Health Legislation (Research Involving Human Embryos and Prohibition of Human Cloning) Act 2003 (Vic)
Health Legislation (Research Involving Human
Embryos and Prohibition of Human Cloning) Act
2003
Act No. 11/2003
TABLE OF PROVISIONS
Section Page PART 1—PRELIMINARY 1
1. Purpose 1 2. Commencement 2 3. Principal Act 2 4. Purposes of Principal Act 2 5. Definitions and interpretation 3 6. New section 5A inserted 6
5A. Act to bind the Crown 6
PART 2—EXCESS EMBRYOS 7
7. New Part 2A inserted 7 PART 2A—REGULATION OF CERTAIN USES INVOLVING EXCESS ART EMBRYOS 7 Division 1—Interpretation 7
21A. Definitions 7 21B. Meaning of excess ART embryo 9
Division 2—Offences 10
21C. Offence—use of excess ART embryo 10 21D. Offence—use of embryo that is not an excess ART embryo 12 21E. Offence—breaching a licence condition 12 Division 3—Embryo Research Licensing Committee of the
NHMRC 13
21F. Functions of Committee 13 21G. Powers of Committee 13
i
Section Page
Division 4—Licensing System 13
21H. Person may apply for licence 13 21I. Determination of application by Committee 14 21J. Notification of decision 15 21K. Period of licence 16 21L. Licence is subject to conditions 16 21M. Variation of licence 18 21N. Suspension or revocation of licence 18 21O. Surrender of licence 19 21P. Notification of variation, suspension or revocation of licence 19
Division 5—Reporting and Confidentiality 19 21Q. NHMRC Licensing Committee to make certain
information publicly available 19 21R. Confidential commercial information may only be
disclosed in certain circumstances 20 Division 6—Review provisions 23
21S. Meaning of terms 23 21T. Review of decisions 24
Division 7—Monitoring Powers 24 21U. Powers available to inspectors for monitoring
compliance 24 21V.
Monitoring powers 25 21W.
Power to secure 27 21X.
Inspector must produce identity card on request 27 21Y.
Consent 27 21Z.
Compensation for damage 28
8. New Division 5 inserted in Part 3 28 Division 5—Application of Part 28
35A. Meaning of "research" in this Part 28
PART 3—OFFENCES 30
9. New Part 4A inserted 30 PART 4A—PROHIBITED PRACTICES 30 Division 1—Human Cloning 30
38A. Offence—creating a human embryo clone 30 38B. Offence—placing a human embryo clone in the human body or the body of an animal 30 38C. Offence—importing or exporting a human embryo clone 30 38D. No defence that human embryo clone could not survive 31
ii
Section Page
Division 2—Other Prohibited Practices 31 38E. Offence—creating a human embryo other than by
fertilisation, or developing such an embryo 31 38F. Offence—creating a human embryo for a purpose other
than achieving pregnancy in a woman 31 38G.
Offence—creating or developing a human embryo containing genetic material provided by more than 2 persons
32
38H. Offence—developing a human embryo outside the body
of a woman for more than 14 days 32 38I.
Offence—using precursor cells from a human embryo or a human foetus to create a human embryo, or developing such an embryo
33
38J.
Offence—heritable alterations to genome 33 38K. Offence—collecting a viable human embryo from the
body of a woman 34 38L.
Offence—creating a chimeric or hybrid embryo 34 38M.
Offence—placing of an embryo 34 38N. Offence—importing, exporting or placing a prohibited
embryo 35 38O. Offence—commercial trading in human eggs, human
sperm or human embryos 36
10. Amendment of Part 5 38 11. New section 38P inserted 38
38P. Application of Division 38
12. New section 50A inserted 38
50A. Application of Division 38
PART 4—MISCELLANEOUS 39
13. Register to be kept for licensed centre 39 14. New section 104A inserted 39
104A. Application of Part 39
15. New section 110A inserted 39
110A. Formation of embryos 39
16. Infertility Treatment Authority 40 17. Search warrants 41 18. Indictable offences 41 19. Amendment of heading to Part 14 41 20. New Division 1 substituted in Part 14 41 Division 1—Review of Parts 2A and 4A 41
166. Review of operation of Parts 2A and 4A 41
iii
Section Page
21. New Division 3 inserted in Part 14 43 Division 3—Savings and Transitional Provisions (2003 Act) 43
200. Definition 43 201. Status of certain licences and approvals 43 202. Regulations 44 203. General transitional provision 44
22. Consequential amendments 44 23. Repeal of certain provisions 52 24. Consequential amendment of Gene Technology Act 2001 52 25. Consequential amendments of other Acts 52
═══════════════
ENDNOTES 54
iv
Victoria
No. 11 of 2003
Health Legislation (Research Involving
Human Embryos and Prohibition of
Human Cloning) Act 2003†
[Assented to 6 May 2003]
The Parliament of Victoria enacts as follows:
PART 1—PRELIMINARY
1. Purpose
The purpose of this Act is to amend the Infertility provision for—
(a)
the regulation of certain activities involving the use of human embryos; and
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 2 | Part 1—Preliminary |
(b)
the prohibition of human cloning and certain other practices associated with reproductive technology.
2. Commencement
This Act comes into operation on a day or days to be proclaimed.
3. Principal Act
See:
| Act No. | In this Act, the Infertility Treatment Act 1995 is |
| 63/1995. | called the Principal Act. |
| Reprint No. 1 as at 1 January | |
| 1998 and | |
| amending | |
| Act Nos 12/1998, 46/1998, 52/1998, 74/2000, 2/2001, 59/2001 and | |
| 11/2002. LawToday: dpc.vic. gov.au |
4. Purposes of Principal Act
In section 1 of the Principal Act—
(a) after paragraph (b) insert—
"(ba) to regulate certain activities involving the use of human embryos;
(bb) to prohibit human cloning and certain
other practices associated with
reproductive technology;";
(b) in paragraph (c) omit ", zygotes";
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 1—Preliminary s. 5
(c) after paragraph (f) insert—
"(fa) to confer functions on the Embryo
Research Licensing Committee of the National Health and Medical Research Council;".
