Signed contracts - EU4Health 2021 Annual Work Programme

Area of action 1: Crisis preparedness

HADEA/2022/OP/0002 - Service contract for a study on guidance on methodologies to assess the performance of vaccination programmes

Objectives

On 1 September 2022, HaDEA signed a service contract with a group of economic operators, namely Technopolis B.V., Schuttelaar & Partners, Consultancy for Food and Life Sciences NV and Stichting Nederlands Instituut voor Onderzoek van de Gezondheidszorg.

The contractors are expected to:

• Carry out a mapping of existing methodologies to monitor the performance of all vaccination programmes in EU countries;
• Develop a set of recommendations with a view to improving the identified methodologies;
• Organise a one-day conference with all EU competent national authorities;
• Finalise the set of recommendations, translate and disseminate these to all EU countries. 

Contract value: 
€645 000

Contractor:
Technopolis B.V., Schuttelaar & Partners, Consultancy for Food and Life Sciences NV and Stichting Nederlands Instituut voor Onderzoek van de Gezondheidszorg         

Period: 
01/09/2022 – 29/02/2024  

Status: Finalised

Results achieved: 

• A set of recommendations for EU countries on how to address the gaps identified during the mapping of methodologies to monitor the performance of vaccination programmes;
• Seven methodologies for the monitoring of the performance of vaccinations programmes identified and described: Electronic Vaccine Registers (EVR)/IIS, administrative data, national surveys, social listening, embedded studies, research collaborations, and using surveillance systems;
• 24 EU countries considering to implement one or several options developed in this study. 

Read the contract award notice and the final report to learn more.

HADEA/2021/OP/0005 - A study on bringing AMR medical countermeasures to market

Objectives

On 24 February 2022, HaDEA signed a service contract with PricewaterhouseCoopers EU Services for the preparation of a study on “Bringing AMR medical countermeasures to market”.                    

This study is aimed at collecting evidence and providing options for action to help bring more antimicrobial resistance medical countermeasures (AMR MCMs) to market in the European Union. Evidence collected will include a technological review of the AMR MCMs (e.g. medicines - including vaccines and medical devices), gathering evidence from the literature and detailing the potential of its usefulness, a gap analysis and an assessment of the needs of the EU Member States and key stakeholders. The study is also expected to develop options for action including appropriate operational, funding and support mechanisms under HERA and to identify tools ensuring that any safe and effective product brought to market with EU support is also immediately available to EU countries in the event of a public health emergency.

Contract value: €900 000 

Contractor: PricewaterhouseCoopers EU Services                           

Contractor’s country: Belgium           

Period: 24/02/2022 – 23/11/2022 (9 months)    

Status: Finalised

Results achieved: the contractor provided a review of the AMR MCMs, a needs assessment in EU countries and amongst stakeholders, and a cost estimation and options for action, with the aim of bringing more AMR MCMs to market in the EU. 

Read the contract award notice, the interim report and final study to learn more. 

HADEA/2021/OP/0006 - Feasibility study on stockpiling of medical countermeasures in the area of AMR

Objectives

On 11 March 2022, HADEA signed a service contract with McKinsey Solutions. The overall aim of this contract is to conduct a feasibility study and analysis on stockpiling solutions (physical vs other) of medical countermeasures for antimicrobial resistance (AMR).

The service contract covers elements, such as:

1. Identification and assessment of options for stockpiling (physical vs virtual alternatives);
2. Assessment of needs and availability of AMR countermeasures, both at Member State and EU level;
3. Mapping and assessment of relevant stockpiling systems of different kinds, which are already operated at EU and/or global level (e.g. WHO);
4. Identification of appropriate funding mechanisms, including procurement options;
5. Identification and assessment of operational deployment mechanisms;
6. Liability and regulatory aspects/constraints.

Contract value: €824 000

Contractor: McKinsey Solutions

Contractor’s country: Belgium           

Period: 11/03/2022 – 10/09/2022 (6 months)

Status: Finalised

See the contract award notice to learn more.

