Assisted Human Reproduction
Introduction / Purpose of the 2024 Act
The main purpose of the Health (Assisted Human Reproduction) Act 2024 is to put in place a regulatory framework in respect of the provision of assisted human reproduction (AHR) treatment and the undertaking of associated research. The 2024 Act provides for the establishment of the Assisted Human Reproduction Regulatory Authority (AHRRA) which will be responsible primarily for the licensing of AHR treatment providers and researchers and ensuring the compliance of licence holders with the provisions of the Act.
The 2024 Act seeks to set out general criteria for the provision of all AHR treatments, with specific additional rules to be applied to the provision of different individual types of AHR treatment, including, for instance, posthumous assisted human reproduction and pre-implantation genetic diagnosis.
It also builds upon and adds to the conditions for the use of donated gametes and embryos which were set by the Children and Family Relationships Act 2015 (CFR Act 2015). In addition, there are provisions in relation to the storage of gametes and embryos.
The 2024 Act sets out the circumstances under which surrogacy may be permitted in Ireland, including that the surrogacy agreement is gestational only (i.e., the surrogate’s egg is not used), any child born will have a genetic link to at least one intending parent, it is non-commercial (i.e., altruistic), and must be approved by the AHRRA in advance.
AHRRA
It is prohibited for an unlicensed person to provide or undertake a regulated activity. It is prohibited for a licence holder to provide or undertake a regulated activity which is not in accordance with the provisions of the licence or the Act. It is prohibited for a research licence holder to use embryos donated for research for any other purpose.
The Minister, after consultation with the AHRRA, may by regulations specify an upper age limit for an AHR treatment (rather than an upper age limit being set in primary legislation).
The AHRRA shall prepare a document for each specific type of AHR treatment, which sets out the basic information a person seeking such treatment ought to know. Each AHR information document will be published on the AHRRA’s website and provided by the AHR treatment provider to any person seeking, or potentially seeking, the relevant AHR treatment. There is specific information which should be included in the AHR information document related to storage of gametes and embryos and domestic surrogacy.
AHR Treatment
Only up to two individuals may be classified as intending parents of a child born through AHR treatment, and they must be spouses, civil partners, or cohabitants. The law must not conflict with existing medical treatment consent laws.
Gametes and embryos from intending parents are not considered as “relevant donations” when used in further AHR treatment. This section also provides legal clarifications concerning surrogacy and reconciles with existing legislation (Act of 2007, Act of 2015), ensuring AHR laws do not contradict prior acts.
Prohibitions and Regulations for AHR Providers
No person can provide or undertake any AHR-related activity without holding a valid license for that activity. Research involving embryonic stem cells (ESC) must be ethical and be licensed. The Minister can regulate the type of ESC research and must consult AHRRA before doing so. ESC researchers must only use relevant donations for ESC research and for no other purposes.
AHR Treatment
AHR treatment shall not be provided to a person under the age of 18 or to a woman unless she is unlikely to become pregnant or give birth without such treatment and pregnancy or birth does not pose a disproportionate risk to her health or the health of the child.
AHR treatment shall not be provided to a person unless the AHR treatment provider is satisfied that that person or any other relevant person does not present a potential significant risk of harm or neglect to any child that may be born as a result of such treatment or any other child.
AHR treatment shall not be provided to a person unless that person and any other relevant person have received appropriate counselling specific to the relevant type of treatment. The consent of persons receiving AHR treatment, and any other relevant person, must be obtained prior to the commencement of such treatment. There are specific details which should be included as part of a person’s consent to donate gametes. There are specific details which should be included as part of a person’s consent to donate embryos.
The Minister can set upper age limits for AHR treatments based on medical evidence of risk, likelihood of success, social or psychological effects, and the best interest of the child to be born. Parents must reasonably be expected to live until the child reaches 18 years of age.
AHR providers must assess whether intending parents pose risks of harm or neglect to any child that might be born. Providers can request specific information from relevant persons to make this assessment.Counselling is mandatory before certain types of AHR treatment, including surrogacy and treatments involving gametes or embryos. Reports on counselling outcomes must be retained by providers for at least 30 years.
Consents
AHR treatment providers must obtain consent from both intending parents before proceeding. The consent form must cover various scenarios, including the use of stored gametes, embryos, or tissues, and provide for the revocation of consent if circumstances change. There are details and conditions under which consent forms are completed for relevant donations of gametes, embryos, or tissues, including the possibility of using them in AHR treatments or ESC research.
Intending parents and surrogate mothers must provide consent for surrogacy agreements, undergo legal and counselling processes, and understand the rights and obligations concerning records and the child’s future rights to know their origins.
Providers can only offer one embryo per treatment cycle for women with a good prognosis and up to two for women with a poor prognosis.
Conditions
There are details which should be included as part of a person’s consent to storage of gametes or embryos where two intending parents are involved, and which should be included as part of a person’s consent to PAHR. Where only one of two intending parents revokes his or her consent as regards to the storage of gametes or embryos, that revocation shall be treated as a revocation of the other intending parent’s consent to such storage. There are specific details which should be included as part of a person’s consent to surrogacy.
AHR treatment providers must offer single embryo transfer in the first treatment cycle to women who have a favourable prognosis of treatment success and that, irrespective of a woman’s prognosis, no more than two embryos should ever be transferred in a single treatment cycle.
There are conditions that need to be met in relation to a person providing his/her consent to donate his/her gametes or embryos to one or more other people for use in their AHR treatment, or to donate his/ her embryos for use in research. An AHR treatment provider shall not accept a donation of gametes for use in providing AHR treatment other than a donation which meets the requirements of the Act.
