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Human Fertilisation and Embryology Act 1990

1990 c. 37 · Enacted 1 November 1990 · Extends to United Kingdom

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An Act to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and gametes; to establish a Human Fertilisation and Embryology Authority; to make provision about the persons who in certain circumstances are to be treated in law as the parents of a child; and to amend the Surrogacy Arrangements Act 1985.

[1st November 1990]

C1Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and consent of the Lords Spiritual and Temporal, and Commons, in this present Parliament assembled, and by the authority of the same, as follows:—C2

Annotations to the whole text

Modifications

C1

Act modified (temp.) by S.I. 1991/1400, art.3

Act modified by S.I. 1991/1400, art. 4(3)

Act referred to (S.) (1.4.1997) by S.I. 1997/291, rules 2.45-2.59 (Ch. 2 Pt. VI)

C2

Act applied (with modifications) (1.10.2009) by The Human Fertilisation and Embryology (Consequential Amendments and Transitional and Saving Provisions) Order 2009 (S.I. 2009/1892), Sch. 4 paras. 1-12

Contents

  1. Principal terms used
  2. 1Meaning of “embryo”, “gamete” and associated expressions.
  3. 1AReference to Directives
  4. 2Other terms.
  5. 2AThird party agreements
  6. 2BMeaning of “importing licensee”, “third country premises” etc
  7. Activities governed by the Act
  8. 3Prohibitions in connection with embryos.
  9. 3ZAPermitted eggs, permitted sperm and permitted embryos
  10. 3AProhibition in connection with germ cells.
  11. 4Prohibitions in connection with gametes.
  12. 4AProhibitions in connection with genetic material not of human origin
  13. The Human Fertilisation and Embryology Authority, its functions and procedure
  14. 5The Human Fertilisation and Embryology Authority.
  15. 6Accounts and audit.
  16. 7Reports to Secretary of State.
  17. 8General functions of the Authority.
  18. 8ZADuties in relation to carrying out its functions
  19. 8ZBDuties of the Authority in relation to the Single European Code: Northern Ireland
  20. 8ADuty of Authority to communicate with competent authorities of EEA states: Northern Ireland
  21. 8BAgency arrangements and provision of services
  22. 8CContracting out functions of Authority
  23. 8DDisclosure of information where functions of Authority exercised by others
  24. 8EPower to assist other public authorities
  25. 9APower to delegate and establish committees
  26. 10Licensing procedure. Repealed
  27. Scope of licences
  28. 11Licences for treatment, storage and research.
  29. Licence conditions
  30. 12General conditions.
  31. 13Conditions of licences for treatment.
  32. 13AConditions of licences for non-medical fertility services
  33. 14Conditions of storage licences.
  34. 14AConditions of licences: human application
  35. 15Conditions of research licences.
  36. 15ADuties of the Authority in relation to serious adverse events and serious adverse reactions
  37. 15BInspection of third country premises etc.: Northern Ireland
  38. 15CThird country premises and third country suppliers: report of inspections etc: Northern Ireland
  39. Grant, revocation and suspension of licences
  40. 16Grant of licence.
  41. 17The person responsible.
  42. 18Revocation of licence
  43. 18AVariation of licence
  44. 19Procedure in relation to licensing decisions
  45. 19ANotification of licensing decisions
  46. 19BApplications under this Act
  47. 19CPower to suspend licence
  48. 20Right to reconsideration of licensing decisions
  49. 20AAppeals committee
  50. 20BProcedure on reconsideration
  51. 21Appeal on a point of law
  52. 22Temporary suspension of licence. Repealed
  53. Directions and guidance
  54. 23Directions: general.
  55. 24Directions as to particular matters.
  56. 25Code of practice.
  57. 26Procedure for approval of code.
  58. Status
  59. 27Meaning of “mother”.
  60. 28Meaning of “father”.
  61. 29Effect of sections 27 and 28.
  62. 30Parental orders in favour of gamete donors. Repealed
  63. Information
  64. 31Register of information
  65. 31ZARequest for information as to genetic parentage etc.
  66. 31ZBRequest for information as to intended spouse etc.
