The BioMed Alliance published a statement on 9 April welcoming the European Commission’s proposal to postpone the application date of the Medical Devices regulation by one year, to 26 May 2021. The statement highlights several key elements that should be taken into account if the postponement will be approved.

Read the statement here.

Read our new March Update to get an overview of our activities and news, particularly related to the COVID-19 Pandemic.

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The BioMed Alliance released a new statement and a letter to Commission President Ursula von der Leyen calling for support for medical and research societies to ensure continued guidance for healthcare professionals during the COVID-19 Pandemic.

The COVID-19 pandemic poses a major challenge that has a disruptive effect on European health systems and societies. European health professionals are working around the clock to save the lives of European patients, and governments and the EU Institutions are doing everything in their power to support their heroic efforts. However, the medical and research societies that health professionals rely on for up-to-date information on clinical practice are facing serious challenges. As medical congresses are being cancelled or postponed, not-for-profit societies are faced with substantial costs that may threaten their existence and thus their ability to provide clinical guidance to health professionals. Therefore, the Biomedical Alliance in Europe calls on the EU and Member States to support medical societies to ensure they can continue providing their services now and in the future.

Read the letter to President Ursula von der Leyen here and the statement here

Take a look at our February Update to find more information about our activities in this month.

EU Health Coalition

The EU Health Coalition, in which the BioMed Alliance is an active member and chairs the research & innovation policy group, announced that the next EU Health Summit takes place on 4-5 May 2020. The high-level summit will be held in the Flemish Parliament and we look forward to organising the programme together with our partners. The conference will focus on the implementation of an updated version of the recommendations that were presented during the last conference in the end of 2018.

More information and the registration form are available here: https://www.euhealthcoalition.eu/event/eu-health-summit-2020/ 

Read the first Update of the new decade here to see how we started the year and to get a glimpse of what lies ahead.

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The BioMed Alliance started 2020 well, with a new President, President-Elect and a new Board Member. We look forward to working with them on the many interesting activities that we are planning this year.

  • In January, we welcomed our new President, Prof. Wilfried Ellmeier from the Medical University of Vienna. He has prepared for this role over the past two years as President-Elect and has extensive experience within the BioMed Alliance.
  • This means that Prof. Axel Pries has stepped down as president and will continue to be active as Past-President. We can all agree that Prof. Pries has been a great president that was very committed to the BioMed Alliance. Under his leadership, the organisation has developed substantially.
  • Prof. Gunhild Waldemar was appointed as President-Elect, her candidacy was approved during the General Assembly last November. Prof. Tobias Welte has taken over her role as treasurer.
  • We will also welcome a new Board Member, Prof. Tom Hemming Karlsen took over the seat of Prof. Colm O’Morain, who has come to the end of his term in the Board and has played an important role in the BioMed Alliance as Board Member, President-Elect, President and Past-President.

For more information about our Board Members, take a look at our Board of Directors Page.

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The BioMed Alliance and FEAM joined forces to co-organise a workshop exploring opportunities and challenges for maximising the impact of health research in the coming years. The event: ‘Working together for the Future of European Health Research’ takes place on 31 January from 11.00-13.00 in the European Parliament. The two-hour workshop includes presentations from leading academics, stakeholder representatives, MEPs, and key policy makers in the European Commission. The event is hosted by MEP Cristian Bușoi (EPP), MEP Graça Carvalho (EPP) and MEP Petra De Sutter (Greens/EFA).

With the increasing disease burden and challenges faced by European healthcare systems, health research is more important than ever. It has a transformative impact on the lives of patients and provides return on investment to society. Nonetheless, bottlenecks persist, including fragmentations in the health research funding system and limitations to the sustainability of funding. Health research is constantly evolving, and policy makers and researchers should work together to ensure that researchers have access to new developments, concepts and technologies needed to develop innovative ideas. At the same time, efforts should focus on effectively scaling-up and implementing these innovations, so they quickly reach patients. Cross-sectoral and cross-border cooperation are key in ensuring health research meets societal needs. Therefore, FEAM and the BioMed Alliance partner with influential policy makers and experienced researchers to have an open discussion on the future of European health research.

For more information, the agenda is available here and the registration form can be found here.

To mark the end of 2019, 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 2019, editorials written by our Board of Directors members and a preview of what lies ahead in 2020.

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During the BioMed Alliance General Assembly on 20 November several governance changes were discussed. Tom Hemming Karlsen from EASL was elected to the BioMed Alliance Board of Directors to replace Colm O’Morain, who has come to the end of his term in the Board. The Assembly also approved the nomination of Gunhild Waldemar as the next President-Elect.

Prof. Karlsen received the most votes out of the total of 6 candidates that applied for the vacant position. His experience as secretary general for EASL has provided him with expertise in EU Affairs and helped him get familiar with BioMed Alliance activities. We look forward to working with him in the coming years to continue expanding the BioMed Alliance.

