Health (Assisted Human Reproduction) Act 2024

Type Act

Publication 2024-07-02

State In force

Source Irish Statute Book

articles 234

(2) Any function delegated under this section to a member of staff of the AHRRA shall be performed by the member under the general direction and control of the chief executive officer and in compliance with such directions, limitations and guidelines as may be specified by the chief executive officer.

(3) The delegation of a function does not preclude the chief executive officer from performing the function.

(4) The chief executive officer may—

(a) vary the delegation of a function under this section, or

(b) revoke the delegation.

(5) On varying or revoking the delegation of a function, the chief executive officer shall, as soon as is practicable, inform each member of staff of the AHRRA to whom the function was delegated of its variation or revocation.

141. Accountability of chief executive officer to committees of Houses of Oireachtas

141. (1) Subject to subsection (2), the chief executive officer shall, at the request in writing of a committee, attend before it to give account of the general administration of the AHRRA.

(2) The chief executive officer shall not be required to give account before a committee for any matter which is or has been, or may be at a future date, the subject of proceedings before a court or tribunal in the State.

(3) Where the chief executive officer is of the opinion that a matter in respect of which he or she is requested to give an account before a committee is a matter to which subsection (2) applies, he or she shall inform the committee of that opinion and the reasons for that opinion and, unless the information is conveyed to the committee at a time when the chief executive officer is before it, the information shall be so conveyed in writing.

(4) Where the chief executive officer has informed a committee of this opinion in accordance with subsection (3) and the committee does not withdraw the request referred to in subsection (1) in so far as it relates to the subject matter of the opinion—

(a) the chief executive officer may, not later than 42 days after being informed by the committee of its decision not to do so, apply to the High Court in a summary manner for determination of the question whether the matter is one to which subsection (2) applies, or

(b) the Chairperson of the committee may, on behalf of the committee, make such an application,

and the High Court shall determine the matter.

(5) Pending the determination of an application under subsection (4), the chief executive officer shall not attend before the committee to give account for the matter that is the subject of the application.

(6) If the High Court determines that the matter concerned is one to which subsection (2) applies, the committee shall withdraw the request referred to in subsection (1), but if the High Court determines that subsection (2) does not apply, the chief executive officer shall attend before the committee to give account for the matter.

(7) In the performance of his or her duties under this section, the chief executive officer shall not question or express an opinion on the merits of any policy of the Government or a Minister of the Government or on the merits of the objectives of such a policy.

(8) With the permission of the Chairperson of a committee making the request under subsection (1), either—

(a) the chairperson of the Board, or

(b) an employee of the AHRRA nominated by the chief executive officer,

may attend before the committee in place of the chief executive officer to give an account of the general administration of the AHRRA, and in that case a reference in subsections (2) to (7) to the chief executive officer shall be read as including a reference to the person attending in his or her place.

(9) In this section, “committee” means a committee appointed by either House of the Oireachtas or jointly by both Houses of the Oireachtas, other than—

(a) the Committee of Public Accounts, the Committee on Members’ Interests of Dáil Éireann or the Committee on Members’ Interests of Seanad Éireann, or

(b) a subcommittee of a committee referred to in paragraph (a).

142. Appearance of chief executive officer before Committee of Public Accounts

142. (1) The chief executive officer shall, whenever required in writing to do so by the Committee of Dáil Éireann established under the Standing Orders of Dáil Éireann to examine and report to Dáil Éireann on the appropriation accounts and reports of the Comptroller and Auditor General (in this section referred as the “Committee”) give evidence to that Committee in relation to—

(a) the regularity and propriety of the transactions recorded or required to be recorded in any book or other record of account subject to audit by the Comptroller and Auditor General that the AHRRA is required by or under this Act or another enactment to prepare,

(b) the economy and efficiency of the AHRRA in the use of its resources,

(c) the systems, procedures and practices employed by the AHRRA for the purpose of evaluating the effectiveness of its operations, and

(d) any matter affecting the AHRRA referred to in a special report of the Comptroller and Auditor General under section 11(2) of the Comptroller and Auditor General (Amendment) Act 1993, or in any other report of the Comptroller and Auditor General (in so far as it relates to the matter specified in paragraph (a), (b) or (c)) that is laid before Dáil Eireann.

(2) In the performance of his or her duties under this section, the chief executive officer shall not question or express an opinion on the merits of—

(a) any policy of the Government or of a Minister of the Government, or

(b) the objectives of such a policy.

143. Membership of either House of Oireachtas or European Parliament, etc.

143. (1) A person is not eligible for appointment as the chief executive officer if the person is—

(a) nominated as a member of Seanad Éireann,

(b) elected as a member of either House of the Oireachtas or to be a member of the European Parliament,

(c) regarded pursuant to Part XIII of the Second Schedule to the European Parliament Elections Act 1997 as having been elected to that Parliament, or

(d) elected or co-opted as a member of a local authority.

(2) A person who is for the time being entitled under the Standing Orders of either House of the Oireachtas to sit therein or who is a member of the European Parliament or of a local authority shall, while he or she is so entitled or is such a member, be disqualified from being the chief executive officer.

144. Acting chief executive officer

144. (1) Subject to subsection (2), the Board may appoint such other employee of the AHRRA to perform the functions of the chief executive officer during—

(a) any period or periods when the chief executive officer is absent from duty or from the State or is, for any other reason, unable to perform the functions of chief executive officer,

(b) any suspension from office of the chief executive officer, or

(2) The Board may at any time terminate an appointment under this section.

Chapter 5 Employees of AHRRA

145. Employees

145. (1) The Board may, subject to subsection (2), appoint persons to be employees of the AHRRA, using an appropriate and transparent recruitment and selection process approved by the Board and determine their duties.

(2) The Board, with the approval of the Minister, given with the consent of the Minister for Public Expenditure, National Development Plan Delivery and Reform, shall determine the remuneration, allowances for expenses and superannuation of employees appointed under this section.

(3) Remuneration and allowances for expenses of employees are payable by the AHRRA out of the funds at its disposal.

(4) The AHRRA may engage such consultants or advisers as it considers necessary for the performance of its functions.

(5) Fees due to a consultant or adviser engaged under this section are payable by the AHRRA out of funds at its disposal.

Chapter 6 Accounts and annual report of AHRRA

146. Accounts of AHRRA

146. (1) The AHRRA shall cause to be kept all proper and usual books or other records of account of all money received or expended by it.

(2) The Board shall, in respect of each financial year, cause to be prepared proper accounts of all income and expenditure and of the property, credits and liabilities of the AHRRA.

(3) (a) Subject to paragraph (b), the financial year of the AHRRA shall be the period of 12 months ending on the 31st day of December in any year, commencing on the establishment day.

(b) Where the establishment day is not the 1st day of January, the first financial year of the AHRRA shall be the period from and including the establishment day to and including the 31st day of December of the year in which the establishment day falls.

(4) The statement of accounts of the AHRRA for each financial year shall, as soon as may be after the end of the financial year, be prepared and the accounts of the AHRRA shall be submitted to the Comptroller and Auditor General for audit, as soon as is practicable, and not later than 3 months after the end of the financial year to which the accounts relate.

(5) Within one month of the Comptroller and Auditor General issuing an audit certificate for the accounts of the AHRRA, a copy of—

(a) the accounts, and

(b) the report of the Comptroller and Auditor General on the accounts,

shall be presented to the Minister who, within 2 months after their receipt, shall cause copies thereof to be laid before each House of the Oireachtas.

147. Annual report of AHRRA

147. (1) Not later than 30 April in each year, the AHRRA shall prepare and adopt an annual report in relation to the performance of the AHRRA’s functions during the immediately preceding calendar year.

(2) As soon as may be but no later than 21 days after adopting the annual report, the AHRRA shall submit a copy of the annual report to the Minister.

(3) The Minister shall, within 21 days of receiving the annual report, cause copies of it to be laid before each House of the Oireachtas.

Chapter 7 Miscellaneous

148. Duty of AHRRA to give information

148. (1) The AHRRA shall—

(a) monitor and keep under review occurrences and developments concerning matters relating to its functions, and

(b) without delay, give the Minister information regarding—

(i) any occurrence or development that, in the opinion of the AHRRA, the Minister is likely to consider significant for the performance of his or her functions (whether under this Act or otherwise), or

(ii) any other occurrence or development that falls within a class of occurrences or developments of public interest or concern that has been specified in writing by the Minister.

(2) The Minister may issue directions in writing in relation to the furnishing of information under subsection (1) and, if he or she does so, the AHRRA shall comply with those directions.

(3) The AHRRA shall submit, when required by the Minister to do so, a report on any matters connected with the functions of the AHRRA and specified in writing by the Minister.