Results achieved: 

The contractor assessed stockpiling and procurement options, concluding that the most feasible means of stockpiling against supply chain disruptions may be identified as increases in private sector inventories. This could be complemented by virtual stockpiling in the shape of a transparent platform to disclose antibiotic shortages and product availability, while physical stockpiling against current and future shortages would – at the current level of supply chain transparency – require broad product coverage and thus likely be complex and costly. Read the final report for more information: D1-D5 and D6/D7. 

HADEA/2021/OP/0007 - Service contract for the design of flexible EU manufacturing and innovation capacity of medical countermeasures for serious cross-border threats to health

Objectives

On 30 March 2022, HADEA signed a service contract with McKinsey Solutions. The overall aim of this contract is to assesses the scientific, engineering, legal and economic considerations for the implementation and maintenance of a flexible (multi-technology) EU manufacturing and innovation capacity for medical countermeasures for serious cross-border threats to health. The creation of this flexible EU manufacturing and innovation capacity should allow surge and scalable manufacturing of needed medical countermeasures in the case of a health emergency.

Contract value: €2 700 000                         

Contractor: McKinsey Solutions

Contractor’s country: Belgium           

Period: 30/03/2022 – 27/02/2023 (11 months)              

Status: Finalised

See the contract award notice and final study to learn more.

HADEA/2021/OP/0009 - Feasibility study, design and prototype development for a mapping platform on COVID-19 therapeutics in the EU

Objectives

The general objective of this service contract is to gather all the information on the developments, production capacity and supply of COVID-19 therapeutics in the EU, including products in research and development phases.

In addition, the contractor is expected to design an IT mapping platform prototype to regroup, store and visualise such information. The mapping platform prototype includes a module in order to not only incorporate COVID-19 therapeutics, but also a wider range of products that might be needed for preparedness and response to any further public health threat.

The platform prototype has been handed over to the Commission with training material to help ensure its sustainability.

Contract value: €3 890 000                         

Contractor: Deloitte Consulting & Advisory BV

Contractor’s country: Belgium           

Period: 07/04/2022 – 06/12/2022 (9 months)    

Status: Finalised

See the contract award notice and final study to learn more.

HADEA/2021/OP/0010 - Service contract to identify obstacles to vaccination of physical, practical or administrative nature and develop recommendations

Objectives

The main objective of this service contract is to provide support to EU countries in overcoming obstacles to vaccination of physical, practical and administrative nature, with a view to increase vaccination coverage rates in the EU.

The contractor is expected to map vaccination services in all EU Member States to identify obstacles to vaccination of physical, practical and administrative nature. Best practices in volunteering EU Member States are being piloted. By the end of the contract, final recommendations for overcoming obstacles to vaccination of physical, practical and administrative nature will be delivered to the European Commission.

Contract value: €5 051 963                         

Contractor: Kantar Belgium                            

Contractor’s country: Belgium           

Period: 14/07/2022 – 13/07/2025 (36 months)  

Status: Ongoing

Website 

See the contract award notice to learn more.

Results achieved:

Since its launch in 2022, the Overcoming Obstacles to Vaccination project has completed tasks involving 

• The identification of obstacles encountered during citizens’ vaccination journeys across the EU;
• The identification and classification of exemplary practices to overcoming such obstacles promoted by Health Authorities
• The development of a communication plan to promote findings through different communication channels (e.g. LinkedIn page and a multilingual website) and inform about ongoing developments of the project, 
• The design and implementation of 9 pilots. 

HADEA/2021/OP/0011 - EU Immunisation Initiative: Service contract for systematic reviews of scientific evidence on vaccines and capacity building activities NITAG

Objectives

The contractor supports the activities of the EU/EEA National Immunisation Technical Advisory Groups’ (NITAG) Collaboration by conducting systematic reviews of scientific evidence on vaccines including COVID-19. Capacity-building activities fall also under the remit of the service contract.

The ultimate goal of the service contract is to support EU Member States in their decision-making on national vaccination programmes, including COVID-19 vaccines and any adaptations of those vaccines due to the emergence of SARS-CoV-2 variants.

