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!

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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.

Another year has come to an end, and it has been a busy one again for BioMed Alliance. In our special end-of-the year Update you will get an overview of this year’s key highlights and a glimpse of what is to come in 2022. Read the December Update here.

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BioMed Alliance has released a new statement ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS). The new EHDS can play a key role in facilitating health data sharing for healthcare provision, health research and policy making if certain key aspects are taken into account.

The BioMed Alliance Task Force on Health Data Sharing, in close cooperation with the European Association of Urology (EAU) and the European Organisation for Research and Treatment of Cancer (EORTC) have therefore proposed a set of recommendations for the governance, implementation and incentivisation of adoption of the EHDS.  The statement particularly highlights the need to involve a broad range of stakeholders and to align different legislative approaches with a clear and enabling EU legal framework

Read the statement here

The BioMed Alliance Taskforce on IVD, in collaboration with the European Haematology Association and the European Federation of Clinical Chemistry and Laboratory Medicine, conducted a survey on the current use of different IVD tests in diagnostic laboratories.

The objective of the questionnaire was to gain insight into the current situation for medical laboratories, in particular on the degree of 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. In total, we received 203 answers from medical laboratories across the EU and Norway. We analysed all the responses received and elaborated a report showcasing the main results as well as some explanatory figures.

The results to the questionnaire showed that respondents represent 25 out of 27 EU countries, with a wide range of diagnostic fields and laboratory types. Responses show notably that compliance to the IVDR will be a major effort for diagnostic laboratories, requiring trained personal, additional time and budget. It was also clear that guidance documents are urgently needed to help diagnostic laboratories to properly conduct the transformations required from the IVDR, and many respondents see the availability of appropriate guidance both as an issue/problem and a solution. According to the respondents, various forms of guidance could be used, whether as templates, practical examples, or workshops, once again requiring appropriate resources. Furthermore, it stands out from the responses that postponement of the date of application of the IVDR was greatly needed in order to ensure the continuity of high-quality diagnostic care of patients. Fortunately, this action has already been initiated in October 2021 by the European Commission. Therefore, the diagnostics labs call on the European Parliament and the Council to quickly adapt the regulation timelines and on the MDCG and the Commission to continue the work according to the Joint Implementation Plan, particularly with respect to appropriate guidance documents.

For more information, you may read the entire report on the main findings here.

The Coalition on Reducing Bureaucracy in Clinical Trials, in which BioMed Alliance is an active member, just published a series of concrete and consensus-based recommendations for reducing administrative burdens in clinical trials. The recommendations reflect the needs and perspectives of investigators and patients, but are also taking into account the views of regulators, sponsors, ethics committees and other stakeholders to ensure the broadest possible uptake of the proposed the solutions.

The recommendations are gathered in four clusters: safety reporting, informed consent, regulatory guidelines and harmonisation of requirements accross the EU.

The Coalition Recommendations are available for reading on the website of the Coalition here.

Poster AI session

AI & Healthcare: a match made in heaven? The use of Artificial Intelligence in healthcare is significantly increasing, with promising new developments that are transforming healthcare. AI has enormous potential to enhance patient care and facilitate health research, but there are also challenges and risks ahead.

Join us on 29 November from 13.30-15.00 for an online discussion on the future of healthcare and the integration of AI in clinical practice and health research. At the occasion of the BioMed Alliance General Assembly, a series of interesting speakers will share their experience and knowledge on the use of AI & the regulatory framework that intends to facilitate the development and use of AI technologies, while mitigating risks. There will also be time for questions and reflection on what the future will look like, and how we can ensure that clinicians, healthcare professionals and patients are part of the transition.

Speakers:

  • Dr. Angela Spatharou (EMEA Lead for Healthcare & Life Sciences, IBM, and EIT Health Supervisory Board member)
  • Dr. Gerard R. Dawson (CEO & CSO P1vital LTD and ECNP)
  • Salvatore Scalzo (Policy and Legal Officer AI Policy, DG CNECT, European Commission)
  • Prof. Frank Rademakers (Emeritus Professor Cardiology KU Leuven and CORE-MD)

The session is open to all upon registration here. More information is available on the agenda.

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3 DAYS - 100 NATIONS - 300 SPEAKERS - 6,000 PARTICIPANTS - BERLIN & DIGITAL

The annual World Health Summit took place from 24-26 October and included a series of interesting sessions with keynote speakers like Commission President Ursula von der Leyen, Minister Jens Spahn, Commissioner Stella Kyriakides, Dr. Tedros Adhanom Ghebreyesus and many more.

The BioMed Alliance organised a session on Sunday 24 October at 11.00: Europe: Follower or Leader in Health Research and Innovation? The session was chaired by BioMed Alliance President Wilfried Ellmeier and featured prominent speakers including Dr. Özlem Türeci (Chief Medical Officer BioNTech), Jan-Philipp Beck (CEO EIT Health), Jan Geissler (CEO Patvocates), Prof. Karin Sipido (KU Leuven) and Robert Madelin (Chairman FIPRA). Discussions dove into the research and innovation landscape in Europe, persisting challenges and what Europe must do to position itself as a frontrunner in Biomedical and Translational research.

Read our new October 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 session at the World Health Summit, a new statement on HERA, the newly announced transitional provisions for the IVDR, the recent TEHDAS stakeholder forum, new health research funding calls and members' news.

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.

Gastein
World Health Summit
Alpbach

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

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