Roderic O'Gorman (Dublin West, Green Party)
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533. To ask the Minister for Health if preimplantation genetic testing for monogenic disorders (PGT-M), including for serious hereditary conditions such as Huntington’s disease, is being actively considered as part of the current consultations on changes to the access criteria and range of services provided through the publicly-funded assisted human reproduction (AHR) treatment initiative; if so, when these consultations are expected to conclude; if the Department is reviewing the AHR referral and eligibility criteria to ensure that individuals and couples at risk of passing on serious genetic conditions, but who do not have fertility issues, can access IVF with PGT-M through the public health system; and if she will make a statement on the matter. [28426/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Model of Care for Fertility was developed by the Department of Health in conjunction with the HSE’s National Women & Infants Health Programme (NWIHP) to ensure that fertility-related issues are addressed through the public health system at the lowest level of clinical intervention necessary.

This Model of Care comprises three elements, starting in primary care (i.e., GPs) and extending into secondary care (i.e., six Regional Fertility Hubs located across the country) and, where necessary, AHR (assisted human reproduction) treatment (e.g., IVF (in-vitro fertilisation) and ICSI (intra-cytoplasmic sperm injection)), with patients being referred onwards through structured pathways.

Phase One of the roll-out of the Model of Care involved the establishment, at secondary care level, of six Regional Fertility Hubs within maternity networks covering the entire country. This means that a significant proportion of individuals presenting with fertility-related issues are managed at this level of intervention. Patients are referred by their GPs to their local Regional Fertility Hub, which provides a range of treatments and interventions. These Hubs have been fully operational for a number of years now.

Phase Two of the roll-out of the Model of Care relates to the introduction of AHR treatment, including IVF, provided through the public health system at tertiary level.

Appropriate funding has been made available to support access to AHR treatment via HSE-approved private providers. As well as IVF and ICSI, this allocation is also being used to provide IUI (intrauterine insemination), which can, for certain cohorts of people, be a potentially effective, yet less complex and less intrusive form of treatment.

Referrals for publicly-funded, privately-provided AHR treatment commenced in September 2023. Criteria prospective patients should meet in order to access fully-funded AHR services were agreed by the Department and the HSE and subsequently approved by Government in July 2023.

The criteria were agreed following consultation with experts in the field of reproductive medicine and include limits in respect of the age of the intending birth mother, body mass index (BMI) and the number of children a couple already have. They are very much in keeping with those applied in other jurisdictions, even though in most European countries, for instance, such treatments are only partially funded and require often significant out-of-pocket payments by patients.

More information is available on the HSE website in respect of the publicly-funded AHR treatment initiative at:

www2.hse.ie/pregnancy-birth/trying-for-a-baby/your-fertility/getting-ivf-icsi-iui-hse/.

or on public fertility services more generally at:

www2.hse.ie/conditions/fertility-problems-treatments/fertility-treatment/.

The terms of the publicly-funded AHR treatment initiative are underpinned by the primary policy principle of supporting couples experiencing fertility issues. Decisions in respect of any proposed changes to the access criteria and/or the range of services provided through the publicly-funded AHR treatment initiative require further extensive consultation between Department of Health officials, colleagues in the HSE and also with relevant specialists in the field of reproductive medicine. This process is underway.

It is important for me to state that I very much recognise the significance of pre-implantation genetic testing (PGT). This is a very complex area of medicine and it is vital that it is considered within the appropriate policy and clinical context.

The Deputy will be aware the Health (Assisted Human Reproduction) Act 2024, which was enacted on 2nd July 2024 but not yet commenced, provides for the regulation of PGT, including pre-implantation genetic testing for single gene disorders, or PGT-M for short. The 2024 Act sets out the legal parameters and framework within which the provision of PGT-M can be permitted. Specifically, the Act stipulates that testing can only be provided founded on the relevant opinion of a relevant specialist that such provision is necessary to detect whether or not there is a significant risk of a child being born with a serious genetic disease. The Act clearly identifies this relevant specialist as a medical practitioner registered on the specialist division of clinical genetics.

Furthermore, the 2024 Act provides for the establishment of a Register of Genetic Diseases under the auspices of the Assisted Human Reproductive Regulatory Authority, which will provide for a list of identified genetic diseases in respect of which genetic testing such as PGT-M will be permitted.

In the case of rare diseases that are genetic in origin, diagnosis can inform case finding within the family and family planning. For certain disorders, prenatal testing is possible and consideration is being given to the development of PGT services, whereby testing could be provided under certain circumstances and as deemed clinically appropriate.

Within the HSE, the identification and clinical need for consideration of PGT-M would be managed directly under the auspices of specialist clinical genetics services as distinct from fertility services. Clinical genetic services factor in the implication and impact of the genetic disorder on the health and well-being of a prospective child in their considerations and recommendations.