Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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231. To ask the Minister for Health the estimated full-year cost to develop a clear pathway of care from general practitioners for those with fertility concerns, including general practitioner--access to diagnostics where appropriate. [25134/22]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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233. To ask the Minister for Health the estimated full-year cost to commit to four publicly-funded IVF cycles, including medication and mental health supports. [25136/22]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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236. To ask the Minister for Health the estimated full-year cost to establish a publicly-funded one-stop-shop for surrogacy medical testing, including mental health supports. [25139/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 231, 233 and 236 together.

As the Deputy will be aware, a commitment to “introduce a publicly funded model of care for fertility treatment” is included in the Programme for Government.

‎The model of care for infertility was developed by the Department of Health in conjunction with the HSE’s National Women & Infants Health Programme (NWIHP) in order to ensure that infertility issues are addressed through the public health system at the lowest level of clinical intervention necessary.‎‎This model of care comprises three stages, starting in primary care (i.e. GPs) and extending into secondary care (i.e. Regional Fertility Hubs) and then, where necessary, tertiary care (i.e. IVF, and other advanced assisted human reproduction (AHR) treatments), with patients being referred onwards through structured pathways.

Phase One of the roll-out of the model of care has involved the establishment, at secondary care level, of Regional Fertility Hubs within maternity networks, in order to facilitate the management of a significant proportion of patients presenting with infertility issues at this level of intervention. The completion of Phase One of the roll-out, envisaged before the end of this year, will result in fully operational Regional Fertility Hubs in each of the six Hospital Groups across the country.

Initial funding of €2m was assigned in order to commence Phase One of the roll-out of the model of care in 2020 and additional funding of approximately €1m was made available for 2021. These allocations were utilised to enable the setting-up of the Regional Fertility Hubs. According to figures updated by NWIHP in 2021, the total full-year cost of fully operating the six Hubs is estimated to be in the region of €2.87m.

Phase Two of the roll-out of the model of care will see the introduction of tertiary infertility services, including IVF, in the public health system. Substantial planning, development and policy work is required to establish the scope, design and requirements for this component of the model of care. At this juncture, the design and scope of this aspect of the model of care have not been finalised as detailed consideration of a range of issues including service and treatment design, eligibility and access criteria, and associated resource implications is required. This work will also need to be informed by the final Health (Assisted Human Reproduction) Act, the progress of this Bill – which has recently passed Second Stage in the Dáil – and associated regulations that will be developed following the enactment of this legislation. My officials are continuing engagement with the HSE in relation to the necessary programmes of work required to further advance consideration of the issues arising for commencing Phase Two of the roll-out of the model of care.

Finally, in respect of surrogacy services, Part 7 of the Health (Assisted Human Reproduction) Bill 2022 outlines the proposed circumstances under which domestic surrogacy will be permitted in Ireland. The proposed specific conditions include a requirement for all surrogacy agreements to be altruistic and authorised by the new Assisted Human Reproduction Regulatory Authority prior to the provision of AHR treatment. The surrogate mother and the intending parent(s) must have provided fully-informed consent to the surrogacy agreement, have received appropriate counselling specific to surrogacy, and the surrogate mother must have been assessed as being both physically and psychologically suitable to act as a surrogate mother. The scope of surrogacy related-services, if any, that may be incorporated into the model of care for infertility will be considered as part of the above-mentioned programmes of work.

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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232. To ask the Minister for Health the estimated full-year cost to expand publicly-funded regional fertility hubs for each province. [25135/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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My Department is working with the HSE’s National Women & Infants Health Programme to implement a Model of Care for Infertility to ensure that infertility issues are addressed through the public health system at the lowest level of clinical intervention necessary.

This model of care comprises three stages, starting in primary care (i.e., GPs), extending into secondary care (i.e., Regional Fertility Hubs) and then, where necessary, tertiary care (i.e., IVF and other advanced assisted human reproduction (AHR) treatments), with patients being referred onwards through structured pathways.

Phase One of the roll-out of the Model of Care for Infertility has involved the establishment of Regional Fertility Hubs one within each of the six maternity networks across the country. These Hubs aim to maximise the outcome for women and their partners by offering an assessment and management service on-site that will streamline the process and minimise delays in access to fertility services.

These Hubs offer a tailored, multi-disciplinary approach. Patients are referred, if they meet the relevant criteria, by their GPs to their local Hub, which is being resourced so that it has available specific expertise in this area from a medical perspective, a nursing perspective and a laboratory perspective.

Following the provision of funding in 2020 and again in 2021, six Regional Fertility Hubs have been established and are now operational in the National Maternity Hospital, the Rotunda, the Coombe, Cork University Maternity Hospital, University Hospital Galway and at Nenagh General Hospital (under the governance of University Maternity Hospital Limerick).

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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234. To ask the Minister for Health the estimated full-year cost to introduce regulation of IVF clinic services. [25137/22]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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235. To ask the Minister for Health the estimated full-year cost to enact the Assisted Human Reproduction (AHR) Bill 2022. [25138/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 234 and 235 together.

As the Deputy will be aware, the Health (Assisted Human Reproduction) Bill 2022 (AHR Bill) passed Second Stage in the Dáil on March 23^rd2022 and has been referred to the Select Committee on Health for Third Stage.

The AHR Bill proposes to introduce, for the first time in this country, a regulatory framework for assisted human reproduction (AHR), which is a complex, innovative and fast-moving area of medicine.

Ireland is currently very much an outlier internationally. The State is not funding advanced AHR treatment at present and we do not have a specific regulatory framework in place in respect of this area of health care. This means that individuals are currently availing of complex and sometimes risky procedures without the benefit of a regulatory framework.

The new rules, regulations and provisions that will be provided through this legislation will help bring guidance, clarity and peace of mind.

Post-commencement of the Act, the main ensuing budgetary requirements will relate to the establishment and running costs of the Assisted Human Reproduction Regulatory Authority (AHRRA for short).

A Regulatory Impact Analysis in respect of the AHRRA was undertaken in 2017 and it estimated the combined set-up and operational costs for one year as being between €1.6m and €2.5m, dependent primarily on the level of functions or services the new body may share with another public body or other public bodies. The budgetary requirements for the AHHRA will be kept under ongoing consideration as more detailed planning for the establishment of the Authority progresses and, having regard to amendments, if any, to the proposed legislation that may impact on the AHRRA as the Bill progresses through the Houses of the Oireachtas.