: 48 months, signed on 04/10/2023

Status: Ongoing

HADEA/2022/P5/01 (Specific Contract under the Framework Contract HADEA/2022/OP/0012 (PHEG 1)) - Disease preventions - Support Services for the Mental Health Expert Group on Public Health (MH-PHEG) I

Objectives:

The purpose of this specific contract is to support:

• The organisation of maximum 2 physical meetings, 4 webinars, 3 studies, 2 scientific webinars
• The preparation of 2 discussion papers and 1 survey on health topics

This will allow Member States to discuss priority areas in the field of mental health and address the concrete actions. The contractor will draw a list of promising and best practices. One of the key responsibilities of the contractor is to identify and compile a list of promising and best practices from the submitted entries. The contractor will then carefully review and evaluate the practices based on predefined criteria or guidelines.

Contract value: €500 000 

(Main) contractor: Intellera Consulting Spa 

Contractor’s country: Italy       

Period: 13/09/2023 - 31/05/2025 (20 months)                    

Status: Ongoing

SC 2023 P3 01 - Enhancing the implementation of the Directive on Patients' Rights in Cross-Border Healthcare

Objective:

The objective of the contract is to inform the stakeholders who might be potentially concerned by an EU citizen’s decision to seek healthcare abroad, (such as healthcare professionals, healthcare providers, payers, national/local administrations, patients’ organizations, etc.) about their rights and the Directive’s provisions. The action shall also raise awareness about the European Reference Networks (ERNs), and the existing possibilities for patients affected by a rare or low prevalence and complex diseases and conditions to obtain a consultation with an existing ERN.

The contractor will assist the Commission by performing three main tasks:

• Organisation of up to 10 national workshops in EU countries
• Organisation of one EU-level event in Luxembourg for the representatives of EU countries
• Costumisation and further adaptation of the communication materials on the Directive on patients’ rights and ERNs

Contract value: €499 815.18

Contractor: Netcompany-Intrasoft

Contractor’s country: Greece

Period: 30/10/2023 - 29/04/2025 (18 months)                    

Status: Ongoing

SC/2023/P3/04 (Specific contract based on framework Contract No HADEA/2022/OP/0012 - Multiple Framework Contracts in cascade for support services to manage expert groups in the field of health 2023-2025) - Support to NCAPR in implementing the Pharmaceutical Strategy for Europe's Affordability Agenda

Objectives:

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

Main contractor: Intellera Consulting Spa 

Contractor’s country: Italy

Period: 19/02/2024 - 19/02/2025 (12 months)                    

Status: Ongoing

HADEA/2023/P1/03 - specific contract implementing framework contract SANTE/2021/OP/0002: Study on Gap analysis on knowledge and skills and recommendations for future training needs on Medical Countermeasures

Objectives: 

The contractor will carry out a study to allow HERA to design its training strategy and implement an efficient training programme, and ensure its complementarity and EU added value. The study will: 

1. Report on training needs and target groups to be reached, with clear identification of needs, gaps and existent offer available to EU Member States in line with HERA’s mandate and objectives; 
2. Provide recommendations for HERA’s strategy and training programme with a roadmap for implementation.

Contractor: ICF SA

Contractor’s country: Belgium

Period:  9 months (+ 2 months extension/amendment by contract), contract signed on 11/10/2023

Status: Finalised 

HADEA/2023/OP/0036 - Speed up the development of and access to innovative medical countermeasures - LOT 1 - Vaccines to combat antimicrobial resistance (AMR)

Objective: 

The scope of the call for tenders focuses on the speed-up of the development of promising vaccines, medicinal products and diagnostics, that are indicated to diagnose/detect, prevent, protect from, or treat conditions associated to serious cross-border health threats and to the acquisition of the priority right to purchase to ensure access to the investigational medicinal products (IMPs) and products.

Contract value: €12 593 449              

Contractor: BIOFABRI S.L.U.

Contractor’s country: Spain    

Period: 48 months, contract signed on 27/05/2024

Status: Ongoing

Read the contract award notice to learn more.

