HEALTH (ASSISTED HUMAN REPRODUCTION) ACT 2024

SCHEDULE 1 Fit and Proper Person

SCHEDULE 1

Fit and Proper Person

Section 2

1. In this Schedule—

“person concerned”, in relation to a relevant person which is a body corporate, means—

(a) a person who exercises control (within the meaning of section 11 or 432 of the Taxes Consolidation Act 1997) in relation to the body,

(b) a member (including the chairperson) of the body, or the board or board of directors of the body, or any other person acting in such capacity,

(c) the managing director or chief executive officer of the body, or any other person acting in such capacity, or

(d) a person to whom paragraph 2(f) relates or, in the case of a relevant person who falls within clause (a) of the definition of “relevant person”, would relate if the AHRRA grants the licence concerned;

“relevant person” means—

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

(b) the holder of a licence.

2. Subject to section 162, the AHRRA shall, in determining whether a relevant person is a fit and proper person to be granted a licence or to continue to be the holder of a licence, as the case may be, have regard to the following

(a) letters of reference;

(b) whether the relevant person, or any other person concerned, stands convicted of—

(i) an indictable offence under this Act or an offence in another jurisdiction equivalent to such an indictable offence,

(ii) an indictable offence under an enactment prescribed for the purposes of this subparagraph, or

(iii) an offence involving fraud or dishonesty;

(c) if the relevant person is a body corporate, whether any of its directors has a declaration under section 819 of the Act of 2014 made against him or her or is deemed to be subject to such a declaration by virtue of Chapter 5 of Part 14 of that Act, or is subject to or deemed to be subject to—

(i) a disqualification order, within the meaning of Chapter 4 of Part 14 of the Act of 2014, whether by virtue of that Chapter or any other provision of that Act, or

(ii) a disqualification outside the State to like effect which corresponds to a disqualification order within the meaning of Chapter 4 of Part 14 of the Act of 2014;

(d) if the relevant person is an individual, whether he or she is adjudicated bankrupt or is subject to proceedings for a declaration of bankruptcy or becomes an arranging debtor;

(e) if the relevant person is a body corporate, whether it—

(i) has commenced a voluntary winding-up or is subject to a winding-up order or is subject to proceedings for such an order,

(ii) is subject to the appointment of a receiver or examiner, or

(iii) has proposed to compromise an arrangement that is sanctioned under section 453(2) of the Act of 2014;

(f) if the relevant person is a body corporate incorporated under the law of another jurisdiction—

(i) whether an event which corresponds to an event referred to in clause (c) has occurred in relation to any of its directors, or

(ii) whether an event which corresponds to an event referred to in clause (e) has occurred in relation to the body corporate;

(g) whether the relevant person, or a person acting on behalf of the relevant person in the relevant person’s capacity as such, has (or has access to), or continues to have (or have access to), as the case may be, the requisite technical knowledge or qualifications, or both, to undertake the proposed relevant activity, or continue to undertake the relevant activity, as the case may be;

(h) whether the relevant person is likely to be in a position to meet, or continue to meet, as the case may be, any financial commitments or obligations that the AHRRA reasonably considers will be entered into or incurred by the relevant person—

(i) in undertaking the proposed relevant activity, or in continuing to undertake the relevant activity, as the case may be,

(ii) in ceasing to undertake the proposed relevant activity or the relevant activity, as the case may be, or

(iii) the previous performance of the relevant person when granted a licence.

SCHEDULE 2 Prohibited ESC Research

SCHEDULE 2

Prohibited ESC Research

Section 10

1. ESC research involving the creation of an embryo specifically for use in research and whether or not the embryo is created by the fertilisation of a human egg by a human sperm or by other means.

2. (a) ESC research involving—

(i) the creation of a human embryo clone,

(ii) placing a human embryo clone into the body of a person,

(iii) placing a human embryo clone into the body of an animal, or

(iv) using a human embryo clone for the purposes of research.