(4) A report under subsection (3) shall—

(a) address matters of general or specific concern, and

(b) be made in such form and within such period,

as specified in the requirement.

149. Disclosure of confidential information

149. (1) Except in the circumstances specified in subsection (2), a person shall not disclose confidential information obtained while performing functions as—

(a) a member of the Board or a committee of the Board,

(b) a person appointed under section 132(2),

(d) a person engaged under section 145(4) by the AHRRA as an advisor or consultant,

(e) an employee of a person referred to in paragraph (b) or (d), or

(f) an authorised officer.

(2) A person does not contravene subsection (1) by disclosing confidential information if the disclosure—

(a) is made to or authorised by the AHRRA,

(b) is made to the Minister by or on behalf of the AHRRA or in compliance with this Act, or

(3) In this section, “confidential information” means any, or any combination, of the following:

(a) information that is expressed by the AHRRA to be confidential, either as regards particular information or as regards information of a particular class or description;

(b) information relating to proposals of a commercial nature or tenders submitted to the AHRRA by any person;

(d) information entered in the National Surrogacy Register;

(e) information entered in the Voluntary Register (within the meaning of section 124);

(f) information that would allow identification of a person availing of AHR.

150. Processing of personal data

150. (1) The AHRRA may process personal data for the purposes of the functions assigned to it by or under this Act or any other enactment.

(2) Such processing shall go no further than is necessary for the carrying out of those functions.

151. Power to specify form of documents

151. (1) Subject to sections 19(2), 20(2), 21(2) and (3), 22(2), 23(2) and (3), and 25(2) and (3), the AHRRA may specify the form of documents required for the purposes of this Act as it thinks fit.

(2) The AHRRA’s power under subsection (1) may be exercised in such a way as to specify two or more forms of any document (whether in paper or electronic form or both) referred to in that subsection, whether as alternatives, or to provide for particular circumstances or particular cases, as the AHRRA thinks fit.

(3) The form of a document specified under this section shall be—

(a) completed in accordance with such directions and instructions as are specified in the document,

(b) accompanied by such other documents (including a statutory declaration) as are specified in the document, and

(i) the AHRRA,

(ii) another person on behalf of the AHRRA, or

(iii) any other person,

so provided in the manner (if any) specified in the document.

(4) Without prejudice to subsection (3)(a), the directions and instructions referred to in that subsection may specify the circumstances in which one of 2 persons, each of whom has attained the age of 18 years and each of whom has capacity to sign the form concerned specified under this section, may sign the form on behalf of the other person where the other person is physically unable to sign the form.

152. Immunity from suit

152. (1) Civil or criminal proceedings shall not lie in any court against the AHRRA or a relevant person in respect of any thing said or done in good faith by the AHRRA or a relevant person, as the case may be, in the course of the performance or purported performance of their respective functions under this Act.

(2) In this section, “relevant person” means—

(a) a member of the Board or a committee of the Board,

(b) a person appointed under section 132(2),

(d) an employee of a person referred to in paragraph (b), or

(e) an authorised officer.

PART 10 Licences

153. Application for grant of licence

153. (1) Subject to subsection (4), a person may make an application in the specified form, accompanied by the specified fee, to the AHRRA for the grant of a licence to undertake the relevant activity the subject of the application at the premises specified in the application.

(2) Without prejudice to the generality of subsection (3) or section 151, a licence application may require any information to be provided in relation to any of the matters to which the AHRRA shall have regard to by virtue of section 154.

(3) Where a licence application is made to the AHRRA, it may, by notice in writing given to the applicant, require the applicant to provide in the specified form such additional information in relation to any matter to which the application relates as the AHRRA reasonably considers necessary to assist it to determine the application.

(4) A person who is a body corporate may not make a licence application unless it is—

(a) a company,

(b) an EEA company within the meaning of Part 21 of the Act of 2014, or

(5) A licence application may relate to two or more relevant activities.

154. Criteria to which AHRRA shall have regard in determining licence application

154. (1) The AHRRA shall, in determining a licence application under section 155, have regard to the criteria specified in Schedule 3 in the case of a relevant activity which falls within paragraph (a) of the definition of “relevant activity” and Schedule 4 in the case of a relevant activity which falls within paragraph (b) of that definition in so far as such criteria are relevant to the proposed relevant activity the subject of the application.

(2) (a) Subject to subsections (3) and (4), the Minister may, by regulations specify, for the purposes of paragraph 5 of Schedule 3 or paragraph 8 of Schedule 4 additional criteria that the AHRRA shall have regard to in determining a licence application under section 155.

(b) Regulations made under paragraph (a) may be subject to conditions and be of general application or apply to such relevant activities as may be specified in the regulations.

(3) In making regulations under subsection (2), the Minister shall, in addition to having regard to the other provisions of this Act, have regard to the following in relation to the proposed additional criteria:

(a) in the case of AHR treatment—

(i) whether, in the opinion of the Minister, the criteria assist in the furtherance of the objective that the health and safety of children who may be born as a result of such treatment is the principal consideration, and

(ii) whether, in the opinion of the Minister, the criteria assist in the furtherance of the objective that the health and safety of persons provided with such treatment is the principal consideration after the principal consideration referred to in subparagraph (i);

(b) in the case of ESC research, whether, in the opinion of the Minister, the criteria are directed towards promoting ESC research which may produce results, amongst other beneficial results (if any), that contribute towards the objective referred to in paragraph (a)(i) or (ii), or both such objectives.

(4) On and after the establishment day, the Minister shall not make regulations under subsection (2) except after consultation with the AHRRA.

155. Grant or refusal of licence

155. (1) Subject to section 154 and subsections (2), (4), (5) and (6), the AHRRA shall determine a licence application by—

(a) granting a licence to the applicant authorising the applicant to undertake the proposed relevant activity (whether in whole or in part) the subject of the application under and in accordance with the provisions of the licence and this Act, and—

(i) at the premises specified in the licence for the purpose, and

(ii) subject to such conditions (if any) attached to the licence by virtue of section 156(1) as the AHRRA thinks fit,

(b) giving a notice in writing to the applicant refusing to grant a licence to undertake the proposed relevant activity the subject of the application.

(2) The AHRRA shall, to the extent practicable, determine a licence application not later than 90 days after the day on which the AHRRA is satisfied that the applicant has complied with all the requirements of or under this Part in so far as they relate to the application.

(3) Where the AHRRA—

(a) grants a licence for part only of the proposed relevant activity the subject of the licence application concerned,

(b) grants a licence to which conditions are attached by virtue of section 156(1), or

the AHRRA shall, at the same time, give the applicant notice in writing of the reasons for the partial grant, conditions or refusal, as the case may be.

(4) A licence shall include the following at a minimum:

(a) the name of the holder of the licence;

(b) the physical address of the premises at which the relevant activity the subject of the licence may be undertaken and (if applicable) the electronic address of such premises;

(d) the nature of the relevant activity the subject of the licence.

(5) Subject to subsection (6), a licence shall not authorise the undertaking of a relevant activity at more than one premises and any licence that purports to do so shall be void.

(6) Subsection (5) shall not apply to a relevant activity which falls within paragraph (b) of the definition of “relevant activity” but without prejudice to the AHRRA’s discretion to grant a licence authorising the undertaking of such activity at only one premises specified in the licence.

156. Conditions which may be attached to licence, etc.

156. (1) The AHRRA may attach to a licence one or more than one of the types of conditions specified in Part 1 of Schedule 5 in the case of a relevant activity which falls within paragraph (a) of the definition of “relevant activity” and Part 1 of Schedule 6 in the case of a relevant activity which falls within paragraph (b) of that definition.

(2) (a) The conditions specified in Part 2 of Schedule 5 shall be deemed to be attached to each licence authorising the provision of AHR treatment.

(b) The conditions specified in Part 2 of Schedule 6 shall be deemed to be attached to each licence authorising the undertaking of ESC research.

(3) (a) Subject to subsections (5) and (6), the Minister may by regulations specify—

(i) for the purposes of paragraph 2 of Part 1 of Schedule 5 or paragraph 3 of Part 2 of that Schedule, or

(ii) for the purposes of paragraph 3 of Part 1 of Schedule 6 or paragraph 3 of Part 2 of that Schedule,

additional types of conditions which may be attached, or be deemed to be attached, as the case may be, to a licence.

(b) Regulations made under paragraph (a) may be of general application or apply to such relevant activities as may be specified in the regulations.

