Ireland’s Presidency of the Council of the European Union will prioritise the implementation of digital health systems and data sharing, the Minister for Health has told the European Parliament’s Committee on Public Health (SANT).
Addressing the Committee earlier this week, Minister Jennifer Carroll MacNeill said the Irish Presidency’s health agenda – themed Investing in health to enable competitiveness – aims to strengthen the EU’s global competitiveness while ensuring high-quality, effective healthcare delivery for European citizens.
The Presidency programme is structured around areas of strategic focus, including the future of medicines, promoting innovation in life sciences, clinical trials, and regulatory frameworks to support competitiveness and sustainable access to treatments.
The central focus of the Presidency is the advancement of key EU legislative priorities. Two priority legislative dossiers – the Biotech Act I and simplification of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) – will be at the forefront. These aim to address challenges and opportunities related to access, innovation, and competitiveness in the health and life sciences sectors. The Irish Presidency will seek a Council General Approach on medical device regulatory reforms, progress negotiations on the Biotech Act Regulation, and conduct trilogue negotiations to secure political agreement on the Biotech Act Directive should the Parliament adopt its position in time.
The Irish presidency will also prioritise the implementation of digital health systems and data sharing. Progressing the European Health Data Space will be key, enabling secure, interoperable data use to support research, innovation, and the development of safe and effective AI in healthcare.
Minister Carroll MacNeill, said: “At a time of geopolitical uncertainty, health security threats, demographic change and pressure on public finances, cooperation at European level on health has never been more important. Ireland is committed to delivering a Presidency that is fair, pragmatic and focused on results for patients across Europe.
“Healthier populations, resilient health services, innovation and a predictable regulatory environment are fundamental to Europe’s economic and social strength. Health policy will play a pivotal role in advancing the Irish Presidency’s priorities of values, security and competitiveness, by working to progress key files that support innovation and patient safety, including the Biotech Act, and the simplification of the Medical Devices and In Vitro Diagnostics Regulations.”
Advancing life sciences
Speaking in the Dail recently, the Minister said Ireland’s Presidency Health Agenda aims to position health and competitiveness as “mutually reinforcing priorities”.
“We will advance the EU life sciences agenda and promote innovative and proactive healthcare that focusses on prevention and the roll-out of digital health across the EU,” she said.
“Ireland’s Presidency will drive progress on critical EU legislation that advances our health agenda. The Biotech Act I (published in December 2025) is a strategic priority for EU competitiveness and sovereignty. The Act streamlines regulations across clinical trials, advanced therapy medicinal products, and biomanufacturing. It mobilises €10 billion in investment funding (2026-27) via the Biotech EU initiative with the European Investment Bank. Key measures include simplified clinical trial procedures, innovation support mechanisms, and biosecurity safeguards. This flagship legislation will dominate health policy discussions during our Presidency,” she added.
“The Medical Devices Regulation & In Vitro Diagnostics Regulation (amendments published in December 2025) will simplify and modernise device approval while maintaining patient safety. Expected outcomes include €3–5 billion in annual cost savings for manufacturers, faster patient access to innovative devices, and reduced shortages of critical medical equipment.”
