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The Legal Framework of New Zealand Concerning Germline Interventions

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Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn

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Zusammenfassung

New Zealand’s legal system uses statute law and regulatory bodies to regulate genome editing techniques applied to germline cells. This paper will set out the regulation of germline editing techniques in New Zealand. Based on this analysis, this paper will then point to existing legal problems and questions in relation to germline interventions before proposing solutions and approaches to these problems. Ultimately, the use of new genome editing technologies such as clustered regularly interspaced short palindromic repeat (CRISPR) and the enzyme Cas9 (together, CRISPR and Cas9) has vast potential consequences given that unintended heritable changes could be passed from generation to generation. New Zealand’s legal framework provides for decision-makers to regulate germline interventions, yet significant gaps in law and outdated advice given by relevant advisory bodies mean that New Zealand’s legal framework inadequately addresses the significant and pressing implications of germline interventions in modern science. This paper reflects New Zealand’s legal position as at 30 April 2017.

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Notes

  1. 1.

    Conklin, B. as cited in Ledford (2015), 20.

  2. 2.

    Baltimore et al. (2015), 36–38.

  3. 3.

    Advisory Committee on Assisted Reproductive Technology “Use of Gametes and Embryos in Human Reproductive Research: Determining Policy for New Zealand: A Discussion Paper” Wellington: Advisory Committee on Assisted Reproductive Technology at 43.

  4. 4.

    Pagon et al. (1993).

  5. 5.

    Human Assisted Reproductive Technology Act 2004, s 5.

  6. 6.

    Human Assisted Reproductive Technology Act 2004, s 5.

  7. 7.

    Advisory Committee on Assisted Reproductive Technology (2006), at 45.

  8. 8.

    Araki and Ishii (2014), 108.

  9. 9.

    Ledford (2016), 156.

  10. 10.

    Mans et al. (2015).

  11. 11.

    Ledford (2015), 20.

  12. 12.

    Lappe (1991), 621–639.

  13. 13.

    Liang et al. (2015), 363–372.

  14. 14.

    Cyranoski and Reardon (2015).

  15. 15.

    Lanphier and Urnov (2015), 410.

  16. 16.

    Human Assisted Reproductive Technology Order 2005, sch 1, pt 1.

  17. 17.

    Human Assisted Reproductive Technology Order 2005, sch 1, pt 1.

  18. 18.

    Human Assisted Reproductive Technology Order 2005, sch 1, pt 2, s 6.

  19. 19.

    Human Assisted Reproductive Technology Act 2004, s 16.

  20. 20.

    Bill of Rights 1688 (Imp).

  21. 21.

    Imperial Laws Application Act 1988, sch 1.

  22. 22.

    Fitzgerald v Muldoon and Others [1976] 2 NZLR 615.

  23. 23.

    Pora v R (New Zealand) [2015] UKPC 9.

  24. 24.

    New Zealand Māori Council v Attorney-General [1987] 1 NZLR 641.

  25. 25.

    Human Assisted Reproductive Technology Act 2004, s 4(f); Hazardous Substances and New Organisms Act 1966, s 8.

  26. 26.

    Tavita v Minister of Immigration [1994] 2 NZLR 257 (CA).

  27. 27.

    Interpretation Act 1999, s 5.

  28. 28.

    Jones (2014), 75.

  29. 29.

    Human Assisted Reproductive Technology Act 2004, s 3(a).

  30. 30.

    Human Assisted Reproductive Technology Act 2004, s 3(a).

  31. 31.

    Human Assisted Reproductive Technology Act 2004, s 3(b).

  32. 32.

    Human Assisted Reproductive Technology Act 2004, s 3(e).

  33. 33.

    Human Assisted Reproductive Technology Act 2004, s 3(d).

  34. 34.

    Human Assisted Reproductive Technology Act 2004, s 3(f).

  35. 35.

    Human Assisted Reproductive Technology Act 2004, s 4.

  36. 36.

    Human Assisted Reproductive Technology Act 2004, s 4(a).

  37. 37.

    Human Assisted Reproductive Technology Act 2004, s 4(b).

  38. 38.

    Human Assisted Reproductive Technology Act 2004, s 4(d).

  39. 39.