(b) In this paragraph, “human embryo clone” means a human embryo that is a genetic copy of another living or deceased human, but does not include a human embryo created by fertilisation of a human egg by a human sperm.

3. (a) ESC research undertaking mitochondrial donation or mitochondrial replacement with human gametes or embryos.

(b) In this paragraph—

“enucleated egg or embryo” means an egg or embryo from which the nuclear DNA has been removed;

“mitochondrial donation” and “mitochondria replacement” mean the removal of any nuclear DNA from an egg or embryo that has abnormal mitochondria and the insertion of this nuclear DNA into another enucleated egg or embryo that has healthy mitochondria.

4. (a) ESC research involving—

(i) the creation of a human-animal hybrid embryo,

(ii) the use of a human-animal hybrid for any purpose,

(iii) placing a human-animal hybrid into the body of a person or animal,

(iv) placing a human gamete or embryo into the body of an animal, or

(v) placing an animal gamete or embryo into the body of a person.

(b) In this paragraph, “human-animal hybrid embryo” means an embryo created or altered by—

(i) the fertilisation of a human gamete with an animal gamete,

(ii) the fertilisation of an animal gamete with a human gamete,

(iii) the insertion of an animal cell into a human embryo,

(iv) the insertion of a nucleus from a human cell into an animal egg,

(v) the insertion of a nucleus from an animal cell into a human egg, or

(vi) any other combination of human and animal material.

5. Any other type of ESC research specified, for the purposes of this paragraph, in regulations made under section 10(3).

SCHEDULE 3 Criteria that AHRRA shall have Regard to in Determining Licence Application to Provide AHR Treatment

SCHEDULE 3

Criteria that AHRRA shall have Regard to in Determining Licence Application to Provide AHR Treatment

Section 154

1. Whether the applicant is a fit and proper person to be granted a licence to provide the AHR treatment concerned, both at the time the licence application is made and at the time that the application is determined by the AHRRA.

2. Whether the applicant is tax compliant, both at the time that the licence application is made and at the time that the application is determined by the AHRRA.

3. Whether the applicant has, or has available, the requisite skills and experience to provide the AHR treatment the subject of the licence application to a sufficient standard.

4. Whether the premises specified in the licence application at which it is proposed to provide the AHR treatment the subject of the licence application are suitable for the provision of such treatment (including whether such premises are an authorised tissue establishment within the meaning of the Regulations of 2006).

5. Any additional criteria specified, for the purposes of this paragraph, in regulations made under section 154(2).

SCHEDULE 4 Criteria that AHRRA shall have Regard to in Determining Licence Application to Undertake ESC Research

SCHEDULE 4

Criteria that AHRRA shall have Regard to in Determining Licence Application to Undertake ESC Research

Section 154

1. Whether the applicant is a fit and proper person to be granted a licence to undertake the ESC research concerned, both at the time the licence application is made and at the time that the application is determined by the AHRRA.

2. Whether the applicant is tax compliant, both at the time that the licence application is made and at the time that the application is determined by the AHRRA.

3. Whether the ESC research concerned is likely to advance—

(a) knowledge, treatments or other procedures relating to AHR, or

(b) knowledge or treatment of serious diseases or other serious medical conditions.

4. Whether the aims of the ESC research referred to in paragraph 3 could not reasonably be achieved through alternative forms of research that do not require the use of, as the case may be—

(a) embryos,

(b) embryonic stem cells or stem cell lines, or

(c) induced pluripotent stem cells or stem cell lines.

5. Whether or not the ESC research concerned has been assessed and approved by a research ethics committee.

6. Whether the applicant has, or has available, the requisite skills and experience to undertake the ESC research the subject of the licence application.

7. Whether the premises specified in the licence application at which it is proposed to undertake the ESC research the subject of the application are suitable for such undertaking.

