Human Assisted Reproductive Technology Order 2005

Reprint
as at 25 March 2011

Coat of Arms of New Zealand

Human Assisted Reproductive Technology Order 2005

(SR 2005/181)

Silvia Cartwright, Governor-General

Order in Council

At Wellington this 27th day of June 2005

Present:
Her Excellency the Governor-General in Council


Note

Changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in this reprint.

A general outline of these changes is set out in the notes at the end of this reprint, together with other explanatory material about this reprint.

This order is administered by the Ministry of Health.


Pursuant to section 6 of the Human Assisted Reproductive Technology Act 2004, Her Excellency the Governor-General, acting on the advice and with the consent of the Executive Council, makes the following order.

Order

1 Title
  • This order is the Human Assisted Reproductive Technology Order 2005.

2 Commencement
  • This order comes into force on 22 August 2005.

3 Interpretation
  • In this order, unless the context otherwise requires,—

    brother, in relation to a person, means a brother of full-blood or half-blood, a stepbrother, or a brother by adoption

    cousin, in relation to a person, means a cousin of any degree

    donated eggs

    • (a) means eggs that are donated for reproductive purposes; but

    • (b) does not include eggs contributed by the spouse or partner of the patient

    donated sperm

    • (a) means sperm that is donated for reproductive purposes; but

    • (b) does not include sperm contributed by the spouse or partner of the patient

    family member, in relation to a person, means—

    • (a) any other person who is or has been related to the person by blood, marriage, civil union, de facto relationship, or adoption:

    • (b) any other person who is a member of the person’s whānau or other culturally recognised family group

    partner, in relation to a person, means—

    • (a) the person’s civil union partner; or

    • (b) the person’s de facto partner

    patient, in relation to donated eggs or donated sperm, means the person who is the subject of the procedure in which the eggs or sperm are used

    sister, in relation to a person, means a sister of full-blood or half-blood, a stepsister, or a sister by adoption.

4 Purpose
  • The purpose of this order is—

    • (a) to declare certain medical procedures to be established procedures under section 6 of the Act for the purposes of the definition of assisted reproductive procedure in section 5 of the Act; and

    • (b) in so doing, to specify those medical procedures that do not require the approval of the ethics committee under the Act.

5 Established procedures
  • Each medical procedure described in the Schedule is an established procedure.


Schedule
Established procedures

cl 5

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:

  • (a) collection of sperm:

  • (b) preparation of sperm:

  • (c) placing prepared sperm into the cervix, uterus, or Fallopian tubes:

  • (d) alteration of hormonal control of the ovaries and uterus using drugs:

  • (e) stimulation of multiple follicle development using drugs:

  • (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:

  • (a) recruitment of an egg donor, either by the clinic or the egg recipient:

  • (b) alteration of hormonal control of the ovaries and uterus using drugs:

  • (c) stimulation of multiple follicle development using drugs:

  • (d) triggering ovulation using drugs:

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

  • (f) discarding of eggs.

Collection of sperm for purposes of donation

A procedure that involves either or both of the following:

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

  • (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:

  • (a) collection of eggs:

  • (b) in vitro culture of eggs:

  • (c) preparation of eggs for freezing:

  • (d) freezing of eggs:

  • (e) storage of eggs at low temperatures:

  • (f) thawing of eggs:

  • (g) alteration of hormonal control of the ovaries and uterus using drugs:

  • (h) stimulation of multiple follicle development using drugs:

  • (i) triggering ovulation using drugs:

  • (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:

  • (a) preparation of embryos for freezing:

  • (b) freezing of embryos:

  • (c) storage of embryos at low temperatures:

  • (d) thawing of embryos:

  • (e) in vitro culture of embryos:

  • (f) inspection and grading of embryos:

  • (g) alteration of hormonal control of the ovaries and uterus using drugs:

  • (h) stimulation of multiple follicle development using drugs:

  • (i) triggering ovulation using drugs:

  • (j) embryo transfer into the uterus or Fallopian tubes:

  • (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:

  • (a) collection of eggs:

  • (b) preparation of sperm:

  • (c) in vitro culture of eggs:

  • (d) transfer of sperm and eggs into the Fallopian tubes:

  • (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:

  • (a) collection of eggs:

  • (b) collection and preparation of sperm:

  • (c) in vitro culture of eggs:

  • (d) in vitro culture of sperm:

  • (e) addition of sperm to eggs:

  • (f) in vitro culture of embryos:

  • (g) inspection and grading of embryos:

  • (h) embryo transfer into the uterus or Fallopian tubes:

  • (i) alteration of hormonal control of the ovaries and uterus using drugs:

  • (j) stimulation of multiple follicle development using drugs:

  • (k) triggering ovulation using drugs:

  • (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:

  • (a) collection of ovarian tissue:

  • (b) preparation of the ovarian tissue for freezing:

  • (c) freezing of ovarian tissue:

  • (d) storage of ovarian tissue at low temperatures:

  • (e) thawing of ovarian tissue:

  • (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:

  • (a) biopsy of embryos to remove 1 or more cells:

  • (b) transportation of the cells to an approved laboratory:

  • (c) analysis of the genetic or chromosomal constitution of cells obtained by biopsy:

  • (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:

  • (a) collection of sperm:

  • (b) freezing of sperm:

  • (c) storage of sperm at low temperatures:

  • (d) thawing of sperm:

  • (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—

    • (a) the donor is a family member of the patient; or

    • (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,—

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

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

    • (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—

    • (a) the donor is a family member of the patient; and

    • (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).

