Enda Kenny (Mayo, Fine Gael)
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Question 158: To ask the Minister for Health and Children if, in respect of the regulation for fertility treatment, she will indicate the regulations that apply here; if fertility units are inspected by the Irish Medicines Board to ensure compliance to the EU directive on quality and safety of cells and tissues; her views, in respect of ethical issues, on the inclusion in these inspections of standards specific to the fertility area similar to the HFEA in the UK; if she will have the IMB or another organisation check on compliance in this regard at no extra cost; and if she will make a statement on the matter. [18181/08]

Mary Harney (Dublin Mid West, Progressive Democrats)
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At present there is no legislation in Ireland governing the intervention in the natural process of creating human life; instead, medical practice is governed by guidelines issued by the Medical Council. My Department is developing an appropriate regulatory framework for Assisted Human Reproduction services. This work involves, inter alia, examining the approaches to regulation in other jurisdictions — including the one mentioned by the Deputy — and considering the ethical and legal issues that arise. It will also take into account the report of the Joint Oireachtas Committee on Health and Children on this area — when completed — and any judgment of the Supreme Court in the RvR (frozen embryo) case.

In addition, the European Communities (Quality and Safety of Human Tissues and Cells) Regulations (Statutory Instrument No.158 of 2006) came into law on 7 April, 2006. The Regulations apply to tissues establishments that are involved in the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications. Further Regulations (Statutory Instrument No. 598 of 2007) were signed on 31st August 2007 in respect of human tissues and cells traceability requirements, notification of serious adverse reactions and events and certain technical requirements.

The aim of the Regulations is to ensure a high level of protection of human health. The Regulations include criteria for assessing the status of prospective donors, inspection and control measures, traceability of donations and qualifications and training for persons working in tissue establishments.

Fertility clinics are tissue establishments under the Regulations. They must be inspected and authorised by the Irish Medicines Board (IMB), which is the competent authority under the Regulations, to ensure that they meet quality and safety standards. The Regulations, which were made under section 3 of the European Communities Act 1972, gave effect to EU Directives 2004/23/EC, 2006/17/EC and 2006/86/EC. Regulations made under the 1972 Act cannot materially exceed the scope of the relevant Directives: the extension of the IMB's remit to include inspection of ethical or other matters similar to those which come within the remit of the United Kingdom's Human Fertilisation and Embryology Authority (HFEA) would require primary legislation.