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.

BeWell org picture

The BeWell consortium held its kick-off meeting on 14 July to discuss its upcoming activities around the project. BioMed Alliance is a partner in the project and works with 23 other organisations within the blueprint alliance for a future health workforce strategy on digital & green skills. Through different activities, the project will focus on how to upskill and reskill the European health workforce, particularly related to green and digital skills.

The project is funded by Erasmus+ and it started on 1 July and will run for 4 years. It contributes to the Pact for Skills initiative under the European Skills Agenda 2020 aiming to empower the healthcare workforce to participate in the twin transition. The Pact will facilitate collaboration between a wide range of public and private stakeholders by setting up a large-scale skills partnership embracing local, regional and national levels. 

Read the press release following the kick-off meeting here.

Our June update is out now and provides some great summer reading material on our activities and the latest news at EU level. In this edition you can find more information on our press release on concerns around the availability of medical devices, our selection for the HERA Civil Society Forum, our recent activities related to the European Health Data Space, an event on the HTA regulation, new IHI calls and members' news.

The BioMed Alliance published a new press release calling on Member States to take action and prevent a potential shortage of medical devices, ahead of the discussions during the EPSCO meeting on 14 June on the implementation of the Medical Devices Regulation.

Clinicians and researchers across all medical specialties strongly support the aim of the EU Medical Device Regulation to improve the standards of clinical evidence for high-risk medical devices, but are concerned that a large number of devices is at risk of being taken off the market due to unforeseen circumstances.

Read the press release here.

Read our May Update to get more information on our activities and the latest news at EU level. In this edition you can find more information on the proposal for the European Health Data Space and our related event, a recent article from our IVD task force, the CORE-MD survey (please note the deadline has now been extended to 30 June), a recap of our regulatory affairs committee meeting and BioMed Alliance participation in health policy events

The BioMed Alliance In Vitro Diagnostics (IVD) Task Force has written an article on the Critical Implications of the In Vitro Diagnostics Regulation (IVDR) for Innovation in Diagnostics, which is now online in HemaSphere here. The publication is very timely as it came just in time for the In Vitro Diagnostics Regulation (IVDR) Application date on 26 May 2022, which brings substantial differences in the approval and certification process of IVDs and additional requirements for diagnostic laboratories.

The article addresses different elements around the IVDR implementation and its consequences for innovation and the work of laboratories, including for the development and use of in-house devices. It builds on the conclusions from our recent survey addressing laboratory preparedness for the IVDR and provides recommendations on important challenges to be addressed and for the way forward.

Our April Update will provide you with an overview of a busy month for BioMed Alliance filled with activities and events. Read the Update to get more information on our recent Spring Meeting, our upcoming event on the European Health Data Space, an internal webinar on medical societies' efforts to support citizens & healthcare professionals affected by the conflict in Ukraine, a CORE-MD survey on education in regulatory affairs, our recent internal workshop on the EU Health Research Landscape, an upcoming IHI Stakeholder Event and members’ news.

BioMed COREMD

The CORE-MD Project has launched a new survey, aiming to assess educational needs of clinicians, notified bodies and regulators related to regulatory affairs. The survey takes around 10-15 minutes to complete and is open until 30 June. We need your help to promote it to ensure a large number of clinicians apply!

The CORE-MD survey will help to assess what sort of knowledge clinicians have on regulatory affairs (particularly related to medical devices), what sort of training they have followed, and what gaps in the knowledge exist. It will lead to the establishment of a roadmap which will inform policy makers and stakeholders on the needs for methodological expertise and educational requirements for the assessment of high-risk medical devices, specifically in the context of the EU Medical Device Regulation. This activity will be very helpful, as training in regulatory affairs can help clinicians to better contribute to the safety of the devices that they use to treat their patients.

The BioMed Alliance is a partner in CORE-MD, a European Union Horizon 2020 project that runs for 3 years from April 2021. It will review methodologies for the clinical evaluation of high-risk medical devices and recommend new designs to set an appropriate balance between innovation, safety, and clinical effectiveness. Within work package 4 which has developed this survey, we work to identify the training needs of all stakeholders to enhance their expertise in methodologies for the assessment of high-risk medical devices, and develop appropriate educational objectives.

It would be great if you could fill out the survey and share it with clinicians in your network so we can get as many replies as possible.

Fill out the survey here

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The European Health Data Space (EHDS) can have a very positive effect on health research, care and innovation but it is necessary that certain barriers are addressed to maximise related opportunities. The EU Health Coalition, with the support of BioMed Alliance, EAU, EFPIA and COCIR are organising a hybrid workshop with stakeholders and policy makers on 18 May to 'Maximise EHDS impact on better health data sharing'.