(4) Where the Minister makes regulations under subsection (2), he or she shall, in addition to having regard to the other provisions of this Act, have regard to the following in relation to the proposed additional types of conditions:

(a) in the case of AHR treatment—

(i) whether, in the opinion of the Minister, the condition assists in the furtherance of the objective that the health and safety of children who may be born as a result of such treatment is the principal consideration, and

(ii) whether, in the opinion of the Minister, the condition assists in the furtherance of the objective that the health and safety of persons provided with such treatment is the principal consideration after the principal consideration referred to in subparagraph (i);

(b) in the case of ESC research, whether, in the opinion of the Minister, the condition is directed towards promoting ESC research which may produce results, amongst other beneficial results (if any), that contribute towards the objective referred to in paragraph (a)(i) or (ii), or both such objectives.

(5) On and after the establishment day, the Minister shall not make regulations under subsection (3) except after consultation with the AHRRA.

(6) A condition specified, by virtue of regulations made under subsection (3)—

(a) for the purposes of paragraph 3 of Part 2 of Schedule 5, or

(b) for the purposes of paragraph 3 of Part 2 of Schedule 6,

shall not be deemed to be attached to a licence granted before the condition was so specified.

157. Notification of grant of licence, etc.

157. The AHRRA shall, as soon as is practicable after it grants a licence, publish a notice on its website stating, at a minimum—

(a) the name of the holder of the licence,

(b) the physical address of the premises at which the relevant activity the subject of the licence may be undertaken and (if applicable) the electronic address of such premises,

(d) the nature of the relevant activity the subject of the licence.

Chapter 2 Assignment or amendment of licence

158. Assignment of licence

158. (1) This section applies where the holder of a licence (in this section referred to as the “proposed assignor”) wishes to assign the licence to another person (in this section referred to as the “proposed assignee”).

(2) The proposed assignor and the proposed assignee shall make a joint licence application to the AHRRA for the AHRRA’s consent in writing to the assignment and, in the case of such application, section 153 and the other provisions of this Part (including section 157 and Chapter 6) applicable to a licence application and its determination under section 155 shall, with all necessary modifications apply accordingly.

(3) The assignment of a licence purporting to be effected without the consent referred to in subsection (2) shall be void.

(4) References in this Act to the grant of a licence shall include references to the assignment of a licence in any case where the licence has been assigned or reassigned in accordance with this section.

159. Material amendment to licence

159. (1) The holder of a licence who wishes to amend the licence in any material way shall make a licence application for such amendment and, in the case of such application, section 153 and the other provisions of this Part (including section 157 and Chapter 6) applicable to a licence application and its determination under section 155 shall, with all necessary modifications, apply accordingly.

(2) Subject to subsections (3) and (4), the Minister may by regulations specify classes of amendments to a licence that are, for the purposes of this section, non-material.

(3) Where the Minister makes regulations under subsection (2), he or she shall, in addition to having regard to the other provisions of this Act, also have regard to the principle that the amendments that fall within the class should be trivial, insignificant, minor or inconsequential.

(4) On and after the establishment day, the Minister shall not make regulations under subsection (2) except after consultation with the AHRRA.

(5) (a) The holder of a licence who wishes to make an amendment to the licence which it considers to be non-material amendment may make an application in the specified form, accompanied by the specified fee, to the AHRRA for the AHRRA to make such amendment to the licence.

(b) Where the AHRRA is satisfied that the amendment sought is a non-material amendment (including in any case where it is so satisfied by virtue of submissions referred to in paragraph (c) made to it), it shall make the amendment to the licence and issue the licence as so amended to the holder and the licence as so amended shall, on and after the date of such issue and for all purposes, replace the licence as in force immediately before it was so amended.

(c) Where the AHRRA is not satisfied that the amendment sought is a non-material amendment, it shall, in the interest of procedural fairness, give a notice in writing to the holder stating—

(i) the AHRRA’s reasons why it is not satisfied, and

(ii) that the holder may, if the holder wishes to do so, within the period specified in the notice (being a period of not less than four weeks from the date that the holder receives the notice), make, in view of those reasons only, submissions in writing on those reasons for the AHRRA’s further consideration before the AHRRA decides whether or not it is satisfied that the amendment is a non-material amendment.

(d) Where submissions referred to in paragraph (c) made before the expiration of the period concerned referred to in that paragraph do not satisfy the AHRRA that the amendment sought is a non-material amendment, or no such submissions are made before the expiration of that period, the AHRRA shall, as soon as is practicable after that expiration, give the holder notice in writing that the AHRRA is not satisfied that the amendment sought is a non-material amendment and setting out the reasons why the AHRRA is not so satisfied.

(e) Where paragraph (b) applies, the AHRRA shall, as soon as is practicable after issuing the amended licence as referred to in that paragraph to the holder, publish on its website, at a minimum, sufficient particulars of the amendment made to the licence to enable members of the public to understand the nature of the amendment and sufficient particulars of the licence to readily identify it.

(f) Where paragraph (d) applies, the AHRRA shall, as soon as is practicable after it gives the notice referred to in that paragraph to the holder, publish on its website, at a minimum, a copy of the notice.

(6) In this section—

“material amendment”, in relation to a licence, means any amendment to the licence other than a non-material amendment;

“non-material amendment”, in relation to a licence, means an amendment which falls within a class of amendments specified in regulations made under subsection (2).

Chapter 3 Surrender of licence

160. Surrender of licence

160. (1) The holder of a licence may make an application in the specified form, accompanied by the specified fee, to the AHRRA for the surrender of the licence.

(2) Where an application under subsection (1) is made to the AHRRA, the AHRRA may, by notice in writing given to the applicant, require the applicant to provide in the specified form such additional information in relation to any matter to which the application relates as the AHRRA reasonably considers necessary to assist him or her to determine the application under section 161.

161. Determination of application under section 160

161. (1) The AHRRA shall determine an application under section 160(1) by—

(a) if the applicant has satisfied the AHRRA that all the obligations of the applicant arising from being the holder of the licence concerned (and whether or not such obligations arise under this Act or another enactment) have been discharged, approving the surrender of the licence by notice in writing given to the applicant specifying the date on which the surrender shall take effect, or

(b) in any other case, giving a notice in writing to the applicant refusing the application and stating the AHRRA’s reasons for the refusal.

(2) The surrender of a licence purporting to be effected without the approval referred to in subsection (1)(a) shall be void.

Chapter 4 Minister may declare certain persons who are not individuals to be fit and proper persons

162. Minister may declare person, etc., who is not individual to be fit and proper person

162. (1) Subject to subsections (2) to (4) and notwithstanding the provisions of Schedule 1, the Minister may, by order, declare that—

(a) a person (not being an individual) specified in the order is a fit and proper person to be granted and to hold—

(i) any licence, or

(ii) a licence which falls within a class of licences specified in the order,

(b) a person who falls within a class of persons (not being individuals) specified in the order is a fit and proper person to be granted and to hold—

(i) any licence, or

(ii) a licence which falls within a class of licences specified in the order.

(2) The Minister shall, in exercising his or her power under subsection (1)(a) in relation to a person, have regard to the following:

(a) the legal nature of the person;

(b) the statutory functions (if any) of the person;

(3) The Minister shall, in exercising his or her power under subsection (1)(b) in relation to a class of persons, have regard to the following:

(a) the legal nature of the persons who fall within the class;

(b) the statutory functions (if any) of the persons who fall within the class;

(4) On and after the establishment day, the Minister shall not make an order under subsection (1) except after consultation with the AHRRA.

Chapter 5 Database of AHR Treatment Providers and ESC Researchers

163. Establishment of Database of AHR Treatment Providers and ESC Researchers

163. (1) The AHRRA shall, as soon as is practicable after the coming into operation of this section, establish and maintain a database to be known as the Database of AHR Treatment Providers and ESC Researchers.

(2) The Database shall be in the form of an electronic database published on the AHRRA’s website.

(3) The AHRRA shall, as soon as is practicable after it grants a licence, enter the following data in the Database:

(a) the name of the holder of the licence;

(b) the physical address of the premises at which the relevant activity the subject of the licence may be undertaken and (if applicable) the electronic address of such premises;

(d) the nature of the relevant activity the subject of the licence.

164. Correction of database

164. (1) For the purposes of keeping the Database correct, the AHRRA may amend or delete any particulars entered in the Database.

(2) The AHRRA shall take such steps as it considers necessary from time to time to ensure that the particulars entered in the Database are accurate.

Chapter 6 Appeals

165. Appeals against certain decisions of AHRRA

165. (1) In this section—

“relevant decision” means a decision of the AHRRA—

(a) under section 155(1) to which section 155(3) applies, or

(b) under section 161(1)(b);

“relevant person”, in relation to a relevant decision, means—

(a) in the case of paragraph (a) of the definition of “relevant decision”, the person who makes the licence application concerned, or

(b) in the case of paragraph (b) of the definition of “relevant decision”, the holder of the licence concerned.

(2) The relevant person may, on notice to the AHRRA, appeal against a relevant decision to the High Court not later than 3 months after the date on which the relevant decision was notified to the relevant person by the AHRRA.