An embryo, other than a supernumerary embryo, cannot be donated to another person. A supernumerary embryo (an embryo which remains unused following the completion of a person’s AHR treatment) may be donated for use by another person in AHR treatment if certain conditions are met, including that it is in accordance with relevant provisions of the CFR Act 2015.
Donation
Individuals may donate gametes if they meet specific age limits, and supernumerary gametes can be donated after completing their own AHR treatment. Supernumerary embryos can be donated either for further AHR treatment or ESC research, but donations must comply with legal and ethical conditions, including limits on the number of families that can receive gametes from the same donor.
The Act regulates how gametes, embryos, and tissues are stored and disposed of after a set period unless an extension is granted. If payment for storage is missed, providers can dispose of the material after 12 months, following notice.
Posthumous AHR treatment (PAHR) can only occur one year after the death of one partner, and only gametes collected before death can be used for reproduction.
General Provisions
It is prohibited for a person to give or receive any payment or other reward for the donation of his or her gametes or embryos in order for those gametes or embryos to be used in the provision of AHR treatment procedures to other people or in research. The reimbursement of reasonable expenses incurred by a donor as part of the donation process is permitted.
All prospective donors (whether gamete or embryo donors) must be screened in accordance with the relevant selection, evaluation and testing requirements outlined in the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006.
.There are specific, limited circumstances under which an AHR treatment provider may disclose non-identifying medical information relating to a donor or a person born following an AHR treatment procedure involving donated material
A person under the age of 18 who is due to undergo medical treatment which is likely to cause a significant impairment to his or her fertility to be provided with AHR treatment to facilitate the storage of his or her gametes.
Posthumous Assisted Human Reproduction
Posthumous assisted human reproduction (PAHR) is the application of AHR to achieve a pregnancy using the gametes, or an embryo created using the gametes, of a deceased person. The PAHR provisions enable a surviving female partner (i.e., spouse, civil partner or cohabitant) to continue a parental project after the death of her partner, provided the appropriate consents have been provided, all parties have received counselling and provided a one-year grieving period has elapsed since her partner’s death.
This includes providing for PAHR where it involves the posthumous retrieval of gametes from the deceased person and where PAHR might also involve donor gametes (provided the embryo involved was created before the deceased person’s death). Under the provisions, the deceased person would be recognised as a parent of any child born following PAHR as long as all relevant conditions have been met, including that the surviving female partner would carry the resulting pregnancy.
Pre-Implantation Genetic Diagnosis
Pre-implantation genetic testing (PGT) can only be conducted to detect significant genetic diseases or for HLA matching for existing children with life-limiting conditions. Sex selection is prohibited unless there’s a significant risk of a genetic disease affecting one sex. Genetic counselling is mandatory before any genetic testing procedures. The AHRRA will maintain a Register of Genetic Diseases for conditions that can be detected through PGT.
The 2024 Act provides for PGD (Pre-implantation Genetic Diagnosis), which is a procedure for genetically testing embryos for specific genetic diseases caused by a single gene or chromosomal mutations that can be inherited, as an optional service for those who wish to avail of it, with eligibility criteria and restrictions in respect of access to PGD (e.g., relating to the severity of a specific disease and its impact on the health, well-being and quality of life of the person to be born). In addition, the AHRRA will establish and maintain a Register of Genetic Diseases for which PGD is to be permitted.
PGS (Pre-implantation Genetic Screening), is a procedure that allows the selection of euploid embryos for transfer involving the biopsy of one or two blastomeres from a 6-8 cell embryo in order to remove one or more cells, and the selection of an embryo for transfer to the womb based on the results of the analysis. PGS will be permitted under certain circumstances where the goal would be to increase the chances of a live birth resulting from AHR treatment.
HLA matching (Human Leukocyte Antigen Matching) is the use of PGD for the purpose of testing and selecting embryos that would result in a child whose tissue was compatible with that of a child who suffers from a life-limiting condition. It is stipulated that HLA matching can only be provided on a case-by-case basis following an application made to, and granted by, the AHRRA.
Sex selection is a procedure carried out to increase the probability, or to ensure, that an embryo will be of a particular sex. Sex selection will be permitted under strict conditions, including that there is a significant risk of a child being born with a genetic disease which is both on the Register of Genetic Diseases and affects only one sex (or affects one sex significantly more than the other).
The Act provides for the establishment and maintenance by the AHRRA of the Register of Genetic Diseases, which will list diseases in respect of which PGD and sex selection may be undertaken.
Storage and Use
The Minister may make regulations to specify a maximum period for the storage of gametes, but in the meantime a period of 10 years is applicable, although this is extendable on a case-by-case basis with the express permission of the AHRRA.
The Minister may make regulations to specify a maximum period for the storage of embryos, but in the meantime a period of 10 years is applicable, although this is extendable on a case-by-case basis with the express permission of the AHRRA.
The Act outlines the conditions which need to be met in order to allow the donation of a supernumerary embryo for use in research. An AHR treatment provider shall not accept a donation of an embryo for use in providing AHR treatment and that a researcher shall not accept a donation of an embryo for use in research, other than donations which meet the requirements of the Act.
There are limitations on the use of donated gametes and embryos for AHR treatment. The use of gamete donation in AHR treatment is prohibited that would involve an embryo created through the fertilisation of a donor’s gametes with gametes from a close family member of that donor.