5. Definitions and interpretation
(1) In section 3(1) of the Principal Act, insert the
following definitions—
' "animal" does not include a human;
"chimeric embryo" means—
(a) a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or (b) a thing declared by the regulations to be a chimeric embryo; "Commonwealth Act" means the Research
Involving Human Embryos Act 2002 of the
Commonwealth;
"Commonwealth authority" means the
following—
(a) a body corporate established for a public purpose by or under a Commonwealth Act; (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together—
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by either sub- paragraph (i) or (ii);
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 5 | Part 1—Preliminary |
"human embryo" means a live embryo that has a human genome or an altered human genome and that has been developing for less than
8 weeks since the appearance of 2 pro-nuclei
or the initiation of its development by other
means;
"human embryo clone" means a human embryo
that is a genetic copy of another living or
dead human, but does not include a human
embryo created by the fertilisation of a
human egg by human sperm;
"human sperm" includes human spermatids;
"hybrid embryo" means—
(a) an embryo created by the fertilisation of a human egg by animal sperm; or (b) an embryo created by the fertilisation of an animal egg by human sperm; or (c) a human egg into which the nucleus of an animal cell has been introduced; or (d) an animal egg into which the nucleus of a human cell has been introduced; or (e) a thing declared by the regulations to be a hybrid embryo;
"inspector" means a person appointed as an
inspector under section 33(1) of the
Commonwealth Act;
"NHMRC Licensing Committee" means the
Committee established by section 13 of the
Commonwealth Act;
"oocyte in the process of fertilisation" means an
oocyte at any stage of human development from the commencement of penetration of the oocyte by human sperm up to but not
including the appearance of 2 pro-nuclei;
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 1—Preliminary s. 5 "precursor cell" means a cell that has the
potential to develop into a human egg or
human sperm;
"the NHMRC" means the National Health and
Medical Research Council established by the
National Health and Medical Research
Council Act 1992 of the Commonwealth;
"woman" means a female human.'.
(2) In section 3(1) of the Principal Act—
(a) "embryo", "parthenogenesis",
the definitions of "clone", "donor zygote", "zygote" are repealed;
(b)
in the definition of "donor treatment procedure" omit "or a donor zygote";
(c)
in the definition of "fertilisation procedure", paragraph (a) is repealed;
(d)
in the definition of "oocyte", omit "but does not include a parthenogenetic oocyte";
(e) in the definition of "research"—
(i) at the end of paragraph (a) omit "and";
(ii) paragraph (b) is repealed;
(f)
in the definition of "store", omit "zygote," (where twice occurring).
(3) In section 3 of the Principal Act, after sub-section
(1) insert—
'(1A) For the purposes of establishing that a human embryo clone is a genetic copy of a living or dead human—
(a)
it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 6 | Part 1—Preliminary |
(b) it is not necessary to establish that the copy is an identical genetic copy. (1B) For the purposes of the definition of "human
embryo" in sub-section (1), in working out
the length of the period of development of a
human embryo, any period when the
development of the embryo is suspended is
to be disregarded.
(1C) For the purposes of the definition of "human embryo clone" in sub-section (1), a human embryo that results from the technological process known as embryo splitting is taken not to be created by a process of fertilisation
of a human egg by human sperm.
(1D) In this Act, a reference to an embryo is a reference to a human embryo, unless the contrary intention appears.'.
(4) In section 4(1) of the Principal Act—
(a)
in paragraph (f), for "a zygote or" substitute "an";
(b)
in paragraph (g), omit ", zygote" (where twice occurring).
6. New section 5A inserted
After section 5 of the Principal Act insert—
"5A. Act to bind the Crown
(1) This Act binds the Crown, not only in right
of the State of Victoria, but also, so far as the
legislative power of the Parliament permits,
the Crown in all its other capacities.
(2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.".
__________________
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7
PART 2—EXCESS EMBRYOS
7. New Part 2A inserted
After Part 2 of the Principal Act insert—
'PART 2A—REGULATION OF CERTAIN USES INVOLVING EXCESS ART EMBRYOS
Division 1—Interpretation
21A. Definitions
In this Part—
"accredited ART centre" means a person
or body accredited to carry out assisted
reproductive technology by—
(a) the Reproductive Technology
Accreditation Committee of the
Fertility Society of Australia; or(b) body or other bodies in addition
to, or instead of, the body
mentioned in paragraph (a)—thatif the regulations prescribe another bodies, as the case requires;
"AHEC" means the Australian Health
Ethics Committee established by the
National Health and Medical Research
Council Act 1992 of the
Commonwealth;
"confidential commercial information"
means information that has a
commercial or other value that would
be, or could reasonably be expected to
be, destroyed or diminished if the
information were disclosed;
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
"disclose", in relation to information, means give or communicate in any way;
"excess ART embryo" has the meaning given by section 21B;
"HREC" means a Human Research Ethics
Committee;
"licence" means a licence issued under
section 21I;
"proper consent", in relation to the use of an excess ART embryo, means—
(a) consent obtained in accordance with the Ethical Guidelines on Assisted Reproductive Technology (1996) issued by the
NHMRC; or(b) if other guidelines are issued by the NHMRC under the National Health and Medical Research Council Act 1992 of the
Commonwealth and prescribed by
the regulations under the
Commonwealth Act for the
purposes of paragraph (b) of the
definition of "proper consent" in
section 8 of that Act—consent
obtained in accordance with those
other guidelines, rather than the
guidelines mentioned in
paragraph (a);
"responsible person", in relation to an excess ART embryo, means—
(a)
each person who provided the egg or sperm from which the embryo was created; and
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 (b) the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and (c) a person mentioned in
any person who was the spouse of or sperm mentioned in that paragraph was provided; and
(d) the woman mentioned in
any person who was the spouse of embryo was created.
21B. Meaning of excess ART embryo
(1) In this Part—
"excess ART embryo" means a human
embryo that—
(a) was created, by assisted
reproductive technology, for use
in the assisted reproductive
technology treatment of a woman;
and(b) is excess to the needs of—
(i) the woman for whom it was created; and
(ii) her spouse (if any) at the time the embryo was created.
(2) For the purposes of paragraph (b) of the
definition of "excess ART embryo", a human embryo is excess to the needs of the persons mentioned in that paragraph at a particular
time if—
(a)
each such person has given written authority for use of the embryo for a purpose other than a purpose relating to
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
the assisted reproductive technology
treatment of the woman concerned, andthe authority is in force at that time; or
(b) each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
Division 2—Offences
21C. Offence—use of excess ART embryo
(1) A person commits an offence if the person intentionally uses an excess ART embryo, unless—
(a) the use by the person is authorised by a licence; or (b) the use by the person is an exempt use within the meaning of sub-section (3). (2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
5 years.
