Our May Update is out now, providing an analysis of recent BioMed Alliance activities and relevant developments at EU level. Take a look now to find more information about the new BioMed Alliance statement on the IVDR implementation and consequences for the diagnostics sector, an overview of the Spring Meeting and a leaflet on our activities so far in 2021. The Update also includes information on EU policies, including an overview of our contributions to health data policies, information on the Research & Innovation Days and an overview of public consultations. As usual you will also find an overview of upcoming events and highlighted activities of BioMed Alliance Members.

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Laboratory experts from the BioMed Alliance IVD Working Group released a new statement highlighting a looming threat for the diagnostic sector: the slow implementation of the new In Vitro Diagnostic Regulation (IVDR). They argue that urgent actions are necessary now to prevent a collapse of the diagnostic sector.

The application date of the new In Vitro Diagnostics Regulation is only one year away (26 May 2022) and there are widespread concerns that the implementation is not progressing quickly enough and that the diagnostic sector is not ready. The new regulation proposes stricter safeguards for tests and additional elements in the regulatory framework for IVD tests, but so far, its implementation has been slow. As a result, not all elements and guidance are in place, making it harder for the diagnostic sector to prepare.

The BioMed Alliance has provided an overview of the implementation process and the steps to take and hopes that the issue will feature high on the EU agenda so pressing questions can be addressed.

Read more here

Read our April Update for an overview of the latest BioMed Alliance Activities. This month you will find more information about: the new BioMed Alliance’s member, the kick-off meeting of the CORE-MD project, the important messages communicated during the STOA Workshop, the TEHDAS Joint Action open call for stakeholders, our upcoming 2021 Spring Meeting, the joint call for an extended mandate of the ECDC, upcoming activities and our members’ news.

The BioMed Alliance joined the European Chronic Disease Alliance (ECDA) and 9 other European health organisations in a joint letter addressed to the Council of the European Union to call for an extended mandate of the European Centre for Disease Prevention and Control (ECDC).

The joint letter highlights the need for an integrated public health approach where the scope of the ECDC is expanded to other health issues than solely communicable diseases. Indeed, the letter emphasises the clinical links between communicable diseases and non-communicable diseases which require to take into account non-communicable diseases when considering the actions to prevent and control infectious diseases. The letter also argues that enhancing the data collection-efforts could provide important health benefits and foster health promotion.

The full Letter is available for reading here.

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The BioMed Alliance continues to grow and is excited to welcome the European Society of Radiology (ESR). The ESR joined in April and is the 36th member of the Alliance.

ESR was founded in 2005 by the merger the European Congress of Radiology and the European Association of Radiology to strengthen and unify European radiology and safeguard its general interests. The ESR’s mission is to serve the health care needs of the general public through the support of science, teaching and research and the quality of service in the field of Radiology in all European countries gathering around 122,343 affiliated members. We look forward to a fruitful collaboration.

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The BioMed Alliance and its members EFLM, EHA and ESC have just released a press release on the online workshop of the STOA Panel on the need for better EU policies for health. The organisations contribute to the workshop this afternoon, which brings together a mix of policy makers and experts from the field to discuss challenges around the new In Vitro Diagnostics Regulation and the need for more evidence-based EU health related policies. More information is available here.

The BioMed Alliance is very happy to announce the launch of the EU-funded CORE-MD project, a consortium of stakeholders working together to identify ways to enable the scientific, fair, and systematic evaluation of medical devices. Today, we held the kick-off meeting formally starting the work on the project.

For the first time, BioMed Alliance has been named as a partner in a European project including 22 partners involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices. The consortium is led by the European Society of Cardiology (ESC) with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) and cooperates closely with the BioMed Alliance Taskforce on Regulatory Affairs and Medical Devices. The BioMed Alliance is co-leading Work-Package 4 “Networking” of CORE-MD which objective is to establish methods for networking between notified bodies and regulators with clinical and scientific experts.

The CORE-MD project will last three years and aims at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. The first steps of the project will be to review the methods used in clinical trials for evaluating high-risk medical devices.

For more information, the press release is available here.

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Save-the-date for the workshop organised by the STOA Panel in collaboration with the BioMed Alliance, ESC, EHA and EFLM on 22 April 2021 from 14:00-16:00 CET.

