DRW Monthly
October 2007
Issue No. 11

Developments in Human Embryonic Stem Cell Research Regulation in Australia

A legislative framework to regulate the use of human embryonic stem cells for therapeutic cloning in Australia was established in 2006 with the passage of the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Act 2006. The Amendment Act came into force on 12 June 2007. The Act's passage overturned a four-year ban on therapeutic cloning or the somatic cell nuclear transfer of human embryos for stem cell research. Prior to it's adoption, the Prohibition of Human Cloning for Reproduction Act 2002 (PHC Act) and the Research Involving Human Embryos Act 2002 (RIHE Act) provided the national regulatory basis to address several ethical issues tied to assisted reproductive technology (ART) developments as well as other biotechnology and medical research advances that emerged in the 1990s.

The PHC Act specifically prohibited the creation of human embryo clones and human embryos for purposes other than achieving pregnancy. The RIHE Act established a framework for the use of excess ART embryos and instituted a National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee. The Committee was appointed to issue licenses to researchers interested in deriving new embryonic stem cell lines from the excess ART embryos.(1) As a result of the amended Act, the NHMRC licensing committee is now authorized to issue licenses to permit therapeutic cloning for research, training and clinical applications, for both human embryo clones and animal-human hybrid embryo clones up to 14 days old. The amended 2006 Act has also revised the definition of human embryo such that a biological entity created by fertilization or any other process and has a human nuclear genome or an altered human nuclear genome is now considered to be an embryo at a later stage of its development.(2) The PHC Act, however, continues to prohibit human reproductive cloning.

The NHMRC's Ethical Guidelines on the Use of Assisted Reproductive Technology (ART) in Clinical Practice and Research (ART guidelines) and the National Statement on Ethical Conduct in Human Research have also been recently updated to incorporate the 2006 amendments to the Act. The amended ART guidelines provide ethical advice in areas such as human egg donation; research on embryos unsuitable for implantation; research on embryos created by somatic cell nuclear transfer; and proper consent in relation to the donation of human eggs and embryos. The revised National Statement now offers more detailed guidance on consent, chapters on human tissue samples, human stem cells and research involving fetal tissue.(3)

A more recent regulatory development on the Australian state level occurred earlier this month in which Queensland became the third state to pass laws allowing research involving human embryonic stem cells. Victoria and New South Wales are the two other states that have already passed these laws to mirror those passed by the federal Parliament. As the remaining states and territories gradually move towards introducing nationally consistent legislation to permit therapeutic cloning, it is hoped that Australia will once again be in a position reclaim its leadership role in the global stem cell research community.

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