The Biomedical Alliance in Europe produced a statement outlining the practical consequences of the General Data Protection Regulation (GDPR) on health research. While the overarching purpose of the regulation is commendable, in practice researchers experience that its implementation hinders health research.

BioMed Alliance statement on Data protection Regulation

Scientific communities from industry and academia through the Biomedical Alliance in Europe (BioMed Alliance) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have teamed up to address the gaps within the translational research ecosystem and call for more focus and funding for translational research and pan European mechanisms for coordination and implementation

Read the joint statement here

Update February

biomed esicmWe are glad to welcome the  European Society of Intensive Care Medicine (ESICM) to the Biomedical Alliance in Europe, bringing the total amount of members to 30. ESICM unites more than 9000 professionals in intensive care medicine and we are sure that the organisation will provide valuable input and expertise in our activities. 

ESICM was established in 1982 and the organisation supports and promotes the advancement of knowledge in intensive care medicine through education, research and professional development.

The number of specialties and the diversity in our membership continue to increase allowing us to work intensively on even more projects.

Update January

BioMed Alliance Members have produced a cartoon highlighting the importance of high-quality and unbiased continuing medical education for medical professionals.

Medical professionals participate in continuing education to keep their knowledge up to date and to be able to provide the best standard of care to their patients. This education is provided by independent medical associations that rely on networks of experts. It is vital that they are able to continue this important mission and that education for doctors remains impartial and based on the most relevant and reliable scientific information.

Today, experts from the Biomedical Alliance in Europe (BioMed Alliance) are advising the Joint Research Centre (JRC) of the European Commission in Ispra, Italy, on the clinical evaluation of high-risk medical devices. Representatives of the healthcare professions will discuss how scientists and clinicians can help to implement the new EU Medical Devices Regulation (MDR) and the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR).

Read the press release here

BioMed Alliance welcomes the initiative proposed by Coalition S and supports the promotion of open access publishing. Nonetheless, we have certain concerns about the scope and implementation of Plan S, which aims to promote open access and ensure that scientific publications that receive funding from its members are made freely accessible immediately upon publication. BioMed Alliance has issued a statement outlining its feedback on Plan S.

Read the BioMed Alliance statement here

 

The Biomedical Alliance in Europe (the BioMed Alliance) is happy to announce that two new members have joined the ranks in January 2019. We would like to welcome the European Brain Council (EBC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) to the BioMed Alliance and we look forward to a fruitful cooperation. This year has already had a good start and there are many more interesting activities and events to look forward to.

The EBC aims to promote brain research to improve the quality of life of people that live with mental or neurological conditions. It is a platform that fosters interaction between societies, patient organisations, professional societies and industry partners. You can find more info here: https://www.braincouncil.eu/ 

EFORT promotes the exchange of scientific knowledge and experience in the field of prevention and both the conservative and surgical treatment of diseases and injuries related to the musculo-skeletal system. It brings together national orthopaedic and trauma associations from 39 countries across Europe. You can find more info here: https://www.efort.org/

We are sure that both new members will provide valuable new input to the activities of the BioMed Alliance therefore we can continue to advance biomedical innovation at European level.

The BioMed Alliance supports the European Parliament ITRE (Industry, Research, Energy) Committee proposal to establish a Steering Board for Health under Horizon Europe and to increase the research programme budget to €120 billion. We welcome the Partial General Approach, reached by the Competitiveness Council on 30 November as well.

The BioMed Alliance encourages the members of the European Parliament to reach an agreement as soon as possible and to vote on the rapporteurs’ reports on Horizon Europe, the flagship programme of research and innovation at the European Union level. Therefore, the research community calls on EU policymakers to initiate trialogue inter- institutional negotiations without delay and to establish a Steering Board for health to maximize the European potential in research and innovation.

Read the BioMed Alliance statement here

The BioMed Alliance submitted written recommendations, in response to the call for consultation on Scientific bodies under the new EU legislative framework. The new  EU Medical Device Regulation 2017/745 (MDR) foresees an independent mechanism of scrutiny of conformity assessment of certain high-risk medical devices (class III and IIb) which is going to be conducted by expert panels. The expert panels will address a range of clinical areas of relevance such as:

  • Provision of advice in relation to implementation of the EU Medical Device Regulation 2017/745 (MDR), and of the EU In-vitro Diagnostics Regulation 2017/746 (IVDR)
  • Scrutiny of the clinical evaluation dossiers of certain high-risk medical devices

The BioMed Alliance’s response can be found here.

The BioMed Alliance is teaming up with other European Organisations to hold a EU Health Summit on 29 November 2018 in Brussels. We are leading one of the 4 working groups on Research and Innovation.

The BioMed Alliance along with the partner organisations have put together recommendations for a shared vision for the future of health in Europe, calling upon the next European Commission and European Parliament to bring about necessary changes.