(3) A use of an excess ART embryo by a person
is an exempt use for the purposes of sub-
section (1) if—
(a) the use consists only of—
(i) storage of the excess ART embryo; or
(ii) removal of the excess ART embryo from storage; or
(iii) transport of the excess ART embryo; or
(b)
the use consists only of observation of the excess ART embryo; or
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7
(c)
the use consists only of allowing the excess ART embryo to succumb; or
(d)
the use is carried out by an accredited ART centre, and—
(i) suitable to be placed in the body
the excess ART embryo is not created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
(ii) investigations conducted in
connection with the assisted
reproductive technology treatment
of the woman for whom thethe use forms part of diagnostic or
(e)
the use is carried out by an accredited ART centre and is for the purposes of achieving pregnancy in a woman other
than the woman for whom the excess
ART embryo was created; or(f)
the use is of a kind prescribed by the regulations for the purposes of this paragraph.
(4) Despite section 130(1) of the Magistrates'
Court Act 1989, a defendant does not bear a burden of presenting or pointing to evidence in accordance with that section in relation to any matter in sub-section (1) or (3) of this
section.
(5) In sub-section (3)—
"diagnostic investigation", in relation to an
excess ART embryo, means any
procedure undertaken on embryos for
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
the sole purpose of diagnostic
investigations for the direct benefit ofthe woman for whom it was created;
"observation", in relation to an excess ART
embryo, includes taking a photograph of the embryo, or taking a recording of the embryo from which a visual image can be produced.
21D. Offence—use of embryo that is not an excess ART embryo
(1) A person commits an offence if—
(a) the person intentionally uses, outside the body of a woman, a human embryo that is not an excess ART embryo; and (b) the use is not for a purpose relating to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre, and the person knows or is reckless as to that fact. (2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
5 years.
21E. Offence—breaching a licence condition
(1) A person commits an offence if the person intentionally engages in conduct, knowing that the conduct contravenes a condition of a
licence that applies to the person, or reckless
as to whether the conduct contravenes a
condition of such a licence.(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
5 years.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 (3) In this section—
"engage in conduct" means—
(a) do an act; or
(b) omit to perform an act.
Division 3—Embryo Research Licensing Committee of the NHMRC
21F. Functions of Committee
The functions of the NHMRC Licensing
Committee under this Part are—
(a)
to perform functions in relation to licences under Division 4; and
(b)
to perform functions in relation to databases under Division 5; and
(c)
to perform such other functions as are conferred on it by this Part or any other law.
21G. Powers of Committee
The NHMRC Licensing Committee has power to do all things necessary or convenient to be done for or in connection with the performance of its functions under this Part.
Division 4—Licensing System
21H. Person may apply for licence
(1) A person may apply to the NHMRC
Licensing Committee for a licence
authorising use of excess ART embryos.
(2) An application under sub-section (1)—
(a)
must be made in accordance with the requirements (if any) specified in
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
writing by the NHMRC Licensing
Committee; and
(b)
must be accompanied by the fee (if any) prescribed by the regulations.
21I. Determination of application by Committee
(1) This section applies if a person has made an
application under section 21H for a licence.(2) The NHMRC Licensing Committee must
decide, in accordance with this section,
whether or not to issue the licence.
(3) The NHMRC Licensing Committee must not
issue the licence unless it is satisfied of the
following—
(a)
that appropriate protocols are in place—
(i) obtained before an excess ART
to enable proper consent to be and
(ii) to enable compliance with any restrictions on such consent;
(b) proposed in the application may
damage or destroy the embryo—that
appropriate protocols are in place to
enable compliance with the conditionif the use of an excess ART embryo respect of an embryo created before 5 April 2002;
(c)
that the activity or project proposed in the application has been assessed and approved by a HREC that is constituted
in accordance with, and acting in
compliance with, the NHMRC National
Statement on Ethical Conduct in
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 Research Involving Humans (1999), as
in force from time to time.(4) In deciding whether to issue the licence, the
NHMRC Licensing Committee must have
regard to the following—
(a) restricting the number of excess ART embryos to that likely to be necessary to achieve the goals of the activity or project proposed in the application; (b) knowledge or improvement in
the likelihood of significant advance in the use of excess ART embryos proposed in the application, which could not reasonably be achieved by other means;
(c) parts of guidelines, issued by the
NHMRC under the National Health and
Medical Research Council Act 1992 of
the Commonwealth and prescribed by
the regulations under theany relevant guidelines, or relevant section 21(4)(c) of that Act;
(d) the HREC assessment of the (3)(c);
(e)
such additional matters (if any) as are prescribed by the regulations.
21J. Notification of decision
(1) The NHMRC Licensing Committee must notify its decision on an application for a licence under section 21H to the following—
(a) the applicant;
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
(b) the HREC that assessed and approved the activity or project proposed in the application as mentioned in section 21I(3)(c);
(c) the Authority.
(2) If the NHMRC Licensing Committee decides
to issue the licence, it must, in addition to issuing the licence to the applicant, give a copy of the licence to the bodies mentioned
in sub-section (1)(b) and (c).
21K. Period of licence
(1) A licence—
(a) comes into force on the day specified in the licence, or if no day is specified, on the day on which it is issued; and (b) remains in force until the day specified in the licence, unless it is suspended, revoked or surrendered before that day. (2) A licence is not in force throughout any period of suspension.
21L. Licence is subject to conditions
(1) A licence is subject to the condition that before an excess ART embryo is used as authorised by the licence—
(a)
each responsible person in relation to the excess ART embryo must have given proper consent to that use; and
(b)
the licence holder must have reported in writing to the NHMRC Licensing Committee that such consent has been obtained, and any restrictions to which the consent is subject; and
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7
(c) if the licence authorises use of an excess ART embryo that may damage or destroy the embryo—the licence holder must have reported in writing to the NHMRC Licensing Committee that the embryo was created before 5 April 2002. (2) A licence is subject to the condition that the
use of an excess ART embryo must be in
accordance with any restrictions to which the
proper consent under sub-section (1) is
subject.
(3) If a licence authorises the use of an excess
ART embryo that may damage or destroy the
embryo, the licence is subject to the
condition that such use is authorised only in
respect of an embryo created before 5 April
2002.
(4) A licence is subject to such other conditions as are specified in the licence.
(5) The conditions specified in the licence may
include, but are not limited to, conditions
relating to the following—
(a)
the persons authorised by the licence to use excess ART embryos;
(b)
the number of excess ART embryos in respect of which use is authorised by the licence;
(c) reporting;
(d) monitoring;
(e)
information to be given by the licence holder to persons authorised by the licence to use excess ART embryos.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
(6) The licence conditions set out in sub-sections
(1), (2) and (3) apply to all persons who are authorised by the licence to use excess ART embryos.
