Dáil Éireann Debate, Wednesday - 10 June 2026
236. Deputy Pádraig O'Sullivan asked the Minister for Health the reason Ireland ranked as the slowest of all EU member states for the time from EU Clinical Trial Regulation approval to the first clinical trial site being ready, at 213 days, for studies commenced between 2023 and 2025; the steps being taken to reduce clinical trial set-up times; and if she will make a statement on the matter. [44375/26]
View answer237. Deputy Pádraig O'Sullivan asked the Minister for Health the number of pharmaceutical industry-sponsored clinical trials commenced in Ireland in each year since 2021; her views on the fact that Ireland initiated far fewer trials than comparable countries such as Denmark over the same period; and if she will make a statement on the matter. [44376/26]
View answerI propose to take Question No. 236 and question No. 237 together.
I apologise for the delayed response and thank the deputy for this opportunity to highlight progress towards expanding the number of clinical trials taking place in the State.
Although Ireland is growing in terms of clinical trials activity, my Department has worked with stakeholders to identify a number of challenges for companies and organisations wishing to set up trials in the State, including long start-up times, regulatory and site-specific challenges. The expert National Clinical Trials Oversight Group (NCTOG) thoroughly explored clinical trial approval timelines and site readiness throughout 2024-2025 and I published their Final Recommendations at the end of 2025.
We are now finalising the appointment of the Clinical Trials Advisory Council (CTAC) to oversee the implementation of the NCTOG’s Final Recommendations. The CTAC will include expert membership drawn from across the sector, and will commence activities in the coming weeks. These activities will have a forward-facing, long-term, and sustainable focus, and include the establishment of a National Clinical Trials Body to oversee our clinical trials sector. The NCTOG's 20 key recommendations, across six priority areas, will create a more agile and streamlined regulatory system for clinical trials whilst maintaining the highest standards of data and patient protection, in addition to supporting the expert workforce needed to administer growing numbers of clinical trials. The resulting reduction in start-up times for clinical trials, and standardisation of the regulatory processes, will enable greater numbers of clinical trials to be conducted in Ireland, also helping strengthen Irish participation in multinational trials and increasing Irish patients' access to innovative life-changing treatments.
The COVID-19 pandemic, alongside reduced regulatory approvals being granted, and the transition to the EU Clinical Trials Regulation, are the likely contributors to the slowing of research activity between 2021 and 2023. The Irish Pharmaceutical Healthcare Association produces an annual Clinical Trial Activity Comparison Report which includes numbers of pharmaceutical industry-sponsored clinical trials commenced each year. There were approximately 61 industry-sponsored clinical trials in Ireland in 2021, 37 in 2022, 41 in 2023, 51 in 2024, and 73 in 2025. (https://www.ipha.ie/wp-content/uploads/2026/05/IPHA-Clinical-Trials-Activity-comparison-report-2026.pdf and https://www.ipha.ie/wp-content/uploads/2024/05/IPHA-Clinical-Trials-Activity-Comparison-Report-2024.pdf).
Our current efforts are in alignment with measures proposed in the European Commission's Biotech Act (Part 1), as well as commitments in our 2025 Programme for Government. Countries such as Denmark and Spain have made considerable progress in growing their clinical trials sector through national-level approaches, focusing on cross-sector partnership and collaboration with industry, and it is our ambition to similarly expand the clinical trials sector in Ireland.
