Health (Assisted Human Reproduction) Act 2024

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Number 18 of 2024

HEALTH (ASSISTED HUMAN REPRODUCTION) ACT 2024

CONTENTS

PART 1

Preliminary and General

Section

1. Short title, collective citation and commencement

2. Interpretation - general

3. Regulations, etc.

4. Expenses

5. Circuit Court’s jurisdiction under this Act

6. Review of operation of Act

PART 2

General Provisions Relating to Relevant Activities

7. Definition - Part 2

8. Application

9. Prohibition against person providing or undertaking relevant activity except pursuant to licence

10. Prohibition against holder of licence providing or undertaking relevant activity except in accordance with licence and this Act, etc.

11. Prohibition against ESC researcher using relevant donation (ER) for any purpose other than in undertaking ESC research

12. Upper age limits for AHR treatment

13. AHR information document

14. Provisions supplementary to section 13 - relevant storage (G), relevant storage (E) or relevant storage (T)

15. Provisions supplementary to section 13 - surrogacy

16. Provision of AHR treatment

17. Safety of children - AHR treatment provider

18. AHR counselling

19. Consent

20. Provisions supplementary to section 19 - relevant donation (G)

21. Provisions supplementary to section 19 - relevant donation (E) and relevant donation (ER)

22. Provisions supplementary to section 19 - relevant storage (G), relevant storage (E) or relevant storage (T) in case of two intending parents

23. Provisions supplementary to section 19 - PAHR

24. Two intending parents and section 19 revocation

25. Provisions supplementary to section 19 - surrogacy

26. Embryo transfer

PART 3

Gamete and Embryo Donation for use in AHR Treatment and Embryo Donation for use in ESC Research

27. Gamete donation for use in AHR treatment

28. Provisions supplementary to section 27

29. Prohibition against donating embryos, etc.

30. Embryo donation for use in AHR treatment

31. Embryo donation for use in ESC research

32. Provisions supplementary to sections 30 and 31

33. Limits on use of relevant donation (G) and relevant donation (E)

34. Prohibited AHR treatment based on genetic grounds

35. Prohibition of commercial relevant donation

36. Reasonable expenses of relevant donor

37. Screening and evaluation of potential relevant donor (G) or relevant donor (E)

38. Disclosing medical information about certain persons

PART 4

Storage of Gametes, Embryos and Tissues

39. AHR treatment provided to certain children

40. Disposal of relevant storage (G)

41. Disposal of relevant storage (E)

42. Disposal of relevant storage (T)

PART 5

Posthumous Assisted Human Reproduction

43. Requirements applicable to provision of PAHR

PART 6

Pre-Implantation Genetic Testing

44. Definitions - Part 6

45. PGT-M and PGT-SR

46. PGT-A

47. HLA matching

48. Sex selection

49. Establishment of Register of Genetic Diseases

50. Genetic counselling

PART 7

Domestic Surrogacy

51. Definitions - Part 7

52. Permitted surrogacy

53. Approval of surrogacy agreements

54. Safety of children - AHRRA

55. Surrogate mothers - domestic surrogacy

56. Intending parents - domestic surrogacy

57. Prohibition of commercial surrogacy - domestic surrogacy

58. Surrogacy agreements and reasonable expenses

59. Non-enforceability of surrogacy agreements, etc.

60. Advertisements for surrogacy - domestic surrogacy

61. Requirement for independent legal advice - domestic surrogacy

62. Information to be provided to and recorded by AHRRA in relation to surrogacy agreements

63. Provisions applicable in case of relevant donation (G)

64. Consent to child born as result of AHR treatment provided pursuant to surrogacy agreement to live with intending parents

65. Application for parental order - domestic surrogacy

66. Grant of parental order - domestic surrogacy

67. Effect of parental order - domestic surrogacy

68. National Surrogacy Register

69. Interaction of National Surrogacy Register and register of births - domestic surrogacy

70. Access to certain information from National Surrogacy Register and National Donor-Conceived Person Register - domestic surrogacy

71. Information in respect of intending parents or surrogate mother to be given to adult (AHR) - domestic surrogacy

72. Information in respect of relevant donor (G) to be provided to child born as result of AHR treatment provided pursuant to surrogacy agreement in which embryo transferred was created using relevant donation (G)