2023 P1 05 - Training on management of medical countermeasures for preparedness and response to cross border health threats

Objectives:

The contract will support the implementation of seven thematic trainings on selected topics related to the development, production, procurement and distribution of medical countermeasures for preparedness and response to cross border health threats.

Contract value: €592 932 

Contractor: INTELLERA CONSULTING SPA

Contractor’s country: Italy        

Period: 14 months, contract signed on 11/04/2024

Status: Ongoing

HADEA/2023/OP/0036- Speed up the development of and access to innovative medical countermeasures - LOT 1 - Vaccines to combat antimicrobial resistance (AMR)

Objectives 

To speed up the development of vaccine candidates targeting bacterial infections as an alternative treatment strategy to address the rising incidence of AMR. Such vaccines offer a potential solution by preventing infections and consequently reducing the use of antibiotics.

Contract value: €12 593 

Contractor: BIOFABRI S.L.U.

Contractor’s country: Spain        

Period: 48 months, contract signed on 27/05/2024

Status: Ongoing

Read the contract award notice.

HADEA/2023/OP/0052 - Speed-up the development, availability, and access to anti-tuberculosis medicines for children

Objectives

The contract aims at purchasing services to speed up availability and access in the EU to age-appropriate anti-tuberculosis medicines. To achieve this goal, the contractor will carry out clinical and/or non-clinical services for finalising the development and submitting the market authorization for the concerned products for their commercialisation in the EU.

Contract value: €5 000 000

Contractor: MACLEODS PHARMA ESPANA SLU

Contractor’s country: Spain                      

Period: 48 months, contract signed on 02/08/2024

Status: Ongoing

Read the contract award notice.

HaDEA/2023/P1/06 - Feasibility study on integrated surveillance systems on antimicrobial resistance (AMR) and antimicrobial consumption (AMC) encompassing human health, animal health, plant health, food, wastewater and the environment

Objectives

The main objective of the study is to define the necessary elements for the design and implementation of effective integrated One Health surveillance systems on AMR and AMC at national level in the EU/EEA.

The study is expected to identify barriers and key enablers for integrated surveillance systems in order to propose solutions and support EU/EEA countries to develop integrated systems for the surveillance of AMR and AMC encompassing human health, animal health, plant health, food, wastewater and the

environment (in particular water and soil).

Contract value: €334.800

Contractor: Open Evidence SL

Contractor’s country: Spain  

Period: 10 months, contract signed on 18/09/2024

Status: ongoing

HADEA/2023/P1/07 - Specific Contract under Framework Contract HADEA/2023/OP/0039 - Simulation exercise on medical countermeasures readiness and response to a natural cross-border threat to health

Objectives

The purpose of this contract is to organise a 1-day simulation exercise based on a non-intentional/natural biological threat scenario with pandemic potential. The exercise requested is required to focus on a non-intentional event but will consider a different biological threat and will aim at exercising decision making at EU-level.

Contract value: €339 500

Contractor: PRICEWATERHOUSECOOPERS EU SERVICES EESV

Contractor’s country: Belgium          

Period: 12 months, contract signed on 11/12/2024 

Status: Ongoing

SC 2023 P4 01 - Operation of the Technical Group for the assessment of tobacco characterising flavours, including maintenance of the group of sensory assessors - 2024-2025 under Single Framework Contract No HADEA/2023/OP/001

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 European Parliament and of the Council on Tobacco Products Directive, which provides that Member States shall prohibit the placing on the market of tobacco products with characterising flavours.

Contract value: €627 200

Contractor: University of Crete

Contractor’s country: Greece

Period: 12 months, contract signed on 10/07/2024 

Status: Ongoing 

Health systems and healthcare workforce

SC 2023 P3 02 - Technical and administrative support to the Medical Device Coordination Group (MDCG)- implementing the framework contract for services number - HADEA/2022/OP/0012

Objectives: 

The purpose of this specific contract is to ensure a coherent implementation of the Regulations (EU) 2017/745 (MDR) and 2017/7464 (IVDR) by providing administrative support to the operation of the Medical Device Coordination Group (MDCG) meetings and MDCG sub-group meetings.

