Assisted Reproduction Authority
Assisted Human Reproduction Regulatory Authority
The Minister may appoint a date for the establishment of the AHRRA.
The Act lists the main functions of the AHRRA, including those related to the licensing of AHR treatment providers and research facilities, the publication and maintenance of codes of practice, and the maintenance of the National Donor-Conceived Person
The AHRRA may enter into an agreement with another public body to perform functions on the AHRRA’s behalf.
Board and Officers of AHRRA
The Board of the AHRRA is appointed by the Minister and consists of 11 members, ten ordinary members and one Chairperson. The Minister is to appoint a person to fill a casual vacancy arising when a member of the Board resigns, dies, ceases to hold office, ceases to be qualified to hold office or is removed from office. The Minister may remove all the members of the Board if he/she is of the opinion that the Board’s functions are not being performed in an effective and efficient manner, or for other stated reasons.
Neither the CEO of the AHRRA nor a licence holder is eligible for appointment as a member of the Board or a committee of the Board, and that any AHRRA staff member is not eligible for appointment as a member of the Board.
The Act provides for the appointment by the Board of a Chief Executive Officer (CEO). The Board remove the CEO. The Act lists the main functions of the CEO. The Act provides for the delegation of functions by the CEO to a member of the staff of the AHRRA.
The CEO is to attend before a Committee of the Houses of the Oireachtas to give account of the general administration of the AHRRA. The chief executive is to give evidence to the Oireachtas Committee of Public Accounts.
The Board appoints employees of the AHRRA and may engage such consultants or advisers as it considers necessary for the performance of its functions.
Where are standard provisions in respect of the financial accounts of State-funded bodies and in relation to setting out the requirement to prepare and adopt an annual report and make it available to the Minister.
The AHRRA is to give information to the Minister as appropriate, in addition to the annual report. A person shall not, except in specified circumstances, disclose confidential information obtained while performing functions on behalf of the AHRRA.
Licences
There are procedures for an application for a licence to provide AHR treatment or undertake research. The Act sets out criteria which the AHRRA shall have regard to when determining a licence application. The AHRRA may attach specific conditions when granting a licence application.
The AHRRA shall publish specified information on its website following the granting of the process for a licence holder making an application to assign that licence to another person. There is a procedure for a licence holder making an application to amend that licence in a material way and making an application to surrender that licence.
The Minister may declare a person who is not an individual to be a fit and proper person to be granted and hold a licence.
AHR Treatment Providers and ESC Researchers
There is a Database of AHR Treatment Providers and ESC Researchers, which is published on the AHRRA’s website and include details of all licence holders. AHRRA may amend or delete details on the Database of AHR Treatment Providers and ESC Researchers in order to ensure it is accurate. There is an appeal to the High Court by licence applicants who have been refused a licence, have had a licence granted in part, or have had a licence granted with conditions; or by licence holders who have had an application to surrender a licence refused.
A licence holder must have that licence prominently displayed in the relevant premises.
The Minister, through regulations, may get the fee to be paid to the AHRRA for specific types of applications and set the annual fee to be paid to the AHRRA by licence holders.
There are transitional periods for pre-existing AHR treatment providers or relevant researchers from the time of the establishment of the AHRRA – namely, 30 days within which to make themselves known to the AHRRA and six months within which to make a licence application.
Enforcement
The 2024 Act provides for the appointment by the AHRRA of authorised officers to exercise any or all of the powers conferred on them by the Act. The powers of authorised officers are set out, including in relation to inspecting premises and securing documents.
AHRRA may prepare and publish codes of practice for the purpose of providing guidance in respect of the provision of different types of AHR treatment or the undertaking of research. Codes of practice issued by the AHRRA shall be admissible as evidence in any proceedings under the Act or before a court or tribunal.
Chapter 4 applies in circumstances where a licence holder has contravened a provision of the licence held or the Act. Enforcement notices may be issued by the AHRRA to direct a licence holder to remedy a contravention of a provision of that licence or the Act. A licence holder to whom an enforcement notice has been issued to apply to the Circuit Court for the cancellation of any direction specified in the notice.
There are events, the occurrence of which would lead to the immediate termination of a licence.
