Area of action 1: Crisis preparedness
SC/2022/P3/07 - Specific contract for a study designing a monitoring and evaluation framework following and assessing the progress towards the objectives of the strengthened EU One Health Action Plan against Antimicrobial resistance (AMR), under the Better Regulation framework contract (SANTE)
Objectives:
On 30 November, HaDEA signed a new contract for a study aiming at designing a monitoring and evaluation framework following and assessing the progress towards the objectives of the strengthened EU One Health Action Plan against Antimicrobial resistance (AMR) and towards the actions proposed in the Council Recommendations on AMR.
The scope of this study is to support the European Commission in continuous monitoring of the effectiveness of the European Union (EU) level actions against antimicrobial resistance (AMR). The Study will include the identification of existing indicators and data sources, the development of new indicators and the design of new data collection activities when needed.
Contract value: €220 300
Contractor: Economisti Associati
Contractor’s country: Italy
Period: 11/2023 – 08/2024 (10 months)
Status: Ongoing
HADEA/2022/CPN/0009 - Ever-warm facilities (EU FAB) for vaccines and therapeutics production
Objectives:
The objective of this procurement procedure is to reserve capacities and a priority right for manufacturing of vaccines in case of a future public health emergency. This is to ensure that in the initial phase of a public health emergency sufficient manufacturing capacities are available before industry has scaled up their own production. The total number of doses to be reserved for manufacturing in cases of crisis is 325 million doses, all technologies included.
Contract value: Max ceiling €160 000 000
Contractors:
- Vector-based vaccines: Bilthoven Biologicals B.V
- Protein-based vaccines (joint tenders) : Laboratorios Hipra S.A; CZ Vaccines and Laboratorio Reig Jofre SA
- mRNA vaccines (joint tenders): Pfizer Ireland Pharmaceuticals; Pfizer Manufacturing Belgium
Contractors' countries: Belgium, Ireland, the Netherlands, Spain
Period: 03/2023 – 03/2031
Status: Ongoing
Read the contract award notice to learn more.
HADEA/2022/NP/0014 - Supply of Modified vaccinia Ankara against mpox
Objectives:
On 14 June 2023, HaDEA signed a service contract with Bavarian Nordic A/S. The contractor shall ensure the supply of Modified vaccinia Ankara (MVA), vaccines for mpox, marketed under the commercial name of Jynneos and their delivery-to-delivery points in the Member States, Iceland and Norway. The total amount of purchased doses is 334 540.
Contract value: €45 999 250
Contractor: Bavarian Nordic A/S
Contractor’s country: Denmark
Period: 14/06/2023 – 13/06/2023 (12 months)
Status: Finalised
HADEA/2022/OP/0027 - Study on market research and mapping of innovative diagnostic testing solution
Objectives:
On 26 May 2023, HaDEA signed a service contract for a study with McKinsey Solutions SRL. The objective of this study is to support the gathering of information and mapping of innovative diagnostic solutions, currently in the market and/or in early research and development phase, that could be used for preparedness and response to cross-border health threats. The study will also cover the analysis of the supply chains of diagnostic solutions, any possible bottlenecks, and potential solutions to tackle the identified obstacles.
Contract value: €930 000
Contractor: McKinsey Solutions SRL
Contractor’s country: Belgium
Period: 26/05/2023 – 26/02/2024 (9 months)
Status: Ongoing
Read the contract award notice to learn more
HADEA/OP/2023/0005 - Service contract to design, develop, deliver and maintain of HERA’s Advanced Technology for Health INtelligence and Action IT System (ATHINA)
Objectives:
The contractor shall purchase the design, development, delivery and maintenance of an IT system to support the daily activities of the Health Emergency and Preparedness Response Authority (HERA) and generate actionable insights for decision making. In order to deliver the IT system ATHINA, the requested services include the analysis, design, development and maintenance of ATHINA, and the management of analytics.
Contract value: €24 500 000
Contractor: To be decided
Contractor’s country: To be decided
Period: TBD (36 months)
Status: N/A
Area of action 2: Health systems
SC/2022/P3/05 (under SANTE/2021/OP/0002) - Supporting the current regulatory governance for medical devices to improve working methods and ensure regulatory governance
Objectives:
On 18 April 2023, HaDEA signed a service contract for a study with Ernst & Young Consulting BV (EY). This study aims at mapping, describing, and identifying key benefits and challenges of the current governance structure in the medical devices sector and its impact on innovation, with a view of informing possible adaptations to further optimise the system in short, medium and long term. The study will build on a number of surveys and activities in the field, including the organisation of workshops on governance and/or relevant policy-specific topics. The input gathered by the study will be used by the Contracting Authority in the implementation of the EU legislation on medical devices and/or feed in the upcoming evaluation.