The European Parliament Panel for the Future of Science and Technology (STOA) is organising a workshop in cooperation with the BioMed Alliance, the European Society of Cardiology (ESC), the European Haematology Association (EHA) and the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). The workshop will focus on the new the In Vitro Diagnostics Regulation (IVDR) and the need for more evidence-based EU health related policies.

The meeting will be chaired by MEP Alexandra Geese, member of the STOA panel, and gather prominent experts on the questions related to medical devices and in-vitro diagnostics, health data and evidence-based health policies. Among the panellists are several members of the BioMed Alliance and key policy makers, including BioMed Alliance President Prof. Wilfried Ellmeier, Prof. Alan Fraser (Medical Devices Taskforce Chair), Prof. Elizabeth Macintyre (BoD Member and chair of the IVD WG) and several members of the IVD WG.

The goal of the workshop is to inform MEPs about the implementation of the new IVDR and its consequences for the health system. Discussions will also focus on the need for early engagement with medical experts to help to ensure that EU health-related legislation matches the situation in practice to ensure effective, evidence-based EU health initiatives that are targeted towards the unmet needs of patients and public health systems.

Registration to the workshop is open to the public and possible here until 21 April.

Read our March Update for an overview of the latest BioMed Alliance Activities. This month you will find more information about: the signature of the Memorandum of Understanding between BioMed Alliance and EIT Health, a preview of the up-coming BioMed Alliance Spring Meeting, the STOA Workshop organised by the European Parliament in collaboration with the BioMed Alliance and several members, a summary of BioMedScape Working Group first meeting kicking-off the work on the project, a new survey on patients involvement in Continuing Medical Education we implemented, an overview of the Strategic Plan and the Work Programme for Horizon Europe adopted by the Commission, upcoming activities and our members’ news.

The BioMed Alliance has prepared a response to the consultation on the inception impact assessment for the new Health Emergency Response Authority (HERA) with its Board of Directors.

HERA is supposed to enhance EU resilience against cross-border health threats and was described by the Commission as the European equivalent of the US Biomedical Advanced Research and Development Authority (BARDA).

The BioMed Alliance welcomes HERA and believes it must receive the necessary support to properly fulfil its intended purposes. We argue that stakeholders should play a leading role in its implementation and HERA must be embedded in a forward-looking and research-driven environment.

The BioMed Alliance’s response to the consultation can be found here.

Read our February Update for an overview of the latest BioMed Alliance activities. This month you will find more information about: treatment optimisation and why it must be better embraced in our health system, the new proposal for the European Partnership for Health Innovation, a new workshop on health in Horizon Europe, the launch of Europe’s Beating Cancer Plan, the use of health data in the light of the GDPR, the European Patient Ombudsman Award for the Best Medical Practice, upcoming activities and members’ news

Read our first Update of 2021 here to see how we kicked off the year. This month you will find more information about two consultations launched by the European Commission on HERA and on the European Health Data Space, the UK participation in Horizon Europe, an update on BioMedScape, the date of the next BioMed Alliance General Assembly, upcoming activities and members’ news.

Early January the European Commission launched a consultation on the inception impact assessment for the new regulation for the European Health Data Space (EHDS) that is scheduled to be adopted during the 4th quarter of this year. The proposal seeks to address issues related to access to and exchange of health data for healthcare delivery, scientific research and innovation, policy making and regulatory activities. While the European Health Data Space aims to facilitate data exchange and enhance access to data for research and policy making, it will also increase patient access and control over their own data.

The BioMed Alliance has prepared a response to this consultation sharing its views on the inception impact assessment. You can read the response here.

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The European Commission is currently actively recruiting experts for the EXPAMED Expert panels again, which will evaluate high-risk medical devices and in vitro diagnostics. Due to several circumstances including BREXIT, there is an urgent need for additional experts; in particular in the fields of gynaecology, diabetes, orthopaedics and ophthalmology. Experts are asked to apply by 29 January 2021 on the website of the European Commission.

The BioMed Alliance raised awareness on this call in 2019 and the Commission now requests the support of medical societies to promote the call for experts again. The expert panels will play a very important role in the evaluation process of medical devices under the Medical Devices Regulation (application date: 26 May 2021), and the In Vitro Diagnostics Regulation (application date: 26 May 2022).

For more information, please find the BioMed Alliance briefing on this topic here and the application form here.

Save-the-date for an interactive webinar hosted by MEP Maria da Graca Carvalho and MEP Dolors Montserrat on 3 February 2021 from 15:00-17:00 CET.

