Visual EHDS 19.02

The BioMed Alliance has published a new statement in light of the trilogue discussions on the proposal for a European Health Data Space. Medical societies, and the healthcare professionals and researchers that they represent, welcome the intention of the proposal to facilitate health data sharing for healthcare and research, if the necessary elements are in place. However, some of the provisions that are currently being discussed could lead to fragmentation, legal uncertainty and data bias in the datasets that will be available for research within EHDS.

Read our recommendations here.

New vacancy 02.24

Start: March 2024

The Biomedical Alliance in Europe is a not-for-profit organisation representing 34 leading European associations devoted to medical care and biomedical research. It represents more than 400,000 researchers and health professionals (

The BioMed Alliance’s principal goals and objectives are to promote the aims and values of researchers, healthcare professionals and not-for-profit European medical associations and organisations across all medical disciplines.

We facilitate cooperation between our members and represent them in policy and advocacy issues related to health research, continuing medical education and regulatory affairs, including Medical Devices, Academic Clinical Trials, In Vitro Diagnostics and health data sharing. Succinctly, we act as a single voice on transversal health and health research issues, to facilitate multi-stakeholder communication at European level.


Rue de la Loi 34/36, Brussels


You will be part of a small team that is responsible for supporting collaboration and communication among the member organisations. You will be involved in the organization of events, communication, the development of advocacy actions, engagement and capacity building with EU decision makers and EU health stakeholders and in providing information to member organizations.


  • monitor the EU policy agenda (research and health related)
  • support the team in developing policy campaigns and help implement a broad range of advocacy activities
  • draft reports, minutes and policy briefings
  • actively develop and maintain a network of contacts and use contact management tools such as contact databases
  • support the team in drafting newsletters and communication activities related to the organization’s activities
  • organise meetings and events
  • communicate with a broad network of professionals, experts and policy makers

 Candidate Profile

  • You are highly proficient in spoken and written English, as our work is exclusively carried out in that language.
  • You have good writing and analytical skills.
  • You have a genuine enthusiasm for public affairs & advocacy and an appetite to discover the not-for-profit universe.
  • You have an interest in health and research policy or would like to learn more about these policy areas.
  • You should have an outstanding academic record to be able to deal with the multidisciplinary aspects of the role.
  • You are an EU citizen or holder of a Belgian work permit

 What we offer:

We provide a friendly working environment and the opportunity to acquire excellent professional experience with the purpose to help in starting your career. You will also be able to enhance your knowledge of EU affairs, health and research policy and the activities of medical & research societies.

Description of the proposed contract:

You will start with 6 months of internship followed by a full employment contract of 6 months. The contract is remunerated and could be prolonged after the 1-year commitment. The position is under the “Formation Professionelle en Entreprise (FPI)’s rules proposed by Bruxelles Formation. To be eligible for this type of contract, you must be enrolled in the Actiris platform.


Please send your CV, and a short news item written by you on a topic that you consider of interest for the Biomed Alliance, to our Executive Director Loredana Simulescu: This email address is being protected from spambots. You need JavaScript enabled to view it. no later than 19 February.

Read our new January Update, to get an update on BioMed Alliance activities and new developments in the EU policy sphere. In this edition you will find more information about our newest member, a statement and Commission proposal on extended transition periods for IVDs, our participation in an event on genomic data in EHDS, a consultation on the Cross-Border Threats to Health Regulation, IHI Call 6 & 7 that are open now, our presentation at the HERA board on our recent discussion paper, members news and upcoming events.

The BioMed Alliance is proud to welcome a new member, the European Society for Clinical Cell Analysis (ESCCA). We look forward to working with this newest member to continue to raise awareness on the perspectives of medical and research societies across Europe.

ESCCA is a scientific society founded to ensure the continuation of the activities of the European Working Group on Clinical Cell Analysis (EWGCCA). EWGCCA was formed in 1996 with a Biomed-2 grant in order to establish collaboration between sixteen European centres that use and develop flow cytometric applications mainly for clinical purposes. Since 1996 EWGCCA has organised very successful annual European Courses and Euroconferences aimed at the standardisation, validation and dissemination of flow cytometric know-how and its implementation in clinical laboratories. The Courses and Conferences have included presentations by high-profile speakers from the USA. The annual ESCCA European Courses now rank among the world’s largest educational events in flow cytometry.

BioMed Alliance Statement

In a new statement, BioMed Alliance highlights its increasing concerns about approaching widespread issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe. Persisting problems with the implementation of the In Vitro Diagnostics Regulation (IVDR), insufficient certificates issued, the failure to deliver the EUDAMED database and general unpreparedness of the sector could lead to the disappearance from the market of a large number of essential IVDs in the near future and related loss of international competitivity compared to other jurisdictions. The document calls for a mix of short-term solutions (including an extension of the transition period) and more longer-term reforms of the system to ensure pressing challenges are addressed.

Read more here

Read our special end of the year Update for December 2023. In this Update you will get an overview of the main policy developments in December, and to mark the end of the year we look back at our main highlights throughout 2023 and at what is to come in 2024.

Together with a large multi-stakeholder group, representing the entire spectrum of the healthcare ecosystem and consisting of 36 European patient organisations, medical associations, health research infrastructures and health industry associations, we have issued a joint statement to raise the alarm about the significant legislative shortcomings and uncertainties in the proposed Regulation for a European Health Data Space (EHDS).

The multi-stakeholder group is issuing this joint statement in advance of the plenary vote in the European Parliament scheduled on 13 December 2023. In addition, the group is raising its concerns ahead of a COREPER meeting on 6 December 2023 in the hope that Member States will make much-needed changes to the legislative text before reaching general approach.

There remain serious legislative problems with the EHDS, which is now being fast-tracked through both the European Parliament and Council. Stakeholders are concerned that if these problems are not addressed, then the legislation could generate more risks than benefits. The significant degree of legal ambiguity and uncertainty could pose risks for the protection of patient data as well as health research collaborations. As it stands, the potential effects of some of the key provisions in the EHDS are the opposite of what the original policy objectives were aiming for.

Read the statement here.

In our new November Update you will find more information about our recent General Assembly, the new EHDS Statement, our consultation reply on the revision of the pharmaceutical legislation, a new HERA Civil Society Forum paper, recent CORE-MD workshops, a call for experts in public health emergencies, and a new survey on in silico medicine.

The BioMed Alliance is disappointed to see a partial opt-in approach for the re-use of health data for research in the new ENVI-LIBE position on the European Health Data Space (EHDS). The committees voted on the text on 28 November, and their provisions calling for a general opt-out system and a partial opt-in system could lead to barriers to health data sharing and fragmentation in the system. It is unfortunate that the recommendations of the scientific community were neglected and that life-saving health research on diseases, cures and prevention may be slowed down.

We hope that the upcoming plenary vote and trilogue negotiations will make sure that EHDS can still fulfil its intended objectives to facilitate health research.

Read more about our position here

On 8 November, the BioMed Alliance submitted its public reply to the Consultation on the Revision of the EU general pharmaceuticals legislation. The Commission proposal which entails a substantial review of the EU legislative framework for pharmaceuticals, includes provisions on e.a. general pharmaceuticals, orphan medicinal products, paediatric medicines and the EMA.
The Alliance welcomed the proposals and the intention to address persisting challenges including medicine shortages, their affordability and antimicrobial resistance in its reply, but stressed that certain aspects still need to be refined or further clarified. The reply mainly focused on the need to: support research and innovation, create balanced and effective incentives, draft a fit-for-purpose definition of Unmet Medical Needs, support repurposing and to better support the development, evaluation and approval of paediatric medicines.
In our October Update you can read more abouts the main highlights for BioMed Alliance and at EU level in this month. In this edition of our monthly Update you will find more information about our recent move, the upcoming General Assembly, elections in our Board, activities on medical device shortages, contributions of Prof. Macintyre and Prof. Waldemar to EU events, new initiatives to address medicine shortages and an upcoming CORE-MD webinar.

pictures statement 11.23

In a new statement, the BioMed Alliance urgently calls on policy makers to take action to ensure the European Health Data Space (EHDS) will not severely jeopardise health research. The health research community is extremely concerned about a partial opt-in system for the re-use of data for policy making and research in EHDS, which is currently being discussed by policy makers. Opt-in approaches significantly impinge on the availability of datasets for researchers to gain new insights into human health and understanding of disease, or for developing new diagnostics and treatments for patients. While the Alliance believes the original Commission proposal put sufficient safeguards in place to protect patient privacy, an opt-out approach could be a compromise solution if it is implemented appropriately. The statement also lists a series of key considerations which should be taken into account by decision makers in the Council and the Parliament to preserve life-saving research.

Read the statement here

Read our September Update which includes the main highlights for BioMed Alliance and at EU level in September 2023. In this edition you will find more information about our upcoming General Assembly, a recent meeting on EHDS with policy makers, a presentation at IMDRF, a DARWIN EU call for data partners, a new survey on unmet medical needs, members news and upcoming meetings.

