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.
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.
- Prohibition of Human Cloning for Reproduction Act 2002
- Research Involving Human Embryos Act 2002
- Research Involving Human Embryos Regulations 2017
- Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006
- Customs (Prohibited Import) Regulations 1956 (section 5L)
- Customs (Prohibited Export) Regulations 1958 (section 8A)
- 2001 human cloning reports from the House of Representatives, Parliament of Australia
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
- Human Cloning for Reproduction and Other Prohibited Practices Act 2003 No 20
- Research Involving Human Embryos (New South Wales) Act 2003 No 21
- Legislation is being drafted in the Northern Territory.
- Human Cloning for Reproduction and Other Prohibited Practices Act 2003 (No. 51 of 2003)
- Human Embryonic Research Regulation Act 2003 (No. 52 of 2003)
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.
- View the Legislation review: Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002, Reports – see 'Download' section
- Media release - 19 December 2005 – see 'Download' section
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 Objective criteria on embryos that are unsuitable for implantation (the Objective Criteria) and accompanying contextual information were issued as guidelines by the CEO of NHMRC on 6 December 2007
- NHMRC's Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research 2017 (updated 2023)
- Licence application forms
- Monitoring arrangements.
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 email@example.com.