The European Commission proposal for the European Health Data Space (EHDS) is intended to facilitate health data sharing and access for healthcare delivery (primary use of data) and health research and policy making (secondary use of data). During the meeting we will discuss the EHDS proposal, how it will affect health data sharing, best practices in relation to health data sharing, benefits for research, and barriers to health data sharing that should be addressed in the EHDS implementation.

We hope that you will be able to join us on 18 May from 11.00-13.00, either in Brussels or online, to discuss the future of European Health Data Sharing!

Find the draft programme here

Register here

The developments around the Russian army's invasion of Ukraine are a clear violation of international law, and they have already had horrifying consequences and led to a serious humanitarian and health crisis. Support is essential, including through the provision of funds, medicines, medical equipment and expertise. Many European medical societies have put in place a variety of measures and activities to help local medical societies and healthcare professionals in Ukraine. In addition, these societies often had ties with Russian or Belarusian societies, and they had to decide whether to continue scientific exchange or to cut some or all ties. The BioMed Alliance has implemented a short survey to get a general picture of how BioMed Alliance members respond or plan to respond to the war in Ukraine, which was filled in by 27 organisations.

European Medical societies bring together healthcare professionals and researchers from all over Europe, and they often have Ukrainian medical societies or healthcare professionals among their members. All societies that replied to the survey issued a statement on the situation, almost half of all societies also indicated that they maintain close contact with local societies and provide support (48%). In addition, societies frequently donate to aid organisations (30%) or encourage members to donate (33%) and offer free membership (37%) or fellowships (11%) to Ukrainian clinicians. There are also societies that provide webinars and e-learning on treating war injuries (7%) or that provide equipment or medicines (7%) so healthcare professionals in the area can provide better care in challenging conditions. Many societies have also decided to exclude Russian or Belarusian colleagues from participating in their activities, and to refrain from organising meetings in Russia.

The BioMed Alliance is organising an internal webinar on 11 April, where we will hear from the European Commission how the EU is responding and what medical societies are doing and could do to help healthcare professionals and citizens in the area.

Statements & information from BioMed Alliance members mentioned in the survey:

EAACI https://www.eaaci.org/newsfeed/newsfeed-top/4858-eaacirussia
EACTS https://www.eacts.org/ukraine-message/
EAN https://www.eanpages.org/2022/03/18/general-position/
EAS https://www.eas-society.org/news/598104/EAS-Newsletter-March-08-2022.htm and https://www.eas-society.org/news/597883/The-EAS-stand-in-solidarity-with-the-people-of-Ukraine.htm
EASL https://easl.eu/news/solidarity-ukraine/
EAU https://uroweb.org/news/updated-statement-on-the-war-in-ukraine
ECNP https://www.ecnp.eu/?sc_itemid={125465E9-4D0B-47CA-9694-9E97585BB69D}
ECO https://www.europeancancer.org/resources/246:eco-statement-of-support-for-ukraine.html
EFIS https://www.efis.org
EFLM https://www.eflm.eu/upload/docs/EFLM-stands-for-peace.png
EFORT https://www.efort.org/message-of-support-for-ukraine/  
EHA https://ehaweb.org/organization/newsroom/news-and-updates/eha-national-societies-and-ukraine/
EORTC https://twitter.com/EORTC/status/1499004404506284037
ERA https://www.era-online.org/en/era-declaration-of-support-for-ukraine/
ERS https://www.ersnet.org/news-and-features/news/ers-statement-to-support-aid-in-ukraine/
ESAIC https://www.esaic.org/esa-news/esaic-message-of-support-for-ukraine/ and https://www.esaic.org/supporting-resources/
ESC https://www.escardio.org/The-ESC/Member-National-Cardiac-Societies/ESC-Statement-on-the-War-in-Ukraine
ESE https://www.ese-hormones.org/advocacy/support-for-the-ukrainian-endocrine-community/eses-statements-and-actions/
ESHRE https://www.eshre.eu/ and https://www.eshre.eu/Press-Room/ESHRE-News
ESICM https://www.esicm.org/solidarity-statement-for-all-people-impacted-by-the-conflict-in-ukraine/
ESMI https://e-smi.eu/solidarity-with-ukraine/
ESPGHAN https://www.espghan.org/our-organisation/Announcements
ESR https://www.myesr.org/article/3430
EUFOREA https://www.euforea.eu/sites/default/files/EUFOREA%20Board%20and%20Management%20Team%20statement.pdf
EULAR https://www.eular.org/eular_stands_for_peace.cfm
UEG https://ueg.eu/about/who-we-are#Ukraine

Take a look at our March Update to read about the latest news on our activities and new developments at EU level. This month you can get more information on medical society support for those affected by the conflict in Ukraine, the BioMed Alliance Spring Meeting and Workshop on Health Research Policy, a survey on support for research, our recent meeting of the CME experts committee, our activities on health data sharing and members news.