(3) The High Court may, on the hearing of an appeal under subsection (2) made by the relevant person—

(a) either—

(i) confirm the relevant decision the subject of the appeal, or

(ii) cancel that decision and replace it with such other decision as the Court thinks fit, which (and without prejudice to the generality of the foregoing) may be a decision to require the AHRRA to reconsider the relevant decision in accordance with such directions as are given to the AHRRA for the purpose of that reconsideration,

and

(b) give the AHRRA such directions or, in the case of directions referred to in paragraph (a)(ii), such further directions as the Court thinks fit and direct how the costs of the appeal are to be borne.

(4) The AHRRA shall, on complying with a direction given by the High Court under subsection (3), give notice in writing to the relevant person concerned of the AHRRA’s compliance with the direction.

(5) The decision of the High Court on an appeal under subsection (2) shall be final except that the AHRRA or the relevant person concerned may by leave of the Court or the Court of Appeal appeal against the decision to the Court of Appeal on a specified question of law.

Chapter 7 Miscellaneous

166. Display of licence

166. The holder of a licence shall cause the licence or an exact copy thereof to be exhibited at all times in a conspicuous position in the premises (or, if section 155(6) applies, each premises) the subject of the licence.

167. Lost, etc., licence

167. Where a licence has been lost, defaced or destroyed, the AHRRA may, upon application in the specified form, accompanied by the specified fee, being made to it by the holder of the licence, issue to the holder another licence in the like terms, and any such licence so issued shall, for the purposes of this Act, be deemed to have been granted under section 155.

168. Fees for licences

168. (1) Subject to subsections (2) and (6), the Minister may by regulations specify the fees to be paid to the AHRRA for relevant applications and, for that purpose—

(a) different amounts may be specified for such applications which fall within different classes of such applications specified in the regulations, and

(b) the regulations may specify the circumstances in which—

(i) an exemption from the payment of such a fee applies, or

(ii) a waiver, remission or refund (whether in whole or in part) of such fee applies.

(2) The Minister shall, when specifying, in regulations made under subsection (1), the fee to be paid to the AHRRA for relevant applications, have regard to the administrative costs associated with processing applications, including the cost of determining whether the requirements for making the relevant applications have been met.

(3) Subject to subsections (4) to (6), the Minister may by regulations specify the annual fee to be paid to the AHRRA by holders of a licence and for that purpose—

(a) different amounts may be specified for such holders which fall within different classes of such holders specified in the regulations, and

(b) the regulations may specify the circumstances in which—

(i) an exemption from the payment of such a fee applies, or

(ii) a waiver, remission or refund (whether in whole or in part) of such fee applies.

(4) The Minister shall, when specifying, in regulations made under subsection (3), the annual fee to be paid to the AHRRA by the holders of licences, have regard to the need to defray the costs incurred by the AHRRA in the performance of its functions in relation to the holder concerned.

(5) An annual fee specified in regulations made under subsection (3) shall be paid to the AHRRA not later than each anniversary of the date specified for the purpose in the licence concerned.

(6) On and after the establishment day, the Minister shall not make regulations under subsection (1) or (3) except after consultation with the AHRRA.

(7) In this section, “relevant applications” means—

(a) licence applications,

(b) applications under section 159(5),

(d) applications under section 167.

169. Transitional

169. (1) Subject to subsection (2), where, immediately before the establishment day, there is a person under whose supervision a relevant activity is being lawfully undertaken in any premises, then, on and after that day—

(a) that activity shall be deemed to be authorised to be undertaken in those premises pursuant to a licence (in this section referred to as the “deemed licence”) granted to that person, and

(b) that person shall be deemed to be the holder of the deemed licence (in this section referred to as the “deemed holder”),

and the other provisions of this Act shall be construed accordingly.

(2) Paragraphs (a) and (b) of subsection (1) shall cease to apply in relation to the relevant activity and person referred to in that subsection immediately upon—

(a) the expiration of 30 days after the establishment day except where the deemed holder has, before the expiration of that period, given a notice in writing to the AHRRA stating—

(i) his or her name and address for service, and

(ii) the address of the premises at which that activity is being undertaken,

(b) the expiration of 6 months after the establishment day except where a licence application is made to the AHRRA before the expiration of that period for the grant of a licence to authorise the undertaking of that activity in those premises (and whether or not it is the deemed holder who makes that application), or

whichever first occurs.

(3) (a) A relevant event shall not of itself relieve a relevant person from discharging, on or after the occurrence of such event, the person’s obligations, as regards the relevant activity concerned, that existed immediately before such occurrence.

(b) In this subsection—

“relevant activity concerned”, in relation to a relevant person, means so much of the relevant activity referred to in subsection (1) as is under the supervision of the relevant person;

“relevant event”, in relation to a relevant person, means the relevant person ceasing to be the holder of a deemed licence in respect of the relevant activity concerned without becoming the holder of a licence in respect of such activity;

“relevant person” means a person referred to in subsection (1).

(4) Section 153(4) shall not apply in the case of a licence application referred to in subsection (2).

PART 11 Enforcement

Chapter 1 Definitions

170. Definitions - Part 11

170. In this Part—

“code of practice” means a code of practice published or approved of under section 173 as it is in effect from time to time;

“complainant”, in relation to a complaint, means the person who made the complaint;

“complaint” means a complaint under section 180;

“enforcement notice” means a notice under section 176(2);

“holder” means the holder or former holder, as appropriate, of a licence;

“investigation” means an investigation under section 182;

“investigation report”, in relation to an investigation, means a report in writing prepared, following the completion of the investigation, by the authorised officer appointed under section 182(1)(b) to carry out the investigation—

(a) stating that the authorised officer—

(i) is satisfied that a relevant contravention by the holder of a licence the subject of the investigation has occurred or is occurring, or

(ii) is not so satisfied,

as appropriate,

(b) if paragraph (a)(i) is applicable, stating the grounds on which the authorised officer is so satisfied, and

(i) the basis on which the authorised officer is not so satisfied, and

(ii) the authorised officer’s opinion, in view of such basis, on whether or not a further investigation of the holder of the licence is warranted and, if warranted, the authorised officer’s opinion on the principal matters to which the further investigation should relate;

“major sanction”, in relation to the holder of a licence, means—

(a) the revocation of the licence and a prohibition (which may be a permanent prohibition, a prohibition for a specified period or a prohibition subject to specified conditions) against the former holder of the licence making a licence application for a new licence or a particular class of licence,

(b) the suspension for a specified period of the licence and a prohibition for a specified period against the holder of the suspended licence making a licence application for a new licence or a particular class of new licence,

(c) a direction to the holder that the holder pay a sum, as specified in the direction but not exceeding €50,000, to the AHRRA, being the whole or part of the cost to the AHRRA of an investigation of the holder, or

(d) any combination of the sanctions specified in paragraph (a) or (b) with the sanction specified in paragraph (c);

“minor sanction”, in relation to the holder of a licence, means—

(a) the issue, to the holder, of—

(i) advice,

(ii) a caution,

(iii) a warning, or

(iv) a reprimand,

(b) any combination of any of the sanctions specified in paragraph (a);

“relevant contravention”, in relation to the holder or former holder of a licence, means that the holder—

(a) has contravened a relevant provision,

(b) is contravening a relevant provision,

(c) has contravened a relevant provision in circumstances that make it likely that the contravention will continue or be repeated,

(d) has given information to the AHRRA under Part 10, in relation to an application made under that Part, that was false or misleading in a material particular, or

(e) has failed to comply with an enforcement notice;

“relevant provision” means a provision of—

(a) a licence, or

(b) this Act.

Chapter 2 Authorised officers

171. Appointment of authorised officers

171. (1) The AHRRA shall appoint one or more persons, including but not limited to members of staff of the AHRRA, to exercise any or all of the powers conferred on them by this Act and such a person shall be an authorised officer.

(2) Each authorised officer shall be given a certificate of his or her appointment and, when exercising any power conferred on him or her by this Act, shall produce, on request by any person affected, the certificate or a copy of the certificate, together with a form of personal identification.

(3) (a) Paragraph (b) applies to an authorised officer appointed under subsection (1) who is not a member of staff of the AHRRA.

(b) The authorised officer shall be so appointed as such on such terms and conditions as the AHRRA thinks fit with the approval of the Minister and the consent of the Minister for Public Expenditure, National Development Plan Delivery and Reform.

