Dáil Éireann Debate, Tuesday - 30 January 2024
565. Deputy Paul Murphy asked the Minister for Health if he will instruct the HPRA to investigate and provide an outcome for a complaint submitted about First IVF Clane and if he will make a statement about the investigation conducted into First IVF Clane. [4209/24]
View answerThe Deputy will appreciate that it would not be appropriate for me to comment on individual cases nor am I in a position to intervene or comment on the specific case referred to.
However, I was advised that the HPRA inspected First IVF, in Clane, in June 2022 as part of its routine inspection programme. As a result of significant deficiencies identified in that inspection, the HPRA immediately directed First IVF to discontinue embryo biopsy procedures and required additional actions. An action plan was submitted to the HPRA in July 2022 which included a detailed plan of corrective actions.
The clinic was placed on a heighted programme of inspection and follow-up to monitor the progress of the implementation of the corrective and preventative action plan. Two follow-up on-site inspections, one of which was an unannounced, were conducted to review the implementation of the corrective actions and during these inspections it was determined that this was progressed appropriately. During this process, no evidence was found that the quality and safety of tissues and cells were compromised. First IVF continues to be subject to regular inspections.
The HPRA’s role is outlined in Tissues and Cells legislation (Statutory instrument 158 of 2006) and the inspection of the fertility clinics in Ireland is confined to certain activities that are listed on tissue establishment authorisations and how the clinics comply with the relevant legislative requirements. This relates primarily to the way sperm, eggs and embryos are procured, processed, and stored, to ensure their quality and safety. The HPRA’s role does not extend to oversight of clinical care.
As the Deputy will be aware, the Health (Assisted Human Reproduction) Bill 2022 was introduced to, and passed Second Stage in, the Dáil in March 2022 and has been referred to the Select Committee on Health for Third Stage. The first session of the Committee Stage took place on 24th January 2024.
The focus of this Bill is on the regulation, for the first time in this country, of a wide range of assisted human reproduction (AHR) practices undertaken within the jurisdiction.
Ireland currently does not have a regulatory framework in place in respect of this area of health care.
Once enacted, this legislation will lead to a regulatory framework being put in place in respect of this complex, innovative and fast-moving area of medicine, which is currently predominately provided through the private sector.
The provisions outlined within the AHR Bill will seek to ensure that AHR practices and related areas of research are conducted in a more consistent and standardised way and with the necessary oversight. The establishment of the AHR Regulatory Authority (AHRRA) is a key priority in this regard.
It is important to note that this new framework will regulate how AHR treatments are provided. In the first instance the legislation provides for a licensing system and treatment providers will be required to hold the requisite licence in order to provide treatments. The AHRRA will oversee and monitor this system, including to ensure that providers operate within the scope of the law and their licence. This regulatory framework will help bring guidance and clarity to service users, as well as to providers.
I wish to reiterate my commitment to ensuring that a robust regulatory framework for AHR is put in place as quickly as possible.