Contract value: €249 135      

Main contractor: Intellera Consulting S.P.A.

Contractor’s country: Italy       

Period: 1/09/2023 – 1/01/2026 (28 months)

Status: Ongoing

SC 2023 P3 03 - Support to the technical secretariat for the Notified Bodies Coordination Group, 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 to 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 to assist the Chairpersons of the NBCG-Med in carrying out technical-related duties.

Contract value: €298 867.50 

Main Contractor: Intellera Consulting S.P.A.

Contractor’s country: Italy       

Period: 14 months, contract signed on 20/09/2023

Status: Ongoing

Specific Contract HaDEA 2023 P3 04 - Support to NCAPR in implementing the Pharmaceutical Strategy for Europe's Affordability Agenda, implementing the framework contract for services HADEA/2022/OP/0012 

Objectives: 

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: Predictby Research and Consulting S.L.U.

Contractor’s country: Spain                      

Period: 12 months, contract signed on 19/02/2024

Contract award notice: NA 

Status: Ongoing

HADEA/2023/OP/003 - Building capacity and knowledge for the implementation of the EU Health Technology Assessment Regulation

Objectives: 

Regulation (EU) 2021/22821 (hereinafter referred to as “HTAR”) on health technology assessment (hereinafter referred to as “HTA”) will be applicable from January 2025. This action sets out training and capacity building measures to support the implementation of the HTAR.

This contract aims to: 

1. Provide training services to ensure EU Health Technology Assessment (HTA) agencies consolidate their knowledge and experience on joint HTA work; 
2. Establish a competency framework on the technical expertise required for carrying out joint clinical assessments (JCAs) and join scientific consultations (JSCs) for both medicinal products and medical devices.

The trainings include online classes, recorded modules and tutoring, and will provide a better understanding of the HTAR, including the framework of joint HTA, the methodology, procedural rules, and timeframes for the preparation of JCAs and JSCs.

The established competency framework for assessors and experts involved in joint clinical assessments and scientific consultations will be used as a guide for national and regional HTA bodies to help them recruit or identify the appropriate personnel with the necessary skills and competencies to perform the required tasks. 

Contract value: €918 220

Contractors: The ‘HAG-INSIGHT’ Consortium, led by AGENAS (Agenzia Nazionale per i Servizi Sanitari Regionali)

Contractors' countries: The consortium members are based in 9 Member States and 1 EFTA country. The consortium leader is based in Italy, and other consortium members come from AT, EL, ES, IE, NL, PT, SE, SI  as well as NO.             

Period:  28 months, contract signed on 10/10/2024

Status: Ongoing

Contract award notice: N/A

Contract No HADEA- SC 2023 P5 01 under FWC No HADEA/2021/OP/0012

Re-evaluation of 72 Healthcare Providers (HCP) following the 2023 fifth-year Independent Evaluation of European Reference Networks and Healthcare Providers

Objectives

The purpose of the service is for the contractor, as independent evaluation body, to perform technical re-evaluations of the 72 Healthcare Providers (HCPs) that submitted improvement plans, in line with Article 12 of Directive 2011/24/EU on patients' rights in cross-border healthcare. 

Contract value: €362 977.90 

Contractors: IDOM, Consulting, Engineering, Architecture, S.A.U. (leader) and Fundación Pública Andaluza Progreso y Salud (partner) 

Contractors' country:  Spain

Period: 7 months, contract signed on 10/7/2024 

Status: Ongoing

Digital

HADEA/2023/OP/0024 — Capacity building for Secondary Uses of Health Data for the European Health Data Space (EHDS)

Objectives: 

The aim of this service contract is to strengthen the skills of staff in health data access bodies (HDABs), and standardise the skills of European Health Data Space (EHDS) ambassadors, i.e. people with a platform/channel to reach out to stakeholders engaged on secondary use of health data, through knowledge creation, transfer, and best practices exchange among EU countries, on five digital business capabilities, all of which are crucial for the secondary use of health data in the perspective of the EHDS. The requested services include the preparation of training materials and delivery of trainings, the preparation of materials to support local implementations, including a twinning approach. Additionally, the requested services include verification and monitoring local implementations. This capacity building intervention is expected to facilitate, accelerate, and harmonise the implementation of the European Health Data Space provisions related to the secondary use of health data.