172. Powers of authorised officers

172. (1) For the purposes of this Act, an authorised officer may exercise any of the following powers:

(a) enter (if necessary by the use of reasonable force) and inspect, at any reasonable time, any premises—

(i) specified in a licence,

(ii) not specified in a licence but at which he or she has reasonable grounds for believing that a relevant activity is being undertaken, or

(iii) at which he or she has reasonable grounds for believing that books, records or other documents relating to relevant activities are kept;

(b) require any person on the premises referred to in paragraph (a) to produce any books, records or other documents relating to relevant activities;

(i) any books, records or other documents relating to relevant activities, or

(ii) any premises (or part thereof) in which books, records or other documents relating to relevant activities are kept;

(d) make plans or take photographs or video or other recordings of the premises or any part thereof.

(2) An authorised officer shall not enter a dwelling, other than—

(a) with the consent of the occupier, or

(b) pursuant to a warrant under subsection (3).

(3) Upon the sworn information of an authorised officer, a judge of the District Court may, for the purposes of enabling an authorised officer to carry out an inspection under subsection (1), issue a warrant authorising a named authorised officer, accompanied by such other authorised officers or members of the Garda Síochána as may be necessary, at any time or times, before the expiration of one month from the date of issue of the warrant, to enter (if necessary by the use of reasonable force) the dwelling and perform the functions of an authorised officer under subsection (1).

(4) A person shall not—

(a) obstruct or interfere with an authorised officer or a member of the Garda Síochána in the course of exercising a power conferred on him or her by this Act, section 31 of the Act of 2015 or a warrant under subsection (3), or

(b) fail or refuse to comply with a request or requirement of, or to answer a question asked by, an authorised officer, or in purported compliance with such request or requirement or in answer to such question, give information to an authorised officer that he or she knows to be false or misleading in a material particular.

(5) Where an authorised officer believes, upon reasonable grounds, that a person has committed an offence under this Act, the authorised officer may require that person to provide him or her with his or her name and the address at which they ordinarily reside and the person shall comply with that requirement.

(6) Nothing in the Act of 2015 or this Act shall be construed to prevent—

(a) an authorised officer from being appointed as an authorised person under section 30 of the Act of 2015, or

(b) an authorised person under section 30 of the Act of 2015 from being appointed as an authorised officer.

Chapter 3 Codes of practice

173. Codes of practice

173. (1) Subject to subsection (2), the AHRRA may and, at the request of the Minister, shall—

(a) prepare and publish a code of practice, or

(b) approve of a code of practice drawn up by any other body,

for the purpose of providing guidance for the provision or undertaking of relevant activities (including a type of relevant activity).

(2) Before publishing or approving of a code of practice under this section, the AHRRA—

(a) may publish in such manner as the AHRRA considers appropriate a draft of the code and shall allow persons 30 days from the date of publication of the draft code within which to make representations in writing to the AHRRA in relation to the draft code or such further period, not exceeding 30 days, as the AHRRA in its absolute discretion thinks fit, and

(b) following consultation and, where relevant, having considered the representations (if any) made, shall submit the draft code to the Minister for his or her consent to its publication or approval of under this section, with or without modifications.

(3) Where the AHRRA publishes or approves of a code of practice under this section, the Minister shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code,

(b) specifying the relevant activity in respect of which the code is so published or approved, as the case may be, and

(4) The AHRRA may, with the consent of the Minister but subject to subsection (5)—

(a) amend or revoke a code of practice published under this section, or

(b) withdraw its approval of any code of practice approved of under this section.

(5) Subsection (2) shall, with all necessary modifications, apply to a code of practice that the AHRRA proposes to amend or revoke, or withdraw its approval of, under subsection (4) as subsection (2) applies to a code of practice that the AHRRA proposes to publish or approve of under this section.

(6) Where the AHRRA amends or revokes, or withdraws its approval of, a code of practice published or approved of under this section, the Minister shall cause a notice to that effect to be published in Iris Oifigiúil—

(a) identifying or specifying the code to which the amendment, revocation, or withdrawal, as the case may be, relates and, if applicable, particulars of the amendment,

(b) specifying the relevant activity in respect of which the code is so amended, revoked or withdrawn, as the case may be, and

(7) The AHRRA shall encourage holders, or classes of holders, as applicable, to comply with codes of practice published or approved of under this section (including such a code as amended from time to time under this section).

(8) The AHRRA shall keep posted on its website a copy of each code of practice published or approved of under this section, as the code is in force from time to time, on and from the date on which the code has effect.

(9) In this section (including subsection (2)(a)), “code of practice” includes part of a code of practice.

174. Admissibility of codes of practice

174. A document bearing the seal of the AHRRA and purporting to be a code of practice or, where such a code has been amended under section 173, the code as so amended shall be admissible in evidence in any proceedings under this Act or before a court or tribunal.

Chapter 4 Enforcement notices

175. Application

175. (1) This Chapter shall not apply to a relevant contravention which falls within paragraph (d) or (e) of the definition of “relevant contravention”.

(2) Without prejudice to the generality of subsection (1) and subject to subsection (3), this Chapter shall not apply to an alleged relevant contravention the subject of a complaint unless—

(a) the complainant consents in writing to this Chapter applying to such contravention instead of Chapter 6, or

(b) the complaint is withdrawn.

(3) (a) Subsection (2)(a) shall not be construed to prevent the AHRRA from continuing to deal with the matter the subject of a complaint under Chapter 6 instead of this Chapter.

(b) Subsection (2)(b) shall not be construed to prevent the AHRRA from dealing with the matter the subject of the complaint under this Chapter instead of Chapter 6 or from declining to deal with such matter under either such Chapter.

176. Issue of enforcement notices

176. (1) Subsection (2) applies where the AHRRA is of the opinion (in this section referred to as the “relevant opinion”) that a relevant contravention by a holder may have occurred or may be occurring.

(2) Without prejudice to the generality of the other provisions of this Part, the AHRRA may give the holder a notice in writing, accompanied by a copy of this Chapter—

(a) stating the relevant opinion,

(b) specifying the relevant contravention as to which it is of that opinion and the reasons why it is of that opinion,

(c) directing the holder to take such steps as are specified in the notice to remedy the relevant contravention or, as the case may be, the matters occasioning it, and

(d) specifying a period (ending not earlier than the period specified in section 177(1)) within which an application under that section to cancel a direction specified in the notice may be made within which those steps must be taken.

(3) The AHRRA shall not give the holder an enforcement notice unless, in the interests of procedural fairness, the AHRRA has first—

(a) given the holder notice in writing stating the nature of the enforcement notice that the AHRRA is minded to give to the holder and the reasons why the AHRRA is so minded,

(b) given the holder a reasonable opportunity, in the circumstances concerned, to make representations in writing to the AHRRA on what is stated in the notice referred to in paragraph (a), and

(4) The steps specified in an enforcement notice to remedy any relevant contravention to which the notice relates may be framed so as to afford the holder a choice between different ways of remedying the contravention.

(5) Where the holder to whom an enforcement notice has been given makes an application under section 177(1) to cancel a direction specified in the notice, the steps specified in the notice, in so far as they relate to that direction, need not be taken by the holder pending the determination, withdrawal or abandonment of the application.

(6) The AHRRA may cancel an enforcement notice by notice in writing given to the holder.

(7) Where the holder fails to take the steps specified in an enforcement notice given to him or her, the AHRRA may, on notice to the holder, apply in a summary manner to the court for an order requiring the holder to take those steps (or to take such varied or other steps for the like purpose as may be specified in the order), and the court—

(a) may—

(i) make the order sought,

(ii) make the order sought subject to such variations to those steps as may be specified in the order, or

(iii) make the order sought subject to such other steps for the like purpose as may be specified in the order,

(b) may dismiss the application,

and whether paragraph (a) or (b) is applicable, may make such order as to the costs as it thinks fit in respect of the application.

177. Application for cancellation of direction specified in enforcement notice

177. (1) The holder to whom an enforcement notice has been given may, on notice to the AHRRA, not later than 30 days after being given the notice, apply to the court for the cancellation of any direction specified in the notice and, on such an application, the court may—

(a) cancel the direction,

(b) confirm the direction, or

and whether paragraph (a), (b) or (c) is applicable, make such order as to costs as it thinks fit in respect of the application.

(2) The decision of the court on a direction specified in an enforcement notice shall be final save that, by leave of the High Court, an appeal by the holder, or the AHRRA, as the case may be, from the decision shall lie to the High Court on a question of law.

178. Rules of court

178. Rules of court may make provision for the expedition of the hearing of proceedings under this Chapter.

Chapter 5 Automatic termination of licence

179. Automatic termination of licence

179. (1) Subject to Chapter 7, a licence terminates immediately upon the occurrence of any of the following events:

(a) where the holder of the licence is an individual, the holder—

(i) dies,

(ii) is adjudicated bankrupt (whether in the State or elsewhere), or

(iii) becomes an arranging debtor (whether in the State or elsewhere);

(b) where the holder of the licence is a body corporate—

(i) the holder commences a voluntary winding-up or becomes subject to a winding-up order,

(ii) a receiver or examiner is appointed to the holder,

(iii) the holder proposes a compromise or arrangement that is sanctioned under section 453(2) of the Act of 2014, or

(iv) where the body is incorporated under the laws of another state, on the commencement of any event which corresponds to an event referred to in subparagraph (i), (ii) or (iii).