    Human Assisted Reproductive Technology Act 2004, s 4(f).

  40. 40.

    Human Assisted Reproductive Technology Act 2004, s 4(g).

  41. 41.

    Human Assisted Reproductive Technology Act 2004, s 5.

  42. 42.

    Human Assisted Reproductive Technology Act 2004, s 8(1).

  43. 43.

    Human Assisted Reproductive Technology Act 2004, s 8(2).

  44. 44.

    Human Assisted Reproductive Technology Act 2004, s 8(3).

  45. 45.

    Human Assisted Reproductive Technology Act 2004, s 8(4).

  46. 46.

    Human Assisted Reproductive Technology Act 2004, s 10(1).

  47. 47.

    Human Assisted Reproductive Technology Act 2004, s 10(2).

  48. 48.

    Human Assisted Reproductive Technology Act 2004, s 10(3).

  49. 49.

    Human Assisted Reproductive Technology Act 2004, s 10A.

  50. 50.

    Human Assisted Reproductive Technology Act 2004, Schedule 1, 2.

  51. 51.

    Human Assisted Reproductive Technology Act 2004, Schedule 1.

  52. 52.

    Human Assisted Reproductive Technology Act 2004, s 12(1).

  53. 53.

    Human Assisted Reproductive Technology Act 2004, s 13.

  54. 54.

    Human Assisted Reproductive Technology Act 2004, s 9(3).

  55. 55.

    Human Assisted Reproductive Technology Act 2004, s 16.

  56. 56.

    Human Assisted Reproductive Technology Act 2004, s 18.

  57. 57.

    Human Assisted Reproductive Technology Act 2004, s 19.

  58. 58.

    Human Assisted Reproductive Technology Act 2004, s 24.

  59. 59.

    Human Assisted Reproductive Technology Act 2004, s 24(1).

  60. 60.

    Human Assisted Reproductive Technology Act 2004, s 6.

  61. 61.

    Human Assisted Reproductive Technology Act 2004, s 6(1).

  62. 62.

    Human Assisted Reproductive Technology Act 2004, s 6(2)(a).

  63. 63.

    Human Assisted Reproductive Technology Act 2004, s 6(2)(b).

  64. 64.

    Human Assisted Reproductive Technology Act 2004, s 6(2)(c).

  65. 65.

    Human Assisted Reproductive Technology Act 2004, s 6(2)(d).

  66. 66.

    Human Assisted Reproductive Technology Act 2004, s 6(2)(e).

  67. 67.

    Human Assisted Reproductive Technology Act 2004, s 28(1)(aa).

  68. 68.

    Human Assisted Reproductive Technology Act 2004, s 28(1)(a).

  69. 69.

    Human Assisted Reproductive Technology Act 2004, s 28(1)(b).

  70. 70.

    Human Assisted Reproductive Technology Act 2004, s 28(1)(c).

  71. 71.

    Human Assisted Reproductive Technology Act 2004, s 29.

  72. 72.

    Human Assisted Reproductive Technology Act 2004, s 30.

  73. 73.

    Advisory Committee on Assisted Reproductive Technology (11 June 2017).

  74. 74.

    Human Assisted Reproductive Technology Act 2004, s 33.

  75. 75.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(a).

  76. 76.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(b).

  77. 77.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(c).

  78. 78.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(d).

  79. 79.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(e).

  80. 80.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(f).

  81. 81.

    Human Assisted Reproductive Technology Act 2004, s 34(4)(g).

  82. 82.

    Human Assisted Reproductive Technology Act 2004, s 35(1)(b).

  83. 83.

    Human Assisted Reproductive Technology Act 2004, s 35(1)(aa), (a) and (c).

  84. 84.

    Human Assisted Reproductive Technology Act 2004, s 35(1)(c).

  85. 85.

    Human Assisted Reproductive Technology Act 2004, s 35(1)(e).

  86. 86.

    Human Assisted Reproductive Technology Act 2004, s 35(1)(c).

  87. 87.

    Human Assisted Reproductive Technology Act 2004, s 36(2)(a).

  88. 88.

    Human Assisted Reproductive Technology Act 2004, s 36(2)(b) and (c).

  89. 89.