Contract value: €480 087.50
Contractor: Ernst & Young Consulting BV (EY)
Contractor’s country: Belgium
Period: 18/04/2023 – 17/10/2024 (18 months)
Status: Ongoing
HADEA/2022/VLVP/0007 - Technical expert in the field of UDI and contact lenses, master UDI-DI solution for highly individualised devices
Objectives:
On 4 April 2022, HaDEA signed a contract with Purecon. The contractor shall provide technical assistance and advice on the development and the implementation of the Master UDI-DI solution and on the drafting of tertiary legislation in the field of the Master UDI-DI*, by providing support to develop the solutions for grouping contact lenses (standard and Made-To-Order) under the same identifier. Moreover, the contractor shall provide technical input necessary for the completion of a solution for the Master UDI-DI and related additional application identifiers and advice to support the drafting of tertiary legislation by DG SANTE.
Contract value: €14 900
Contractor: Purecon
Contractor’s country: Belgium
Period: 04/04/2022 – 03/07/2023 (15 months)
Status: Ongoing
* The UDI is the main identifier of a medical device which is used on its label. It identifies the specific device within a given product family. The UDI-DI is a numeric or alphanumeric code relating to a specific medical device.
HADEA/2022/OP/0024 - Supporting the cooperation between the national authorities and professional sector associations in the blood, tissue and cells and organs sectors
Objectives:
On 27 June 2023, HaDEA signed a service contract with NTT DATA Belgium. The objective is the development of recommendations and guidelines for the management of substances of human origin (SoHO) in hospitals.
These should support the quality, safety, efficacy and optimal use of SoHO in hospitals and cover existing requirements under EU law as well as the provisions of the proposed “Regulation on standards for quality and safety of substances of human origin intended for human application”.
Contract value: €536 653
Contractor: NTT DATA Belgium SRL
Contractor’s country: Belgium
Period: 27/06/2023 – 26/06/2025 (24 months)
Status: Ongoing
Read the contract award notice to learn more.
SC/2022/Beacon/00070 EUDAMED (under FWC DIGIT/2020/OP/0005) - Preparation of test plan, running regression tests, and proposing a full-scale functional audit plan
Objectives:
On 1 March 2023, HaDEA signed a service contract with NTT DATA Belgium. The contractor shall deliver a report on the extent of implementation of the EUDAMED functional specifications to prepare for the initial audit. To do so, the contractor shall oversee the management of the activities, prepare the EUDAMED Test Plan to be able to validate to which extent the current development of EUDAMED conforms with the functional specifications then validate the EUDAMED conformity status with its functional specifications.
Contract value: €74 990
Contractor: NTT DATA Belgium
Contractor’s country: Belgium
Period: 01/03/2023 – 30/06/2023 (4 months)
Status: Ongoing
HADEA/2022/OP/0021 - Service contract for a study on guidance to increase access to healthcare for people with disabilities including information and data on cancer prevention and care
Objectives:
The contractor is requested to:
- Map and analyse the main bottlenecks in accessing healthcare for people with disabilities.
- Provide guidelines on how to increase access and overcome barriers in access to healthcare (e.g., medical settings, digital health services and other relevant settings) for people with disabilities.
- Analyse the situation of people with disabilities in terms of access to cancer screening, cancer diagnosis and care in all Member States. This includes collecting anonymously quantitative and qualitative data on patients with disabilities affected by cancer, barriers in accessibility and affordability of cancer screening, diagnosis and care for disabled patients, and differences in the quality of care they receive.
Contract value: €630 211.19
Contractor: ICF SA
Contractor’s country: Belgium
Period: 01/08/2023 – 31/07/2025 (24 months)
Status: Ongoing
SC/2022/P2/04 - Specific contract under the Framework contract HADEA/2021/OP/0011 - Studies on “Combined health warning strategies across countries” and “Packaging and labelling strategies”, with a subsequent "Assessment report of the current EU combined health warnings”
Objectives:
The contractor will provide an overview of the state of play of strategies covering: a) Health warnings on tobacco products; b) Packaging and labelling of tobacco products.