(2) (a) Where subsection (1)(a)(i) applies to the holder of a licence, the personal representative of the former holder’s estate shall, as soon as is practicable after the death of the former holder, give notice in the specified form to the AHRRA informing the AHRRA of such death.

(b) Where subsection (1)(a)(ii) or (iii) applies to the holder of a licence, the former holder shall, as soon as is practicable after that subsection so applies, give notice in the specified form to the AHRRA informing the AHRRA of such application.

(3) (a) Where subsection (1)(b)(i), (iii) or (iv) applies to the holder of a licence, the former holder shall, as soon as is practicable after that subsection so applies, give notice in the specified form to the AHRRA informing the AHRRA of such application.

(b) Where subsection (1)(b)(ii) applies to the holder of a licence, the receiver or examiner concerned shall, as soon as is practicable after that subsection so applies, give notice in the specified form to the AHRRA informing the AHRRA of such application.

(4) The AHRRA shall, as soon as is practicable after it becomes aware of the termination under this section of a licence, publish a notice on its website—

(a) stating the name of the holder,

(b) giving the particulars of the licence sufficient to identify the licence,

(d) the date on which the termination occurred.

Chapter 6 Complaints, investigations and sanctions

180. Complaints against holders

180. (1) A person may make a complaint in the specified form to the AHRRA alleging that a relevant contravention by a holder may have occurred or may be occurring.

(2) Subject to section 175, where the AHRRA receives a complaint, it shall cause an investigation of the matter, the subject of the complaint, to be carried out unless it is satisfied that the complaint—

(a) is not made in good faith,

(b) is frivolous or vexatious or without substance or foundation, or

(3) Where the AHRRA decides that a complaint falls within subsection (2)(a), (b) or (c), it shall give notice in writing to the complainant and the holder to whom the complaint relates of the decision and the reasons for the decision.

(4) Subject to section 175, where a complaint is withdrawn by a complainant before the investigation report which relates to the complaint has been submitted to the AHRRA pursuant to section 183(2), the AHRRA may proceed as if the complaint had not been withdrawn if it is satisfied that there is good and sufficient reason for so doing.

(5) Where, pursuant to subsection (4), the AHRRA proceeds as if a complaint had not been withdrawn, the investigation concerned shall thereupon be treated as an investigation initiated by the AHRRA, and the other provisions of this Act shall be construed accordingly.

181. Circumstances in which application may be made to High Court for immediate suspension of licence, etc.

181. (1) Without prejudice to subsection (4), where the AHRRA considers that the immediate suspension of the licence of a holder (whether or not the holder is the subject of a complaint) is necessary to protect the integrity of the relevant activity provided or undertaken by the holder, until steps or further steps are taken under Chapter 4 or this Chapter, the AHRRA may, on notice to the holder, make an application in a summary manner ex parte to the High Court for an order to suspend the licence.

(2) The High Court may determine an application under subsection (1) by—

(a) making any order that it considers appropriate, including an order suspending the licence of the holder the subject of the application for such period, or until the occurrence of such event, as is specified in the order, and

(b) giving to the AHRRA any other direction that the High Court considers appropriate.

(3) The AHRRA shall, on complying with a direction of the High Court under subsection (2)(b), give notice in writing to the holder concerned of the AHRRA’s compliance with the direction.

(4) Section 187(3) and (4) and Chapter 8 shall, with all necessary modifications, apply to a licence suspended under subsection (2) as they apply to a licence suspended pursuant to a decision confirmed or given under section 185(3) or 186(2).

182. Investigations

182. (1) Subject to section 180(2) and (4), the AHRRA—

(a) shall, following the receipt of a complaint, or may of its own volition, cause such investigation as it thinks fit to be carried out to identify any relevant contravention, and

(b) for the purposes of the investigation, shall appoint an authorised officer, subject to such terms and conditions as it thinks fit—

(i) to carry out the investigation, and

(ii) to submit to it an investigation report following the completion of the investigation.

(2) The AHRRA may appoint more than one authorised officer to carry out an investigation but, in any such case, the investigation report concerned shall be prepared jointly by the authorised officers so appointed and the other provisions of this Act (including the definition of “investigation report” in section 170 and section 183) shall, with all necessary modifications, be construed accordingly.

(3) The terms and conditions of appointment of an authorised officer may define the scope of the investigation to be carried out by the authorised officer, whether as respects the matters or the period to which it is to extend or otherwise, and in particular may limit the investigation to matters connected with particular circumstances.

(4) Where the AHRRA has appointed an authorised officer to carry out an investigation, the authorised officer shall, as soon as is practicable after being so appointed—

(a) if the investigation arises in consequence of the receipt of a complaint by the AHRRA—

(i) give notice in writing to the holder to whom the complaint relates of the receipt of the complaint and setting out particulars of the complaint,

(ii) give the holder—

(I) copies of any documents relevant to the investigation, and

(II) a copy of this Part,

and

(iii) without prejudice to the generality of section 172, afford to the holder an opportunity to respond within 30 days from the date on which the holder received the notice referred to in subparagraph (i), or such further period not exceeding 30 days as the authorised officer allows, to the complaint,

(b) if the investigation arises on the volition of the AHRRA—

(i) give notice in writing to the holder concerned of the matters to which the investigation relates, and

(ii) give the holder—

(I) copies of any documents relevant to the investigation, and

(II) a copy of this Part,

and

(iii) without prejudice to the generality of section 172, afford the holder an opportunity to respond within 30 days from the date on which the holder received the notice referred to in subparagraph (i), or such further period not exceeding 30 days as the authorised officer allows, to the matter to which the investigation relates.

(5) Where an investigation arises in consequence of the receipt of a complaint by the AHRRA, the authorised officer appointed to carry out the investigation—

(a) shall, as soon as is practicable, give the complainant a copy of the notice referred to in subsection (4)(a)(i) given to the holder to whom the complaint relates, and

(b) shall make reasonable efforts to ensure that the complainant is kept informed of progress on the investigation.

183. Actions to be taken by authorised officer and AHRRA upon completion of investigation

183. (1) Subject to subsection (3), where an authorised officer has completed an investigation, the authorised officer shall, as soon as is practicable after having considered, in so far as they are relevant to the investigation, any information or books, records or other documents (whether kept in manual form or otherwise) provided to the authorised officer pursuant to any requirement under section 172, any statement or admission made by any person pursuant to any requirement under that section, any submissions made and any evidence presented—

(a) prepare a draft of the investigation report, and

(b) give to the holder the subject of the investigation and, if the investigation arose in consequence of the receipt of a complaint, the complainant—

(i) a copy of the draft of the investigation report,

(ii) a copy of this section, and

(iii) a notice in writing stating that the holder and the complainant (if any) may, not later than 30 days from the date on which the notice was respectively received by them, or such further period not exceeding 30 days as the authorised officer allows, each make submissions in writing to the authorised officer on the draft of the investigation report.

(2) Subject to subsection (3), an authorised officer who has complied with subsection (1) following the completion of an investigation shall, as soon as is practicable after—

(a) the expiration of the period or further period, as appropriate, referred to in subsection (1)(b)(iii), and

(b) having—

(i) considered the submissions (if any) referred to in subsection (1)(b)(iii) made before the expiration of that period on the draft of the investigation report concerned, and

(ii) made any revisions to the draft of the investigation report which, in the opinion of the authorised officer, are warranted following such consideration,

prepare the final form of the investigation report and submit it to the AHRRA with any such submissions annexed to the report.

(3) Where an authorised officer states, whether in a draft of the investigation report or in the final form of the investigation report, that he or she is satisfied that a relevant contravention by the holder to whom the investigation relates has occurred or is occurring, the authorised officer shall not make any recommendation, or express any opinion, in the report as to the minor sanction or major sanction that he or she thinks ought to be imposed on the holder in respect of such contravention in the event that the AHRRA is also satisfied that a relevant contravention by the holder has occurred or is occurring.

(4) Subject to subsection (5), where the AHRRA has considered an investigation report (and any submissions annexed thereto) submitted to it pursuant to subsection (2), the AHRRA—

(a) if it is satisfied that a relevant contravention by the holder the subject of the investigation has occurred or is occurring, shall, subject to subsection (6) and section 184—

(i) impose a minor sanction on the holder, or

(ii) impose a major sanction on the holder,

as it thinks fit in the circumstances of the case,

(b) if it is not satisfied that a relevant contravention by the holder the subject of the investigation has occurred or is occurring but is of the opinion that a further investigation of the holder is warranted, shall cause the further investigation to be carried out pursuant to its powers under section 182(1), or

(c) if it is not satisfied that a relevant contravention by the holder to whom the investigation relates has occurred or is occurring and is not of the opinion that a further investigation of the holder is warranted, and the investigation arose from a complaint, shall dismiss the complaint.