  67. 31ZCPower of Authority to inform donor of request for information
  68. 31ZDProvision to donor of information about resulting children
  69. 31ZEProvision of information about donor-conceived genetic siblings
  70. 31ZFPower of Authority to keep voluntary contact register
  71. 31ZGFinancial assistance for person setting up or keeping voluntary contact register
  72. 31AThe Authority's register of licences
  73. 31BThe Authority's register of serious adverse events and serious adverse reactions
  74. 32Information to be provided to Registrar General.
  75. 33ADisclosure of information
  76. 33BConsent required to authorise certain disclosures
  77. 33CPower to provide for additional exceptions from section 33A(1)
  78. 33DDisclosure for the purposes of medical or other research
  79. 34Disclosure in interests of justice.
  80. 35Disclosure in interests of justice: congenital disabilities, etc.
  81. Mitochondrial donation
  82. 35AMitochondrial donation
  83. Fees
  84. 35BFees
  85. Surrogacy
  86. 36Amendment of Surrogacy Arrangements Act 1985.
  87. Abortion
  88. 37Amendment of law relating to termination of pregnancy.
  89. Conscientious objection
  90. 38Conscientious objection.
  91. Enforcement
  92. 38AInspection, entry, search and seizure
  93. 39Powers of members and employees of Authority. Repealed
  94. 40Power to enter premises. Repealed
  95. Offences
  96. 41Offences.
  97. 42Consent to prosecution.
  98. Miscellaneous and General
  99. 42APowers to make regulations in relation to standards of quality and safety
  100. 43Keeping and examining gametes and embryos in connection with crime, etc.
  101. 44Civil liability to child with disability.
  102. 45Regulations.
  103. 45APower to make consequential provision
  104. 45BOrders
  105. 46Notices.
  106. 47Index.
  107. 48Northern Ireland.
  108. 49Short title, commencement, etc.
  109. Schedule 1: The Authority: Supplementary Provisions
  110. Status and capacity
  111. 1Paragraph 1
  112. 2Paragraph 2
  113. Expenses
  114. 3Paragraph 3
  115. Appointment of members
  116. 4Paragraph 4
  117. 4AParagraph 4A
  118. Tenure of office
  119. 5Paragraph 5
  120. 5AParagraph 5A
  121. 5BParagraph 5B
  122. Disqualification of members of Authority for House of Commons and Northern Ireland Assembly
  123. 6Paragraph 6
  124. Remuneration and pensions of members
  125. 7Paragraph 7
  126. Staff
  127. 8Paragraph 8
  128. Proceedings
  129. 9Paragraph 9
  130. 10Paragraph 10
  131. 11Paragraph 11
  132. Instruments
  133. 12Paragraph 12
  134. 13Paragraph 13
  135. Investigation by Parliamentary Commissioner
  136. 14Paragraph 14
  137. Application of Statutory Instruments Act 1946
  138. 15Paragraph 15
  139. Schedule 2: Activities for which licences may be granted
  140. Licences for treatment
  141. 1Paragraph 1
  142. Embryo testing
  143. 1ZAParagraph 1ZA
  144. Sex selection
  145. 1ZBParagraph 1ZB
  146. Power to amend paragraphs 1ZA and 1ZB
  147. 1ZCParagraph 1ZC
  148. Licences for non-medical fertility services
  149. 1AParagraph 1A
  150. Licences for storage
  151. 2Paragraph 2
  152. Licences for research
  153. 3Paragraph 3
  154. Purposes for which activities may be licensed under paragraph 3
  155. 3AParagraph 3A
  156. General
  157. 4Paragraph 4
  158. Schedule 3: Consents to use OR STORAGE OF GAMETES, EMBRYOS OR HUMAN ADMIXED EMBRYOS ETC
  159. Consent
  160. 1Paragraph 1
  161. 2Paragraph 2
  162. Procedure for giving consent
  163. 3Paragraph 3
  164. Variation and withdrawal of consent
  165. 4Paragraph 4
  166. 4AParagraph 4A
  167. Use of gametes for treatment of others
  168. 5Paragraph 5
  169. In vitro fertilisation and subsequent use of embryo
  170. 6Paragraph 6
  171. Embryos obtained by lavage, etc.
  172. 7Paragraph 7
  173. Storage of gametes and embryos
  174. 8Paragraph 8
  175. Cases where consent not required for storage
  176. 9Paragraph 9
  177. 10Paragraph 10
  178. 11Paragraph 11
  179. Renewal of consent to storage of gametes
  180. 11AParagraph 11A
  181. 11BParagraph 11B
  182. Renewal of consent to storage of embryos
  183. 11CParagraph 11C
  184. 11DParagraph 11D
  185. Creation, use and storage of human admixed embryos
  186. 12Paragraph 12
