Dáil Éireann Debate, Wednesday - 6 May 2026
871. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to delays in the sign off of fertility treatment by the Health Products Regulatory Authority (details supplied); the actions she will take to address this matter; and if she will make a statement on the matter. [32100/26]
View answer872. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to significant delays in the sign off of fertility treatment for a family (details supplied); the actions she will take to ensure they are supported; and if she will make a statement on the matter. [32101/26]
View answerI propose to take Questions Nos. 871 and 872 together.
The Health Products Regulatory Authority (the HPRA) is Ireland’s competent authority for the regulation of tissues and cells and has responsibility for authorisation of the assisted human reproduction facilities which operate in Ireland.
By way of overview, the regulation of processes that impact the quality and safety of tissues and cells in Ireland is conducted as part of the EU system of licencing and inspection.
Under Irish regulation, companies and healthcare facilities that provide ‘prescribed activities’ which refer to the donation, procurement, testing, processing, preservation, storage or distribution of tissues or cells for human applications must hold a Tissue Establishment Authorisation (TEA) issued by the HPRA.
Where a company subsequently seeks to introduce new processes or amend an existing process, an application for a TEA variation must be made to the HPRA. Where it is considered that the changes represent a significant change an inspection may be considered. Whilst there is no legislative timeline set out in the statutory instrument [Statutory Instrument No. 158/2006 European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006] the HPRA’s internal procedures require that the variation process should be completed within 90 days from receipt of the variation application by the HPRA, taking account of clock-stops in the event that a further input from the applicant is required.
My Department has been in contact with the HPRA and it is my understanding that the variation application for the fertility treatment the Deputy has referred to was received by the HPRA on 9th March this year. It was technically assessed and further information was requested on 30th April, which is 52 days after receipt of the application. The HPRA request for additional details does introduce a clock-stop on the assessment timeline which will restart on the day the clinic submits its responses.
I trust this answers the Deputy’s query.