The November update provides an overview of a busy month for the BioMed Alliance and at EU level, take a look for more information.

Read up on the latest developments related to the BioMed Alliance and EU Affairs in our new October Update

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The first meeting of the BioMed Alliance working group on In Vitro Diagnostics (IVD) is taking place on 12 November. This meeting will include experts from medical societies and experts from e.g. the European Commission and notified bodies. The meeting will focus on exchanging information on the new Regulation for In Vitro Diagnostics (IVDR) and on exploring how medical societies can support regulators in the implementation.

Interactions with the European Commission on the MDR implementation showed that there is an urgent need to set up a BioMed Alliance IVDR working group. The new regulation will significantly affect the evaluation and approval processes of in vitro diagnostics and medical professional input is essential for effective implementation. The first meeting will focus on the requirements of the IVDR and will define the future objectives and activities of the working group.

For more information, contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

The European CanCer Organisation (ECCO) has joined the BioMed Alliance as a new member bringing our membership to a total of 32 societies. We are happy that the ECCO Board and new CEO have made the decision to participate in our growing alliance and we are looking forward to working with them again on a number of common projects.

ECCO is a not-for-profit federation focussed on oncology that advocates for the right of all European cancer patients to high-quality treatment and care, promoting interaction between all organisations involved in cancer at European level. It is a multidisciplinary organisation that has 27 Member Societies representing over 150 000 professionals.

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The BioMed Alliance has joined thousands of academics, European organisations and Nobel-prize winners in signing an open letter calling on the Commission to revise the new job title of Commissioner Mariya Gabriel to include a reference to research. The Board of Directors fully supports the initiative to request changing her official title to ‘Commissioner for Education, Research, Innovation and Youth’ as they consider that this better reflects the broad portfolio of the Commissioner.

The BioMed Alliance believes that research is vital to European wellbeing and prosperity and that its importance should be recognised by continuing including the word research in the job title of the Commissioner that is responsible for this policy area.

More information about this initiative is available here: http://www.futureofresearch.eu

The European Commission has opened a call for experts to be appointed as members of the expert panels for medical devices as described in the Medical Device Regulation.

The call is open until 10 November 2019 for all eligible applicants with expertise related to medical devices.

By participating, experts will contribute to ensuring the safety of medical devices. They will review the clinical evidence submitted for approval of high-risk medical devices and provide advice to e.g. the European Commission, Notified Bodies and Manufacturers.

Facts & Figures

  • Deadline: 10 November 2019
  • Application form: https://ec.europa.eu/eusurvey/runner/mdexperts2019
  • Experts will contribute to the evaluation of medical devices and in vitro diagnostics
  • 246 experts needed
  • 1000 additional experts needed for a general list
  • 10 Panels for different thematic areas in medical devices, one panel for IVDs and a screening panel will be established
  • Sub-groups may be created
  • Time commitment: max 2-3 days per month, mostly remote work
  • Remuneration: €450 per day worked

Role:

The selected experts will need to provide consistent scientific, technical and clinical advice concerning high risk medical devices and certain in-vitro diagnostics.

Eligibility:

In order to apply, experts must hold a EU, EFTA or Turkish citizenship, possess a relevant university degree at graduate level, have at least 10 years of relevant professional experience, have a good command of the English language and they may not have a financial interest or other interest in the medical device industry. Secondly, applications will be evaluated on the basis of a set of additional selection criteria.

More information:

Find the dedicated BioMed Alliance briefing here

European Commission information:

Find our latest ‘Update’ here for an overview of the latest news on the BioMed Alliance in September.

AMR Letter

The BioMed Alliance has joined an informal group of 16 other organisations active in human and animal health and signed an open letter to the Members of the European Parliament on antimicrobial resistance (AMR). AMR is an emerging worldwide threat to both human and animal health. The letter urges Members of Parliament to bring antimicrobial resistance to the forefront of EU interinstitutional discussions and to support the establishment of a dedicated AMR parliamentary group.

Read the full letter here

eu health summit news

The EU health coalition published a new statement calling for a balanced Horizon Europe that fosters both research and innovation and supports cross-fertilisation and collaboration across the framework programme’s pillars and clusters. As leader of the Coalition’s research and innovation group, the BioMed Alliance played an important role in drafting the statement.

In light of the open consultation on Horizon Europe’s Strategic Plan, the BioMed Alliance and its partners call for a balanced approach which ensures cross-fertilisation and coordination across all relevant disciplines. This is particularly important in health research as this can benefit from efforts in multiple clusters and programmes.

Read the full statement here

Our August Update is available now, take a look here to see what the BioMed Alliance has been up to.