There are 2 Commonwealth Acts providing a regulatory framework to prohibit certain unacceptable practices including human cloning, and to regulate uses of excess human embryos created through assisted reproductive technology.

The Research Involving Human Embryos Act 2002 and the Prohibition of Human Cloning Act 2002 were passed by Parliament in December 2002. These Acts establish a regulatory framework to prohibit certain unacceptable practices including human cloning, and to regulate uses of human embryos, including excess embryos, created through assisted reproductive technology (ART) and embryos created through processes other than fertilisation.

See also the NHMRC's Statement on iBlastoids.

Commonwealth Legislation

The Commonwealth legislation was developed in response to community concerns, including ethical concerns, about scientific developments in relation to human reproduction and the use of human embryos.

The legislation was amended in 2006 as a result of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006 (Amendment Act). The amendments came into effect in June 2007. The Prohibition of Human Cloning Act 2002 was renamed the Prohibition of Human Cloning for Reproduction Act 2002.

The Customs Regulations relate to the import or export of stem cells derived from human embryo clones. More information can be found on Import and Export of Cell Lines from Human Embryo Clones.

There have been 2 reviews of the Commonwealth legislation (see below).

State and Territory Legislation

On 5 April 2002, the Council of Australian Governments (COAG) agreed that the Australian Government and state and territory governments would introduce nationally consistent legislation to ban human cloning and other unacceptable practices and to regulate research involving excess ART embryos. The agreement was renewed on 13 April 2007.

To find more information about state and territory legislation visit the links provided in the following sections.

Australian Capital Territory

New South Wales

Northern Territory

  • Legislation is being drafted in the Northern Territory.

Queensland

South Australia

Tasmania

Victoria

Western Australia

Reviews of Human Cloning and Human Embryo Research Legislation

The Lockhart Review (2005)

The reviews of the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002 in 2005 were a statutory requirement of the Acts.

The Legislation Review Committee website is maintained as an historical record of the main documentation for the independent reviews and can be accessed via the National Library of Australia.

Review reports

Media release

Following passage of the Amendment Act, and consideration of related recommendations arising out of the Lockhart Review, NHMRC made changes to the following guidelines and related administrative processes:

The Heerey Review (2010)

The Amendment Act in 2006 included a requirement for this review. Information about the review and its recommendations is provided in the report of the independent review.

Human embryos from processes other than fertilisation 

The Research Involving Human Embryos Act 2002 requires that research involving human embryos, including excess embryos from assisted reproductive technology treatments and the creation and/or use of embryos arising by processes other than fertilisation, can only be conducted under a licence issued by the Embryo Research Licensing Committee (ERLC).

The Research Involving Human Embryos Act 2002 defines a human embryo as a discrete entity that has arisen from either:

a) the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or
b) 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.

The use or creation of entities that meet the definition of a human embryo (potentially including some types of embryoids, blastoids or embryo-like structures) is illegal in Australia unless it is conducted under a licence issued by ERLC.

In 2022, ERLC issued a licence for the creation and use of artificially generated embryos that closely resemble human blastocysts (‘iBlastoids’). More detail on the background and process of the iBlastoid embryo research licence is outlined in the NHMRC Statement on iBlastoids.

Advancements in human embryo research continue to develop rapidly. While ERLC pays close attention to international developments, any decision taken by ERLC, once it receives a valid licence application for this research, must be based on the requirements outlined under Australian law.

Researchers are strongly encouraged to contact the NHMRC embryo regulation team for advice about whether any proposed research involving embryo-like structures (for example, embryoids, blastoids, gastruloids) is regulated by the Australian legislation. Contact the NHMRC embryo regulation team at embryo.research@nhmrc.gov.au.