(7) Licence conditions specified in the licence
apply to—
(a) the licence holder; and
(b)
such other persons authorised by the licence to use excess ART embryos as are specified in the licence.
21M. Variation of licence
(1) The NHMRC Licensing Committee may, by notice in writing given to the licence holder, vary a licence if the Committee believes on reasonable grounds that it is necessary or
desirable to do so.
(2) The NHMRC Licensing Committee may
vary a licence under sub-section (1) on its
own initiative or on application by the
licence holder.
(3) Without limiting sub-section (1), the
NHMRC Licensing Committee may vary the
licence by specifying additional conditions
or varying existing conditions.(4) The NHMRC Licensing Committee must not
vary a licence in such a way that, had a
person applied under section 21H for the
licence as varied, the Committee would not
have been permitted by this Part to issue the
licence.
21N. Suspension or revocation of licence
(1) The NHMRC Licensing Committee may, by
notice in writing given to the licence holder,
suspend or revoke a licence if the Committee
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 believes on reasonable grounds that a
condition of the licence has been breached.
(2) If a licence holder is convicted of an offence
Commonwealth Act or the Prohibition of
Human Cloning Act 2002 of theunder this Part or Part 4A or under the Committee must, by notice in writing given to the licence holder, revoke each licence held by the licence holder.
21O. Surrender of licence
A licence holder may surrender a licence by
written notice given to the NHMRC
Licensing Committee.
21P. Notification of variation, suspension or revocation of licence
(1) If the NHMRC Licensing Committee varies,
suspends or revokes a licence, the
Committee must notify—
(a) the licence holder; and
(b) the HREC; and
(c) the Authority.
(2) The NHMRC Licensing Committee must
also notify the HREC and the Authority if a
licence is surrendered.
Division 5—Reporting and Confidentiality
21Q. NHMRC Licensing Committee to make certain information publicly available
(1) The NHMRC Licensing Committee must
maintain a database containing the following
information in relation to each licence
(including a licence as varied)—
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos | |||||||||||
|
(2) The database is to be made publicly
available.
(3) The database may be kept and made publicly available in electronic form.
(4) Information mentioned in sub-section (1)
must not be such as to disclose confidential
commercial information.
21R. Confidential commercial information may
only be disclosed in certain circumstances
(1) A person commits an offence if—
(a) the person discloses confidential has only because of performing duties or functions under this Part or the Commonwealth Act; and
(b) the person knows that the information and
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 (c) the disclosure is not— (i) to a State agency, the Commonwealth or a Commonwealth authority in the
course of carrying out duties or functions under this Part or the Commonwealth Act; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
(2) A person commits an offence if—
(a) commercial information that the person
the person discloses confidential permitted under sub-section (1) or this sub-section; and
(b) the person knows that the information and
(c) the disclosure is not—
(i) to a State agency, the Commonwealth or a Commonwealth authority in the
course of carrying out duties or functions under this Part or the Commonwealth Act; or
(ii) by order of a court; or
(iii) with the consent of each person to whom the information has a commercial or other value.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
(3) An offence against sub-section (1) or (2) is punishable by imprisonment for a term not exceeding 2 years.
(4) In this section—
"court" includes a tribunal, authority or person having power to require the production of documents or the
answering of questions;
"State agency" means the following—
(a) the Crown in right of the State;
(b) a Minister of the State;
(c) a State Government department;
(d) instrumentality of the State,
including a body corporatethe Authority or any other by or under a law of the State;
(e) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons
together—(i) the Crown in right of the State;
(ii) a person or body covered by paragraph (b) or (d);
(iii) a person or body covered by or (ii).
Note: For the definition of confidential commercial information, see section 21A.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 Division 6—Review provisions
21S. Meaning of terms In this Division— "Administrative Appeals Tribunal" means
the Administrative Appeals Tribunal
established by the Administrative
Appeals Tribunal Act 1975 of the
Commonwealth;
"decision" has the same meaning as in the Administrative Appeals Tribunal Act 1975 of the Commonwealth;
"eligible person", in relation to a decision of the NHMRC Licensing Committee, means—
(a) section 21I not to issue a
in relation to a decision under licence; or
(b) in relation to a decision in respect of the period throughout which the licence is to be in force under section 21K—the licence holder;
or(c) in relation to a decision to specify a licence condition under section 21L(4)—the licence holder; or (d) in relation to a decision to vary or refuse to vary a licence under section 21M—the licence holder; or (e) or revoke a licence under
in relation to a decision to suspend the licence holder immediately
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
before the suspension or
revocation.
21T. Review of decisions
(1) An eligible person may apply to the
Administrative Appeals Tribunal for review
of the following decisions of the NHMRCLicensing Committee—
(a)
a decision under section 21I not to issue a licence;
(b)
a decision in respect of the period throughout which the licence is to be in force under section 21K;
(c)
a decision to specify a licence condition under section 21L(4);
(d)
a decision to vary or refuse to vary a licence under section 21M;
(e)
a decision to suspend or revoke a licence under section 21N.
(2) This section has effect subject to the
Administrative Appeals Tribunal Act 1975
of the Commonwealth.
Division 7—Monitoring Powers 21U. Powers available to inspectors for
monitoring compliance
(1) For the purpose of finding out whether this
Part or the regulations made for the purposes of this Part have been complied with, an inspector may—
(a) enter any premises; and
(b)
exercise the monitoring powers set out in section 21V.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 (2) An inspector is not authorised to enter premises under sub-section (1) unless—
(a) the occupier of the premises has consented to the entry; or (b) the premises are premises at which the occupier of the premises is carrying out activities authorised by a licence issued under section 21I, and the entry is at a reasonable time.
21V. Monitoring powers
(1) The monitoring powers that an inspector
may exercise under section 21U(1)(b) are as
follows—
(a) to search the premises and any thing on the premises; (b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any human embryo or thing on the premises that relates to this Part;
(c)
to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d)
to inspect any book, record or document on the premises;
(e)
to take extracts from or make copies of any such book, record or document;
(f)
to take onto the premises such equipment and materials as the inspector requires for the purpose of
exercising powers in relation to the
premises.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 7 | Part 2—Excess Embryos |
(2) For the purposes of this Part, monitoring
powers include the power to operate
equipment at premises to see whether—
(a) the equipment; or
(b)
a disk, tape or other storage device that—
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it—
contains information that is relevant to
determining whether there has been
compliance with this Part or the
regulations made for the purposes of
this Part.