8. Any additional criteria specified, for the purpose of this paragraph, in regulations made under section 154(2).

SCHEDULE 5 Types of conditions that ahrra may attach to licence authorising provision of ahr treatment or that are deemed to be attached to such licence

SCHEDULE 5

Types of conditions that ahrra may attach to licence authorising provision of ahr treatment or that are deemed to be attached to such licence

Section 156

PART 1 Types of Conditions that AHRRA may Attach to Licence

PART 1

Types of Conditions that AHRRA may Attach to Licence

1. A condition requiring the holder of a licence to give notice in writing to the AHRRA of any change of circumstances that a reasonable person would consider might be a change in circumstances—

(a) that will or may adversely affect, in a material way, the provision of the AHR treatment authorised by the licence, or

(b) that, if the holder did not hold that licence and were to make a licence application for a licence in the like terms, the provisions of Part 10, as in force at the time that the licence was granted, would prevent the AHRRA from granting a licence in such terms to the holder.

2. Any type of condition specified, for the purposes of this paragraph, in regulations made under section 156(3).

PART 2 Conditions Deemed to be Attached to Licence

PART 2

Conditions Deemed to be Attached to Licence

1. A condition that the holder of a licence continues to be a fit and proper person to hold the licence.

2. (a) A condition that the AHR treatment provider shall not place a relevant gamete or embryo into the body of a woman in an attempt to achieve a pregnancy.

(b) In this paragraph—

“enucleated egg or embryo” means an egg or embryo from which the nuclear DNA has been removed;

“genome” means an organism’s complete set of DNA, including all of its genes;

“mitochondrial donation” and “mitochondria replacement” mean the removal of any nuclear DNA from an egg or embryo that has abnormal mitochondria and the insertion of this nuclear DNA into another enucleated egg or embryo that has healthy mitochondria;

“relevant gamete or embryo” means a human gamete or embryo—

(i) the genome of which has been modified such that the modification could be inherited by children born from the gamete or embryo or the descendants of such children, or

(ii) which has undergone mitochondrial donation or mitochondrial replacement.

3. A condition specified for the purposes of this paragraph in regulations made under section 156(3).

SCHEDULE 6 Types of Conditions that AHRRA May Attach to Licence Authorising Undertaking of ESC Research or that are Deemed to be Attached to such Licence

SCHEDULE 6

Types of Conditions that AHRRA May Attach to Licence Authorising Undertaking of ESC Research or that are Deemed to be Attached to such Licence

Section 156

PART 1 Types of Conditions that AHRRA may Attach to Licence

PART 1

Types of Conditions that AHRRA may Attach to Licence

1. A provision requiring the holder of a licence to give notice in writing to the AHRRA of any change in circumstances that a reasonable person would consider might be a change in circumstances—

(a) that will or may adversely affect, in a material way, the undertaking of the ESC research authorised by the licence, or

(b) that, if the holder did not hold that licence and were to make a licence application for a licence in the like terms, the provisions in Part 10, as in force at the time that the licence was granted, would prevent the AHRRA from granting a licence in such terms to the holder.

2. A condition that the holder of a licence shall not import embryonic stem cell lines or induced pluripotent stem cell lines for use in ESC research.

3. Any type of condition specified, for the purposes of this paragraph, in regulations made under section 156(3).

PART 2 Conditions Deemed to be Attached to Licence

PART 2

Conditions Deemed to be Attached to Licence

1. A condition that the holder of a licence continues to be a fit and proper person to hold the licence.

2. A condition that the holder of a licence shall not develop or maintain an embryo in vitro beyond the 14th day of its development following fertilisation but excluding any period during which the development of the embryo has been suspended.

3. A condition specified, for the purposes of this paragraph, in regulations made under section 156(3).

SCHEDULE 7 Redress for Contravention of Section 189(5)

SCHEDULE 7

Redress for Contravention of Section 189(5)

Section 189

Complaints to rights commissioner

1. (1) In proceedings under Part 4 of the Workplace Relations Act 2015 in respect of a complaint of a contravention of section 189(5), it shall not be necessary for the employee to show that he or she has at least one year’s continuous service with the employer concerned.