    Human Assisted Reproductive Technology Act 2004, s 39.

  90. 90.

    Human Assisted Reproductive Technology Act 2004, s 39(2)(a) and (b).

  91. 91.

    Human Assisted Reproductive Technology Act 2004, s 41(1)(a).

  92. 92.

    Human Assisted Reproductive Technology Act 2004, s 40.

  93. 93.

    Advisory Committee on Assisted Reproductive Technology (2006), 1.

  94. 94.

    Advisory Committee on Assisted Reproductive Technology (2006), 40.

  95. 95.

    Advisory Committee on Assisted Reproductive Technology (2006), 16.

  96. 96.

    Advisory Committee on Assisted Reproductive Technology (2006), 16.

  97. 97.

    Advisory Committee on Assisted Reproductive Technology (2006), at 16.

  98. 98.

    Advisory Committee on Assisted Reproductive Technology (2006), at 16.

  99. 99.

    Advisory Committee on Assisted Reproductive Technology (20 December 2013).

  100. 100.

    See Advisory Committee on Assisted Reproductive Technology (2013, 2016).

  101. 101.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 3.

  102. 102.

    Hazardous Substances and New Organisms Act 1966, s 4.

  103. 103.

    Environmental Protection Authority Act 2011, s 7 and 8.

  104. 104.

    Hazardous Substances and New Organisms Act 1966, s 2.

  105. 105.

    Hazardous Substances and New Organisms Act 1966, s 2A(1)(d).

  106. 106.

    Hazardous Substances and New Organisms Act 1966, s 6(c).

  107. 107.

    Hazardous Substances and New Organisms Act 1966, s 6(d).

  108. 108.

    Hazardous Substances and New Organisms Act 1966, s 6(e).

  109. 109.

    Hazardous Substances and New Organisms Act 1966, s 6(f).

  110. 110.

    Hazardous Substances and New Organisms Act 1966, s 7.

  111. 111.

    Health and Disability Commissioner (2006), at 2.

  112. 112.

    Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996, sch 1, right 4(1).

  113. 113.

    Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996, sch 1, right 6.

  114. 114.

    Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996, sch 1, right 7.

  115. 115.

    Ministry of Health “Operational Standards for Ethics Committees” (2002) Wellington, New Zealand at 5.

  116. 116.

    Ministry of Health (2014), at 2.

  117. 117.

    Medicines Act 1981, s 23A.

  118. 118.

    Contraception, Sterilisation, and Abortion Act 1977, s 46.

  119. 119.

    Health Practitioners Competence Assurance Act 2003, s 174.

  120. 120.

    Bill of Rights Act 1990, s 11.

  121. 121.

    See UNESCO International Bioethics Committee (1997); World Medical Association (2001), 373; Hildt (2016), 7.

  122. 122.

    Human Assisted Reproductive Technology Act 2004, s 2(2).

  123. 123.

    Advisory Committee on Assisted Reproductive Technology (2013), at 5.

  124. 124.

    See further the work of Jones G, for example Jones (2017), at 14.

  125. 125.

    Jones (2017), at 14.

  126. 126.

    Ran et al. (2013), 1380–1389.

  127. 127.

    Advisory Committee on Assisted Reproductive Technology (2016), at 5.

  128. 128.

    National Academy of Sciences and National Academy of Medicine (2017), recommendation 5.1.

  129. 129.

    Committee on Social Affairs, Health, and Sustainable Development (25 April 2017).

  130. 130.

    Ledford (2015), 20.

  131. 131.

    Jones (2014), 81.

  132. 132.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 4.

  133. 133.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 4.

  134. 134.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 4.

  135. 135.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 10.

  136. 136.

    Interpretation Act 1999, s 5.

  137. 137.

    Jones (2014), 75.

  138. 138.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 11.

  139. 139.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 6.

  140. 140.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 11.

  141. 141.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 18.

  142. 142.

    Jones (2014), 75.

  143. 143.

    Jones (2014), 75.

  144. 144.

    Interpretation Act 1999, s 5.

  145. 145.

    Tipene-Matua (2006).

  146. 146.

    Advisory Committee on Assisted Reproductive Technology (2006), at 18.

  147. 147.

    Jones (2017), at 7.

  148. 148.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 17.