Contract value: €1 967 800                         

Contractor: Universitatsklinikum Freiburg              

Contractor’s country: Germany         

Period: 09/09/2022 – 08/09/2026 (48 months)  

Status: Ongoing

See the contract award notice to learn more.

Preliminary results: 

• 8 systematic reviews on topics identified and agreed by NITAG and ECDC: 
  • Efficacy, effectiveness, and safety of HPV vaccination in women with conization (CRD42023428998) 
  • Efficacy, effectiveness, and safety of respiratory syncytial virus vaccines (CRD42023439128) 
  • Efficacy, effectiveness and Safety of the 15-Valent Pneumococcal Conjugate Vaccine for Preventing Pneumococcal Infections in Children and Adults (CRD42023440133)
  • Systematic review update on the efficacy, effectiveness and safety of newer and enhanced seasonal influenza vaccines for the prevention of laboratory confirmed influenza in individuals aged 18 years and over (CRD42023441114)
  • Maternal Vaccination against COVID-19, Influenza, Pertussis, and Respiratory Syncytial Virus: A Scoping Review (https://osf.io/v3rgt/)
  • Efficacy, effectiveness and safety of respiratory syncytial virus vaccines: results of the first update of a living systematic review and meta-analysis, 18 May 2023 to 8 April 2024 (review update)
  • Population effects of influenza vaccination in children and adolescents (6 months-17 years) (CRD42024546400)
  • Efficacy, effectiveness, immunogenicity and safety of HPV vaccination in non-HIV immunocompromised individuals – a systematic review and meta-analyses (CRD42024554574)
• Training programme on methodologies for assessing evidence and carrying out reviews, synthesis and evaluations and subsequent transformation into technical documents/guidance (attended by 66 members of NITAG);
• Two Annual EU/EEA NITAG Collaboration Meetings in 2023 and 2024 (at ECDC premises in Stockholm), attended by 89 participants from EU and EEA countries;  
• Four Twinning Exchanges in 2023 and 2024, attended by 24 participants from 6 EU countries.  

HADEA/2021/NP/0004 (exceptional negotiated procedure) - eTravel tool (Healthy Gateways) (including amendment to original contract)

Objectives

This contract aims to support the continuation of the operations of the digital single-entry point and database for e-Travel tool developed by the Joint Action Healthy Gateways, and the hand-over / integration into the EU digital system, including transfer of several supporting tasks to the participating Member States

Contract value: €1 400 000                        

Contractor: Panepistimio Thessalias (University of Thessaly, UTH)

Contractor’s country: Greece

Period: 16/12/2021 – 13/05/2024 (29 months)  

Status: Finalised

HADEA/2022/OP/0017: EU preparedness: analysis, planning, reporting and training programmes for health specialists

Objectives

On 1 November 2022, HADEA signed a service contract with GFA Consulting Group GmbH. The objective of this contract is the development of the EU preparedness training programme and capacity building activities at the EU and national level. The EU preparedness training programme will focus on the development, implementation, monitoring and evaluation of national and EU preparedness plans to strengthen crisis preparedness, and on the rollout of pilot training courses. It will be complemented by capacity building activities at the EU and national level. Moreover, the contractor will produce a study including the analysis of preparedness capacity gaps and training needs and the development of adequate EU preparedness training, adapted to the national and Union level. The study aims to support the development of the training programme and the pilot training courses.

Contract value: €5 450 002.90

Contractor: GFA Consulting Group GmbH

Contractor's country: Germany

Period: 13/12/2022 - 13/12/2025 (36 months)

Status: ongoing

Preliminary results: 

• Study report including the analysis of EU countries' preparedness capacity gaps, type of competencies and training needs;  
• Mapping report of existing preparedness and response training programmes at EU and international level;  
• EU preparedness training programme package, including list of identified contact points, the structure, the methodology of training needs assessment, training curricula, case studies with core and advanced modules and simulation exercises, materials to be distributed to the participants and methods used to deliver the training; 
• 17 workshops, exchange visits, pilot trainings in the first 2 years of implementation. These were attended by 420 participants from EU and EEA countries (public health experts working in health and other sectors and in organisations which contribute to crisis management, including intermediate and national level preparedness planners).

