1Short title
This Act may be cited as the Research Involving Human Embryos Act 2002.
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Bill homepage (APH)This Act may be cited as the Research Involving Human Embryos Act 2002.
Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table.
Commencement information | ||
|---|---|---|
Column 1 | Column 2 | Column 3 |
Provision(s) | Commencement | Date/Details |
1. Sections 1 and 2 and anything in this Act not elsewhere covered by this table | The day on which this Act receives the Royal Assent | 19 December 2002 |
2. Sections 3 to 9 | The 28th day after the day on which this Act receives the Royal Assent | 16 January 2003 |
3. Sections 10 to 12 | At the end of the period of 6 months beginning on the day on which this Act receives the Royal Assent | 19 June 2003 |
4. Sections 13 to 48 | The 28th day after the day on which this Act receives the Royal Assent | 16 January 2003 |
This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent.
Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act.
The object of this Act is to address concerns, including ethical concerns, about scientific developments in relation to human reproduction and the utilisation of human embryos by regulating activities that involve the use of certain human embryos created by assisted reproductive technology or by other means.
This Act applies as follows:
to things done, or omitted to be done, by constitutional corporations;
to things done, or omitted to be done, in the course of constitutional trade or commerce;
to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;
to the Commonwealth and Commonwealth authorities;
for purposes relating to the collection, compilation, analysis and dissemination of statistics;
to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.
See also section 28B in relation to mitochondrial donation licences.
In this section:
constitutional trade or commerce means trade or commerce:
between Australia and places outside Australia; or
among the States; or
by way of the supply of services to the Commonwealth or to a Commonwealth authority.
For constitutional corporation, see subsection 7(1).
This Act binds the Crown in each of its capacities.
Nothing in this Act renders the Crown liable to be prosecuted for an offence.
This Act extends to every external Territory.
In this Act:
Commonwealth authority means the following:
a body corporate established for a public purpose by or under an Act;
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:
the Commonwealth;
a body covered by paragraph (a);
a body covered by either of the above subparagraphs.
constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.
corresponding State law, in relation to a State, means a law of that State declared by the Minister, by notice in the Gazette, to be a corresponding State law for the purposes of this Act.
human embryo means a discrete entity that has arisen from either:
the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or
any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;
and has not yet reached 8 weeks of development since the first mitotic division.
hybrid embryo means:
an embryo created by the fertilisation of a human egg by animal sperm; or
an embryo created by the fertilisation of an animal egg by human sperm; or
a human egg into which the nucleus of an animal cell has been introduced; or
an animal egg into which the nucleus of a human cell has been introduced; or
a thing declared by the regulations to be a hybrid embryo.
inspector means a person appointed as an inspector under subsection 33(1).
NHMRC Licensing Committee means the Committee established by section 13.
Secretary means the Secretary of the Department.
spouse, in relation to a person, includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.
State includes the Australian Capital Territory and the Northern Territory.
the NHMRC means the National Health and Medical Research Council established by the National Health and Medical Research Council Act 1992.
unsuitable for implantation, in relation to a human embryo, means a human embryo that:
is diagnosed by preimplantation genetic diagnosis as unsuitable for implantation, in accordance with the Ethical guidelines on the use of assisted reproductive technology in clinical practice and research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time; or
is determined to be unsuitable for implantation in the body of a woman, in accordance with objective criteria specified in guidelines issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992 and prescribed by the regulations for the purposes of this paragraph.
use includes develop, or development, as the case requires.
woman means a female human.
For the purposes of the definition of human embryo in subsection (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.
A reference in this Act to an embryo (including a human embryo) is a reference to a living embryo.
A reference in this Act to a human egg is a reference to a human oocyte.
A reference in this Act to a human embryo does not include a reference to:
a hybrid embryo; or
a human embryonic stem cell line.
In this Part:
accredited ART centre means a person or body accredited to carry out assisted reproductive technology by:
the Reproductive Technology Accreditation Committee of the Fertility Society of Australia; or
if the regulations prescribe another body or other bodies in addition to, or instead of, the body mentioned in paragraph (a)—that other body or any of those other bodies, as the case requires.
AHEC means the Australian Health Ethics Committee established by the National Health and Medical Research Council Act 1992.
clinical practice licence means a licence referred to in section 28G.
clinical practice research and training licence means a licence referred to in section 28F.
clinical trial licence means a licence referred to in section 28E.
clinical trial research and training licence means a licence referred to in section 28D.
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.
disclose, in relation to information, means give or communicate in any way.
donor, in relation to a particular use of a mitochondrial donation technique, has the meaning given by subsection 28R(2).
engage in conduct means:
do an act; or
omit to perform an act.
excess ART embryo has the meaning given by section 9.
general licence means a licence issued under section 21.