(3) If the inspector, after operating equipment at
the premises, finds that the equipment, or
that a tape, disk or other storage device at the
premises, contains information mentioned in
sub-section (2), the inspector may—
(a) premises to put the information in
operate equipment or facilities at the document so produced; or
(b)
if the information can be transferred to a tape, disk or other storage device that—
(i) is brought to the premises; or
(ii) is at the premises and the use of which has been agreed to in writing by the occupier of the premises—
operate the equipment or other facilities
to copy the information to the storage
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 7 device, and remove the storage device
from the premises.
21W. Power to secure
If an inspector, during a search of premises, believes on reasonable grounds that there is at the premises a human embryo or a thing that may afford evidence of the commission
of an offence against this Part, the
monitoring powers include securing the
embryo or thing pending the obtaining of a
warrant (whether by the inspector or byanother person) to seize it.
21X. Inspector must produce identity card on
request
(1) An inspector is not entitled to exercise any
powers under this Part in relation to premises
if—
(a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and (b) the inspector fails to comply with the requirement. (2) In this section "identity card" means
identity card issued under section 34(1) of
the Commonwealth Act.
21Y. Consent
(1) Before obtaining the consent of a person for
the purposes of section 21U(2)(a), the
inspector must inform the person that he or
she may refuse consent.
(2) An entry of an inspector by virtue of the
consent of a person is not lawful unless the
person voluntarily consented to the entry.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 8 | Part 2—Excess Embryos |
21Z. Compensation for damage
(1) The owner of equipment or other facilities is
entitled to compensation for damage to the
equipment or other facilities if—
(a) the damage was caused to the equipment or other facilities as a result of it being operated by an inspector as mentioned in this Part; and (b) the damage was caused as a result of insufficient care being exercised by the inspector operating the equipment or other facilities. (2) Compensation is payable by the NHMRC Licensing Committee.
(3) In determining the amount of compensation
payable, regard is to be had to whether the occupier of the premises and the occupier's employees and agents, if they were available
at the time, had provided any warning or
guidance as to the operation of the
equipment or other facilities that wasappropriate in the circumstances.'.
8. New Division 5 inserted in Part 3
In Part 3 of the Principal Act, after Division 4 insert—
'Division 5—Application of Part 35A. Meaning of "research" in this Part
(1) In this Part, "research", in relation to an
excess ART embryo within the meaning of embryo for which a licence is required under that Part.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 2—Excess Embryos s. 8 (2) Research comprised of a use of an excess
ART embryo within the meaning of Part 2A for which a licence is required under that Part may only be carried out in accordance with that Part.'.
__________________
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 9 | Part 3—Offences |
PART 3—OFFENCES
9. New Part 4A inserted
After Part 4 of the Principal Act insert—
'PART 4A—PROHIBITED PRACTICES
Division 1—Human Cloning
38A. Offence—creating a human embryo clone
(1) A person commits an offence if the person intentionally creates a human embryo clone.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
15 years.
38B. Offence—placing a human embryo clone in the human body or the body of an animal
(1) A person commits an offence if the person intentionally places a human embryo clone in the body of a human or the body of an
animal.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
15 years.
38C. Offence—importing or exporting a human
embryo clone
(1) A person commits an offence if the person
intentionally imports a human embryo clone
into Victoria.
(2) A person commits an offence if the person
intentionally exports a human embryo clone
from Victoria.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 3—Offences s. 9 (3) An offence against sub-section (1) or (2) is
an indictable offence punishable by
imprisonment for a term not exceeding
15 years.
38D. No defence that human embryo clone could
not survive
It is not a defence to an offence under section 38A, 38B or 38C that the human embryo clone did not survive or could not have survived.
Division 2—Other Prohibited Practices
38E. Offence—creating a human embryo other than by fertilisation, or developing such an embryo
(1) A person commits an offence if the person intentionally creates a human embryo by a process other than the fertilisation of a
human egg by human sperm, or intentionally
develops a human embryo so created.(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38F. Offence—creating a human embryo for a
purpose other than achieving pregnancy in
a woman
(1) A person commits an offence if the person
intentionally creates a human embryo outside
the body of a woman, unless the person's
intention in creating the embryo is to attempt
to achieve pregnancy in a particular woman.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 9 | Part 3—Offences |
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
(3) Despite section 130(1) of the Magistrates'
Court Act 1989, a defendant does not bear a burden of presenting or pointing to evidence in accordance with that section in relation to any matter in sub-section (1) of this section.
38G. Offence—creating or developing a human
embryo containing genetic material
provided by more than 2 persons
(1) A person commits an offence if the person intentionally creates or develops a human embryo containing genetic material provided
by more than 2 persons.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38H. Offence—developing a human embryo
outside the body of a woman for more than
14 days
(1) A person commits an offence if the person
intentionally develops a human embryo
outside the body of a woman for a period of
more than 14 days, excluding any period
when development is suspended.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 3—Offences s. 9 38I. Offence—using precursor cells from a
human embryo or a human foetus to create
a human embryo, or developing such an
embryo
(1) A person commits an offence if the person
uses precursor cells taken from a human embryo or a human foetus, intending to create a human embryo, or intentionally develops an embryo so created.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38J. Offence—heritable alterations to genome
(1) A person commits an offence if—
(a) the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and
(b)
in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
(2) In this section—
"human cell" includes a human embryonal cell, a human foetal cell, human sperm and a human egg.
(3) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 9 | Part 3—Offences |
38K. Offence—collecting a viable human embryo from the body of a woman
(1) A person commits an offence if the person
removes a human embryo from the body of a
woman, intending to collect a viable human
embryo.
(2) An offence against sub-section (1) is an
indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38L. Offence—creating a chimeric or hybrid
embryo
(1) A person commits an offence if the person intentionally creates a chimeric embryo.
(2) A person commits an offence if the person intentionally creates a hybrid embryo.
(3) An offence against sub-section (1) or (2) is
an indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38M. Offence—placing of an embryo
(1) A person commits an offence if the person intentionally places a human embryo in an animal.
(2) A person commits an offence if the person intentionally places a human embryo in the body of a human, other than in a woman's
reproductive tract.
(3) A person commits an offence if the person
intentionally places an animal embryo in the body of a human for any period of gestation.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 3—Offences s. 9 (4) An offence against sub-section (1), (2) or (3)
is an indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38N. Offence—importing, exporting or placing a prohibited embryo
(1) A person commits an offence if the person
intentionally imports an embryo into Victoria
knowing that, or reckless as to whether, the
embryo is a prohibited embryo.
(2) A person commits an offence if the person
intentionally exports an embryo from whether, the embryo is a prohibited embryo. (3) A person commits an offence if the person
intentionally places an embryo in the body of
a woman knowing that, or reckless as to
whether, the embryo is a prohibited embryo.
(4) In this section—
"prohibited embryo" means—
(a) a human embryo created by a process other than the fertilisation of a human egg by human sperm; or (b) a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt
to achieve pregnancy in a
particular woman; or(c) a human embryo that contains than 2 persons; or
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 9 | Part 3—Offences | |
|
a human embryo that has been or
(e) a human embryo using precursor cells taken from a human embryo or a human foetus; or (f) human cell (within the meaning of
section 38J) whose genome hasa human embryo that contains a alteration is heritable by human descendants of the human whose cell was altered; or
(g) a human embryo that was woman by a person intending to collect a viable human embryo; or
(h) a chimeric embryo or a hybrid embryo. (5) An offence against sub-section (1), (2) or (3)
is an indictable offence punishable by
imprisonment for a term not exceeding
10 years.
38O. Offence—commercial trading in human eggs, human sperm or human embryos
(1) A person commits an offence if the person
intentionally gives or offers valuable
consideration to another person for the
supply of a human egg, human sperm or a
human embryo.
(2) A person commits an offence if the person intentionally receives, or offers to receive, valuable consideration from another person
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 3—Offences s. 9 for the supply of a human egg, human sperm
or a human embryo.
(3) In this section—
"reasonable expenses"—
(a) human egg or human sperm—
in relation to the supply of a expenses relating to the collection, storage or transport of the egg or sperm; and
(b)
in relation to the supply of a human embryo—
(i) does not include any
expenses incurred by a
person before the time when
the embryo became an
excess ART embryo within
the meaning of Part 2A; and(ii) includes, but is not limited to, expenses relating to the storage or transport of the embryo;
"valuable consideration", in relation to the
supply of a human egg, human sperm
or a human embryo by a person,
includes any inducement, discount or
priority in the provision of a service to
the person, but does not include the
payment of reasonable expenses
incurred by the person in connection
with the supply.
(4) An offence against sub-section (1) or (2) is
an indictable offence punishable by
imprisonment for a term not exceeding
10 years.'.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 10 | Part 3—Offences |
10. Amendment of Part 5
(1) For the heading to Part 5 of the Principal Act
substitute—
"PART 5—OTHER MISCELLANEOUS
OFFENCES".
(2) Sections 39, 42, 44, 45, 46(1)(c) and (2), 47, 48, 49 and 57 of the Principal Act are repealed.
11. New section 38P inserted
In Division 1 of Part 5 of the Principal Act, after the heading to the Division insert—
'38P. Application of Division
In this Division—
(a)
"embryo" does not include an excess ART embryo within the meaning of Part 2A; and
(b)
"research" does not include a use of an excess ART embryo for which a licence is required under that Part.'.
12. New section 50A inserted
In Division 2 of Part 5 of the Principal Act, before section 51 insert—
'50A. Application of Division
In this Division—
(a)
"embryo" does not include an excess ART embryo within the meaning of Part 2A; and
(b)
"research" does not include a use of an excess ART embryo for which a licence is required under that Part.'.
__________________
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 13
PART 4—MISCELLANEOUS
13. Register to be kept for licensed centre
In section 62(2) of the Principal Act, after paragraph (b) insert—
"(ba) any human embryo that becomes an excess
ART embryo within the meaning of
Part 2A;".
14. New section 104A inserted
In Division 5 of Part 8 of the Principal Act, before section 105 insert—
'104A. Application of Part
In this Part—
(a)
"embryo" does not include an excess ART embryo within the meaning of Part 2A; and
(b)
"research" does not include a use of an excess ART embryo for which a licence is required under that Part.'.
15. New section 110A inserted
After section 110 of the Principal Act insert—
"110A. Formation of embryos
(1) A person who is not a doctor or scientist who
has been approved under this Part for the purpose of forming embryos outside the body of a woman must not knowingly or recklessly form or attempt to form an
embryo outside the body of a woman. Penalty: 480 penalty units or 4 yearsimprisonment or both.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 16 | Part 4—Miscellaneous |
(2) A person must not knowingly or recklessly form or attempt to form an embryo outside the body of a woman, except at a place
licensed for the purpose under this Part.
Penalty: 480 penalty units or 4 years
imprisonment or both.".
16. Infertility Treatment Authority
(1) In section 122(1)(b) of the Principal Act—
(a) for "this Act" (where first occurring) substitute "Part 8"; (b) for "this Act" (where secondly occurring) substitute "that Part or section 56".
(2) In section 122(1)(f)(i) of the Principal Act, after "Act" insert ", other than Part 2A".
(3) In section 122(2)(b) of the Principal Act, for "this Act" substitute "Part 8 or section 56".
(4) In section 122 of the Principal Act, after sub- section (4) insert—
'(5) In this section "embryos" does not include excess ART embryos within the meaning of Part 2A.'.
(5) In section 137 of the Principal Act, after sub- section (1) insert—
'(1A) In sub-section (1)—
(a)
"embryos" does not include excess ART embryos within the meaning of Part 2A; and
(b)
"research" does not include a use of an excess ART embryo for which a licence is required under that Part.'.
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 17
17. Search warrants
In section 162(1) and (3)(a) of the Principal Act, for "this Act or the regulations" substitute "this Act (other than Part 2A) or the regulations (other
than the regulations made for the purposes of
Part 2A)".
18. Indictable offences
(1) In section 163(1) of the Principal Act—
(a) omit "or (2)";
(b) omit "39, 45, 47, 49,";
(c) for "or 54" substitute ", 54 or 110A".
(2) In section 163 of the Principal Act, after sub- section (2) insert—
"(3) Offences that are indictable offences by
force of this section are additional to any
other offence that is expressed by this Act as
being an indictable offence.".
19. Amendment of heading to Part 14
In the heading to Part 14 of the Principal Act, for
"REPEALS, AMENDMENTS" substitute"REVIEW".