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The EORTC and the BioMed Alliance, together with key members of the European Parliament, will organise a webinar bringing together important health stakeholders to share fresh and diverse perspectives on what can be implemented in the current EU policy programmes to advance Treatment Optimization as part of health systems.

The discussion is timely needed considering the current health challenges and the preparation of the ambitious EU Health Union programme and its policy and legislative measures such as the Pharmaceutical Strategy, the upcoming Horizon Europe, the EU4Health programme, and Europe's Beating Cancer Plan.

Recent health threats such as COVID-19 demonstrated the urgent need to have a healthcare system that places the patient at the centre and has the ultimate goal to solve clinical issues. The drug-driven approach tends to dominate treatment development in oncology and a similar tendency is seen in other medical specialities. Thus, important aspects relating to the use of novel therapies in real-world settings are neglected throughout the process such as: optimal dose, duration, sequence, combination, and quality of life. New drugs reaching the market is not an end, but a start. Treatment optimisation plays an important role in improving the way treatments are utilised in real-world conditions through the conduct of studies. These studies can provide an answer to one or multiple of the above-mentioned clinical research questions.

The agenda is available here.

You can register to the online event here and we very much look forward to welcoming you!

To mark the end of 2020, we would like to share a festive end-of-the-year Update with you. In this December edition you can find a brief summary of our activities in 2020 and a preview of what lies ahead in 2021.

Our November Update provides insights on BioMed Alliance activities and EU policy developments that occurred during this month. This time you will find more information about: our General Assembly, our new member ESHG, the BioMedScape webinar, our work on the revision of the Code of Conduct and creation of a new DoI form, EU proposals for a EU Health Union, the negotiations on the next EU budget, upcoming activities and members’ news.

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The BioMed Alliance continues to grow and is excited to welcome the European Society of Human Genetics (ESHG) to its membership base. The European Society of Human Genetics joined in November, just a couple of weeks before our General Assembly celebrating the 10 years of BioMed. It is the 35th member of the Alliance.

ESHG was founded in 1967 and its aims are to promote research in basic and applied human and medical genetics, to ensure high standards in clinical practice and to facilitate contacts between all persons who share these aims. ESHG strives for the integration of scientific research and its implementation in the clinical field as well as for education of specialists and the public in all areas of medical and human genetics. It gathers today around 3,000 affiliated members.

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The 'EU Health Summit 2020: Time for action' on 26 October was a multi-stakeholder event which aimed to develop implementing actions based on a set of 10 recommendations the future of health in Europe. The event was very successful, gathering more than 600 participants, and featuring among other speakers Commissioner Stella Kyriakides and German Health Minister Jens Spahn. They pointed out their vision on the future European healthcare, including the necessity to bring back the manufacturing of medicines and medical devices to Europe and the creation of the European Health Data Space facilitating health data exchange.

Biomedical Alliance in Europe President Wilfried Ellmeier led the breakout session on Research and Innovation with a panel of three influential speakers. Discussions highlighted that European support, coordination, and cooperation in health research are key.

During the session, Professor Martin Landray (ESC) explained the impact of COVID-19 on clinical trials and that clinical trials must be changed for more flexibility, collaboration and multidisciplinary efforts. Doctor Cristina Bescos (EIT Health) emphasised that the EU is lagging for innovation compared to other jurisdictions; more international cooperation and new business models are key to successful transform research and innovation. Finally, Sabrina Montante (ISS - National Institute of Health in Italy) underlined as well that European coordination is necessary to avoid duplication of efforts. She also warned about the fragmentation of the different funds, and the need to translate scientific research to policymakers with a common language.

Professor Ellmeier pointed out that there are exciting EU policy instruments such as Horizon Europe, the EU4health Programme, the Pharmaceutical Strategy for Europe or the new proposed European Biomedical Research and Development Agency that should contribute to the creation of a long-term ecosystem and ensure that Europe will be a true research and innovation hub.

For more information, visit the website of the European Health Coalition here

The recordings of the Summit are available here

Take a look at our October Update for an overview of all latest BioMed Alliance activities. In this edition you will find more information about: the EU Health Summit, our Open Access policy statement, the BioMed Alliance General Assembly, a new blog post on regulatory affairs and their importance to doctors, former MEP Petra de Sutter’s new position as deputy prime-minister, a workshop series on the use of real-world data for healthcare purposes, upcoming events and news from our members.

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