Update on the Health (Assisted Human Reproduction) Bill 2022
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The Health (Assisted Human Reproduction) Bill 2022 (the "Bill") was published on 10 March 2022.
The Bill seeks to introduce regulation of Assisted Human Reproduction ("AHR") practices and technologies for the first time in Ireland. AHR treatment includes any treatment or procedure, including IVF treatment, for the purposes of surrogacy within the State that involves the handling of gametes or embryos, or both, for the purposes of establishing a pregnancy.
In addition, the Bill seeks to prohibit a person from providing AHR treatment unless that person holds a licence granted by a body established under the legislation, and to that end, the Bill seeks to establish a new regulatory authority to oversee the sector, the Assisted Human Reproduction Regulatory Authority ("AHRRA").
Key Points of the new Bill
- Part 2 sets out the general conditions for AHR treatment, including:
- Providers of AHR must be licenced;
- The minimum age for most treatment is 18 years;
- AHR treatment may be provided to single people or couples;
- Counselling is mandatory for intending parents;
- Provisions regarding consent;
- There is no maximum age in which an individual can receive AHR – the Minister for Health will have power to regulate this;
- Providers must be satisfied that intending parents do not pose a 'significant risk of harm or neglect' to a child born as a result of AHR treatment.
- The minimum age for most treatment is 18 years;
- AHR treatment may be provided to single people or couples;
- Counselling is mandatory for intending parents;
- Provisions regarding consent;
- There is no maximum age in which an individual can receive AHR – the Minister for Health will have power to regulate this;
- Providers must be satisfied that intending parents do not pose a 'significant risk of harm or neglect' to a child born as a result of AHR treatment.
- Part 5 provides for conditions regarding posthumous AHR, i.e. the use of AHR to achieve a pregnancy using the gametes or embryo formed from the gamete of a deceased person. The conditions will require that the deceased person must have given prior consent, a year must have passed since their passing, and only a surviving female partner may undertake posthumous AHR and must carry the pregnancy herself.
- Part 6 provides for pre-implementation genetic diagnosis ("PGD") and sex selection. PGD is the analysis of the embryo to detect any diseases or disabilities before implantation. The Bill provides for limited circumstances in which sex selection and PGD may be permitted, and they will not be permitted for non-medical reasons such as parental preference.
- Part 7 provides for domestic surrogacy which is currently unregulated, subject to certain conditions including:
- Residency conditions being met (s.49);
- No 'commercial' surrogacy (s.54), reasonable expenses accrued by the surrogate will be permitted;
- Both the surrogate and the intended parent(s) meet a range of criteria (s. 52 and s.53);
- The child must have a genetic link to at least one of the intending parents (s.53) and not to the surrogate mother (s.62(3)).
- No 'commercial' surrogacy (s.54), reasonable expenses accrued by the surrogate will be permitted;
- Both the surrogate and the intended parent(s) meet a range of criteria (s. 52 and s.53);
- The child must have a genetic link to at least one of the intending parents (s.53) and not to the surrogate mother (s.62(3)).
- Part 8 establishes the Assisted Human Reproduction Regulatory Authority.
- Part 10 provides for Enforcement, and seeks to create a number of offences including providing false or misleading information to the AHRRA (s.148) and obstruction of the AHRRA/a public body that has entered into a s.79 agreement with the AHRRA (s.149). Section 79 agreements involve the AHRRA entering into agreements with other public bodies to fulfil any of its functions on its behalf.
The Assisted Human Reproduction Regulatory Authority ("AHRRA")
Part 8 of the Bill establishes the AHRRA, with section 78(1) providing that the principal function of the AHRRA will be to protect and promote the health and wellbeing of persons undergoing AHR, children born of AHR, and intending parents. In carrying out this function, the AHRRA will be equipped with a number of powers under section 78(2), including the power to:
Part 8 of the Bill establishes the AHRRA, with section 78(1) providing that the principal function of the AHRRA will be to protect and promote the health and wellbeing of persons undergoing AHR, children born of AHR, and intending parents. In carrying out this function, the AHRRA will be equipped with a number of powers under section 78(2), including the power to:
- Issue licences;
- Amend, revoke or suspend licences;
- Promote and monitor compliance with the Act;
- Establish and maintain a database of all those carrying out research into AHR treatment;
- Collect and publish on its website statistical information on AHR treatment and activities in the State;
- Prepare or approve of, and publish, codes of practice for licence holders, including different codes in respect of different types of licences;
- Specify in a code of practice standards, including appropriate ethical standards, to be observed with the provision or undertaking of relevant activities;
- Establish and maintain a National Surrogacy Register;
Conclusion
It is estimated that infertility affects 1 in 6 heterosexual couples in the State, with infertility treatment predominately provided through the private sector. The Bill marks a positive step towards improving access to AHR treatments to all potential parents, with the establishment of the AHRRA a key development in embedding safe and appropriate clinical AHR practices in Ireland, an area which has been largely unregulated to date.
The Joint Oireachtas Health Committee undertook pre-legislative scrutiny of the General Scheme of the Bill and issued its report with recommendations for improvement of the legislation in 2019 and in April 2021, the Review of Children’s Rights and Best Interests in the Context of Donor Assisted Human Reproduction and Surrogacy in Irish Law was published, in which it made many recommendations to the Oireachtas, including that comprehensive legislation regulating surrogacy be enacted in Ireland at the earliest opportunity.
At the time of writing, the Bill is progressing through the Third Stage before the Dáil. While there is no certain timeline for entry into force, given the extent of pre-legislative scrutiny it is hoped there will be a comparably short period before the Bill becomes law. This is particularly relevant in the context of the announcement by the Minister for Health on 24 July 2023 that publicly funded access to IVF treatment in Ireland will be phased in from September 2023.
The Health (Assisted Human Reproduction) Bill 2022 can be accessed here.
Written by Dena Keane and Charlotte Mooney.