There are two 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.
NHMRC's Statement on iBlastoids is available here.
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 the Import and Export of Cell Lines from Human Embryo Clones page.
There have been two 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, follow the links below.
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
2005 - The Lockhart Review
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 website.
- 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).
- Licence application forms
- Monitoring arrangements
2010 - The Heerey Review
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.
Monash University’s Polo Laboratory published research in the scientific journal Nature on 18 June 2021 (online) that demonstrates the creation of human embryo-like structures by reprogramming adult human skin cells. These structures are called iBlastoids by the research group because they are artificially induced and closely resemble human blastocysts (an early stage of human embryo development).
The NHMRC Embryo Research Licensing Committee (ERLC), as the regulator, made a decision based on the principles of statutory interpretation that iBlastoids come within the definition of a human embryo under the Research Involving Human Embryos Act 2002, and therefore require regulation and oversight.
More detail on the legislative background and process is outlined in the NHMRC Statement on iBlastoids (also available in the download section below).