HREC means a Human Research Ethics Committee.
mitochondrial donation licence means:
a pre‑clinical research and training licence; or
a clinical trial research and training licence; or
a clinical trial licence; or
a clinical practice research and training licence; or
a clinical practice licence.
mitochondrial donation technique means a technique, prescribed by the regulations for the purposes of this definition, that:
can be used to minimise the risk of a woman’s offspring inheriting mitochondria from that woman that would predispose the offspring to mitochondrial disease; and
involves using assisted reproductive technology to create a zygote that:
has nuclear DNA from the woman and a man; and
contains mitochondria from a human egg of a different woman; and
does not involve:
intentionally modifying nuclear DNA or mitochondrial DNA; or
using any cell, or any component part of a cell, of an animal; or
creating a chimeric embryo (within the meaning of the Prohibition of Human Cloning for Reproduction Act 2002) or a hybrid embryo.
National Statement means the National Statement on Ethical Conduct in Human Research, issued by the CEO of the NHMRC under the National Health and Medical Research Council Act 1992, as existing from time to time.
The National Statement could in 2021 be viewed on the website of the NHMRC (https://www.nhmrc.gov.au).
patient means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical practice licence.
For a human embryo to be created for, or placed in the body of, a woman under a clinical practice licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a).
permitted technique for a mitochondrial donation licence of a particular kind means a mitochondrial donation technique that is declared by the regulations to be a permitted technique for a mitochondrial donation licence of that kind.
pre‑clinical research and training licence means a licence referred to in section 28C.
proper consent:
for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8).
relevant State body means a person or body notified by a State to the Chairperson of the NHMRC Licensing Committee for the purposes of this Part.
responsible person:
for the purposes of Division 4 (general licences) of Part 2—has the meaning given by subsection 24(9); and
for the purposes of Division 4A (mitochondrial donation licences) of Part 2—has the meaning given by subsection 28N(8).
trial participant means a woman whose pregnancy is sought to be achieved using a mitochondrial donation technique under a clinical trial licence.
For a human embryo to be created for, or placed in the body of, a woman under a clinical trial licence, the NHMRC Licensing Committee must be satisfied that there is a particular risk of the woman’s offspring inheriting mitochondria from the woman that would predispose the offspring to mitochondrial disease: see paragraph 28P(4)(a).
In this Part:
excess ART embryo means a human embryo that:
was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and
is excess to the needs of:
the woman for whom it was created; and
her spouse (if any) at the time the embryo was created.
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:
each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or
each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.
A person commits an offence if the person intentionally uses an excess ART embryo, unless:
the excess ART embryo is created other than by using a mitochondrial donation technique and the use of the embryo by the person is authorised by a general licence; or
the excess ART embryo is created using a mitochondrial donation technique and the use of the embryo by the person is permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or
the use by the person is an exempt use within the meaning of subsection (2).
Penalty: Imprisonment for 5 years.
A use of an excess ART embryo by a person is an exempt use for the purposes of subsection (1) if:
the use consists only of:
storage of the excess ART embryo; or
removal of the excess ART embryo from storage; or
transport of the excess ART embryo; or
the use consists only of observation of the excess ART embryo; or
the use consists only of allowing the excess ART embryo to succumb; or
the use is carried out by an accredited ART centre, and:
the excess ART embryo is not suitable to be placed in the body of the woman for whom it was created where the suitability of the embryo is determined only on the basis of its biological fitness for implantation; and
the use forms part of diagnostic investigations conducted in connection with the assisted reproductive technology treatment of the woman for whom the excess ART embryo was created; or
the use is carried out by an accredited ART centre, and:
the use is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; and
the excess ART embryo was not created using a mitochondrial donation technique as permitted under section 28B (carrying out activities authorised by mitochondrial donation licences); or
the use is of a kind prescribed by the regulations for the purposes of this paragraph.
Despite subsection 13.3(3) of the Criminal Code, a defendant does not bear an evidential burden in relation to any matter in subsection (1) or (2) of this section.
In subsection (2):
diagnostic investigation, in relation to an excess ART embryo, means any procedure undertaken on embryos for the sole purpose of diagnostic investigations for the direct benefit of the 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.
A person commits an offence if:
the person intentionally uses an embryo; and
the embryo is:
a human embryo created by a process other than the fertilisation of a human egg by a human sperm; or
a human embryo created by a process other than the fertilisation of a human egg by a human sperm that contains genetic material provided by more than 2 persons; or
a human embryo created using precursor cells taken from a human embryo or a human fetus; or
a hybrid embryo; and
the use by the person is not authorised by a general licence or, if subparagraph (b)(i) or (ii) applies, permitted under section 28B (carrying out activities authorised by mitochondrial donation licences).
Penalty: Imprisonment for 5 years.
The creation or development of embryos mentioned in this section is prohibited under Part 2 of the Prohibition of Human Cloning for Reproduction Act 2002, unless authorised by a general licence under this Act, or if subparagraph (b)(i) or (ii) applies, permitted under section 28B of this Act.
A person commits an offence if:
the person undertakes research or training involving the fertilisation of a human egg by a human sperm up to, but not including, the first mitotic division, outside the body of a woman for the purposes of research or training in assisted reproductive technology; and
neither of the following apply:
the person is authorised to undertake the research or training by a general licence;
the person is permitted under section 28B to undertake the research or training because of a pre‑clinical research and training licence, a clinical trial research and training licence or a clinical practice research and training licence.
Penalty: Imprisonment for 5 years.
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