Read our February Update to get more information on our activities and the latest news at EU level. In this edition you can find more information on our statement on the war in Ukraine, our upcoming Spring Meeting & Workshop on Health Research, our new article on CME, a consultation on EU Health Data, our efforts on IVDR, and members news. Read more here.

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The BioMed Alliance has followed developments around the Russian army's invasion of Ukraine with great concern. We believe that the health and wellbeing of citizens must come first: lives must be protected, and citizens must continue to be able to access essential services and get the care that they need.

It is time for the European Union and the international community to stand in solidarity with the population affected by this war, and to provide support and protection to those in need of help.

In time of crisis, humanitarian health assistance, collaboration and mutual aid must prevail and the biomedical health research community can contribute and support the work of international organisations like the International Committee of the Red CrossUnited Nations High Commissioner of Refugees and the World Health Organisation. Support is needed on all fronts, for example by providing funds to recognised humanitarian organisations or even by participating in the Emergency Medical Teams being deployed by WHO in the area.

We are glad to see that our members are already providing support to medical societies and clinicians in the conflict area, and additional support from the international community and relief organisations is necessary to allow healthcare professionals to provide the best care to the victims of this conflict.

The principles of international, humanitarian and human rights law need to be upheld, and we call for a swift and peaceful resolution to the conflict.

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The BioMed Alliance has published an article in the Journal of European CME entitled ‘Continuing Medical Education (CME) in time of crisis: How medical societies face challenges and adapt to provide unbiased CME’. The article is based on the results of two surveys on this topic conducted by the CME Experts Permanent Committee in 2019 and 2021 and evaluates the CME landscape, how medical societies develop and assess CME and how they interact with other stakeholders. It also reflects on the consequences of the COVID-19 Pandemic for the provision of CME and the challenges that are ahead. Read the article here.

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Towards a European Health Union: Role of the BioMed Alliance

Axel Pries Biomed 031

Dear Friends and Colleagues in the BioMed Alliance,

May be, you allow me to start with a provocative question: Why are you investing time and energy into the BioMed Alliance? There is no money in it, little glory and a lot of work!

I guess that for most of us there are two main reasons, which are closely linked: A very friendly and synergistic group drives the BioMed Alliance – and that is done on the basis of a common goal:

Improve health provision throughout Europe and for all medical disciplines based on excellent health research.  

That leads us without any delay to the actual efforts to establish a European Health Union. The COVID-19 pandemic has clearly demonstrated that European coordination and cooperation in health and biomedical research are vital. It was obvious that Europe has a very large potential with respect to biomedical research, innovation, transfer and medical treatment.

But the crisis has also shed a spotlight on the fact that we have a substantial problem in coordination of our efforts and in the optimal use of our resources. This is true in science and research and in the medical field – and especially at the interface between both areas, the translation. Translation is exactly the domain of the member societies of the BioMed Alliance representing over 400.000 researchers, physicians and health professionals in Europe. It is the daily business of all these societies to learn from new scientific insights, to disseminate knowledge, to foster new medical developments and to look far ahead in science based education and planning. It is also clear to all members of these societies that the medical entities they address day in day out do not respect borders or national regulations. They know that medical problems tend to be hard to fight and that success requires sustained efforts, often over decades!

It is our task in Europe to generate optimal mechanisms to deal with the fundamental international nature of diseases, science and medical treatment options in the framework of the political and organizational structure of the EU. The diversity of backgrounds, approaches and concepts in Europe provides for a very rich environment of excellence and ideas. The increasing international standing of European science reflects this. However, this positive diversity should not lead to a fragmentation of resources. The inclusive democratic control processes of the EU should not prevent sustained and coordinated initiatives in research and translation.  

The Framework and Horizon programmes of the EU are by far the most significant transnational funding schemes in Europe. They bring together scientists and researchers from all countries. Nevertheless, they usually do not support the sustained efforts needed to address the most severe questions in medical science. There is always the danger of a ‘flash in the pan’ instead of the continuous development towards real solutions for large problems.

In the current discussion triggered by the CoVid Pandemic the European ‘Health Emergency Response Authority’ (HERA) was established, and is in part addressing the weaknesses described above. HERA is certainly necessary to fight future health emergencies, but it is not sufficient to unleash Europe’s potential in the field of biomedical research, translation and treatment. Its focus is on ‘Health Emergencies’ that represent only a relatively small sector of the entire medical requirements. 

