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.

survey devices 02.23

BioMed Alliance has launched a new survey on current/upcoming shortages of medical devices. With this short survey, the BioMed Alliance would like to assess whether clinicians experience that any devices are no longer available for patient care or will be unavailable in the near future. This will help us to collect additional and updated information on which devices are about to disappear from the market, so we can inform policy makers and ensure that the necessary steps can be taken at EU level. The deadline for this survey is 8 March.

This survey follows our earlier survey on clinicians' experiences with the availability of devices and will allow us to collect more elaborate and updated data. We conducted our previous survey in 2022 and it showed that clinicians already experience issues with the availability of different medical devices under the new Medical Devices Regulation (MDR) and particularly with Orphan Devices. This limited availability can have consequences for the level of patient care and the BioMed Alliance has thus launched a series of advocacy actions leading to the publication of the draft amendment to MDR transition times in January 2023.

EU Health Data Policy

The 36 medical and research societies part of the Biomedical Alliance in Europe have suggested amendments that could be considered in the legislative process of the European Commission Proposal for a European Health Data Space.

The European Health Data Space (EHDS) could have a transformative effect on the healthcare and research sectors by facilitating health data sharing and use for healthcare (primary) and policy making and research (secondary) purposes. The BioMed Alliance welcomes the intention to reduce barriers to data sharing and to ensure that patients, healthcare professionals and researchers have better access to data.

After extensive discussions with researchers, healthcare professionals and policy experts in its Health Data Taskforce, the Alliance suggests several amendments that could improve the implementation of EHDS and make sure it can have a concrete positive impact on the healthcare and research sectors and ultimately on the life of patients. The document also includes case studies of health data sharing that were collected my medical societies from different disciplines.

Read the amendment document here and the adapted version according to the draft ENVI-LIBE Report from 10 February here.

new member 01.23

The BioMed Alliance has welcomed 3 new member organisations this year. We look forward to working with the European Society for Blood and Marrow Transplantation (EBMT) the European Society of Paediatric Endocrinology (ESPE) and the Association for European Paediatric and Congenital Cardiology (AEPC). We are glad that these societies have decided to join us and we are excited to work with them on our growing number of activities.

About EBMT

The European Society for Blood and Marrow Transplantation (EBMT) is a collaborative peer network of professionals working in centres and as individuals in the fields of clinical bone marrow transplantation, gene therapy and cellular therapy. The EBMT has more than 6,000 members in over 70 countries.

About ESPE

The European Society for Paediatric Endocrinology (ESPE) is an international organisation aiming to improve clinical care of children and adolescents with endocrine conditions, including diabetes, through research and education.

About AEPC

The Association for European Paediatric and Congenital Cardiology (AEPC) and its Working Groups aim to enhance collaboration amongst members for scientific research and professional development and to maintain high standards of professional practice. The Members of AEPC are paediatric cardiologists and other specialists working in this field and its related disciplines originating from 32 countries in Europe, and there are also members from other parts of the world.

Reports from clinicians, the European Commission and manufacturers have shown that there are issues around the availability of medical devices coinciding with the implementation of the Medical Devices Regulation. Many devices are at risk of being taken of the market with serious consequences for the provision of healthcare in Europe, and therefore the European Commission has recently announced that it will soon propose new measures to address this pressing issue.

Leading up to this, BioMed Alliance published an important survey on the availability of medical devices in August 2022. It assessed if clinicians experience that any devices that they normally use are no longer available on the market. The survey was developed by BioMed Alliance in cooperation with ESC and EFORT and was available until the end of September. We received 314 replies and the survey results show that clinicians are increasingly concerned about the fact that a rising number of essential devices is no longer available for use in medical care due to various reasons, and that this affects the quality of care for patients. Particularly devices in odd sizes or intended for paediatric or orphan indications were no longer available. Often manufacturers provided MDR related reasons for the non-availabilities, including lengthy certification procedures, high costs of putting the device on the market (particularly an issue for devices intended for small patient groups) and a lack of notified bodies.

BioMed Alliance used the survey results in its advocacy efforts to make sure the issue is addressed at EU level. We have discussed the issue in our Regulatory Affairs Committee, met with permanent representations, stakeholders and industry representatives and presented our survey results in the European Commission's Medical Devices Coordination Group Meetings.

Read the survey report here.

BioMed Alliance is happy to share another special end-of-the-year Update looking back at some of the highlights of the past year and providing information on new policy developments at the end of the Update. Read our December Update here.

Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR) will be discussed by health ministers during the EPSCO meeting on 9 December.

The BioMed Alliance believes that a variety of measures is necessary. It will support an extension of the recertification deadline of 26 May 2024, on condition that standards for clinical evidence are maintained. Added time should be used by policy makers to rectify issues that inhibit full implementation of the MDR, including the capacity of notified bodies and the need for a special framework to support the development and certification of orphan medical devices. Manufacturers should also use the extra time to send in applications of sufficient quality as soon as possible. At the same time, the Medical Device Expert Panels should play a greater role in the early dialogue with manufacturers, and registries should be used to support certification with conditions for market surveillance, as they already provide a wealth of information on the safety of devices and their impact on clinical outcomes. Policy makers should also consider setting up conditional approval procedures in exceptional circumstances to serve as a measure of last resort for devices that are at risk of disappearance and are used to treat life threatening conditions.

More info here.

Take a look at our October Update to stay up to date on our recent activities and important developments at EU level. In this update you will find more information on issues around the availability of medical devices, advocacy efforts related to the European Health Data Space, our response to the consultation on cross-border activities of associations, the EU Health Summit, upcoming IHI calls and other news. Don’t forget to subscribe if you want to receive our Updates directly in your inbox.