The European Commission has recently published its Communication on the new Health Emergency Response Authority (HERA) which is supposed to be established within the Commission and start operations early 2022. The BioMed Alliance welcomes the plans to establish HERA, but also raises certain concerns and needs for clarification in a new statement.  In the document, medical societies highlight the need for better involvement of the scientific community, more extensive communication to stakeholders and the public and a good budgetary balance between HERA development and the realisation of other important health priorities.

Read the statement here

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Read our new September Update  to stay up-to-date on BioMed Alliance activities and EU policy developments. In this edition you will find more information on: our recent and upcoming events and meetings, the work of our IVDR Taskforce, the Commission’s plans for the new HERA, a European Parliament resolution on animal testing, information on interesting EMA and TEHDAS events and news from our members.

The BioMed Alliance has been contributing to several high level events to facilitate discussions on research and innovation with leading opinion makers. On 28 August, President Wilfried Ellmeier led a session at the European Forum Alpbach focussing on 'Financing Research and Innovation in a European Health Union - NO CURE FOR LIFE'. In the coming weeks, we will also contribute to a session at the European Health Forum Gastein and organise a session at the world health summit.

European Health Forum Gastein

BioMed Alliance President-Elect Gunhild Waldemar will feature in the session 'the Heartbeat of Health Innovation' organised by EIT Health on 28 September at 11.00 during the European Health Forum Gastein. The session will focus on how networks & collective action can help us cope with crises and lead the way to a more resilient future.

More information is available here.

World Health Summit

On 24 October from 11.00-12.30 CET the BioMed Alliance is organising a session entitled 'Europe: Follower or Leader in Health Research and Innovation?' with prominent speakers. The session moderated by our president Wilfried Ellmeier features  Dr. Özlem Türeci (BioNTech Chief Medical Officer), Prof. Karin Sipido (KU Leuven), Jan Geissler (Patvocates) and more to be announced soon. The focus of the discussion will be on how EU research can remain competitive and how EU health research initiatives can help work towards reaching important health objectives.

More information is available here.

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World Health Summit
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Read our newly redesigned Update for August to have an overview of the latest BioMed Alliance Activities. Take a look now to find more information about the improved Update, our contribution to the European Forum Alpbach, the upcoming internal webinar on maximising the impact of advocacy strategies, the dissemination of our questionnaire on IVDR, the World Health Summit coming up in October, the public consultation launched by the Good Clinical Trials Collaborative, and the upcoming activities.

The BioMed Alliance Taskforce on IVD in collaboration with the European Haematology Association Taskforce on IVD, and with expertise from Prof. Christa Cobbaert from the European Federation of Clinical Chemistry and Laboratory Medicine, elaborated a questionnaire on the current use of different IVD tests in diagnostic laboratories. The objective of the questionnaire is to gain insight into the current situation for medical laboratories, in particular the degree of (un)preparedness of medical laboratories for the IVDR implementation, and to make an accurate assessment of the potential impact that the IVDR will have on diagnostic laboratories and their test menu.

We are collecting this information to represent diagnostic laboratories in the process of the IVDR implementation, e.g. by providing critical advice to the European Commission and national competent authorities, and to provide relevant information on this important topic to our members. With these actions, we hope to ensure a feasible transition timeline and continuity in laboratory diagnostics beyond May 2022. This is why we need your help to disseminate this questionnaire as widely as possible: please share it with the diagnostic laboratories in your network. We implemented the questionnaire as a Word document, available here, and as an online version on Surveyrock here.

The deadline to fill out the questionnaire has been extended to 17 September 2021, please complete or return the questionnaire by this date!

Read our July Update for an overview of the latest BioMed Alliance Activities. Take a look now to find more information about the message Professor Macintyre conveyd at the Assemblée nationale in Paris on the digital training of healthcare professionals, the new structure of the Regulatory Affairs and Medical Devices Taskforce, our upcoming webinar on advocacy strategies and how to maximise their impact, the launch of our new questionnaire on IVDR, the first calls of the EU4Health 2021 Work Programme, the upcoming activities and our members’ news.

BioMed Alliance submitted a response to the public consultation on the European Health Data Space (EHDS) launched by the European Commission, with the help and input of our new Taskforce on Health Data. On this occasion we also released a statement to convey our views on the current state of development of the EHDS and highlighting the main concerns we expressed in the public consultation. Indeed, the EHDS can be a promising tool in facilitating health data exchange and contributing to better care and health research, if it is implemented properly.

Read more about our statement here.

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On July 7, Professor Elizabeth Macintyremember of the BioMed Alliance Board of Directors, spoke at the Assemblée nationale in Paris at the occasion of a workshop co-organised by EIT Health and the Assemblée nationale, and focusing on digital health skills and tools. The workshop is part of the programme “Digital & Health for all: what action needs to be taken for tomorrow’s public health?” targeting French legislators and policymakers with the aim to explore how the health workforce can be equipped adequately for the rapid digitalization of health research and health care.

During the session, Professor Macintyre emphasised the importance of educating health care professionals (HCPs) on the digital and regulatory aspects of their work, especially as the science, the profession and the regulatory landscape are evolving rapidly.

A wrap-up session presenting the conclusions in French of all the thematic workshops of the programme will take place online on Tuesday 13 July from 14.00-17.30. The session is open to everybody and you can register on aiforhealth.fr

Read our June Update for an overview of the latest BioMed Alliance Activities. Take a look before your summer holidays to find more information about our successful advocacy results following the release of our latest statement on the IVDR implementation, the first meeting of the new BioMed Alliance Taskforce on health data, the BioMed Alliance going at the French National Assembly, an overview of the published Work Programmes for Horizon Europe, information on the Horizon Europe Info Days 2021 and on the political agreement reached on HTA, the upcoming activities and our members’ news

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

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