Read our first Update of 2021 here to see how we kicked off the year. This month you will find more information about two consultations launched by the European Commission on HERA and on the European Health Data Space, the UK participation in Horizon Europe, an update on BioMedScape, the date of the next BioMed Alliance General Assembly, upcoming activities and members’ news.

Early January the European Commission launched a consultation on the inception impact assessment for the new regulation for the European Health Data Space (EHDS) that is scheduled to be adopted during the 4th quarter of this year. The proposal seeks to address issues related to access to and exchange of health data for healthcare delivery, scientific research and innovation, policy making and regulatory activities. While the European Health Data Space aims to facilitate data exchange and enhance access to data for research and policy making, it will also increase patient access and control over their own data.

The BioMed Alliance has prepared a response to this consultation sharing its views on the inception impact assessment. You can read the response here.

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The European Commission is currently actively recruiting experts for the EXPAMED Expert panels again, which will evaluate high-risk medical devices and in vitro diagnostics. Due to several circumstances including BREXIT, there is an urgent need for additional experts; in particular in the fields of gynaecology, diabetes, orthopaedics and ophthalmology. Experts are asked to apply by 29 January 2021 on the website of the European Commission.

The BioMed Alliance raised awareness on this call in 2019 and the Commission now requests the support of medical societies to promote the call for experts again. The expert panels will play a very important role in the evaluation process of medical devices under the Medical Devices Regulation (application date: 26 May 2021), and the In Vitro Diagnostics Regulation (application date: 26 May 2022).

For more information, please find the BioMed Alliance briefing on this topic here and the application form here.

Save-the-date for an interactive webinar hosted by MEP Maria da Graca Carvalho and MEP Dolors Montserrat on 3 February 2021 from 15:00-17:00 CET.

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The EORTC and the BioMed Alliance, together with key members of the European Parliament, will organise a webinar bringing together important health stakeholders to share fresh and diverse perspectives on what can be implemented in the current EU policy programmes to advance Treatment Optimization as part of health systems.

The discussion is timely needed considering the current health challenges and the preparation of the ambitious EU Health Union programme and its policy and legislative measures such as the Pharmaceutical Strategy, the upcoming Horizon Europe, the EU4Health programme, and Europe's Beating Cancer Plan.

Recent health threats such as COVID-19 demonstrated the urgent need to have a healthcare system that places the patient at the centre and has the ultimate goal to solve clinical issues. The drug-driven approach tends to dominate treatment development in oncology and a similar tendency is seen in other medical specialities. Thus, important aspects relating to the use of novel therapies in real-world settings are neglected throughout the process such as: optimal dose, duration, sequence, combination, and quality of life. New drugs reaching the market is not an end, but a start. Treatment optimisation plays an important role in improving the way treatments are utilised in real-world conditions through the conduct of studies. These studies can provide an answer to one or multiple of the above-mentioned clinical research questions.

The agenda is available here.

You can register to the online event here and we very much look forward to welcoming you!

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