Research Involving Human Embryos Act 2003

This Act may be cited as the Research Involving Human

Embryos Act 2003.

In this Act, unless the contrary intention appears—

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 and New Zealand; 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 of the

Commonwealth;

Commonwealth authority means—

a body corporate established for a public purpose by or under an

Act of the Commonwealth; or

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;

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;

excess ART embryo means a human embryo that—

was created, by assisted reproductive technology, for use in the assisted reproductive 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;

HREC means a Human Research Ethics

Committee;

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;

human reproductive material means—

a human embryo; or

human sperm; or

a human egg; or

a thing declared by the regulations to be human reproductive material;

human sperm includes human spermatids;

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 a related Commonwealth Act;

licence means a licence issued under

Division

3 of

Part

2;

NHMRC means the National Health and Medical

Research Council established by the National Health and Medical Research Council Act 1992 of the

Commonwealth;

NHMRC Licensing Committee means the Committee established by section 13 of the Research Involving

Human Embryos Act 2002 of the

Commonwealth;

proper consent, in relation to the use of an excess ART embryo or a human egg, or the creation or use of any other embryo, means consent obtained in accordance with guidelines issued by the Chief

Executive Officer of the NHMRC under the National Health and Medical Research Council Act

1992 of the Commonwealth and prescribed by the regulations under the Research Involving Human

Embryos Act 2002 of the Commonwealth for the purposes of the definition of proper consent in that Act;

record means a record of any kind, including a disk, tape or other article from which information is capable of being reproduced (with or without the aid of another article or device);

related Commonwealth Act means—

the Prohibition of Human Cloning for

Reproduction Act 2002 of the Commonwealth;

or

the Research Involving Human Embryos

Act 2002 of the Commonwealth;

responsible person means—

in relation to an excess ART embryo—

each person who provided the egg or sperm from which the embryo was created; and

the woman for whom the embryo was created, for the purpose of achieving her pregnancy; and

any person who was the spouse of a person mentioned in subparagraph (i) at the time the egg or sperm mentioned in that subparagraph was provided; and

any person who was the spouse of the woman mentioned in subparagraph (ii) at the time the embryo was created;

or

in relation to an embryo other than an excess ART embryo—each person whose reproductive material, genetic material or cell was used, or is proposed to be used, in the creation or use of the embryo;

or

in relation to a human egg—the woman who was the biological donor of the egg;

South Australian clinical practice licence means a licence to carry out artificial fertilisation procedures issued under Part 3 of the Reproductive Technology (Clinical

Practices) Act 1988;

spouse, in relation to a person, includes a person who, although not legally married to the person, is living with the person as the person's spouse on a bona fide domestic basis;

State includes the Australian Capital Territory and the Northern Territory;

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 (2004), issued by the Chief Executive Officer of the

NHMRC; 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 Chief Executive Officer of the NHMRC under the

National Health and Medical Research

Council Act 1992 of the Commonwealth and prescribed by the regulations under the Research Involving

Human Embryos Act 2002 of the Commonwealth for the purposes of the definition of unsuitable for implantation in that Act;

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.

For the purposes of paragraph (b) of the definition of excess

ART embryo in subsection (1), 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 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.

It is intended that the principal objects of this Act be achieved through a regulatory framework and a range of offences that operate in conjunction with, and in a manner that is consistent with, corresponding

Commonwealth and State laws.

A person commits an offence if the person intentionally uses an excess ART embryo, unless—

the use by the person is authorised by a licence; or

the use by the person is an exempt use within the meaning of subsection (2). Maximum penalty: Maximum penalty: Imprisonment for 5 years.

A use of an excess ART embryo by a person is an exempt use for the purpose 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 under a South

Australian clinical practice licence 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 under a South

Australian clinical practice licence and is for the purposes of achieving pregnancy in a woman other than the woman for whom the excess ART embryo was created; or

the use is of a kind prescribed by the regulations for the purposes of this paragraph.

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 licence.

Maximum penalty: Maximum penalty: Imprisonment for 5 years.

NoteThe creation or development of embryos mentioned in this section is prohibited under Part 2 of the Prohibition of Human Cloning for Reproduction

Act 2003, unless authorised by a licence under 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 ART; and

the person is not authorised by a licence to undertake the research or training.

Maximum penalty: Maximum penalty: Imprisonment for 5 years.

A person commits an offence if—

the person intentionally uses, outside the body of a woman, a human embryo—

that was created by fertilisation of a human egg by a human sperm;

and

that is not an excess ART embryo; and

the use is not for a purpose related to the assisted reproductive technology treatment of a woman carried out by an accredited ART centre under a

South Australian clinical practice licence, and the person knows or is reckless as to that fact.

Maximum penalty: Maximum penalty: Imprisonment for 5 years.

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 under this Act, or reckless as to whether the conduct contravenes a condition of such a licence. Maximum penalty: Maximum penalty: Imprisonment for 5 years.

In this section—

engage in conduct means—

do an act; or

omit to perform an act.

To avoid doubt, a person is not criminally responsible for an offence against this Act in respect of particular conduct if—

the conduct by the person is purportedly authorised by a provision of a licence; and

the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and

the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.

In this section—

licence includes a purported licence.

The NHMRC Licensing Committee has the following functions:

to perform functions in relation to licences under

Division

3;

to perform functions in relation to databases under

Division

4;

to perform such other functions as are conferred on it by this Act or any other law.

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.

A person may apply to the NHMRC Licensing Committee for a licence authorising 1 or more of the following:

use of excess ART embryos;

creation of human embryos other than by fertilisation of a human egg by a human sperm, and use of such embryos;

creation of human embryos other than by fertilisation of a human egg by a human sperm that contain genetic material provided by more than 2 persons, and use of such embryos;

creation of human embryos using precursor cells from a human embryo or a human fetus, and use of such embryos;

research and 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 ART;

creation of hybrid embryos by the fertilisation of an animal egg by a human sperm, and use of such embryos up to, but not including, the first mitotic division, if—

the creation or use is for the purposes of testing sperm quality; and

the creation or use will occur in an accredited ART centre.

To avoid doubt, subsection (1)(a), (b), (c) and (d) do not permit the NHMRC Licensing Committee to authorise any use of an excess ART embryo or other embryo that would result in the development of the embryo for a period of more than 14 days, excluding any period when development is suspended.

An application under subsection (1)—

must be made in accordance with the requirements (if any) specified in writing by the NHMRC Licensing Committee; and

must be accompanied by the fee (if any) prescribed by the regulations.