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 strong regulatory framework to prohibit certain unacceptable practices including human cloning, and to regulate uses of excess human embryos created through assisted reproductive technology (ART).
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 2003
- 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)
- Learn more about the 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 Commonwealth, States and Territories 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 reports on the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002
What changed for NHMRC after the review?
There were changes to:
- The National Statement on Ethical Conduct in Human Research, 2007.
The National Statement was tabled in Parliament on 28 March 2007. The new National Statement includes more extensive guidance on consent, and chapters on human tissue samples, human stem cells, and research involving foetal tissue.
With the passage of the Prohibition of Human Cloning for Reproduction and Regulation of Human Embryo Research Amendment Act 2006, and consideration of related recommendations arising out of the Lockhart Review, the 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 the NHMRC on 6 December 2007.
The Objective Criteria provide guidance on the criteria to be used before embryos are considered unsuitable for implantation into the body of a woman.
- The NHMRC’s Ethical Guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research (2007).
The document incorporates guidelines for egg donation and refers to the Objective Criteria. The Objective Criteria are only to be used following a couple’s decision that particular embryos will not be used for assisted reproductive technology (ART) treatment (this is a declaration that the embryos are excess to the reproductive needs of the couple). The guidelines are then used in making decisions on which of these excess embryos may be used for research.
- Licence application forms
- New draft licence application forms were developed to cater for the broadened scope of permitted embryo research activities.
- For more information please email firstname.lastname@example.org
- Compliance with Legislation
- New arrangements were developed to monitor compliance with the increased scope of the legislation.
2010 - The Heerey Review
The requirement for this review was included in the Amendment Act. Information about the review and its recommendations can be found by following the link: http://legislationreview.nhmrc.gov.au.