The overview shall lead to the identification of a set of best practices (products/country level) which will serve as benchmarks for the second part of the study.
The contractor shall then analyse and assess the information identified and described in point a) with respect to their relevance and applicability for relevant categories of tobacco and related products in the EU policy context. More specifically:
- Benchmarking the best previously identified best practices and comparing with EU current policy frameworks.
- Identify possible limitations and areas for improvement within the current EU framework.
- Elaborate high-level policy options.
The analysis shall cover all tobacco and related products. It should be based on the review of existing sources.
Contract value: €220 000
Contractor: OPEN EVIDENCE SL
Contractor’s country: Spain
Period: 01/09/2023 – 31/05/2024 (9 months)
Status: Ongoing
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
The purpose of the contract is to facilitate the understanding of the requirements specified in the new Medical Devices Regulation (MDR) and in-vitro Diagnosis Medical Devices Regulation (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 public in general.
Contract value: €199 972
(Main) contractor: NETCOMPANY-INTRASOFT SA
Contractor’s country: Luxembourg
Period: 01/11/2022 – 31/10/2024 (24 months)
Status: Ongoing
HADEA/2021/P3/02 - Supporting the International Medical Device Regulators Forum (IMDRF) presidency, including the organisation of meetings and communication activities budget to be taken from the AWP 2021 but mentioned in the AWP 2022
Objectives
The overall purpose of this request for service is to provide support to the European Commission (DG SANTE) for the organisation of two physical meetings of five days in the context of the IMDRF different configurations. The support is expected to cover logistical, technical, and administrative support, in particular document management, coordination work and preparation and follow up of each meeting. Participation in the meetings may vary, and for some meetings it could reach up to 500 participants. The contract includes physical meetings in Brussels, Belgium in March 2023 and in Germany in September 2023.
Contract value: €3 799 980
(Main) contractor: NETCOMPANY-INTRASOFT SA
Contractor’s country: Luxembourg
Period: 23/09/2022 – 22/01/2024 (16 months)
Status: ongoing
HADEA/2022/P3/04 - Specific contract under the framework contract HADEA/2021/OP/0012 for the evaluation of European Reference Networks (ERNs) by Independent Evaluation Body
Objectives
The purpose of the service is for the contractor, as Independent Assessment and Evaluation Body (IAEB), to perform technical evaluations of existing European Reference Networks (ERNs) and Healthcare Providers (HCPs) under the framework of Article 12 of Directive 2011/24/EU on patients' rights in cross-border healthcare. To achieve the above-mentioned objectives, the contractor will conduct the tasks outlined in the framework contract HADEA/2021/OP/12.
Contract value: €3 705 908
(Main) contractor: IDOM CONSULTING, ENGINEERING, ARCHITECTURE S.A.U.
Contractor’s country: Spain
Period: 09/11/2022 – 08/12/2023 (13 months)
Status: Ongoing
HaDEA/2022 P3 08 – Study on Hospital Exemption in relation to the implementation of the Advanced Therapy Medicinal Products (ATMP) Regulation (EC) No.1394/2007, implementing the framework contract for services HADEA/2022/OP/0012
Objectives
On 4 September 2023, HaDEA signed a service contract with Intellera Consulting S.P.A., Predictby Research and Consulting S.L.U., CECOFORMA SA.
The objective of this study is to address the knowledge gaps regarding the implementation and the functioning of Hospital Exemption in EU countries.
Throughout the service contract, the contractor will:
- Carry out a desk research on “Hospital Exemption” and “Academic development of ATMPs” in EU Member States;
- Carry out mapping of stakeholders involved in the implementation of HE in EU Member States;
- Carry out an online survey to test the accuracy and completeness of the information gathered in EU Member States;
- Design a template for the national HE implementation report;
- Organise an expert meeting on the study findings (upon invitation).
Contract value: €311 671.50
Contractor: Intellera Consulting S.P.A.
