579. Deputy Denis Naughten asked the Minister for Health the impact, if any, of the EU Health Data Space on the ability to conduct clinical trials in Ireland; and if he will make a statement on the matter. [39949/24]

Clinical trials are a fundamental component of high-quality care and improving patient outcomes. In line with the Programme for Government, my Department has made a commitment to expanding clinical trials in Ireland which is embedded strategically across key policy initiatives including the National Cancer Strategy, the National Strategy for Accelerating Genetics and Genomics, and Impact 2030: Ireland’s Research and Innovation Strategy.

Over the last 15 years, my Department has invested more than €150 million in clinical trials and research support services through the Health Research Board (HRB). This investment has resulted in the establishment of a Trials Methodology Research network and a National Clinical Trials Office.

Ireland became a member of the European Clinical Research Infrastructure Network (ECRIN) in 2018. In July of this year, I established a National Clinical Trials Oversight Group (NCTOG) which is tasked with developing recommendations on increasing the number of trials taking place in Ireland and improving access for patients to participate in more clinical trials.

The European Health Data Space (EHDS) Regulation, which is planned for publication in Q4 2024, will provide a common governance framework and harmonised infrastructure for the use and reuse of electronic health information in and between EU Member States for primary purposes (patient care and treatment) and secondary purposes (research and innovation, policy making, education and training). A key feature of the EHDS will be the establishment of Health Data Access Bodies (HDABs) across EU Member States. HDABs will operate in a federated system and provide access to health data for secondary purposes, including for clinical trials. The EU has prioritised and invested heavily in this infrastructure and it is envisaged that it will increase the EU’s attractiveness as a host site for global health research and innovation, including multinational clinical trials, by:

• Providing visibility of national datasets available through national metadata catalogues;

• Ensuring consistent labelling of data quality and utility to inform dataset selection;

• Standardising Electronic Health Records as a data source across the EU;

• Streamlining processes to access health data across Member States.

Ireland has already begun establishing EHDS infrastructure for secondary health research and my Department has been awarded €3.6 million in EU funding to support the establishment of its HDAB.

Ireland will benefit from this infrastructure and participating in this European health research ecosystem. Implementation of the EHDS should help to overcome previous challenges in increasing clinical trial activity including around accessing high-quality health data. With the expansion of our national research infrastructure, we will also increase our national attractiveness in the global market for clinical trial research. These advances will benefit the healthcare system and improve patient outcomes.