Jim O'Callaghan (Dublin Bay South, Fianna Fail)
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168. To ask the Minister for Health the estimated full-year cost to the Exchequer of the setting up and annual running costs of the new Assisted Human Reproduction Regulatory Authority to support assisted human reproduction, including IVF and surrogacy. [43295/24]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Assisted Human Reproduction) Act 2024 was signed into law on 02 July 2024. This complex and far-reaching legislation encompasses the regulation for the first time of a wide range of practices undertaken in this jurisdiction. The primary purpose of the legislation is to ensure that assisted human reproduction (AHR) practices and related areas of research are conducted in a consistent and standardised way and with the necessary regulatory oversight. The legislation as enacted also provides for the regulation of future surrogacy arrangements undertaken by Irish residents in other jurisdictions. In addition, the legislation allows for the recognition of parentage arising from certain past domestic and international surrogacy arrangements.

The provision of AHR services has, until now, been largely unregulated, which means that individuals are availing of often complex and sometimes risky procedures in a legal vacuum. This legal vacuum has significant consequences not only for couples and individuals using AHR treatments and services, but also for the fertility clinics themselves and for the general public who have a legitimate expectation that all AHR practices and embryo-based research is regulated and carefully monitored.

The Act provides for the establishment of a new regulatory authority, the Assisted Human Reproduction Regulatory Authority (AHRRA), and the appointment of a board and a chief executive officer (CEO). The AHRRA will be the agency specifically responsible for the oversight and regulation of AHR practices and associated research activities. The role of the new Authority will be key to embedding safe and appropriate clinical AHR practices in Ireland.

Intensive work is ongoing in my Department in relation to the commencement of relevant provisions of the Act and the establishment of the Authority. This includes consideration of the range of functions and the staffing and other requirements necessary to fulfil the statutory remit prescribed for the AHRRA in the Act. This is a complex piece of work and while I expect that the Authority will be established during 2025, it isn’t possible, at this time, to provide an estimate of the full-year costs that will arise when the AHRRA is fully up and running.