Dáil Éireann Debate, Wednesday - 1 July 2026
316. Deputy Erin McGreehan asked the Minister for Health the supports in place to enable Irish participation in international clinical trials involving radiopharmaceuticals and targeted radionuclide therapies; and the way in which Ireland can position itself as a hub for such research. [50118/26]
View answerTo enable Irish organisations to participate in international clinical trials involving radiopharmaceuticals and targeted radionuclide therapies, the Department of Health provides support to ensure that appropriate regulatory frameworks and safety standards are applied, and that the necessary research infrastructure is present to allow the trials to take place.
In terms of oversight over the proper and safe medical use of radiopharmaceuticals and radionuclide therapies, including their use in clinical trials, the Department of Health funds two aegis bodies that support and enable Irish organisations in the preparatory stages of trial set-up: the Health Products Regulatory Authority (HPRA), and the Health Information Quality Authority (HIQA). The Environmental Protection Agency (EPA) also provides support in this area, under the aegis of the Department of Climate, Energy, and the Environment. When applications are received from researchers or sponsor companies to undertake clinical trials of radiopharmaceuticals or radionuclide therapies, the appropriate regulatory gatekeeping infrastructure is in place to review and grant approval for such trials. Our agencies thereby ensure compliance with all necessary standards to protect public and environmental health.
With regard to investment in clinical research infrastructure and positioning of Ireland as a hub for clinical trials research on radiopharmaceuticals and radionuclide therapies, this fits more broadly under our Programme for Government 2025 ambitions to expand the number of clinical trials taking place in the State. On 21st November 2025 I launched the Final Report and Recommendations of the National Clinical Trials Oversight Group (NCTOG), which point the way towards a more streamlined clinical trials environment in Ireland. I will soon appoint the Clinical Trials Advisory Council who will oversee the process of implementing the NCTOG’s Final Recommendations, including the establishment of a National Clinical Trials Body. The Final Recommendations include proposed measures to streamline the regulatory environment, standardise costings frameworks, and support and develop our expert clinical trials workforce. We are currently in a period of growth in the sector as evidenced by the upward trend in numbers of clinical trials taking place in Ireland since 2023, and length of time taken for regulatory approval is falling. Implementation of the NCTOG's Final Recommendations will further accelerate progress across all areas and, as a result, Irish patients will gain greater access to life-changing innovative treatments.
One example of the available supports directly relating to clinical trials involving radionuclide therapies is the Health Research Board (HRB; the aegis body of the Department of Health responsible for funding health research) funding of the Irish Research Radiation Oncology Group, which is a national network that aims to develop, improve, and streamline the processes for undertaking research, including clinical trials, in the use of radionuclides in cancer treatment. More broadly, since 2010 the HRB has invested over €100M in clinical trials infrastructures with a particular focus on funding persons in key posts to develop Irish researchers with the skills to support, advise, coordinate and conduct trials and interventions. The most recent set of HRB grants investing in Clinical Research Facilities/Centres (CRF/C) in Ireland from 2021-2026 totals €23M.
Clinical Research Facilities (CRFs) are located on the sites of hospitals. A CRF provides the space, the facilities, access to services and most importantly the staff needed to support clinical trials and other clinical research studies within a hospital setting. They enable researchers and research groups, small and medium enterprises, the health care industry and other key partners to test innovative therapies, technologies and products, and facilitate the translation of scientific discoveries and innovations into improved patient care. CRFs also allow for collaboration between academics and clinicians and provide an environment to train a new generation of clinical researchers and research nurses.
Our efforts to streamline the clinical trials landscape are in line with both our national ambitions as well as wider European measures such as those proposed in the European Biotech Act (Part 1). This will enhance Ireland's competitiveness and reputation as a high-quality host for multinational clinical trials. Ireland has also been a member of the European Clinical Research Infrastructure Network (ECRIN) since 2018, which brings various benefits to patients and researchers, through access to trials and improved availability of new treatments, as well as tools and services that aid the conduct of clinical trials domestically, as well as expanding trials internationally. Continued support for Irish participation in international clinical research networks will help position the State as a hub for clinical trials of all types, including those of radiopharmaceuticals and radionuclide therapies.