  187. 13Paragraph 13
  188. 14Paragraph 14
  189. Parental consent conditions
  190. 15Paragraph 15
  191. Adults lacking capacity: exemption relating to use of human cells etc.
  192. 16Paragraph 16
  193. Consent to use of human cells etc. not required: adult lacking capacity
  194. 17Paragraph 17
  195. Consulting carers etc. in case of adult lacking capacity
  196. 18Paragraph 18
  197. Effect of acquiring capacity
  198. 19Paragraph 19
  199. Use of cells or cell lines in existence before relevant commencement date
  200. 20Paragraph 20
  201. Conditions for grant of exemption in paragraph 20
  202. 21Paragraph 21
  203. Interpretation
  204. 22Paragraph 22
  205. Schedule 3ZA: CIRCUMSTANCES IN WHICH OFFER OF COUNSELLING REQUIRED AS CONDITION OF LICENCE FOR TREATMENT
  206. Part 1: Kinds of treatment in relation to which counselling must be offered
  207. 1Paragraph 1
  208. 2Paragraph 2
  209. 3Paragraph 3
  210. Part 2: Events in connection with which counselling must be offered
  211. 4Paragraph 4
  212. 5Paragraph 5
  213. 6Paragraph 6
  214. 7Paragraph 7
  215. Schedule 3A: SUPPLEMENTARY LICENCE CONDITIONS: HUMAN APPLICATION
  216. A1Paragraph A1
  217. Modification of the definition of partner donation in the second Directive
  218. B1Paragraph B1
  219. Traceability system
  220. 1Paragraph 1
  221. 2Paragraph 2 Repealed
  222. Serious adverse events and serious adverse reactions : Great Britain
  223. 3Paragraph 3
  224. Serious adverse events and serious adverse reactions: Northern Ireland
  225. 3AParagraph 3A
  226. Third party agreements and termination of licensed activities
  227. 4Paragraph 4
  228. Requirements for procurement of gametes and embryos
  229. 5Paragraph 5
  230. Selection criteria and laboratory tests required for donors of reproductive cells
  231. 6Paragraph 6
  232. 7Paragraph 7
  233. 7AParagraph 7A
  234. 8Paragraph 8
  235. Donation and procurement procedures and reception at the tissue establishment
  236. 9Paragraph 9
  237. Requirements for holding a licence under paragraph 1, 1A or 2 of Schedule 2
  238. 10Paragraph 10
  239. Requirements for holding a licence for gametes and embryo preparation processes
  240. 11Paragraph 11
  241. Modifications to the first, second and third Directives
  242. 11AParagraph 11A
  243. 11BParagraph 11B
  244. 11CParagraph 11C
  245. Interpretation of this Schedule
  246. 12Paragraph 12
  247. Schedule 3AA: Requirements where gametes or embryos imported from third country
  248. A1Paragraph A1
  249. Directions
  250. 1Paragraph 1
  251. 2Paragraph 2
  252. 3Paragraph 3
  253. Modifications to the fourth Directive
  254. 3AParagraph 3A
  255. Interpretation of this Schedule
  256. 4Paragraph 4
  257. Schedule 3B: Inspection, entry, search and seizure
  258. Inspection of statutory records
  259. 1Paragraph 1
  260. Inspection of documents held by an importing licensee
  261. 1AParagraph 1A
  262. Arranging inspections
  263. 2Paragraph 2
  264. Entry and inspection of premises
  265. 3Paragraph 3
  266. 4Paragraph 4
  267. 4AParagraph 4A
  268. Entry and search in connection with suspected offence
  269. 5Paragraph 5
  270. Execution of warrants
  271. 6Paragraph 6
  272. Seizure in the course of inspection or search
  273. 7Paragraph 7
  274. Supplementary provision
  275. 8Paragraph 8
  276. 9Paragraph 9
  277. Enforcement
  278. 10Paragraph 10
  279. Interpretation
  280. 11Paragraph 11
  281. Schedule 4: Minor and Consequential Amendments
  282. Family Law Reform Act 1969 (c. 46. )
  283. 1Paragraph 1
  284. Social Security Act 1975 (c. 14. )
  285. 2Paragraph 2 Repealed
  286. Social Security (Northern Ireland) Act 1975 (c. 15. )
  287. 3Paragraph 3 Repealed
  288. Adoption Act 1976 (c. 36. )
  289. 4Paragraph 4 Repealed
  290. Family Law Reform (Northern Ireland) Order 1977 (S. I. 1977/1250 (N. I. 17))
  291. 5Paragraph 5
  292. Adoption (Scotland) Act 1978 (c. 28. )
  293. 6Paragraph 6 Repealed
  294. Adoption (Northern Ireland) Order 1987 (S. I. 1987/2203 (N. I. 22))
  295. 7Paragraph 7
  296. Human Organ Transplants Act 1989 (c. 31. )
  297. 8Paragraph 8 Repealed
  298. Human Organ Transplants (Northern Ireland) Order 1989 (S.I. 1989/2408 (N.I. 21)
  299. 9Paragraph 9 Repealed