Specific contract BEACON-000075 - assessment of the needs to ensure alignment of the Early Warning and Response System (EWRS) with the regulation on serious cross-border threats to health

Objectives

The purpose of this specific contract is to prepare the alignment of the Early Warning and Response System (EWRS) with the Regulation on serious cross-border threats to health, and to propose technical solutions to strengthen the data security and data protection procedures in compliance with the General Data Protection Regulation, thereby improving the usefulness and efficiency of the EWRS.

The new architecture of the EWRS, to be proposed under this contract, will allow for the utilisation of emerging modern technologies, such as digital mobile applications, artificial intelligence models, space-enabled applications, or other technologies for automated contact tracing.

Contract value: €1 600 516                        

Contractors: NTT Data Belgique and Network Research Belgium SA (NRB)

Contractor’s country: Belgium           

Period: 16/01/2023 – 15/01/2024 (12 months)              

Status: Finalised

Specific Contract 2021-P1-03 under the framework contract CHAFEA/2018/HEALTH/03 - feasibility study on contact-tracing tools and applications used at national and EU level and integration within EWRS, selective exchange module

Objectives

The subject of this specific contract is the assessment of the lessons learnt with the COVID-19 large-scale cross-border contact tracing practice at national, EU and International level. To do so, the contractor will analyse the cross-border contact tracing management, asses the feasibility of contact tracing tool to support prevention and control of other transmissible diseases.

Moreover, the contractor is asked to carry out a survey about the use, gaps, and ways to improve cross-border contact tracing performance and will also review the need/impact of particular legal arrangements and improvements required to allow effective cross-border contact tracing always at international, national or subnational level.

Contract value: €319 400                           

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

Contractor’s country: The Netherlands          

Period: 10/06/2022 – 09/07/2023 (13 months)  

Status: Finalised

Specific contract 2021-P2-02 under the framework contract CHAFEA/2018/HEALTH/03 Europe's Beating Cancer Plan - subgroup on cancer and thematic group on comprehensive cancer infrastructures

Objectives

The tasks requested from the contractor are to support the monitoring of the implementation of the plan, to organise sub-group meetings on cancer to consult with Member States. The contractor is requested to support the organisation of 12 meetings of the Subgroup on Cancer and its Thematic Group on Comprehensive Cancer Centres. In addition they are requested to prepare three studies to help with the implementation of the Cancer Plan.

Contract value: €391 820                           

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

Contractor’s country: The Netherlands          

Period: 29/03/2022 – 28/12/2023 (21 months)  

Status: Closed

Results achieved:  

• 12 expert group meetings 
• 12 flash reports, 12 sets of minutes 
• Discussion Paper 1:  
  • Topic: Report on health warnings on alcoholic beverages in EU Member States.  
  • Scope: responses from 22 Member States plus Norway.
  • Impact: report used to inform decision making on EU level policy measures to address health warnings on alcohol labels.  
• Discussion Paper 2:  
  • Topic: Report on a mapping of actions selected from the EU4Health Programme, the Horizon Europe Programme and the Digital Europe Programme.
  • Scope: responses from 40 of the 68 selected projects.  
  • Impact: report used to inform decision making on future policy and funding initiatives to support the Europe’s Beating Cancer Plan and EU Mission on Cancer.  
• Produced Scientific Background Paper:  
  • Topic: Factual Summary Report and Synopsis Report on the topic of Cancer Screening – Update of Council recommendation on cancer screening.  
  • Scope: responses from 87 stakeholders (Factual Summary Report) and additional materials collected outside the scope of the WP and contract.  
  • Impact: synopsis report was used to support the Commission document “Proposal for a Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening replacing Council Recommendation 2003/878/EC - COM(2022) 474 final” 

Specific Contract 2021 P1 02 001 under the FWC SANTE/2021/OP/0002 Study on the barriers to effective development and implementation of national policies on AMR: One Health action plan

Objectives

The purpose of the contract was to support the preparation of future policy initiatives on antimicrobial resistance (AMR), responding to the call for action in the 2019 Council Conclusions on AMR and supporting the implementation of the EU One Health Action Plan against AMR.