Complaints, investigations and sanctions
There is a process which AHHRA should undertake on receipt of a complaint alleging a contravention by a licence holder of a provision of that licence or the Act. AHRRA may apply, where it deems necessary, to the High Court to seek the immediate suspension of a licence.
There are processes the AHRRA should undertake when carrying out an investigation it deems necessary following the receipt of a complaint or of its own volition. The Act sets out the steps the relevant authorised officer should undertake when drafting and submitting his or her investigation report, and the process the AHRRA should undertake when considering the report and following the making of its resultant decision.
This decision may be to, for example, impose “a minor sanction” on the relevant licence holder, impose “a major sanction” on the relevant licence holder (which includes revocation or suspension of that licence, or the payment of up to €50,000 for the costs of the investigation), take some other further action, or take no further action.
A decision to impose a major sanction on a licence holder does not take effect until it is confirmed by the High Court. There is an appeal to the High Court by licence holders who have had a major sanction imposed on them.
Where an appeal has not been made, the AHRRA must make an application to the High Court for confirmation of a decision to impose a major sanction on a licence holder. The Act outlines factors which the AHRRA and the High Court shall have regard to when deciding whether a sanction, minor or major, should be imposed on a licence holder.
There are whistleblower protections for persons reporting potential contraventions by a licence holder of a provision of that licence or the Act.Schedule 7 provides details in respect of redress for an employee of a licence holder who has been penalised or threatened to be penalised by his or her employer after reporting potential contraventions of that employer’s licence.
Offences and related provisions
There are offences in respect of contraventions of various provisions throughout the Act and the range of penalties that are to be imposed accordingly. A licence applicant or a licence holder who provides the AHRRA with false or misleading information shall be guilty of an offence and sets out the range of penalties that are to be imposed accordingly.
A person who obstructs or interferes with the work of the AHRRA or a public body that has entered into an agreement with the AHRRA shall be guilty of an offence.
AHRRA may authorise the CEO or other member of its staff to provide a signed certificate which can be used as evidence in proceedings. Where an offence under the 2024 Act is committed by a body corporate and it is proved that the offence was attributable to a person who was an officer of that body corporate then that person, as well as the body corporate, may have proceedings taken against them.
Anything done by a person in the course of his or her employment shall be treated as if it were done by that person’s employer, whether or not it was done with the employer’s knowledge or approval, and that anything done by a person as agent for another person, with the authority (whether express or implied) of that other person shall be treated as if it were done by that other person.
An offence under the Act may be prosecuted summarily by the AHRRA. There are time limits for taking summary proceedings for an offence under the Act. A court shall order a person convicted under the Act to pay costs and expenses to the Minister or the AHRRA, as appropriate, unless that court finds special reasons for not doing so.
Licence Criteria
Schedule 1 lists the matters that the AHRRA may consider in determining whether a relevant person is deemed to be a fit and proper person to be granted a licence or to continue to be the holder of a licence.
Schedule 2 –lists specific types of embryo and stem cell research which are prohibited under the Act, including: the creation of a human embryo specifically to be used in research; the creation of a human embryo clone; modification of the human genome; and, the creation and use of human- animal hybrid embryos.
Schedule 3 lists the criteria that AHRRA shall have regard to in determining Licence Application to provide AHR Treatment
Schedule 4 lists the criteria that AHRRA shall have regard to in determining Licence Application to undertake ESC Research. It stipulates the conditions under which research involving embryos and stem cells may be permitted. For example, the criteria which would need to be met include: only permitting research involving supernumerary embryos donated for research; the research in question could not reasonably be conducted without the use of embryos, embryonic stem cells or induced pluripotent stem cells, as the case may be; the research would likely lead to advances in knowledge and treatments for AHR or other serious conditions; and, the research was approved by a research ethics committee. It is also stipulated that no embryo may be developed or maintained in vitro beyond the 14th day of its development.
Schedule 5 lists the types of Conditions that AHRRA may attach to Licence authorising provision of AHR Treatment or that are deemed to be attached to such Licence. The schedule lists specific types of conditions which may be, or are deemed to be, attached to a licence for AHR treatment provision.
Schedule 6 lists the types of Conditions that AHRRA may attach to Licence authorising undertaking of ESC Research or that are deemed to be attached to such Licence