  149. 149.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 12.

  150. 150.

    Jones (2017), at 14.

  151. 151.

    Advisory Committee on Assisted Reproductive Technology (2006), at 40.

  152. 152.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 21.

  153. 153.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 21.

  154. 154.

    Jones (2017), at 13.

  155. 155.

    Liang et al. (2015), 363–372.

  156. 156.

    Jones (2017), at 15.

  157. 157.

    Advisory Committee on Assisted Reproductive Technology (30 March 2015), at 11.

  158. 158.

    See further Jones (2017), at 17.

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Author information

Authors and Affiliations

  1. Victoria University of Wellington, Auckland, New Zealand

    Angela Sargent

Authors
  1. Angela Sargent
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Corresponding author

Correspondence to Angela Sargent .

Editor information

Editors and Affiliations

  1. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Jochen Taupitz

  2. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Silvia Deuring

Annex

Annex

1.1 Schedule 1: Overview of the Regulation of Germline Interventions

Human Assisted Reproductive Technologies Act 2004

[…]

8 Prohibited actions

  1. (1)

    Every person commits an offence who takes an action described in Schedule 1.

  2. (2)

    Every person commits an offence who, knowing that an in vitro gamete, an in vitro embryo or an in vitro foetus, or an in vitro being has been formed by an action described in Schedule 1, imports into, or exports from, New Zealand that in vitro gamete, in vitro embryo, in vitro foetus, or in vitro being.

  3. (3)

    Every person commits an offence who, knowing that a gamete, an embryo or foetus, or a being has been formed by an action described in Schedule 1, possesses, without reasonable excuse, that gamete, embryo, foetus, or being.

  4. (4)

    A person who commits an offence against this section is liable on conviction to imprisonment for a term not exceeding 5 years or a fine not exceeding $200,000, or both.

[…]

11 Restrictions on sex selection of human embryos

  1. (1)

    No person may, for reproductive purposes, –

    1. (a)

      select an in vitro human embryo for implantation into a human being on the basis of the sex of the embryo; or

    2. (b)

      perform any procedure, or provide, prescribe, or administer any thing in order to ensure, or in order to increase the probability, that a human embryo will be of a particular sex.

  2. (2)

    Every person commits an offence who contravenes this section and is liable on conviction to imprisonment for a term not exceeding 1 year or a fine not exceeding $100,000, or both.

  3. (3)

    It is a defence to a charge of an offence against this section if the defendant proves that the act to which the charge relates was performed to prevent or treat a genetic disorder or disease.

[…]

16 Assisted reproductive procedures and human reproductive research only to proceed with prior approval

  1. (1)

    Every person commits an offence who performs an assisted reproductive procedure or conducts human reproductive research without the prior approval in writing of the ethics committee.

  2. (2)

    Every person who commits an offence against subsection (1) is liable on conviction to a fine not exceeding $50,000.

[…]

Schedule 1

Prohibited actions

  1. 1

    Artificially form, for reproductive purposes, a cloned embryo. For the purposes of this item, a cloned embryo is not formed by splitting, on 1 or more occasions, an embryo that has been formed by the fusion of gametes.

  2. 2

    Artificially form, for reproductive purposes, a hybrid embryo.

  3. 3

    Implant into a human being a cloned embryo.

  4. 4

    Implant into a human being an animal gamete or embryo.

  5. 5

    Implant into a human being a hybrid embryo.

  6. 6

    Implant into an animal a human gamete or human embryo.

  7. 7

    Implant into an animal a hybrid embryo.

  8. 8

    Implant into a human being a genetically modified gamete, human embryo, or hybrid embryo.

  9. 9

    Implant into a human being gametes derived from a foetus, or an embryo that has been formed from a gamete or gametes derived from a foetus.

Human Assisted Reproductive Technology Order 2005

Schedule: Established Procedures: Part 1, Descriptions of established procedures

Artificial insemination

A procedure in which sperm is artificially introduced into a woman’s body and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of sperm:

  2. (b)

    preparation of sperm:

  3. (c)

    placing prepared sperm into the cervix, uterus, or Fallopian tubes:

  4. (d)

    alteration of hormonal control of the ovaries and uterus using drugs:

  5. (e)

    stimulation of multiple follicle development using drugs:

  6. (f)

    triggering ovulation using drugs.

