On 25th January 2023, key stakeholders from the industry, regulatory authorities, and patients’ representative organisations met at Bibliothèque Solvay, in Brussels, to debate the outcomes of the new Clinical Trials Regulation and the upcoming European Health Data Space. The event was organised by Viedoc, the Society for Clinical Data Management (SCDM), and Re-Imagine Europa (RIE), and supported by key members of the European Parliament.
The EU Clinical Trial Regulation became effective in early 2022 and it is now in the 3-year transition period in which the former system under the EU Clinical Trials Directive and the new system under the EU Clinical Trial Regulation are available in parallel. Recognising the need for improvements, the EU has set forth a very ambitious agenda to foster innovation and create a more rewarding ecosystem for clinical trials. This agenda aims to reimagine the European health space starting from the lessons learned from regulatory flexibilities set up during the pandemic and unleashing the potential of data sharing by fostering a new “data culture” creating a more responsive research environment.
The aim of the event was to discuss lessons learned from different stakeholders on the ongoing application of the EU Clinical Trial Regulation, taking also into consideration the 2022-2026 work plan of the initiative Accelerating Clinical Trials in the EU (ACT EU) and the ongoing negotiation of the European Health Data Space (EHDS). The working lunch, moderated by Erika Staël von Holstein, Chief Executive of Re-Imagine Europa, started with a welcome address from Tomislav Sokol, Member of the European Parliament. In his intervention, Mr Sokol contextualised the ongoing negotiations of the European Health Data Space, in which he is co-Rapporteur, clarifying the importance of defining the patient’s role in consenting to the secondary use of data. Dr Andrzej Rys, Principal Scientific Adviser of the DG SANTE of the European Commission, presented the main objectives and expected benefits of the EHDS legislation, which is directly linked to other legal proposals and initiatives within the European Digital Single Market and the European Strategy for data, according to his presentation.
“This Commission has great ambition to put the digital market in Europe and data, not only medical data, in some kind of order and regulation.” – Andrzej Rys
The debate continued with contributions from several speakers representing the different stakeholders of the health sector. Among them were Emer Cooke, Executive Director of the European Medicines Agency (EMA), Kaisa Immonen, Director of Policy at the European Patients’ Forum, Björn Eriksson, Director General of the Swedish Medical Products Agency (MPA), Vytenis Andriukaitis, Former European Commissioner for Health and Food Safety and Chair of AP4HE, Mats Klaar, Chief Executive Officer at Viedoc, and Jonathan R. Andrus, Societal regulatory liaison at Society for Clinical Data Management (SCDM).
“Transparency is key to what we do. We need transparency to help us build trust and without trust, we become irrelevant to people.” – Emer Cooke
The attendees participated in a very fruitful and dynamic debate and all speakers agreed on the necessity of involving the patients in the discussion, following a co-designing approach. Participants also agreed on the sensitiveness of the topic when it comes to the secondary use of health data and to the application of ACT EU. Part of the debate was centered in the need to foster innovation and encourage the development of future clinical trials. On the other hand, attendees also pointed out that data privacy and patients’ safety are and should continue to be the main concern and focus of these policies.
“When you discuss the Clinical Trials regulation, the ACT EU initiative, you are always taking into account three contexts: the medical context, the scientific context and the regulatory context.” – Björn Eriksson
In the closing address, Nils Torvalds, Member of the European Parliament and Re-Imagine Europa’s Advisory board, who hosted the event, summed up the discussion and positively instigated all participants to continue the work developed so far, always with the focus on the patients and on creating better treatments.
The event brought together around 50 attendees representing all sides of the clinical trials spectrum: from patients to industry representatives, legislative bodies, and national regulatory authorities. A report including the main takeaways of the debate will be prepared, and shared with all the participants and other key stakeholders.