Contractor’s country: Italy
Period: 04/09/2023 - 3/12/2024 (16 months)
Status: Ongoing
Area of action 3: Cancer
HADEA/2022/P2/02 - Specific contract under Framework Contract SANTE/2021/OP/0002 - Study on the evaluation of the EU Action Plan on Childhood Obesity
Objectives:
In this study the contractor will evaluate the progress in the key areas in the Action Plan on Childhood Obesity and will provide an overview of the efforts carried out by the EU countries during the period 2014 – 2020. In addition to such overall assessment of the main past activities at the national level, the contractor will also map for each Eu country the ongoing and/or the planned actions on childhood obesity and related areas and analyse their strengths and weaknesses in their implementation.
The contractor will be identifying obstacles and remaining challenges, including examples of how the obstacles and challenges have been addressed within the collected examples.
Contract value: €826 900
(Main) contractor: OPEN EVIDENCE SL
Contractor’s country: Spain
Period: 03/08/2023 – 02/08/2024 (12 months)
Status: ongoing
HADEA/2022/P2/03 (Based on SANTE/2021/OP/0002) - Study on the effectiveness of health information on alcoholic beverages
Objectives:
On 31 March 2023, HaDEA signed a contract for a study with ICF S.A. The study shall map existing health information on alcoholic beverage labels and assess the effectiveness of different types of health information on the labels of alcoholic beverages. This study is part of the ongoing evidence-gathering to support the Commission on a possible proposal to introduce health warnings on labels of alcoholic beverages as mentioned in Europe’s Beating Cancer Plan.
Contract value: €521 600
Contractor: ICF S.A.
Contractor’s country: Belgium
Period: 31/03/2023 – 31/12/2023 (9 months)
Status: Ongoing
HADEA/2022/P3/06 - Mapping and evaluating the implementation of the Europe’s Beating Cancer Plan
Objectives:
On 2 May 2023, HaDEA signed a contract for a study with Open Evidence. The study is intended to support the review of the Europe Beating Cancer Plan. The objectives of the study are the following:
- Assessing whether the action taken is sufficient to achieve the objectives, or whether additional measures are necessary;
- Identifying further actions to support, coordinate and complement Member States’ efforts to reduce the suffering caused by cancer;
- Setting the baseline and building a monitoring framework to assess the outcomes of Europe’s Beating Cancer Plan.
Contract value: €884 150
Contractor: Open Evidence SL
Contractor’s country: Spain
Period: 02/05/2023 – 01/05/2024 (12 months)
Status: Ongoing
HADEA/2022/OP/0019 - Development of a code of conduct on fair access of cancer survivors to financial services
Objectives:
On 14 April 2023, HaDEA signed a service contract with Deloitte Consulting & Advisory BV. The contractor shall purchase a comparative study on the legal frameworks for safeguarding fair access to financial services (including insurance) in Member States for cancer survivors in a long-term remission, including their impact. The service shall also include a review of medical evidence on remission, including an identification of ongoing and future trends. As a final output, the contractor shall develop a proposal for a code of conduct on fair access of cancer survivors to financial services. The contractor will also support the Commission and the contracting authority with the organisation of an event to launch the code of conduct.
Contract value: €1 830 000
Contractor: Deloitte Consulting & Advisory BV
Contractor’s country: Belgium
Period: 14/04/2023 – 13/06/2024 (14 months)
Status: Ongoing
HADEA/2022/OP/0023 - Study on obstacles for cancer survivors to return to work
Objectives:
A study on obstacles for cancer patients and survivors to remain in work and to return to work. The contractor develops a mapping of implemented or planned policies and related legislation in all EU Member States. The mapping should include an assessment/evaluation of the implementation of these policies/legislation with the view of supporting job retention and return to work for cancer patients and survivors.
Contract value: €546 250
Contractor: Ecorys Europe EEIG - GEIE
Contractor’s country: Belgium
Period: 05/2023 – 05/2024 (12 months)
Status: Ongoing
HADEA/2021/P1/04 - Specific contract under framework contract SANTE/2021/OP/0002 - Acquisition of legal assistance to support the process of assessing the data storage contacts to be notified to the Commission under Article 15(9) of the Tobacco Products Directive 2014/40/EU
Objectives:
The contractor will provide external legal assistance for the Commission to carry out, in a timely manner, the assessment of incoming data storage contracts for new primary repositories.
The main deliverables of this contract will be the assessment of up to 150 draft storage contracts.