73. Information in respect of other persons that may be requested from AHRRA - domestic surrogacy

74. Provisions supplementary to sections 70 to 73

75. Applications to AHRRA not correctly completed - domestic surrogacy

76. Additional information - domestic surrogacy

77. Provisions supplementary to sections 75 and 76

78. Onus on AHR treatment provider to be satisfied that certain provisions of this Part have been complied with

PART 8

International Surrogacy

Chapter 1

Interpretation, application and approval of surrogacy jurisdictions

79. Interpretation – Part 8

80. Application

81. Approval of surrogacy jurisdiction

Chapter 2

General provisions relating to international surrogacy

82. Definition – Chapter 2

83. AHR information document (SJ)

84. Provisions supplementary to section 83

85. Safety of children - AHRRA

86. AHR counselling (SJ)

87. Consent - international surrogacy

88. Provisions supplementary to section 87

Chapter 3

Permitted international surrogacy

89. Permitted international surrogacy

90. Approval of surrogacy agreements (SJ)

91. Surrogate mothers - international surrogacy

92. Intending parents - international surrogacy

93. Prohibition of commercial surrogacy - international surrogacy

94. Surrogacy agreements (SJ) and reasonable expenses

95. Non-enforceability of surrogacy agreements (SJ)

96. Advertisements for surrogacy - international surrogacy

97. Role of intermediaries

98. Requirement for independent legal advice - international surrogacy

99. Information to be provided to and recorded by AHRRA in relation to surrogacy agreements (SJ)

100. Provisions applicable in case of relevant donation (SJG)

101. Consent to child born as result of AHR treatment (SJ) provided pursuant to surrogacy agreement (SJ) to live with intending parents

102. Application for parental order - international surrogacy

103. Grant of parental order - international surrogacy

104. Effect of parental order - international surrogacy

105. National Surrogacy Register - children born as result of AHR treatment (SJ)

106. Interaction of National Surrogacy Register and register of births - international surrogacy

107. Access to certain information from National Surrogacy Register and National Donor-Conceived Person Register - international surrogacy

108. Information in respect of intending parents or surrogate mother to be given to adult (AHR) - international surrogacy

109. Information in respect of relevant donor (SJG) to be provided to adult born as result of AHR treatment (SJ) provided pursuant to surrogacy agreement (SJ) in which embryo transferred was created using relevant donation (SJG)

110. Information in respect of other persons that may be requested from AHRRA - international surrogacy

111. Provisions supplementary to sections 107 to 110

112. Applications to AHRRA not correctly completed - international surrogacy

113. Additional information - international surrogacy

114. Provisions supplementary to sections 112 and 113

115. Failure to comply with undertakings

Chapter 4

Jurisdiction and offences

116. Definition - Chapter 4

117. Jurisdiction

118. Evidence in proceedings for offences outside State

119. Double jeopardy

PART 9

Assisted Human Reproduction Regulatory Authority

Chapter 1

Definitions and establishment day

120. Definitions - Part 9

121. Establishment day

Chapter 2

Establishment and functions of Assisted Human Reproduction Regulatory Authority, etc.

122. Establishment of Assisted Human Reproduction Regulatory Authority

123. Functions of AHRRA

124. Voluntary Register of Relevant Donors and Donor-Conceived Persons

125. Agreements between AHRRA and public bodies relating to performance by public bodies of functions of AHRRA

Chapter 3

Board of AHRRA

126. Establishment and membership of Board of AHRRA

127. Casual vacancies

128. Functions of Board

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

130. Removal of member of Board

131. Potential conflicts of interest

132. Removal of all members of Board

133. Meetings of Board

134. Committees of Board

135. Ineligibility of holders, etc., for appointment as member of Board

136. Remuneration and expenses of members of Board and committees

Chapter 4

Chief executive officer of AHRRA

137. Appointment of chief executive officer

138. Resignation, removal or disqualification of chief executive officer

139. Functions of chief executive officer

140. Delegation of functions

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

196. Evidentiary presumptions

197. Offences by bodies corporate

198. Vicarious liability

199. Summary proceedings

200. Time limit for offences that may only be brought by summary proceedings

201. Costs of prosecutions

PART 12

Past Domestic and International Surrogacy

Chapter 1

Past domestic surrogacy

202. Definitions – Chapter 1

203. Operation of Chapter and section 151 before establishment day, etc.

204. Application for parental order - past domestic surrogacy

205. Grant of parental order and relevant child (Chapter 1)

206. Effect of parental order - past domestic surrogacy

207. National Surrogacy Register and relevant child (Chapter 1)

208. Interaction of National Surrogacy Register and register of births - past domestic surrogacy

209. Information in respect of intending parents or surrogate mother to be given to adult (AHR) - past domestic surrogacy

210. Provisions supplementary to section 209

211. Applications to AHRRA not correctly completed - past domestic surrogacy

212. Additional information - past domestic surrogacy

213. Provisions supplementary to sections 211 and 212

Chapter 2

Past international surrogacy

214. Definitions – Chapter 2

215. Operation of Chapter and section 151 before establishment day, etc.

216. Application for parental order - past international surrogacy

217. Grant of parental order and relevant child (Chapter 2)

218. Effect of parental order - past international surrogacy

219. National Surrogacy Register and relevant child (Chapter 2)

220. Interaction of National Surrogacy Register and register of births - past international surrogacy

221. Information in respect of intending parents or surrogate mother to be given to adult (AHR) - past international surrogacy