20. New Division 1 substituted in Part 14
For Division 1 of Part 14 of the Principal Act substitute—
"Division 1—Review of Parts 2A and 4A 166. Review of operation of Parts 2A and 4A
(1) The NHMRC must cause an independent review of the operation of—
(a)
Part 2A to be undertaken as soon as possible after the second anniversary of
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 20 | Part 4—Miscellaneous |
the day on which the Commonwealth
Act received the Royal Assent; and
(b) Part 4A to be undertaken as soon as possible after the second anniversary of the day on which the Prohibition of Human Cloning Act 2002 of the Commonwealth received the Royal Assent. (2) The review is to be undertaken by persons
chosen by the NHMRC, with the agreement
of the Minister.
(3) The persons undertaking the review must
give the Minister a written report of the
review before the third anniversary of the
day on which the relevant Commonwealth
Act received the Royal Assent.
(4) The persons undertaking the review must
consider and report on the scope and
operation of Parts 2A and 4A taking into
account the following—
(a) developments in technology in relation to assisted reproductive technology; (b) scientific research and the potential
developments in medical research and research;
(c) community standards;
(d) the applicability of establishing a National Stem Cell Bank. (5) The report must contain recommendations about amendments (if any) that should be made to this Act, having regard to the
matters mentioned in sub-section (4).
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 21 (6) The persons undertaking the review must
consult—
(a) the State and the Commonwealth; and
(b)
a broad range of persons with expertise in or experience of relevant disciplines—
and the views of the State, the in paragraph (b) must be set out in the report to the extent that it is reasonably practicable to do so.
(7) The Minister must cause a copy of the report
to be laid before each House of the she receives it.".
21. New Division 3 inserted in Part 14
After Division 2 of Part 14 of the Principal Act insert—
'Division 3—Savings and Transitional
Provisions (2003 Act)
200. Definition
In this Division, "the amending Act"
means the Health Legislation (Research
Involving Human Embryos and
Prohibition of Human Cloning) Act 2003.201. Status of certain licences and approvals force immediately before the commencement of section 7 of the amending Act, ceases to have effect by force of this sub-section on and from that commencement to the extent to which it relates to a use of an excess ART
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 22 | Part 4—Miscellaneous |
embryo within the meaning of Part 2A for which a licence is required under that Part.
202. Regulations savings or transitional nature consequent to—
(a)
the coming into operation of any provision of the amending Act;
(b)
the repeal of any provision of this Act by the amending Act;
(c)
the coming into operation of a regulation under this Act as amended by any provision of the amending Act.
203. General transitional provision
(1) Subject to sub-section (2), this Division does
not affect or take away from the operation ofthe Interpretation of Legislation Act 1984.
(2) If a provision of this Division, or a regulation
made under this Division, is inconsistent with a provision of the Interpretation of Legislation Act 1984, the provision of this
Division or the regulation (as the case requires) prevails.'.
22. Consequential amendments
(1) In Part 2 of the Principal Act—
(a)
insert the following heading to section 12— "Donation of gametes or embryos";
(b) in section 12(3) and (4)—
(i) for "A zygote or embryo" substitute "An embryo";
(ii) for "the zygote or embryo" (wherever occurring) substitute "the embryo";
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 22 (iii) for "a zygote or embryo" (wherever occurring) substitute "an embryo";
(c) in section 12(5)—
(i) for "A zygote or embryo" substitute "An embryo";
(ii) for "the zygote or embryo" substitute "the embryo";
(d) in section 13(1), omit ", zygote,";
(e) in section 13(4), omit "zygote or";
(f) in section 14(1)(b) and (2), omit ", zygote";
(g) in section 14(4)—
(i) for "a zygote or embryo" substitute "an embryo";
(ii) for "the zygote or embryo" substitute "the embryo";
(h)
in section 15(1), (2) and (4), omit ", zygote" (wherever occurring);
(i) in section 17(a), omit ", zygotes";
(j) in section 18(1)—
(i) omit ", a zygote";
(ii) in paragraph (c), omit ", zygotes"; (k) in section 19(1)(b), omit ", zygote";
(l) in section 19(3)—
(i) omit "a zygote or";
(ii) omit "zygote or";
(m) in section 20(1), (2) and (3)—
(i) for "a zygote or embryo" substitute "an embryo";
(ii) omit "a zygote or" (where secondly and thirdly occurring).
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 22 | Part 4—Miscellaneous |
(2) In Part 3 of the Principal Act—
(a) for section 22(1)(a) and (b) substitute— "(a) carry out research, outside the body of a
woman, involving the formation or use
of an oocyte in the process offertilisation; or
(b)
carry out research, outside the body of a woman, involving an embryo—";
(b) section 22(2) is repealed;
(c) in section 22(3), omit "or (2)";
(d)
insert the following heading to section 24— "Ban on destructive research on non- excess ART embryos";
(e)
insert the following heading to section 25— "Authority must not approve destructive research on non-excess ART embryos";
(f)
insert the following heading to section 26— "Authority must not approve certain research on oocytes in the process of fertilisation";
(g) in section 26—
(i) for "a zygote" substitute "an oocyte in the process of fertilisation";
for Research Involving Embryos"; for "zygote continue to develop to to develop into a human embryo"; (ii)
(h) for the heading to Division 2 substitute (i) insert the following heading to section 27— "Consent to research involving embryos";
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 22 (j) in section 27—
(i) sub-section (1) is repealed;
(ii) in sub-section (2)—
(A) omit "a zygote or";
(B) in paragraph (a), omit "zygote or";
(C) paragraph (b) is repealed;
(D) in paragraph (c), omit "zygote or" (where twice occurring);
(k) in section 28(1), omit ", zygote";
(l)
in section 29(1), omit ", zygote" (where twice occurring);
(m)
in section 30, omit ", zygote" (wherever occurring);
(n) in section 32(1)(a), omit ", zygotes";
(o) Division 3 is repealed;
(p) in section 34, omit "or (2)".
(3) In Part 4 of the Principal Act—
(a) in section 37(3)(b), omit ", zygote";
(b) in section 38(2), omit "donor zygote or".