(5) The AHRRA shall, as soon as is practicable after making a decision under subsection (4), give notice in writing of the decision and the reasons for the decision to the holder the subject of the investigation concerned and, if subsection (4)(a) applies in the case of that holder, set out in that notice—

(a) the minor sanction or major sanction imposed on the holder for the relevant contravention specified in the notice in respect of which the AHRRA is satisfied as referred to in that subsection, and

(b) the reasons for the imposition of such minor sanction or major sanction, as the case may be.

(6) Where subsection (4)(a) applies in the case of a holder, the AHRRA shall, in deciding the minor sanction or major sanction to be imposed on the holder, take into consideration the matters referred to in section 188.

(7) Where subsection (4) applies in the case of an investigation which arose from a complaint, the AHRRA shall give the complainant a copy of the notice under subsection (5) given or to be given to the holder the subject of the investigation at the same time as the notice is given to the holder or as soon as is practicable thereafter.

184. **Confirmation of High Court required before decision under section 183(4)(a) to impose major sanction takes effect**

184. Subject to section 181, a decision under section 183(4)(a) to impose a major sanction on a holder shall not take effect unless the decision is confirmed by the High Court under section 185(3) or 186(2).

185. Appeal to High Court against decision to impose major sanction

185. (1) A holder the subject of a decision under section 183(4)(a) by the AHRRA to impose a major sanction on the holder may, not later than 30 days from the date the holder received the notice under section 183(5) of the decision and on notice to the AHRRA, appeal to the High Court against the decision.

(2) The High Court may, on the hearing of an appeal under subsection (1) by a holder, consider any evidence adduced or argument made, whether or not adduced or made to an authorised officer or the AHRRA.

(3) Subject to subsection (4), the High Court may, on the hearing of an appeal under subsection (1) by a holder—

(a) either—

(i) confirm the decision the subject of the appeal, or

(ii) cancel that decision and replace it with such other decision as the Court considers appropriate, which may be a decision—

(I) to do either or both of the following:

(A) impose a different major sanction on the holder;

(B) impose a minor sanction on the holder,

(II) to impose neither a major sanction nor a minor sanction on the holder,

and

(b) whether paragraph (a)(i) or (ii) is applicable, make such order as to costs as it thinks fit in respect of the appeal.

(4) The High Court shall, for the purposes of subsection (3)(a)(i) or (ii)(I), take into consideration the matters referred to in section 188.

186. Application to High Court to confirm decision to impose major sanction

186. (1) Where a holder does not, within the period allowed under section 185(1), appeal to the High Court against a decision under section 183(4)(a) by the AHRRA to impose a major sanction on the holder, the AHRRA shall, as soon as is practicable after the expiration of that period and on notice to the holder, make an application in a summary manner to the High Court for confirmation of the decision.

(2) The High Court shall, on the hearing of an application under subsection (1), confirm the decision under section 183(4)(a) the subject of the application unless the Court considers that there is good reason not to do so.

187. Provisions supplementary to sections 185 and 186

187. (1) The decision of the High Court on an appeal under section 185(1) or an application under section 186(1) is final except that the AHRRA or the holder the subject of the decision may, by leave of that Court or the Court of Appeal, appeal against the decision to the Court of Appeal on a specified question of law.

(2) Where the High Court confirms or gives a decision under section 185(3) or 186(2), the AHRRA shall, as soon as is practicable after the decision is confirmed or given, as the case may be, give notice in writing of the decision to the holder the subject of the decision and, if the decision provides for the imposition of a major sanction on the holder, particulars of the major sanction including, in the case of a major sanction which falls within paragraph (a) or (b) of the definition of “major sanction” in section 170, the day on which the major sanction takes effect, being a day not earlier than 7 days from the date on which the decision is confirmed or given.

(3) Subject to Chapter 7, a licence which is suspended pursuant to a decision confirmed or given under section 185(3) or 186(2) by the High Court shall not be in force during the period of its suspension.

(4) A holder whose licence has been revoked or suspended pursuant to a decision confirmed or given under section 185(3) or 186(2) by the High Court shall comply with any directions of the AHRRA given to the person in respect of the surrender or temporary surrender of the licence and any copies thereof.

(5) Where an investigation arose from a complaint, the AHRRA shall give to the complainant a copy of a notice given or to be given under subsection (2) to a holder at the same time as the notice is given to the holder or as soon as is practicable thereafter.

188. Matters to be considered in determining sanctions to be imposed

188. (1) The AHRRA or the High Court, as appropriate, in considering—

(a) the minor sanction or major sanction to be imposed on a holder pursuant to section 183(4)(a), or

(b) the minor sanction (if any) or major sanction (if any) to be imposed on a holder pursuant to a decision confirmed or given under section 185(3) or 186(2),

shall take into account the circumstances of the relevant contravention concerned (including the factors occasioning it).

(2) Without prejudice to the generality of subsection (1), the AHRRA or the High Court, as appropriate, may, in relation to the holder of the licence concerned, have regard to—

(a) the need to ensure that any sanction imposed—

(i) is appropriate and proportionate to the relevant contravention, and

(ii) if applicable, will act as a sufficient incentive to ensure that any like relevant contravention will not occur in the future,

(b) the seriousness of the relevant contravention,

(d) any excuse or explanation by the holder for the relevant contravention or failure to co-operate with the investigation concerned,

(e) the duration of the relevant contravention,

(f) the repeated occurrence of relevant contraventions by the holder,

(g) if applicable, the continuation of the relevant contravention after the holder was notified of the investigation concerned,

(h) if applicable, the absence, ineffectiveness or repeated failure of internal mechanisms or procedures of the holder intended to prevent relevant contraventions from occurring,

(i) if applicable, the extent and timeliness of any steps taken to end the relevant contravention and any steps taken for remedying the consequences of the relevant contravention, and

(j) any precedents set by a court, the AHRRA or another person in respect of previous relevant contraventions.

189. Protection for persons reporting relevant contravention, etc.

189. (1) Subject to subsection (3), a person who, apart from this section, would be so liable shall not be liable in damages in respect of the communication to the AHRRA, whether in writing or otherwise, of his or her opinion that any relevant contravention by a holder may have occurred or may be occurring, or that a contravention of a provision of this Act by a person other than a holder may have been or may be being committed, unless—

(a) in communicating his or her opinion to the AHRRA did so—

(i) knowing it to be false, misleading, frivolous or vexatious, or

(ii) reckless as to whether it was false, misleading, frivolous or vexatious,

(b) in connection with the communication of his or her opinion to the AHRRA, gave information that he or she knew to be false or misleading in a material particular.

(2) The reference in subsection (1) to liability in damages shall be construed as including a reference to liability to any other form of relief.

(3) Subsection (1) shall not apply to a communication, or giving of information, that is a protected disclosure within the meaning of the Protected Disclosures Act 2014.

(4) Subsection (1) is in addition to, and not in substitution for, any privilege or defence available in legal proceedings, by virtue of any statutory provision or rule of law in force immediately before the coming into operation of this section, in respect of the communication by a person to another (whether that other person is the AHRRA or not) of an opinion of the kind referred to in subsection (1).

(5) Subject to subsection (6), an employer shall not penalise or threaten penalisation against an employee, or cause or permit any other person to penalise or threaten penalisation against an employee, for—

(a) having formed an opinion of the kind referred to in subsection (1) and communicated it, whether in writing or otherwise, to the AHRRA unless the employee—

(i) in communicating his or her opinion to the AHRRA did so—

(I) knowing it to be false, misleading, frivolous or vexatious, or

(II) reckless as to whether it was false, misleading, frivolous or vexatious,

(ii) in connection with the communication of his or her opinion to the AHRRA, gave information that he or she knew to be false or misleading in a material particular,

(b) giving notice of his or her intention to do the thing referred to in paragraph (a).

(6) Subsection (5) shall not apply to a communication, or giving of information, that is a protected disclosure within the meaning of the Protected Disclosures Act 2014.

(7) Schedule 7 shall have effect for the purposes of subsection (5).

(8) In this section—

“contract of employment” means a contract of employment or of service or of apprenticeship, whether the contract is express or implied and, if express, whether it is oral or in writing;

“employee” means a person who has entered into or works under (or, where the employment has ceased, entered into or worked under) a contract of employment and references, in relation to an employer, to an employee shall be construed as references to an employee employed by that employer;

“employer”, in relation to an employee, means the person with whom the employee has entered into or for whom the employee works under (or, where the employment has ceased, entered into or worked under) a contract of employment, and includes—

(a) a person (other than an employee of that person) under whose control and direction an employee works, and

(b) where appropriate, the successor of the employer or an associated employer of the employer;

“penalisation” means any act or omission by an employer, or by a person acting on behalf of an employer, that affects an employee to his or her detriment with respect to any term or condition of his or her employment, and, without prejudice to the generality of the foregoing, includes—

(a) suspension, lay-off or dismissal,

(b) the threat of suspension, lay-off or dismissal,

(d) transfer of duties, change of location of place of work, reduction in wages or change in working hours,

(e) the imposition or the administering of any discipline, reprimand or other penalty (including a financial penalty),

(f) unfair treatment, including selection for redundancy,

(g) coercion, intimidation or harassment,

(h) discrimination, disadvantage or adverse treatment,

(i) injury, damage or loss, and

(j) threats of reprisal.

(9) For the purposes of this section, a reference to “dismissal” includes—

(a) a dismissal within the meaning of the Unfair Dismissals Acts 1977 to 2015, and

(b) a dismissal wholly or partly for or connected with the purpose of the avoidance of a fixed-term contract being deemed to be a contract of indefinite duration under section 9(3) of the Protection of Employees (Fixed-Term Work) Act 2003.

(10) Paragraphs (a), (c), (d), (e) and (f) of the definition of “penalisation” in subsection (8) shall not be construed in a manner which prevents an employer from—

(a) ensuring that the business concerned is carried on in an efficient manner, or

(b) taking any action required for economic, technical or organisational reasons.

Chapter 7 Provisions supplementary to Chapters 5 and 6

190. Effect of termination or revocation of licence

190. (1) On and after the date, or the occurrence of the event, as the case may be, on which the termination or revocation of a licence under Chapter 5 or 6, as the case may be, takes effect, the holder of the licence shall cease to be able to exercise any powers under the licence.

(2) All the holder’s obligations under the licence or this Act shall continue to apply to the holder and the holder shall continue to discharge the obligations unless—

(a) the effect of subsection (1) prevents the holder from doing so, or

(b) in the case of the revocation of a licence under Chapter 6, the notice concerned under section 187(2) specifies that the holder is not required to discharge the obligation concerned.

191. Effect of suspension of licence

191. Where a licence is for the time being suspended under Chapter 6—

(a) the only powers which may be exercised under the licence during the suspension are those specified for the purpose in the order concerned under section 181(2) or the notice concerned under section 187(2), and

(b) all of the holder’s obligations under the licence or this Act continue to apply to the holder and the holder shall continue to discharge the obligations unless—

(i) the effect of paragraph (a) prevents the holder from doing so, or

(ii) the notice concerned under section 187(2) specifies that the holder is not required to comply with the obligation concerned during such suspension.

192. No fee refundable following termination, revocation or suspension of licence, etc.

192. The termination under Chapter 5, or the revocation or suspension under Chapter 6, as the case may be, of a licence shall not entitle the holder to—

(a) any refund of all or any part of any specified fee the holder has paid to the AHRRA pursuant to this Act in relation to the licence, or

(b) any compensation from the State in relation to any expenditure, or loss of income, incurred by the holder in relation to the licence.

193. Offences - general

193. (1) A person who contravenes section 9 shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €100,000 or imprisonment for a term not exceeding five years, or both.

(2) A holder who contravenes section 10 shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €50,000 or imprisonment for a term not exceeding three years, or both.

(3) A person who contravenes section 29(1) or (2), 35(1), 52(2) or (3), 53(1), 57(3), 60(1), 89(2) or (3), 90(1), 93(3), 96(1) or 172(4) or (5) shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €50,000 or imprisonment for a term not exceeding two years, or both.

(4) Without prejudice to the generality of the powers of the court to enforce an order under section 176(7)(a), if the holder concerned fails to comply with the order, the holder shall be guilty of an offence and shall be liable on conviction on indictment to a fine not exceeding €250,000.

(5) Subject to subsection (6), a person who makes a communication under section 189(1) which the person knows to be false, that any relevant contravention by a holder may have occurred or may be occurring, or that a contravention of a provision of this Act by a person other than a holder may have or may be being committed, shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €50,000 or imprisonment for a term not exceeding 3 years, or both.

(6) Subsection (5) shall not apply to a communication that is a protected disclosure within the meaning of the Protected Disclosures Act 2014.

(7) A person who, without reasonable excuse, contravenes a direction referred to in section 187(4) shall be guilty of an offence and shall be liable on summary conviction to a class A fine or imprisonment for a term not exceeding 12 months, or both.

(8) An employer who contravenes section 189(5) shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine and imprisonment for a term not exceeding 12 months, or both, or

(b) on conviction on indictment, to a fine not exceeding €50,000 or imprisonment for a term not exceeding 3 years, or both.

194. False or misleading information

194. (1) Any relevant person who knowingly or recklessly provides the AHRRA with information which is false or misleading in a material particular in his or her capacity as a relevant person shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a class A fine or imprisonment for a term not exceeding 12 months or both, or

(b) on conviction on indictment, to a fine not exceeding €50,000 or imprisonment for a term not exceeding five years, or both.

(2) In this section, “relevant person” means—

(a) in the case of a licence application, the applicant, or

(b) a holder.

195. Obstruction

195. (1) A person shall not interfere with or otherwise obstruct (including obstruct by withholding information reasonably required by, or by knowingly or recklessly providing false or misleading information to)—

(a) the AHRRA,

(b) a member of staff of the AHRRA,

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Health (Assisted Human Reproduction) Act 2024

141. Accountability of chief executive officer to committees of Houses of Oireachtas

142. Appearance of chief executive officer before Committee of Public Accounts

143. Membership of either House of Oireachtas or European Parliament, etc.

144. Acting chief executive officer

Chapter 5 Employees of AHRRA

145. Employees

Chapter 6 Accounts and annual report of AHRRA

146. Accounts of AHRRA

147. Annual report of AHRRA

Chapter 7 Miscellaneous

148. Duty of AHRRA to give information

149. Disclosure of confidential information

150. Processing of personal data

151. Power to specify form of documents

152. Immunity from suit

PART 10 Licences

Chapter 1 Grant or refusal of licence and related matters

153. Application for grant of licence

154. Criteria to which AHRRA shall have regard in determining licence application

155. Grant or refusal of licence

156. Conditions which may be attached to licence, etc.

157. Notification of grant of licence, etc.

Chapter 2 Assignment or amendment of licence

158. Assignment of licence

159. Material amendment to licence

Chapter 3 Surrender of licence

160. Surrender of licence

161. Determination of application under section 160

Chapter 4 Minister may declare certain persons who are not individuals to be fit and proper persons

162. Minister may declare person, etc., who is not individual to be fit and proper person

Chapter 5 Database of AHR Treatment Providers and ESC Researchers

163. Establishment of Database of AHR Treatment Providers and ESC Researchers

164. Correction of database

Chapter 6 Appeals

165. Appeals against certain decisions of AHRRA

Chapter 7 Miscellaneous

166. Display of licence

167. Lost, etc., licence

168. Fees for licences

169. Transitional

PART 11 Enforcement

Chapter 1 Definitions

170. Definitions - Part 11

Chapter 2 Authorised officers

171. Appointment of authorised officers

172. Powers of authorised officers

Chapter 3 Codes of practice

173. Codes of practice

174. Admissibility of codes of practice

Chapter 4 Enforcement notices

175. Application

176. Issue of enforcement notices

177. Application for cancellation of direction specified in enforcement notice

178. Rules of court

Chapter 5 Automatic termination of licence

179. Automatic termination of licence

Chapter 6 Complaints, investigations and sanctions

180. Complaints against holders

181. Circumstances in which application may be made to High Court for immediate suspension of licence, etc.

182. Investigations

183. Actions to be taken by authorised officer and AHRRA upon completion of investigation

184. Confirmation of High Court required before decision under section 183(4)(a) to impose major sanction takes effect

185. Appeal to High Court against decision to impose major sanction

186. Application to High Court to confirm decision to impose major sanction

187. Provisions supplementary to sections 185 and 186

188. Matters to be considered in determining sanctions to be imposed

189. Protection for persons reporting relevant contravention, etc.

Chapter 7 Provisions supplementary to Chapters 5 and 6

190. Effect of termination or revocation of licence

191. Effect of suspension of licence

192. No fee refundable following termination, revocation or suspension of licence, etc.

Chapter 8 Offences and related provisions

193. Offences - general

194. False or misleading information

195. Obstruction

184. **Confirmation of High Court required before decision under section 183(4)(a) to impose major sanction takes effect**