Assisted hatching

A procedure that involves thinning or making a hole in the zona pellucida of an embryo by mechanical, chemical, or laser means.

Blastocyst culture

A procedure in which the culture of an embryo or embryos outside the body is prolonged so that embryos might reach the stage of blastocyst.

Collection of eggs for purposes of donation

A procedure in which eggs are collected for the purposes of donation and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    recruitment of an egg donor, either by the clinic or the egg recipient:

  2. (b)

    alteration of hormonal control of the ovaries and uterus using drugs:

  3. (c)

    stimulation of multiple follicle development using drugs:

  4. (d)

    triggering ovulation using drugs:

  5. (e)

    the egg donor undertaking procedures that may be undertaken for, or in connection with, in vitro fertilisation up to and including egg collection:

  6. (f)

    discarding of eggs.

Collection of sperm for purposes of donation

A procedure that involves either or both of the following:

  1. (a)

    recruitment of a sperm donor, either by the clinic or the sperm recipient:

  2. (b)

    collection and preparation of sperm.

Egg cryopreservation

A procedure in which eggs are maintained as potentially viable over a period of time by freezing them and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of eggs:

  2. (b)

    in vitro culture of eggs:

  3. (c)

    preparation of eggs for freezing:

  4. (d)

    freezing of eggs:

  5. (e)

    storage of eggs at low temperatures:

  6. (f)

    thawing of eggs:

  7. (g)

    alteration of hormonal control of the ovaries and uterus using drugs:

  8. (h)

    stimulation of multiple follicle development using drugs:

  9. (i)

    triggering ovulation using drugs:

  10. (j)

    discarding of eggs.

Embryo cryopreservation

A procedure in which embryos are maintained as potentially viable over a period of time by freezing them and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    preparation of embryos for freezing:

  2. (b)

    freezing of embryos:

  3. (c)

    storage of embryos at low temperatures:

  4. (d)

    thawing of embryos:

  5. (e)

    in vitro culture of embryos:

  6. (f)

    inspection and grading of embryos:

  7. (g)

    alteration of hormonal control of the ovaries and uterus using drugs:

  8. (h)

    stimulation of multiple follicle development using drugs:

  9. (i)

    triggering ovulation using drugs:

  10. (j)

    embryo transfer into the uterus or Fallopian tubes:

  11. (k)

    discarding of embryos.

Gamete intrafallopian transfer (GIFT)

A procedure in which eggs are combined with sperm outside the body and transferred into the Fallopian tubes of a woman and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of eggs:

  2. (b)

    preparation of sperm:

  3. (c)

    in vitro culture of eggs:

  4. (d)

    transfer of sperm and eggs into the Fallopian tubes:

  5. (e)

    any other steps of in vitro fertilisation using sperm and eggs not transferred to the Fallopian tubes.

Intracytoplasmic sperm injection (ICSI)

A procedure that may involve collection and preparation of sperm in which sperm is injected into an egg outside the body.

In vitro fertilisation (IVF)

A procedure in which the eggs of a woman are combined with the sperm of a man outside the body and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of eggs:

  2. (b)

    collection and preparation of sperm:

  3. (c)

    in vitro culture of eggs:

  4. (d)

    in vitro culture of sperm:

  5. (e)

    addition of sperm to eggs:

  6. (f)

    in vitro culture of embryos:

  7. (g)

    inspection and grading of embryos:

  8. (h)

    embryo transfer into the uterus or Fallopian tubes:

  9. (i)

    alteration of hormonal control of the ovaries and uterus using drugs:

  10. (j)

    stimulation of multiple follicle development using drugs:

  11. (k)

    triggering ovulation using drugs:

  12. (l)

    discarding of eggs and embryos.

Ovarian tissue cryopreservation

A procedure in which ovarian tissue is collected and maintained as potentially viable over a period of time by freezing it and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of ovarian tissue:

  2. (b)

    preparation of the ovarian tissue for freezing:

  3. (c)

    freezing of ovarian tissue:

  4. (d)

    storage of ovarian tissue at low temperatures:

  5. (e)

    thawing of ovarian tissue:

  6. (f)

    discarding of ovarian tissue.

