Written answers

Wednesday, 10 February 2021

Department of Health

Assisted Human Reproduction

Photo of Niamh SmythNiamh Smyth (Cavan-Monaghan, Fianna Fail)
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763. To ask the Minister for Health the details of a scheme (details supplied); the criteria for same; the eligibility criteria for the scheme; the waiting list for same; the hospitals in which the scheme is being operated; the way in which to obtain a referral; and if he will make a statement on the matter. [6581/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, a commitment to introduce the model of care for infertility, which was developed by officials in my Department in conjunction with the HSE’s National Women & Infants Health Programme, is included in the Programme for Government, “Our Shared Future”. This model of care will ensure that infertility issues will be addressed through the public health system at the lowest level of clinical intervention necessary. It will comprise 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). Structured referral pathways will be put in place and patients will be referred onwards for further investigations or treatment as required and as clinically appropriate. It is intended that, in line with available resources, this model of care for infertility will be rolled out on a phased basis over the course of the coming years.

Phase One of the roll-out of the model of care has commenced and involves the establishment, at secondary care level, of Regional Fertility Hubs in maternity networks. which will facilitate the management of a significant proportion of patients presenting with infertility issues. Funding of €2m was provided to the HSE to commence Phase One of the roll-out of the model of care in 2020. This was utilised specifically in respect of the development of the first four Regional Fertility Hubs – namely, Cork Maternity University Hospital, the Rotunda Hospital, the National Maternity Hospital and the Coombe Women & Infants University Hospital.

Additional funding of just over €1m is being made available to enable the continuation of Phase One of the roll-out in 2021, including through the setting-up of the final two Regional Fertility Hubs, to be located in Galway and Limerick.

The roll out of Phase One has been slowed due to the management of the Covid-19 pandemic by the health service broadly and its impact upon the provision of elective health services, including fertility services.

Phase Two of the roll-out will see the introduction of tertiary infertility services, including IVF, in the public health system. Phase Two will not commence until such time as infertility services at secondary level have been developed across the country and the AHR legislation is commenced. Drafting of the AHR legislation is ongoing, in conjunction with the Office of the Attorney General.

Overall, the implementation of the model of care will help to ensure the provision of safe, effective and accessible infertility services at all levels of the public health system as part of the full range of services available in obstetrics and gynaecology.

Photo of Niamh SmythNiamh Smyth (Cavan-Monaghan, Fianna Fail)
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764. To ask the Minister for Health the way in which private sector IVF is regulated; the plans he has in place in this area; and if he will make a statement on the matter. [6582/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, currently there is no specific legislation in Ireland governing assisted human reproduction (AHR). There is limited existing regulation relating to the use of gametes and embryos.

In 2006 the Health Products Regulatory Authority (HPRA) was designated as the competent authority for SI No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations, which governs the quality and safety standards in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, including gametes and embryos. These regulations empower the HPRA to authorise and monitor tissue establishments, which include some fertility clinics.

Of further relevance, the Children and Family Relationships (CFR) Act 2015 reforms and updates family law to address the needs of children living in diverse family types. Parts 2 and 3 of that Act are the responsibility of the Minister for Health. These Parts of the CFR Act regulate aspects of AHR involving donated gametes and embryos and are specifically concerned with parentage rules for children born through donor assisted human reproduction (DAHR) procedures, obligations applying to facilities providing such procedures and the establishment of the National Donor-Conceived Person Register.

Accordingly, the drafting of a bill on AHR and associated areas of research, based on the published General Scheme of the Assisted Human Reproduction Bill, was approved by Government. This comprehensive and far-reaching piece of legislation encompasses the regulation, for the first time, of a wide range of practices, including in vitro fertilisation (IVF).

The General Scheme also provides for the establishment of an independent regulatory authority for AHR, and a number of the main envisaged functions of this body relate to the licensing of AHR treatment providers and ensuring compliance with the provisions of the legislation.

The drafting of the Assisted Human Reproduction Bill is ongoing by my officials, in conjunction with the Office of the Attorney General. The publication of the AHR Bill is a priority for my Department and the Government, and a commitment to enact this legislation is included in the Programme for Government, “Our Shared Future”.

Overall, the provisions outlined within the General Scheme will ensure that AHR practices and related areas of research are conducted in a more consistent and standardised way and with the necessary oversight. The aim of the AHR legislation is to promote and ensure the health and safety of parents and others involved in the process while, most importantly, consideration of the welfare and best interests of children born as a result of AHR is the key principle underpinning all legislative measures in this area.

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