The Biomedical Alliance is committed to working with other stakeholders in the health and research sectors to achieve common objectives and to exchange knowledge. We believe that stakeholders in the health and research fields can achieve more when they cooperate as we all have a clear interest in fostering research and innovation and improving healthcare.

Cooperation is limited to those areas where parties have a clear common interest and objectives do not contradict one another.

The BioMed Alliance cooperates and interacts with many actors in the EU policy field, some examples are listed below:

EU Institutions

The BioMed Alliance is in contact with policy makers and experts in different institutions to provide expert advice and to stay updated on EU affairs. As a stakeholder in the health and research policy field, we participate in different events and meetings and invite policy makers to our public meetings. In addition, we reply to public consultations and respond to calls.

EMA

The BioMed Alliance is officially registered as an EMA Stakeholder. By registering as a stakeholder, the BioMed Alliance can easily be identified for consultation on relevant issues, is kept up to date on events, receives communications and is informed on EMA consultations.

CORE-MD

The BioMed Alliance has been named as partner in the CORE -MD project, a European project funded under Horizon 2020 to contribute to evidence-based decision making for medical devices. The project, which was launched in April 2021, 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. BioMed Alliance is co-leading the work package 4 “Network and Community Building” which has for objective to establish methods for networking between notified bodies and regulators with clinical and scientific experts. Within the project, the role of BioMed Alliance is to act as a disseminator and educator.

The consortium will be led by ESC and EFORT and is composed of a mix of medical professional associations, the European Patients’ Forum, national regulatory agencies and public health institutes, academic institutions, notified bodies and manufacturers. For more information see the CORE-MD website.

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under grant agreement No 965246.

TEHDAS Joint Action

The BioMed Alliance has been selected to participate as a stakeholder in the Joint Action Towards the European Health Data Space (TEHDAS). TEHDAS is a European project that started in February 2021 and funded by the Health Programme of the European Union. It is coordinated by the Finnish Innovation Fund SITRA and led by the Member States to develop joint European principles for the secondary use of health data. The aim of the Joint Action is to guide the establishment of the European Health Data Space and we have been selected as a stakeholder in three working groups of TEHDAS: the Stakeholder forum, the Work Package 5 “Sharing data for health” and the Work Package 7 “Connecting the dots”. Through these work packages, BioMed Alliance and the experts from our newly created Taskforce on Health Data are participating to the work of the Joint Action by providing expertise and information to guide the development of the new EHDS.

More information on the TEHDAS Joint Action is available here.

EU Health Coalition

The EU Health Coalition is a multi-stakeholder initiative looking at how to map the future of healthcare in Europe, make the most of innovation, the role of the European Union in addressing these challenges and critically, cooperate between different sectors to deliver the best outcomes for patients in Europe.

Within the EU Health Coalition, a dedicated Research and Innovation policy group is co-led by BioMed Alliance. The policy group has proposed recommendations with the aim to enhance the health research landscape in Europe. The proposed recommendations call for an increased EU budget for health research, setting-up a cross-sectorial health research Public Private Partnership and better coordination and support for health research. 

The next EU Health Summit taking place on 15 November in the Flemish Parliament will provide an excellent occasion to get together with a broad range of health stakeholders and policy makers to discuss the future of health in the EU. More information is available here.

Coalition on Reducing Bureaucracy in Clinical Trials

The BioMed Alliance is an active member of the stakeholder coalition on reducing bureaucracy in clinical trials, which aims to address the unnecessary complexity in clinical trials to facilitate research. The Coalition produced a statement 'Reducing bureaucracy in clinical trials: now is the time' which was jointly produced by medical societies and patient advocates. The work within the coalition is ongoing, and a number of Coalition Recommendations has been drafted and a series of roundtables was organised to gather additional input from policy makers and external stakeholders. More information on the coalition is available on its website here.

EPF

The European Patient Forum (EPF) is an umbrella organisation that represents patient groups across Europe in different disease groups. We cooperate with them on topics of mutual interest to get the valuable input of patient representatives. EPF is also a member of our CME Experts Committee.

European Commission Medical Devices Coordination Group (MDCG)

The BioMed Alliance is a registered stakeholder and participates in meetings of different working groups of the Medical Device Coordination Group (MDCG). This group brings together competent authorities and aims to facilitate a harmonised implementation of the EU medical device regulations in member states. Through the stakeholder meetings and consultations, the BioMed Alliance provides feedback on the implementation of the Medical Devices Regulation and In Vitro Diagnostics Regulation. Published MDCG Guidance documents can be found here.

HERA

The European Health Emergency Preparedness and Response Authority (HERA) has recently been established within the European Commission to prevent, detect, and rapidly respond to health emergencies. The BioMed Alliance has been selected as a member of the The Civil Society Forum, which helps to ensure that HERA receives regular input on the views of the civil society stakeholders.

UEMS-EACCME

The BioMed Alliance has signed a memorandum of understanding with the European Union of Medical Specialists (UEMS) to ensure continued dialogue between our organisations. We are particularly in close contact with the European Accreditation Council for Continuing Medical Education (EACCME) to discuss issues around the accreditation of CME activities and to share the experiences and views of medical societies.

EIT Health

The European Institute of Innovation and Technology is made up of various knowledge and innovation communities that each focus on a different sector. EIT Health focuses on health and ageing and aims to facilitate cooperation and create a supportive environment for innovation in health. BioMed Alliance signed a memorandum of understanding with EIT Health to facilitate cooperation on a range of activities that are of relevance to our members.

BeWell

BioMed Alliance is a partner in the Erasmus+ funded project BeWell, the Blueprint alliance for a future health workforce strategy on digital and green skills. The project brings together a wide range of European health associations and organisations including healthcare professional organisations, universities, industry and others. It aims to develop a green and digital skills strategy between 2022 and 2026 and more information on its activities is available here.