222. Provisions supplementary to section 221

223. Applications to AHRRA not correctly completed - past international surrogacy

224. Additional information - past international surrogacy

225. Provisions supplementary to sections 223 and 224

PART 13

Consequential and other Amendments

226. Amendment of Irish Nationality and Citizenship Act 1956

227. Amendment of Guardianship of Infants Act 1964

228. Amendment of section 46 of Status of Children Act 1987

229. Amendment of section 15 of Passports Act 2008

230. Amendment of Act of 2004

231. Amendment of section 39 of Civil Liability and Courts Act 2004

232. Amendment of Act of 2015

233. Delegation by Minister to AHRRA

234. Savings - sections 34 to 38

SCHEDULE 1

Fit and Proper Person

SCHEDULE 2

Prohibited ESC Research

SCHEDULE 3

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

SCHEDULE 4

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

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

PART 1

Types of Conditions that AHRRA may Attach to Licence

PART 2

Conditions Deemed to be Attached to 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

PART 1

Types of Conditions that AHRRA may Attach to Licence

PART 2

Conditions Deemed to be Attached to Licence

SCHEDULE 7

Redress for Contravention of Section 189(5)

Acts Referred to

Assisted Decision-Making (Capacity) Act 2015 (No. 64)

Children and Family Relationships Act 2015 (No. 9)

Civil Liability and Courts Act 2004 (No. 31)

Civil Partnership and Certain Rights and Obligations of Cohabitants Act 2010 (No. 24)

Civil Registration Act 2004 (No. 3)

Civil Registration Acts 2004 to 2019

Companies Act 1990 (No. 33)

Companies Act 2014 (No. 38)

Comptroller and Auditor General (Amendment) Act 1993 (No. 8)

Criminal Justice Act 1951 (No. 2)

Ethics in Public Office Act 1995 (No. 22)

European Parliament Elections Act 1997 (No. 2)

Guardianship of Infants Act 1964 (No. 7)

Higher Education Authority Act 2022 (No. 31)

Interpretation Act 2005 (No. 23)

Irish Nationality and Citizenship Act 1956 (No. 26)

Irish Nationality and Citizenship Acts 1956 to 2004

Legal Services Regulation Act 2015 (No. 65)

Local Government Act 2001 (No. 37)

Medical Practitioners Act 2007 (No. 25)

Passports Act 2008 (No. 4)

Petty Sessions (Ireland) Act 1851 (14 & 15 Vict., c. 93)

Protected Disclosures Act 2014 (No. 14)

Protection of Employees (Fixed-Term Work) Act 2003 (No. 29)

Public Service Management (Recruitment and Appointments) Act 2004 (No. 33)

Standards in Public Office Act 2001 (No. 31)

Status of Children Act 1987 (No. 26)

Taxes Consolidation Act 1997 (No. 39)

Unfair Dismissals Act 1977 (No. 10)

Unfair Dismissals Acts 1977 to 2015

Workplace Relations Act 2015 (No. 16)

Number 18 of 2024

HEALTH (ASSISTED HUMAN REPRODUCTION) ACT 2024

An Act to regulate the provision of any treatment or procedure, including such treatment or procedure for the purposes of surrogacy within or, in relation to certain persons connected with the State, outside the State, that involves the handling of gametes, embryos or tissues, or any combination thereof, for the purposes of establishing, or preserving the possibility of establishing, a pregnancy (to be known as “AHR treatment”) and, to that end, to prohibit a person from providing, within the State, AHR treatment unless the person holds a licence, granted by a body established by this Act, to be known as “An tÚdarás Rialála um Atáirgeadh Daonna Cuidithe” or, in the English language, the “Assisted Human Reproduction Regulatory Authority” (otherwise referred to in this Act as the “AHRRA”), authorising the person to provide the AHR treatment concerned; to regulate research involving embryos, the derivation, collection, storage or use of embryonic stem cells or stem cell lines or the derivation, collection, storage or use of induced pluripotent stem cells or stem cell lines (to be known collectively as “ESC research”), and, to that end, to prohibit a person from undertaking ESC research unless the person holds a licence, granted by the AHRRA, authorising the person to undertake the ESC research concerned; to provide certain rights for a person born as a result of AHR treatment to access information concerning his or her origins; to provide for a comprehensive regulatory scheme (including the suspension or revocation of licences granted under this Act and the imposition of, inter alia, pecuniary sanctions on holders, or certain former holders, of licences) overseen by the AHRRA; to provide for consequential and other amendments to other enactments; and to provide for related matters.

[2nd July, 2024]

Be it enacted by the Oireachtas as follows: