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 November 17, the Civil Society Forum of the European Commission’s Health Emergency Preparedness and Response Authority (HERA) adopted its first discussion paper on the strategy and future role of HERA. The drafting of the paper was coordinated by the BioMed Alliance and it recommends increased investment into health emergency preparedness and response in addition to closer integration of strategies on the EU level. It focuses on a range of issues including strong and separate funding streams, enhanced coordination and the need to have a broader scope beyond merely medical countermeasures to immediate health emergencies. The paper will inform the upcoming mid-term review of HERA’s mandate in 2024

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.

Read our May Update to get more information about new developments at EU level and our recent activities. In this Update you can read about our recent Spring Meeting, a new statement on the involvement of animals in biomedical research, an upcoming workshop on EU4Health, an EMA consultation on their guidance on registries and members' news.

Picture statement 05.23

The medical & scientific community represented within the BioMed Alliance has published a new statement expressing its strong concerns about the consequences of the European Citizens Initiative ‘Save cruelty free cosmetics - Commit to a Europe without animal testing’ for biomedical research. While the first two parts of the Citizens’ Initiative refer to protecting the animal testing ban for cosmetics and to transforming the chemicals regulation (the BioMed Alliance has no official position on this), the third part on modernising science could affect the European health research sector.

This Citizens Initiative calls on the Commission to introduce a ‘legislative proposal plotting a roadmap to phase-out all animal testing in the EU before the end of the current legislative term’ and is currently being considered by EU policy makers. The initiative was also discussed in a hearing in the European Parliament on 25 May and the Commission is preparing a response.

The proposed phase-out will have a detrimental effect on biomedical research and will significantly hinder the search for new insights into the characteristics and progress of diseases and the development of life saving treatment options for patients.

Read the statement here.


Read our April Update to get more information about new developments at EU level and our recent activities. In this Update you can read about our upcoming Spring Meeting, the recent CORE-MD Consortium Meeting, the Revision of the EU Pharmaceutical Legislation, the European Health Data Space Amendments and an article on a new citizens initiative aiming to ban animal involvement in research.

Take a look at the March 2023 Update here, for information about BioMed Alliance activities and news at EU level. In this edition you will find more information about the dates of our General Assembly, our new statement on the proposal for an opt-out approach in the EHDS, additional information on our upcoming Spring Meeting, the new BeWell newsletter, the next CORE-MD webinar, the recent IMDRF conference, a call for transnational funding and Members' news.

Opt out statement

Considering the ongoing political discussions, the BioMed Alliance has published a new statement on suggestions to introduce an opt-out model in the European Health Data Space (EHDS) proposal. BioMed Alliance believes that an opt-out model could be an appropriate way forward, if certain conditions are fulfilled to ensure it does not become a barrier to life-saving health research.

The discussions on the European Health Data Space (EHDS) proposal are continuing and there are diverging views in the Parliament on the model through which the secondary use of health data will be allowed. As a compromise, the ENVI-LIBE rapporteurs have suggested to introduce an opt-out model, where citizens can indicate that they would like to exclude the re-use of their health data from EHDS. While we believe the original Commission proposal already put in place the necessary safeguards, we do think the opt-out model could be an appropriate compromise considering the political situation, if the necessary provisions are in place to make sure it is workable in practice. It is e.g. essential that the model is implemented in a harmonised way across the EU, includes a differentiated approach for different types of data, is accompanied with sufficient information provision to EU citizens on the benefits of sharing their data and the safeguards in place to protect their privacy and if there are further elaborations on ethical principles.

Read more here

Read our February Update to get more information about new developments at EU level and our recent activities. In this Update you will find more information about our new survey on the reduced availability of medical devices, our proposed EHDS amendments, our contributions to a recent MDCG meeting, an update on the Coalition for Reducing Bureaucracy in Clinical Trials, the next CORE-MD webinar and an upcoming stakeholder conference of the IMDRF.