4
  • [Revoked]

    Schedule clause 4: revoked, on 25 March 2011, by clause 4 of the Human Assisted Reproductive Technology Amendment Order 2011 (SR 2011/53).

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—

    • (a) diagnosis of familial single-gene disorders where—

      • (i) the disorder has been identified in the family or whānau; and

      • (ii) there is a 25% or greater risk of an affected pregnancy; and

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

    • (b) sex determination where—

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

      • (ii) there is a 25% or greater risk of an affected pregnancy; and

      • (iii) no specific test for the particular mutation that causes the disorder is available; and

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

    • (c) diagnosis of familial chromosomal disorders where—

      • (i) the disorder has been identified in the family or whānau; and

      • (ii) there is a 25% or greater risk of an affected pregnancy; and

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

    • (d) diagnosis of non-familial chromosomal disorders (aneuploidy testing) where—

      • (i) the woman is of advanced reproductive age; or

      • (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).

Diane Morcom,
Clerk of the Executive Council.


Issued under the authority of the Acts and Regulations Publication Act 1989.

Date of notification in Gazette: 30 June 2005.


Contents

  • 1General

  • 2Status of reprints

  • 3How reprints are prepared

  • 4Changes made under section 17C of the Acts and Regulations Publication Act 1989

  • 5List of amendments incorporated in this reprint (most recent first)


Notes
1 General
  • This is a reprint of the Human Assisted Reproductive Technology Order 2005. The reprint incorporates all the amendments to the order as at 25 March 2011, as specified in the list of amendments at the end of these notes.

    Relevant provisions of any amending enactments that contain transitional, savings, or application provisions that cannot be compiled in the reprint are also included, after the principal enactment, in chronological order. For more information, see http://www.pco.parliament.govt.nz/reprints/ .

2 Status of reprints
  • Under section 16D of the Acts and Regulations Publication Act 1989, reprints are presumed to correctly state, as at the date of the reprint, the law enacted by the principal enactment and by the amendments to that enactment. This presumption applies even though editorial changes authorised by section 17C of the Acts and Regulations Publication Act 1989 have been made in the reprint.

    This presumption may be rebutted by producing the official volumes of statutes or statutory regulations in which the principal enactment and its amendments are contained.

3 How reprints are prepared
  • A number of editorial conventions are followed in the preparation of reprints. For example, the enacting words are not included in Acts, and provisions that are repealed or revoked are omitted. For a detailed list of the editorial conventions, see http://www.pco.parliament.govt.nz/editorial-conventions/ or Part 8 of the Tables of New Zealand Acts and Ordinances and Statutory Regulations and Deemed Regulations in Force.

4 Changes made under section 17C of the Acts and Regulations Publication Act 1989
  • Section 17C of the Acts and Regulations Publication Act 1989 authorises the making of editorial changes in a reprint as set out in sections 17D and 17E of that Act so that, to the extent permitted, the format and style of the reprinted enactment is consistent with current legislative drafting practice. Changes that would alter the effect of the legislation are not permitted.

    A new format of legislation was introduced on 1 January 2000. Changes to legislative drafting style have also been made since 1997, and are ongoing. To the extent permitted by section 17C of the Acts and Regulations Publication Act 1989, all legislation reprinted after 1 January 2000 is in the new format for legislation and reflects current drafting practice at the time of the reprint.

    In outline, the editorial changes made in reprints under the authority of section 17C of the Acts and Regulations Publication Act 1989 are set out below, and they have been applied, where relevant, in the preparation of this reprint:

    • omission of unnecessary referential words (such as of this section and of this Act)

    • typeface and type size (Times Roman, generally in 11.5 point)

    • layout of provisions, including:

      • indentation

      • position of section headings (eg, the number and heading now appear above the section)

    • format of definitions (eg, the defined term now appears in bold type, without quotation marks)

    • format of dates (eg, a date formerly expressed as the 1st day of January 1999 is now expressed as 1 January 1999)

    • position of the date of assent (it now appears on the front page of each Act)

    • punctuation (eg, colons are not used after definitions)

    • Parts numbered with roman numerals are replaced with arabic numerals, and all cross-references are changed accordingly

    • case and appearance of letters and words, including:

      • format of headings (eg, headings where each word formerly appeared with an initial capital letter followed by small capital letters are amended so that the heading appears in bold, with only the first word (and any proper nouns) appearing with an initial capital letter)

      • small capital letters in section and subsection references are now capital letters

    • schedules are renumbered (eg, Schedule 1 replaces First Schedule), and all cross-references are changed accordingly

    • running heads (the information that appears at the top of each page)

    • format of two-column schedules of consequential amendments, and schedules of repeals (eg, they are rearranged into alphabetical order, rather than chronological).

5 List of amendments incorporated in this reprint (most recent first)