Contract value: €199 800
Contractor: ECONOMISTI ASSOCIATI SRL
Contractor’s country: Italy
Period: 12/10/2022– 11/10/2024 (24 months)
Status: Ongoing
HADEA/2023/OP/0001 - Single framework contract to Provide Services to Support the Assessment of Characterising Flavours in Tobacco Products
Objectives:
The contractor will provide with scientific, economic and technical expertise the Contracting authority and the Commission to facilitate the implementation of the current tobacco control policies.
More specifically, the framework contract 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.
- The conduct of a study on optimisation/adaptation of relevant methodologies and approaches.
To reach these objectives, the contractor will be responsible for establishing and maintaining the technical group of sensory and chemical assessors (as specified in Article 12(1) of Implementing Decision (EU) 2016/786), for the execution of all the tasks under this contract.
Contract value: Ceiling €3 000 000
Main (contractor): PANEPISTIMIO KRITIS UNIVERSITY OF CRETE
Contractor’s country: Greece
Period: 12/09/2023 – 11/09/2027 (48 months)
Status: Ongoing
HADEA/2021/P2/06 - Specific contract under Framework contract CHAFEA/2016/Health/36 - Tobacco Control Conformity Assessment
Objectives:
The objective of the project is to provide support to the Commission with the compliance assessment of the national measures transposing the Delegated Directive in 27 Member States.
Contract value: €75 083.83
Contractor: UNIVERSITY OF CRETE
Contractor’s country: Greece
Period: 22/12/2022- 21/07/2023 ( 7 months)
Status: Finalised
Area of action 4: Digital
SC2022/BEACON/000054 - Support for eHealth Digital Service Infrastructure data controller in the context of data protection and system security
Objectives:
On 10 March 2023, HaDEA signed a service contract with PricewaterhouseCoopers EU Services. The general objective of this contract is to:
- Analyse the existing processes and documentation on data protection and security;
- Propose changes or additions to the documentation;
- Develop a business continuity plan for the eHealth DSI central infrastructure components;
- Conduct a risk assessment and prepare a template for Data Protection Impact Assessment.
Contract value: €425 030
Contractor: PricewaterhouseCoopers EU Services
Contractor’s country: Belgium
Period: 10/03/2023 – 09/12/2023 (9 months)
Status: ongoing
Other actions
2022/P4/01 (under Framework contract EASME/2019/OP/0021) - High-level conference on Mental Health in the EU: Towards a comprehensive approach
Objectives:
The contractor will organise a half-day hybrid high-level conference to raise awareness on the Commission’s Communication on a comprehensive approach to mental health. The aim is to invite 300 participants on site, and up to 1 000 participants attending remotely. The hybrid conference will take place in the morning of Tuesday 10 October 2023 in Brussels. The conference will be followed by a networking lunch and a poster exhibition.
Contract value: €371 272.57
Contractor: Consortium of Netcompany-Intrasoft S.A. – Cecoforma – Action
Contractor’s country: Luxembourg
Period: 6 months
Status: Concluded
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 objective of this call for tenders is to support the management of the Commission health expert groups and their policy development and actions on key public health challenges. Its aim is to acquire managerial, administrative, technical, scientific and dissemination services. These specific requests may focus on various types of services to be provided or on a combination of types of services.
Contract value: €12 000 000
Contractor: Intellera Consulting Spa
Contractor’s country: Italy
Period: 03/2023 – 03/2024 (12 months)
Status: ongoing
HADEA/2023/OP/0020 - Capacity-building and multi-disciplinary training programmes in the field of mental health; and Exchange programmes for health professionals in the field of mental health
Objectives:
The contractor shall provide a study on the assessment and analysis of the needs, gaps and obstacles in terms of capacities, knowledge, competences and training needs for professionals, such as health and others working in relevant settings in the community in the area of mental health. The purpose is to have 2000 healthcare professionals trained across the EU by 2026 & 100 exchanges per year on average. Moreover, the contractor shall also develop, pilot, implement and evaluate a multidisciplinary training programme on mental health, and of targeted capacity-building. The development, implementation and evaluation of a toolkit on a multidisciplinary approach to mental health capacity-building (a European blueprint) to support policymakers, professionals working in community settings shall also be provided.
Contract value: €9 000 000
Contractors: GFA Consulting Group GmbH and Stichting Trimbos Instituut – Institute of Mental Health and Addiction
Contractors' countries: Germany and the Netherlands
Period: 1/2024 - 11/2026 (36 months)
Status: ongoing
Check out the contract award notice for more information.