The study provided a detailed analysis of the existing barriers to the development and effective implementation of:

• National One Health action plans to address AMR;
• Effective infection prevention and control measures in human health; 
• Effective antimicrobial stewardship measures in human health.

The research was conducted under the following study areas: development and implementation of One Health NAPs, infection prevention and control (IPC) measures in hospitals and long-term care facilities (LTCFs); and antimicrobial stewardship measures (AMS) in hospitals, LTCFs, primary care and pharmacies.

The study included an extensive analysis covering the barriers existing at institutional/policy (in EU-27 Member States, plus Norway and Iceland) including financial barriers; the barriers existing at clinical level (e.g. clinical guidelines/practices available in the country) and at behavioural level (e.g. behaviour and practices of healthcare professionals or other relevant stakeholders despite existing guidance).

The data collection and analysis covered the period since the adoption of the 2017 Action Plan (2017) until 2022.                              

Contractor: (Group Leader) Economisti Associati SRL       

Contractor’s country: Italy

Period: 08/06/2022 – 07/06/2023 (12 months)

See the final study to learn more.

Status: Finalised

Area of action 2: Health promotion & disease prevention

HADEA/2022/OP/0003 - Service contract for analysis on workforce availability, education and training needs for the quality and safety of medical applications involving ionising radiation in the EU

Objectives

On 1 September 2022, HaDEA signed a service contract with the European Society of Radiology, ESR. This service contract aims at providing an analysis on workforce availability, education and training needs to ensure quality and safety aspects of medical applications involving ionising radiation in the EU. The service contract also foresees the development of staffing and education/training guidelines for key professional groups involved in ensuring radiation safety and quality of medical radiation applications in EU countries.

By the end of the service contract, the contractor will deliver conclusions and recommendations on the EU workforce availability, education and training needs to ensure quality and safety of medical applications involving ionising radiation.

Contract value: €499 300               

Contractor: Europaische Gesellschaft fur Radiologie Verein (European Society of Radiology, ESR) 

Contractor’s country: Austria            

Period: 01/09/2022 – 31/08/2024 (24 months)

Status: Finalised

See the contract award notice to learn more.

Main results:

• The study covered the following professional groups: radiologists, nuclear medicine physicians, radiation oncologists, medical physicists, radiographers and radiation therapists (RTT - for countries where this is a separate professional group independent from the category of radiographers). 
• The survey carried out to collect data revealed considerable variability in staffing and education aspects across the EU, as well as a widespread lack of relevant data. 
• The draft guidelines and the resulting draft conclusions and recommendations were submitted to peer review and stakeholder consultation for general assessment and identification of potential barriers to implementation. 
• The study’s recommendations include that EU countries create and maintain national workforce registries for each professional group and that mandated continuing professional development (CPD) also includes techniques and knowledge relevant to each professional group, beyond radiation protection issues. 

Read the final report: Analysis on workforce availability, education and training needs for the quality and safety of medical applications involving ionising radiation in the EU

HADEA/2022/OP/0004 - Service contract to design, develop, pilot and deliver an ‘EU Mobile App for Cancer Prevention’

On 7 November 2022, HaDEA signed a service contract with Netcompany-Intrasoft SA. This service contract aims at designing, developing, piloting and launching the ‘EU Mobile App for Cancer Prevention’, a mobile app that will help to ensure a better coverage and access of the wider population to counsels and recommendations on how to reduce cancer risk.

The ‘EU Mobile App for Cancer Prevention’ will widely available to all EU citizens, to individuals at higher risk for cancer and to difficult-to-reach populations. It will include, inter alia, the recommendations of the European Code against Cancer.

Contract value: €3 521 975

Contractor: Netcompany-Intrasoft SA

Contractor’s country: Luxembourg                

Period: 07/11/2022 – 06/02/2026 (39 months)

Status: Ongoing

See the contract award notice to learn more.