The BioMed Alliance has long argued for the foundation of a broader coordinating body in Europe, tentatively named ‘European Council for Health’. The European Council for Health should bring together stakeholders from civil society, industry and politics under a scientific leadership and initiate and coordinate the entire translational spectrum reaching from basic research to innovative medical solutions in prevention, diagnosis and treatment.

The European Council for Health would be a central pillar for a European Health Union by making health research and health provision in Europe more equal and more effective. Let’s work together effectively for a European Health Union by taking the responsibility for Health for all. This is a good reason to invest time and energy into the BioMed Alliance.

With my best regards

Axel R Pries

The BioMed Alliance has updated its Code of Conduct, which provides a unique set of ethical principles relevant to the work of medical and research societies. Over the past years the code has been widely used and referenced as a helpful tool for the Alliance and its members to help ensure professional independence, objectivity and scientific integrity.

The Code of Conduct has now been brought up to date by a special Working Group which created a new version adapted to the current situation and setting high ethic standards and principles for medical and research societies. It was approved during the 2021 General Assembly and will continue to guide the activities of the BioMed Alliance and its members in the future.

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The European Commission has informed us that they are looking for additional candidates to be part of the Medical Devices Expert Panels (EXPAMED). The panels play a key role in evaluating high-risk devices and thus help to ensure the safety of medical devices and in vitro diagnostics in the EU.

The first call for experts was published in 2019, and since then the panels have started their work under the new Medical Devices Regulation and the In Vitro Diagnostics Regulation. Due to different circumstances and a large number of devices to evaluate, additional applications are welcomed in several fields and particularly in:

  • Orthopaedics, traumatology, rehabilitation, rheumatology
  • Endocrinology & Diabetes
  • Obstetrics & Gynaecology, including reproductive medicine
  • In vitro diagnostic medical devices
    • Detection of arboviruses
    • Detection of parasites
    • Detection of haemorrhagic fever and other biosafety level 4 viruses

Interested candidates are asked to apply as soon as possible via the online application form, and you can find more information on the Commission website here or in the BioMed Alliance briefing here.

The year started well for BioMed Alliance, under the lead of its new President Prof. Gunhild Waldemar. Gunhild has been on the Board since 2017 and has been actively involved in many of our activities throughout the years. Her specialty is in neurology, and she is Professor of Clinical Neurology at Rigshospitalet, University of Copenhagen. In the coming two years she aims to help the BioMed Alliance to continue to grow, and to support its members in these turbulent times. Gunhild has taken over from Prof Wilfried Ellmeier, who has successfully been leading the BioMed Alliance over the past two years and will continue to advise as Past-President.

Prof. Elizabeth Macintyre was nominated to become the next President-Elect after Gunhild finishes her term. Elizabeth is currently President of the European Hematology Association and chairs our In Vitro Diagnostics Task Force. She has extensive experience in representing BioMed Alliance and will become President in January 2024.

Unfortunately, this also means that Prof. Axel Pries has finished his term as Past-President and will therefore leave our Board of Directors after many successful years. During his time as President-Elect, President and Past-President the BioMed Alliance grew significantly and expanded its activities. He has been a very motivated advocate for the BioMed Alliance, and he will be missed in the Board!

Presidents 2

BioMed Alliance welcomes the adoption of the European Commission's Proposal to amend the transitional provisions of the IVDR following the favourable vote of the Council yesterday, 20 December 2021 and its adoption in plenary at the European Parliament last week. The adoption of the Proposal was necessary to ensure proper implementation of the IVDR and avoid potentially disastrous consequences for the diagnostic sector. As representatives of many specialties involved in innovative diagnostics, we are particularly relieved that the amended transitional provisions include those involving in-house testing.

However, work still needs to be done to provide the necessary guidance and documents enabling a safe and timely transition to the new framework:

  1. Compliance to the IVDR will be a major effort for diagnostic laboratories, requiring trained personnel, additional time and budget. The Commission must take this into account and put forward solutions to support laboratories in minimising the rising costs.
  2. Guidance documents are urgently needed in order to help diagnostic laboratories to properly conduct the transformations required from the IVDR.
  3. Clarification on modified use of CE-IVD and RUO (research use only) tests is necessary in order to allow labs to take appropriate steps for their safe and legitimate use under the IVDR.

We look forward to continuing our collaboration with the European Commission and to supporting the key actors in accelerating the efforts to optimise diagnostic practise according to the Joint Implementation Plan.

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