August is coming to an end, and we hope you have all had a good summer. Even while enjoying some fun activities in the sun, the BioMed Alliance team continued their activities. Take a look below at the main highlights for BioMed Alliance and at EU level in our August 2023 Update.

In this edition you will find more information about our new health research committee, a call for a new member to our Board of Directors, advocacy activities to address the persisting unavailability of devices, an upcoming IMDRF session in Berlin and a new CORE-MD article on the clinical investigation and evaluation of paediatric devices.

Investigators from the CORE-MD Project revealed at the end of August in an article in the European Heart Journal that a majority of new high-risk medical devices that are used to treat heart disease, have been released to the market in the European Union (EU) with insufficient evidence from clinical trials. BioMed Alliance is a partner in the EU funded CORE-MD project that aims to coordinate research and evidence for high-risk medical devices. The new findings indicate that too little information about the safety and performance of new implantable devices may be available for healthcare professionals to make informed decisions on patient care.

Read more in the new press release

BioMed Alliance, as part of a multi-stakeholder group consisting of 32 European patient organisations, medical associations, research organisations, data collaborations and industry associations met EU officials, including MEP Tomislav Sokol, Co-Rapporteur, as well as several permanent representations that will hold upcoming Presidencies of the Council of the European Union, to discuss how the European Health Data Space (EHDS) can facilitate health research and innovation to create tangible benefits for patients in the EU.

The meeting was held in follow-up to a joint statement issued by the group in June 2023 in which the organisations outlined the challenges of implementing an opt-out mechanism. In that statement, the group agreed that the Commission’s proposal strikes an adequate balance between delivering health-related benefits for patients in the EU and mitigating/eliminating any risks to their rights and interests.

The healthcare community remind that ensuring the trust of patients and other stakeholders in the healthcare system is vital. The group also call on legislators to adopt a consistent, EU-wide approach to unlock the potential value of using health-related data for research and innovation.

The 32 organisations raise their concerns that an opt-out or opt-in mechanism with regard to the secondary use of electronic health data under the EHDS may lead to health data disparities, where datasets underrepresent certain segments of the overall population. This would increase risks and undermine the reliability of data-driven health interventions. Instead of introducing more complexity, such as a general opt-out mechanism, more consideration should be given to ensure transparency and accountability regarding the processing operations performed on electronic health data and the results obtained from secondary use, and to the effectiveness of the safeguards in place.

Read the press release here

Read our July Update to get more information about new video material of the CORE-MD project, the EU Commission's response to an EU Citizen's Initiative aiming to ban animal testing, an open consultation on the revision of the EU pharmaceutical strategy, an update on HERA and contributions of the BioMed Alliance and members' news.

Read our June Update to get more information to get more information about a call for new members for our Board of Directors, a new letter to the Commission and Press Release on shortages of medical devices, a statement on the proposed opt-out in the EHDS, new EU4Health Calls, the BeWell Project General Assembly, and an update on the CORE-MD project on regulatory skills building among clinicians.

BioMed Alliance published a new press release calling on the European Commission to implement concrete actions in order to prevent a critical shortage of medical devices, particularly for children and people living with rare diseases. In an accompanying letter written by a number of prominent experts that was sent to Commissioner Kyriakides, the Alliance expressed its growing fear that Europe is on the track to a potential public health crisis, where essential medical devices may disappear from the EU market. The letter was also signed by health organisations and based on work in the CORE-MD project. It reflects the urgent concerns of healthcare professionals that are not always able to provide the same standard of care due to shortages.

It is only a matter of time before patients, and particularly children, experience serious consequences of the unavailability of devices or may even have a higher risk of mortality

Read the press release here and the letter here

230606 Joint EHDS statement banner with logos

A joint statement of 32 European patient organisations, medical associations, research institutes and healthcare companies including the BioMed Alliance, was published to share their common views on specific recommendations for a potential opt-out mechanism in the EHDS. The group support the approach taken in the Commission's original legislative proposal from May 2022 as it strikes a sensible balance between protection of personal data while enabling the use of data for research and innovation to create tangible benefits for patients and citizens. The stakeholders raise concerns about the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary use research purposes if an opt-out or opt-in mechanism is approved, and call for an impact assessment that will inform implementation of this policy option. It is also in line with the earlier BioMed Alliance statement on the opt-out mechanism considered in current political discussions on the proposal.

Read the statement here.