Wednesday, 10 February 2021

Questions (764)

Niamh Smyth


764. Deputy Niamh Smyth asked 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]

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Written answers (Question to Health)

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.