HADEA/2022/OP/0005 - Service contract to design, develop, pilot and deliver the web IT tool of the prototype (mock-up) version of the ‘Cancer Survivor Smart Card’

Objectives

On 5 December 2022, HaDEA signed a service contract with Bilbomatica SA. The overall aim of this service contract is to design, develop, pilot and deliver the web IT tool of the prototype (mock-up) version of the ‘Cancer Survivor Smart Card’, to improve the quality of life for cancer survivors, including children and young adults’ cancer survivors.

After designing and developing the prototype, the contractor shall organise, train, coach and assess a sample of card’s users, to pilot the prototype version of the ‘Cancer Survivor Smart Card’ in preparation for the final version of the prototype in order to develop the final version of the app and its “Administrator’s” and “User’s” manuals.

Contract value: €2 988 391.19        

Contractor: Bilbomatica SA

Contractor’s country: Spain               

Period: 5/12/2022 – 4/02/2025 (26 months)

Status: Ongoing

See the contract award notice to learn more.

The prototype ‘Cancer Survivor Smart Card’ has been successfully finalised and transferred from the Contractor to the European Commission's environment in January 2025.  

Area of action 3: Health systems & health workforce

HADEA/2022/OP/0001 - Service contract for logistic, administrative and secretarial support to DG SANTE related to the governing bodies of the European Reference Networks (ERNs) and the eHealth Network (eHN)

Objectives

On 14 July 2022, HaDEA signed a contract with infeurope SA and Mercury 97 Ltd. The contractors are expected to provide logistic, administrative, and secretarial support to the Directorate-General for Health and Food Safety (SANTE) regarding the functioning of the governing bodies of the European Reference Networks (ERNs) and the eHealth Network (eHN).

Contract value: €679 240                                

Contractor: infeurope SA and Mercury 97 Ltd.            

Period: 14/07/2022 – 13/07/2025

Status: Ongoing

See the contract award notice to learn more.

HADEA/2021/OP/0012 - Single framework contract for performing independent assessments and evaluations of European Reference Networks (ERNs) and of healthcare providers

Objectives

On 27 September 2022, HaDEA signed a service contract with IDOM Consulting, Engineering, Architecture, S. A. U. and the Fundación Publica Andaluza Progreso y Salud. Through this single framework contract, the contractors will perform upon request independent assessments and evaluations. More specifically, they will:

Conduct documentation reviews of European Reference Networks (ERNs), including online interviews;

Perform documentation reviews of healthcare providers (HCPs) for both general and specific criteria;

Perform onsite audits (if needed, online audits) of ERNs and HCPs.

Contract value (ceiling): €10 000 000                       

Contractors: IDOM Consulting, Engineering, Architecture, S. A. U. and the Fundación Publica Andaluza Progreso y Salud                         

Period: 27/09/2022 – 31/08/2026

Status: Ongoing

See the contract award notice to learn more.

HADEA/2021/P3/01 –  Specific Contract under Framework Contract EASME/2019/OP/0021: Information and communication campaign on the new regulations on Medical Devices

Objectives

On 1 November 202, HaDEA signed a service contract with Netcompany-Intrasoft SA. The purpose of the contract is to facilitate the understanding of the requirements specified in the new Medical Devices (MDR) and In Vitro Devices Regulations (IVDR). 

The information and communication campaign will target all the medical devices stakeholders and will provide them with information on the changes that occurred in the medical devices’ legislative framework with the adoption of the new rules, to ensure a smooth transition from the previous Directives to the MDR and IVDR. The campaign will focus on the need-to-know actors involved in this field, such as manufacturers, notified bodies, importers, distributors, authorised representatives, re-processors of single-use devices, laboratories, healthcare institutions and healthcare professionals, competent authorities, patients and the general public.

Contract value:  €199 972                     

Contractor:  Netcompany-Intrasoft SA

Contractor’s country:  Luxembourg 

Period: 01/11/2022 - 28/02/2025 (28 months)

Status: Ongoing

HADEA/2021/P3/03 (Specific Contract under SANTE/2021/OP/0002 Framework Contract) - Survey key actors operating on the market, namely notified bodies and manufactures (also authorised representatives if appropriate) to get information on devices and certificates.