Contract value: €1 184 288.90

Contractors: NTT DATA Belgique SRL (group leader), Predictby Research and Consulting, S.L.U. (group member) and empirica Gesellschaft für Kommunikations- und Technologieforschung mbH (group member).

Contractor’s country: Belgium, Spain, Germany. The group leader is based in Brussels, Belgium.

Period: 36 months, contract signed on 03/04/2024

Status: Ongoing

Read the contract award notice to learn more. 

Cancer

Specific contract 2023 P2 01 - (PHEG 2) - Support services for Public Health Expert Group - Implementation of Europe's Beating Cancer Plan, including the evaluation study 'Use of sunbeds and cancer risk' (under Framework Contract HADEA/2022/OP/0012)

Objectives: 

The objective of this specific contract is for the contractor to organise 15 meetings of the Subgroup on Cancer and its Thematic Groups under the Public Health Expert Group (PHEG) and to organise and moderate two scientific webinars. 

In addition, the contractor will complete six studies, i.e. three background documents as well as three discussion papers to help with the implementation of the Cancer Plan as well as manage and animate the expert groups in the Health Policy Platform.

Contract value: €430 696

Contractor: Intellera Consulting S.P.A., Predictby Research and Consulting S.L.U., CECOFORMA SA, Empirica

Contractor’s country: Italy, Spain, Belgium, Germany              

Period: 24 months, contract signed on 22/08/2023 

Status: Ongoing 

HADEA/2023/OP/0038 - Study on the quality of life of cancer patients and survivors.  

Objectives:

The subject of this call for tenders is to conduct a study across all 27 EU Member States, Iceland and Norway, to identify common indicators for data collection across those countries that can be used to measure the progress on level of quality of life of cancer patients and survivors. On the basis of the identified indicators and evidence collected, the study will document and analyse the major inequalities detected across countries concerning the quality of life of cancer patients and survivors and how those inequalities are addressed. Recommendations developed by the contractor will be directed at Member States, Iceland and Norway with the relevant strategies for improving the quality of life of cancer patients and survivors, for reducing inequalities across countries and for improving data collection. 

Contract value: €1 283 213

Contractors: Joint tender led by PRICEWATERHOUSECOOPERS EU SERVICES EESV, Open Evidence SL, ondazione IRCCS Istituto Nazionale dei Tumori

Contractors' countries: Belgium, Spain, Italy          

Period: 24 months, contract signed on 18/10/2024

Status: Ongoing

Read the contract award notice. 

SC 2023 P2 02 - Study on the implementation of EURATOM and Union legislation with respect to medical devices emitting ionising radiation implementing (under Framework Contract SANTE/2021/OP/0002)

Objectives:

The objective of this specific contract is to analyse the interrelations and implementation of the current legal framework governing the lifecycle of radiation-emitting medical devices. Feedback will be gathered from different groups of stakeholders on the implementation of quality and safety aspects of this legal framework, and on the difficulties encountered in their implementation.

In addition, the contractor will identify best and worst practices in cooperation between the stakeholders identified above. Best practices will be promoted by drafting and publishing recommendations to highlight methods of good cooperation between concerned stakeholders and possibilities for future improvement.

Contract value: €298 850

Contractors: ECORYS EUROPE, TECHNOPOLIS, EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG, MILIEU CONSULTING, ARCADIA INTERNATIONAL, STICHTING WAGENINGEN RESEARCH

Contractors' countries: Belgium, the Netherlands, Germany

Period: 24 months, contract signed on 11/07/2024

Status: Ongoing

Contract award notice: N/A