Earlier this summer, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international originator biopharmaceutical industry in Ireland, and the Irish national healthcare authority, the Health Service Executive (HSE), announced that a new model clinical trial agreement (CTA) has been approved for use in Ireland. The new model CTA is for tripartite engagements involving a commercial sponsor, contract research organisation and hospital. It is mandatory for use in clinical trials conducted in Ireland unless negotiations among the parties began prior to 20 May 2024.

The use of standardised agreements for clinical trials and clinical investigations is common in many jurisdictions but a relatively new feature of the industry in Ireland. This model CTA represents only the second to be adopted since the first bipartite model CTA was approved in 2022. The objective of these streamlined model CTAs is to accelerate the conduct of clinical trials and medical innovation in Ireland, reduce the financial and administrative burden on hospitals and other participants, and improve patient outcomes. 

The HSE has also announced that work is underway on a further new model CTA for quadripartite engagements (sponsor, contract research organisation, academic partner and hospital). Both the bipartite and tripartite model CTAs are available to download from the HSE’s website here: Clinical Trials - HSE | Research & Development (hseresearch.ie).

If you have any queries on the use or content of the new model CTA or would like to know more generally about the regulatory, legal and contractual aspects of conducting clinical trials or investigations in Ireland, please contact Michael Finn, Deirdre Kilroy or Kelly Mackey in Bird & Bird’s Dublin office.