Objectives

On 2 December 2022, HaDEA signed a service contract with Civic Consulting GMBH.

The scope of the study is to monitor the availability of medical devices on the EU market in the context of the implementation of the Medical Devices Regulations (MDR) as well as identify potential challenges to be addressed.

The contractor is working to:

1. Develop a structured questionnaire for surveying key stakeholders in order to collect data quarterly;
2. Create a dashboard, including relevant indicators, consisting of tables, graphs and others tools useful to show the results of the collected data; the dashboard has to be updated with data collected quarterly;
3. Prepare an annual analysis report of the identified indicators and insights coming from the dashboard;
4. For each quarterly survey, present the outcomes of the analysis in a report with user-friendly layout, including infographics and trend reports, also considering the possible dissemination among stakeholders and the public.

Contract value:  €469 570

Contractor: Civic Consulting GMBH

Contractor’s country: Germany

Period: 02/12/2022 - 01/12/2025 (36 months)

Status: Ongoing

Read more.

HADEA/2021/P3/04 (Specific Contract under SANTE/2021/OP/0002 Framework Contract) - Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

Objectives

On 15 December 2022, HaDEA signed a service contract for a study with Civic Consulting GMBH. The scope of this study was to collect data and information on the reprocessing of single-use devices within the EU to evaluate how the Medical Devices Regulation (MDR) provisions on reprocessing of single-use devices have been implemented by Member States and how such provisions operate. The conclusions of the study include recommendations for optimising the implementation of Article 17 MDR in Europe. 

Contract value:  €252 400

Contractor:  Civic Consulting GMBH

Contractor’s country: Germany            

Period: 15/12/2022 - 14/02/2024 (14 months)

Status: Concluded

Read the final study and check out the dashboard.

HADEA/2022/OP/0018 - Training and networking of Substances of Human Origin (SoHO) Competent Authorities’ staff for oversight

Objectives

The main objective of this call for tenders is to develop a training programme of SoHO national competent authorities’ (NCA) staff involved in oversight tasks, particularly inspections, vigilance and BTC preparation processes assessment, aiming to:

• Reinforce the skills of NCAs staff involved in the above-mentioned activities;
• Facilitate a harmonised interpretation of the EU legislative framework;
• Promote common practices for oversight activities;
• Facilitate exchanges and networking among NCAs staff, and foster possible collaborations among them (for joint inspections, peer audits);
• Promote trust between EU NCAs in the SoHO field.

Contract value: €1 878 162.50

Contractor: Istituto Superiore di Sanità (lead) and Zadig srl Società Benefit

Contractor’s country: Italy       

Period: 36 months, contract signed on 14/12/2022

Status: Ongoing 

Read the contract award notice to know more. 

Main results: By the end of 2024, the contractor has successfully established a training programme and trained 737 NCA staff in virtual as well as physical environments. 

SC 2021 P3 05 - Supporting the National Competent Authorities on Pricing and Reimbursement (NCAPR) in implementing the Pharmaceutical Strategy for Europe ’s Affordability Agenda. under Single Framework Contract No Chafea/2018/Health/03

Objectives

The purpose of the contract is to support the implementation of the Pharmaceutical Strategy for Europe, namely in the area of affordability of medicines, referred in Section 2.3 of the Strategy’.

The objectives are:

• To support the cooperation in a group of Competent Authorities, based on mutual learning and best-practice exchange on pricing, payment and procurement policies, in order to improve the affordability and cost-effectiveness of medicines and health system’s sustainability, including on cancer treatment.
• To take stock of the legislation on price setting and reimbursement mechanisms.

Contract value: €464 008

Contractor: Stichting Nederlands Instituut voor Onderzoek van de Gezondheidszorg (NIVEL)

Contractor’s country: Netherlands

Period: 11 months, contract signed on 04/11/2022

Status: finalised