(2) Where a complaint under subparagraph (1) is made, the rights commissioner shall—

(a) give the parties an opportunity to be heard by the commissioner and to present to the commissioner any evidence relevant to the complaint,

(b) give a decision in writing in relation to it, and

(c) notify the parties of that decision.

(3) A decision of an adjudication officer under section 41 of the Workplace Relations Act 2015 in relation to a complaint of a contravention of section 189(5) shall do one or more of the following, namely—

(a) declare that the complaint was or, as the case may be, was not well founded,

(b) require the employer to take a specified course of action, which may include, in a case where the penalisation constitutes a dismissal, reinstatement or reengagement, or

(c) require the employer to pay to the employee compensation of such amount (if any) as the adjudication officer considers just and equitable having regard to all of the circumstances, but not exceeding 104 weeks’ remuneration in respect of the employee’s employment calculated in accordance with regulations under section 17 of the Unfair Dismissals Act 1977.

(4) Subject to subparagraph (10), a rights commissioner shall not entertain a complaint under this paragraph if it is presented to him or her after the expiration of the period of 6 months beginning on the date of the contravention to which the complaint relates.

(5) Notwithstanding subparagraph (4), a rights commissioner may entertain a complaint under this paragraph presented to him or her after the expiration of the period referred to in subparagraph (4) (but not later than 6 months after such expiration) if he or she is satisfied that the failure to present the complaint within that period was due to exceptional circumstances.

(6) A complaint shall be presented by giving notice of it in writing to a rights commissioner and the notice shall contain such particulars and be in such form as may be specified from time to time by the Minister for Enterprise, Trade and Employment.

(7) A copy of a notice under subparagraph (6) shall be given to the other party concerned by the rights commissioner.

(8) Proceedings under this paragraph before a rights commissioner shall be conducted otherwise than in public.

(9) A rights commissioner shall furnish the Labour Court with a copy of each decision given by the commissioner under subparagraph (2).

(10) Where a delay by an employee in presenting a complaint under this paragraph is due to any misrepresentation by the employer, subparagraph (4) shall be construed as if the reference to the date of the contravention were a reference to the date on which the misrepresentation came to the employee’s notice.

Appeals from decisions of rights commissioner

2. A decision of the Labour Court under section 44 of the Workplace Relations Act 2015, on appeal from a decision of an adjudication officer referred to in paragraph 1(3), shall affirm, vary or set aside the decision of the adjudication officer.

Paragraphs 1 and 2: supplemental provisions

3. In proceedings under Part 4 of the Workplace Relations Act 2015 in relation to a complaint that section 189(5) has been contravened, it shall be presumed, until the contrary is proved, that the employee concerned acted reasonably and in good faith in forming the opinion and making the communication concerned.

4. (a) If penalisation of an employee, in contravention of section 189(5), constitutes a dismissal of the employee as referred to in paragraph (a) of the definition of “penalisation” in section 189(8), the employee (or, in the case of an employee who has not reached the age of 18 years, the employee’s parent or guardian with the consent of the employee) may institute proceedings in respect of that dismissal under the Unfair Dismissals Acts 1977 to 2015 or to recover damages at common law for wrongful dismissal and, if the employee or his or her parent or guardian, as the case may be, does so, a complaint in relation to such dismissal may not be presented to an adjudication officer under section 41 of the Workplace Relations Act 2015.

(b) If an employee (or, in the case of an employee who has not reached the age of 18 years, the employee’s parent or guardian with the consent of the employee) presents a complaint to an adjudication officer under section 41 of the Workplace Relations Act 2015 in respect of a dismissal referred to in clause (a), the employee or his or her parent or guardian, as the case may be, may not institute proceedings in respect of that dismissal under the Unfair Dismissals Acts 1977 to 2015 or to recover damages at common law for wrongful dismissal.