Pre-implantation genetic diagnosis (PGD)

A procedure for genetically testing embryos for specific genetic conditions or chromosomal abnormalities prior to embryo transfer and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    biopsy of embryos to remove 1 or more cells:

  2. (b)

    transportation of the cells to an approved laboratory:

  3. (c)

    analysis of the genetic or chromosomal constitution of cells obtained by biopsy:

  4. (d)

    selection of embryos for transfer on the basis of the results from analysis.

Sperm cryopreservation

A procedure in which sperm are maintained as potentially viable over a period of time by freezing them and that includes any of the following undertaken for, or in connection with, that procedure:

  1. (a)

    collection of sperm:

  2. (b)

    freezing of sperm:

  3. (c)

    storage of sperm at low temperatures:

  4. (d)

    thawing of sperm:

  5. (e)

    discarding of stored sperm.

Part 2: Provisions applicable to procedures generally

1 Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of donated eggs or donated sperm, and –

  1. (a)

    the donor is a family member of the patient; or

  2. (b)

    the donated eggs or donated sperm are used in conjunction with any other donated gametes.

Schedule clause 1: substituted, on 10 July 2009, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2009 (SR 2009/195).

2 For the purpose of clause 1(a), a donation of eggs or sperm is not regarded as being a donation made by a family member if, –

  1. (a)

    in the case of donated eggs, the donor is a sister or cousin of the patient:

  2. (b)

    in the case of donated sperm, the donor is a brother or cousin of the patient’s spouse or partner:

  3. (c)

    in the case of a procedure that involves the use of eggs donated by the patient’s partner and also involves donated sperm, the donor of the sperm is a brother or cousin of the patient.

Schedule clause 2: substituted, on 10 July 2009, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2009 (SR 2009/195).

2A Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of donated eggs or donated sperm, and –

  1. (a)

    the donor is a family member of the patient; and

  2. (b)

    at the time of the donation, the donor or the patient is under 20.

Schedule clause 2A: inserted, on 10 July 2009, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2009 (SR 2009/195).

3 Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of ovarian tissue that has previously undergone cryopreservation.

Schedule clause 3: amended, on 10 July 2009, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2009 (SR 2009/195).

[…]

5 Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of sperm that was collected from a person, who has since died, who did not give consent to the specific use of the sperm before that person’s death.

6 Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of pre-implantation genetic diagnosis for purposes other than the prevention or treatment of a genetic disorder or disease by –

  1. (a)

    diagnosis of familial single-gene disorders where –

    1. (i)

      the disorder has been identified in the family or whānau; and

    2. (ii)

      there is a 25% or greater risk of an affected pregnancy; and

    3. (iii)

      there is evidence that the future individual may be seriously impaired as a result of the disorder; or

  2. (b)

    sex determination where –

    1. (i)

      a familial sex-linked disorder has been identified in the family or whānau; and

    2. (ii)

      there is a 25% or greater risk of an affected pregnancy; and

    3. (iii)

      no specific test for the particular mutation that causes the disorder is available; and

    4. (iv)

      there is evidence that the future individual may be seriously impaired as a result of the disorder; or

  3. (c)

    diagnosis of familial chromosomal disorders where –

    1. (i)

      the disorder has been identified in the family or whānau; and

    2. (ii)

      there is a 25% or greater risk of an affected pregnancy; and

    3. (iii)

      there is evidence that the future individual may be seriously impaired as a result of the disorder; or

  4. (d)

    diagnosis of non-familial chromosomal disorders (aneuploidy testing) where –

    1. (i)

      the woman is of advanced reproductive age; or

    2. (ii)

      the woman has had recurrent implantation failure or recurrent miscarriage.

7 Despite the descriptions of established procedures in Part 1, a procedure is not an established procedure if it involves the use of eggs collected from a person who is dead when the eggs are collected or who dies before the procedure is carried out.

Schedule clause 7: added, on 10 July 2009, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2009 (SR 2009/195).

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Sargent, A. (2020). The Legal Framework of New Zealand Concerning Germline Interventions. In: Taupitz, J., Deuring, S. (eds) Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn . Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, vol 47. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-59028-7_11

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