4008. Deputy Pádraig Rice asked the Minister for Health for an update on the work to examine biobanking in Ireland, and the potential for legislation to underpin it, as recommended by the Irish Health Research Forum in 2023; and if she will make a statement on the matter. [58562/26]

My Department is aware of the policy and legislative complexities that exist in relation to biobanking and the relevant recommendations made by the Irish health research community, including the Irish Health Research Forum.

There are a variety of collections of bio-samples retained for either clinical or research purposes across Ireland, by university researchers, clinicians, hospitals, and industry. The current legal framework in Ireland requires that appropriate consent is gathered upon collection or reuse of the bio-samples and that ethics approval is completed prior to undertaking any health research.

New approaches to consent and access to biobank data is being introduced with the introduction of the European Health Data Space, which includes access to 'health data from biobanks' for secondary use purposes and the streamlining of the EU Clinical Trials Regulation through the EU Biotech Act.

My officials are working to implement the European Health Data Space appropriately in Ireland, and to review any additional supports for biobanking which may be required including the need to provide national legislation where necessary in terms of underpinning national policy.