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.

The Biomedical Alliance in Europe (BioMed Alliance) welcomes the efforts of the European Commission to ensure a full single market freedoms for associations, simplifying their cross-EU activities and promoting their fundamental rights. Our members are professional non-profit medical association based in various European countries and they organize many cross-border activities. The particularity of European medical societies is that they provide services to the health community across Europe such as: congresses, educational events, courses, guidelines, health research and clinical practice activities. The current rules in different countries create obstacles and many barriers additional registrations, different VAT rules, lack of harmonization of cross border employment, different legal provisions of annual revenue allowance for NPOs, lack of mutual recognition of services provided by associations and NPOs such as training certifications (congresses, courses, educational events) from one Member State to another.  

We encourage the European Commission to take this seriously as it affects a 90 billion EURO a year industry, but also the capacity of medical societies to deliver unbiased services for EU health community. In the table below you can find concrete input and recommendations provided by the BioMed Alliance members to consider when putting together a legislative framework aiming at creating a single market for associations.

Read the full feedback here.

Take a look at our September Update to stay up to date on our recent activities. In this update you will find more information on more information on our recent activities and important developments at EU level. Don’t forget to subscribe if you want to receive our updates directly in your inbox.

Healthcare stakeholders statement SM post

On 20 October, BioMed Alliance joined a group of 29 stakeholders in welcoming the European Commission’s proposal on the European Health Data Space (EHDS). The stakeholders, which include medical professional and research organisations (including several of our members), patient representatives, industry associations and data collaborations strongly support the aims of the EHDS as proposed by the European Commission. We believe the adoption of the new legislation “can bring important European alignment to, and rapidly scale up, well-governed access to health data sets for the delivery of healthcare services but also for a wide range of secondary use purposes for better health outcomes.”

The consensus statement encourages decision-makers to strongly support this Regulation and to engage with stakeholders to ensure the final Regulation optimises its potential. The statement also formulates several recommendations to consider when developing the more specific implementation plans to put this Regulation into practice across the Member States: It is in line with the previous BioMed Alliance Statement on the EHDS which is available here.

Main elements:

  1. A broad range of stakeholders must be strongly involved from the outset of the process to guarantee the success of the EHDS.
  2. The EHDS must align with all relevant horizontal and sectoral European laws.
  3. There must be harmonised interpretation and implementation of the Regulation across the EU.
  4. Approvals for secondary use of health data must be consistent and harmonised across Europe.
  5. The scope of EHR systems must be defined clearly within the Regulation.
  6. The successful implementation of the EHDS must be adequately resourced.
  7. Existing health data infrastructures must be leveraged to allow continuity and build on existing expertise.

Read the full statement of the stakeholder group here.

Take a look at our August Updateto stay up to date on our recent activities. In this update you will find more information on more information on our new survey on issues around the limited availability of medical devices, our upcoming General Assembly, the next EU Health Summit, a consultation of a proposed initiative on the cross-border activities of associations, members' news and upcoming meetings. Don’t forget to subscribe if you want to receive our updates directly in your inbox.

Medical Devices

BioMed Alliance has published an important new survey on the availability of medical devices, assessing 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 is available here until 18 September.

Reports from clinicians, the European Commission and manufacturers have shown that there are issues around the availability of medical devices due to delayed certification procedures under the Medical Devices Regulation. This problem may become worse in the coming period if measures are not taken to address it, and many devices are at risk of being taken of the market with serious consequences for the provision of healthcare in Europe. For more information, see a recent BioMed Alliance press release on this topic.

This survey intends to assess whether clinicians in different fields are already experiencing issues around the availability of certain medical devices, which devices are affected and whether they expect to experience any issues in the future. The results will help us to gather more information on the extent of the issue and will serve as a basis for discussions with policy makers and stakeholders on this topic.

Fill out the survey here by 18 September 2022.

Read in our July update how BioMed Alliance kept being active during this sunny month. In this update you will find more information on the new BeWell project, our new consultation response on the European Health Data Space, the upcoming Research & Innovation Days and our CME Expert Committee activities.

EU Health Data Policy

The BioMed Alliance replied to the consultation on the proposal for the European Health Data Space (EHDS), welcoming the proposal but also highlighting a series of key considerations that should be taken into account in negotiations on the proposal and its implementation. The reply was developed following several meetings on EHDS and the collection of input from the taskforce. Among the issues that were raised were the need for synergies between EHDS for primary and secondary use of data, interoperability, the responsibilities of data holders, the need for regulatory clarity and the appropriate involvement of stakeholders. The response also includes a series of practical examples of the benefits and challenges related to health data sharing .

Read the BioMed Alliance consultation response here.