The working group on Research and Innovation has proposed 4 main recommendations to foster health research is Europe.

eu health summit news

You can find more info here

Please find the recommendations here:

Key recommendations for a healthier Europe

Recommendations in full

A Steering Board for Health should coordinate health programmes and health missions under Horizon Europe, guide applicants and create greater visibility for European health research programmes.

The outline of such a steering board for health is presented as an amendment in the proposal for a decision of the European Parliament and of the Council on establishing the specific programme implementing Horizon Europe – the Framework Programme for Research and Innovation. The BioMed Alliance supports the introduction of the amendment 551 and calls on the members of the European Parliament involved in the Horizon Europe political negotiations to maintain the Steering Board for Health proposal in the text legislation. It is time to walk the talk and to ensure deeper and longer-term collaborative and transnational initiatives that address the current gaps in the ‘innovation cycle’ and strengthen cross-fertilisation and collaboration across all relevant disciplines.

Read the BioMed Alliance statement here

On November 29, the BioMed Alliance along with a large number of European organisations involved in health and healthcare policy will host the first ever high-level EU Health Summit to discuss the future of health at EU level. Bringing together European leaders, policy makers and health stakeholders, the summit will take a fresh look into how Europe could develop and take the lead in areas such as research and innovation, health data and digital health, healthcare organisation and financing as well as health in all policies. The aim of the Summit is to distil recommendations for the next European Commission and European Parliament to bring the necessary changes about.

If you would like to attend, please Register here and find more info euhealthsummit.eu/ 

EU Health Summit final 002

The BioMed Alliance has joined 18 EU-level health organisations who have come together to ensure that the needs of patients are prioritised during the Brexit negotiations. This event will explore what pragmatic steps can be taken by EU decision-makers to ensure patients and public health are not forgotten during the Article 50 negotiations, regardless of how the talks progress. It will consider what can be done to ensure public health and health security are prioritised during those talks.

Confirmed speakers include:

  • Prof. Gerd R. Burmester - Professor of Medicine in the Department of Rheumatology and Clinical Immunology at the Charité University Hospital, Free University and Humboldt University of Berlin, Germany
  • Dr Gabriel Siles-Brügge - Associate Professor in Public Policy and the Programme Director for the MA in Public Policy
  • Yvonne Stewart - Head of Brexit Implementation at GlaxoSmithKline
  • Prof. Stafford Lightman - Professor of Medicine at the University of Bristol and Director of the Henry Wellcome Laboratories for Integrative Neuroscience and Endocrinology
  • Prof. Wilfried Ellmeier - Professor of Immunobiology at the Institute of Immunology, Medical University of Vienna
  • Derick Mitchell - Chief Executive of The Irish Platform for Patient Organisations, Science and Industry
  • Adina-Ioana Vălean MEP - Chair of the Committee on the Environment, Public Health and Food Safety

brexit

Registration

The event will take place on 27 September 9.00 – 11.00 am, Room 4Q2, European Parliament. If you would like to attend, please register your details by 20 September.

Precision medicine approaches the treatment of disease via an individual’s genes, environment, and lifestyle. It will allow the accurate prediction of which treatment and prevention strategies for a particular condition will work for whom – either as an individual or a group. It is therefore patient-centred as opposed to the former ‘one size fits all’ approach, and as such it needs a totally new approach, says a White Paper from the BioMed Alliance

More info here

Read the BioMed Alliance White Paper here

The BioMed Alliance supports the European Brain Council (EBC) statement “Counting down to zero: Towards a future with underfunded health research?” which calls on the European Commission, the European Parliament and the Council to increase the budget of the Horizon Europe programme to at least €120 billion, and to dedicate a much higher proportion of the research budget to the “health” cluster.

More info here

Read the European Brain Council (EBC) statement here

Read the BioMed Alliance proposals on Horizon Europe here

ERNs facilitate cross-border discussions on rare diseases or complex cases amongst clinicians and researchers. This briefing to the UK Parliament, led by Genetic Alliance UK, is aimed at producing a statement that outlines the detrimental effects that Brexit could have on patient care if negotiations don’t provide for the NHS to continue to be part of ERNs. Professor Korbonits and other eminent speakers will highlight to Members of the Parliament that continued collaboration between UK and the EU-27 is paramount to continue advancing rare disease research and patient care.

More info here

Effect of Brexit: European Reference Network : Agenda

Christian Ehler, member of the European Parliament since 2004, will visit researchers at the Charité University of Berlin and will meet with Professor Axel Pries, Dean of Charité and President of the BioMed Alliance on Friday 22 June.  Dr. Ehler has just been appointed EPP rapporteur for Horizon Europe.

More info here

The European Commission published its proposal for funding research and innovation through the Horizon Europe program from 2021 to 2027. We are concerned that health research cluster lacks the funding to meet its goals. From H2020’s lessons, the proposed budget of €7.7 billion for health research is inadequate to ensure the European Commission’s objectives, and researchers will have to face the same issues such as oversubscription and lower success rates. It is critical that a higher percentage of the research budget is dedicated to health research in order to address the various societal challenges and the expectations of EU citizens are all met.

More info here

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