(4) In Part 5 of the Principal Act—
(a)
insert the following heading to section 40— "Transfer of gametes or embryos used for research";
(b) in section 40(1)—
(i) in paragraph (a), omit "or zygote";
(ii) in paragraph (b), omit "zygote or";
(iii) paragraph (c) is repealed;
(c) in section 41(b), omit "a zygote or";
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Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 22 | Part 4—Miscellaneous |
(d) in section 43—
(i) in paragraph (b), for "dead; or" substitute "dead.";
(ii) paragraphs (d) and (e) are repealed;
(e)
insert the following heading to section 46— "Ban on certain procedures";
(f) in section 46(1)(b)—
(i) omit "zygote or" (where twice occurring);
(ii) for "people; or" substitute "people."; (g) in section 50(1)(a), omit ", zygote";
(h)
insert the following heading to section 52— "Storing embryos";
(i) in section 52(1), omit "a zygote or";
(j) for section 52(2)(a) substitute—
"(a) it is intended to transfer the embryo to
the body of a woman in a treatment
procedure in accordance with this Act;
and";
(k) in section 52(2)(b)—
(i) omit "zygote or";
(ii) omit "use or";
(l) in section 52(3)(b), omit "zygote or";
(m)
in section 52(4) and (5), for "a zygote or embryo" substitute "an embryo";
(n)
insert the following heading to section 53— "Removal of embryos from storage";
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 22 (o) in section 53(1)—
(i) omit "a zygote or" (where twice occurring);
(ii) in paragraphs (c) and (d), omit "zygote or";
(p) in section 53(2)—
(i) for "a zygote or embryo" substitute "an embryo";
(ii) for "the zygote or embryo" substitute "the embryo";
(q) in section 54—
(i) in paragraph (a), for "a zygote or embryo" substitute "an embryo";
(ii) in paragraph (c), omit "a zygote or";
(r)
insert the following heading to section 55— "Ban on use of gametes or embryos not stored at licensed centre";
(s) in section 55—
(i) omit ", zygote" (wherever occurring);
(ii) in paragraph (b), for "zygote or gamete; or" substitute "gamete.";
(iii) paragraph (c) is repealed;
(t)
(u) in section 56—insert the following heading to section 56— embryos"; (i) in sub-section (1), omit ", zygote" (where twice occurring);
(ii) in sub-section (2), omit ", zygote";
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
| s. 22 | Part 4—Miscellaneous |
(iii) in sub-sections (4) and (5), omit ", zygote" (wherever occurring);
(iv) in sub-section (5), omit "49(1) and (2),".
(5) In Part 7 of the Principal Act—
(a) in section 62(2)—
(i) omit ", zygotes" (wherever occurring);
(ii) in paragraph (c), for "a zygote or embryo" substitute "an embryo";
(iii) in paragraph (f), omit ", zygote";
(b)
in sections 71(1) and 72(1), for "a zygote or embryo" substitute "an embryo";
(c) in section 73(1), omit "or a zygote";
(d) in section 73(5)—
(i) for "a zygote or embryo" substitute "an embryo";
(ii) omit ", zygote";
(e) in sections 74(1) and 76(1), omit "a zygote or"; (f) in section 79(1), for "a zygote or embryo" substitute "an embryo". (6) In Part 7A of the Principal Act, in section 92A, in
the definition of "pre-1 July 1988 donor", omit
", zygote".
(7) In Part 8 of the Principal Act—
(a) in sections 93(f) and 94(e), omit ", zygotes";
(b) section 98(2) is repealed;
(c) in section 106(2)(a), omit "and zygotes";
(d)
in section 116(1)(c), omit ", zygotes" (where twice occurring);
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 22
(e) in section 116(2)(b), for ", zygotes, embryos, substitute "or embryos".
(8) In Part 9 of the Principal Act—
(a) in section 122(1)(d) and (i), omit ", zygotes";
(b) in section 137(1)—
(i) in paragraph (a), for ", gametes and zygotes" substitute "and gametes";
(ii) in paragraph (b)(v), omit "and zygotes".
(9) In Part 12 of the Principal Act—
(a) in section 152(1), omit ", zygotes";
(b) in section 154(1), for ", zygote, embryo, parthenogenetic oocyte or parthenogene" (where twice occurring) substitute "or embryo";
(c)
", zygote, embryo, parthenogenetic oocyte or
in section 162(2), (3)(b) and (7), for substitute "or embryo";
(d)
in section 162(7), for ", zygote, embryo, parthenogene or parthenogenetic oocyte" substitute "or embryo".
(10) In Part 13 of the Principal Act, in
section 165(1)—
(a) in paragraph (l), omit "zygotes or";
(b)
in paragraph (p)(i) and (ii), for ", zygote, embryo, parthenogenetic oocyte or parthenogene" substitute "or embryo";
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Act No. 11/2003
| s. 23 | Part 4—Miscellaneous |
(c)
in paragraph (p)(iv), for ", zygote, embryo, parthenogenetic embryo or parthenogene" substitute "or embryo";
(d) paragraph (q) is repealed.
23. Repeal of certain provisions
Sections 21I(3)(b) and 21L(1)(c) and (3) are repealed on the day on which the provisions of the Commonwealth Act referred to in section 46 of that Act are repealed.
Note: The Commonwealth provisions are to be repealed on
5 April 2005 or an earlier date declared by the
Council of Australian Governments.24. Consequential amendment of Gene Technology Act 2001
Sections 192B, 192C and 192D of the Gene
Technology Act 2001 are repealed.
25. Consequential amendments of other Acts
(1) In sections 38(3) and 39(1A) of the Human
Tissue Act 1982, for "an amount to which
section 57(3) of the Infertility Treatment Act
1995 applies" substitute "reasonable expenses of
a kind referred to in section 38O(3) of the
Infertility Treatment Act 1995".(2) In section 10A(3) of the Status of Children Act
1974, in the definitions of "embryo" and
"syngamy", after "1995" insert ", as in force
immediately before the commencement of section
5(2)(a) of the Health Legislation (Research
Involving Human Embryos and Prohibition of
Human Cloning) Act 2003".
Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Part 4—Miscellaneous s. 25 (3) At the foot of section 10A(3) of the Status of Children Act 1974 insert—
'Note: The Infertility Treatment Act 1995 defined "embryo" and "syngamy" as follows—
"embryo" means any stage of human embryonic development at and from syngamy;
"syngamy" means that stage of development of a
fertilised oocyte where the chromosomes
derived from the male and female pronuclei
align on the mitotic spindle.'.
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Health Legislation (Research Involving Human Embryos and
Prohibition of Human Cloning) Act 2003
Act No. 11/2003
Endnotes
ENDNOTES
†
Minister's second reading speech—
Legislative Assembly: 27 February 2003
Legislative Council: 27 March 2003
The long title for the Bill for this Act was "to amend the Infertility
Treatment Act 1995 so as to make fresh provision for the regulation of
certain activities involving the use of human embryos and for the
prohibition of human cloning and certain other practices associated with
reproductive technology, to make consequential amendments to the Gene
Technology Act 2001 and certain other Acts and for other purposes."
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