Prohibition of Human Cloning Act 2002 – summary of principal provisions
In brief: Allens Lawyer, Kirraley Bowles, provides a summary of the principal provisions of the Prohibition of Human Cloning Act 2002.
- Introduction
- History of the Act
- Human cloning - prohibited practices
- Other prohibited practices
- Application of the Act
- Future opportunities for review
- Conclusion
Introduction
The purpose of the Prohibition of Human Cloning Act 2002 (Cth) (the Act), which came into effect on 16 January 2003, is to prohibit human cloning, as well as other unacceptable practices associated with reproductive technology in Australia. By laying down prohibitions, the legislation is intended to address concerns (including ethical concerns) about scientific developments in relation to human reproduction and the utilisation of human embryos.
History of the Act
On 5 April 2002, the Council of Australian Governments (COAG) agreed that the Commonwealth, States and Territories would introduce nationally consistent legislation to, among other things, ban the cloning of human beings by any method. The catalyst for the COAG decision was the fact that only a minority of Australian jurisdictions have laws regulating human cloning practices. The Commonwealth legislation represents an endeavour to regulate this incipient branch of reproductive science in a uniform and comprehensive manner.
The Act originated from the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 (Cth), which was split on a vote by the Members of the House of Representatives on 29 August 2002 into two separate bills - the Research Involving Embryos Bill 2002 (Cth) and the Prohibition of Human Cloning Bill 2002 (Cth). The bill was split because there was only unanimous support for the provisions prohibiting human cloning.
Human cloning – prohibited practices
According to the Act, the following intentional activities are prohibited:
- Creating a human embryo clone.
A human embryo clone is defined as a human embryo that is a genetic copy of another living or dead human, although this definition does not include a human embryo created by fertilisation. The legislation is broadly worded to apply to a range of cloning techniques, such as somatic cell nuclear transfer and embryo splitting, as well as techniques that may become possible in the future.
The blanket prohibition on cloning affords no exceptions. The Act forbids the copying of another human's genes, whether or not the maker's intention is to destroy the resulting embryo or to allow it to grow full term. Consequently, both therapeutic and reproductive cloning have been banned, despite the fact that these procedures have very different objectives. - Placing a human embryo clone in the body of a human or in the body of an animal.
- Importing a human embryo clone into, or exporting it from, Australia.
The maximum penalty for breaching each of these prohibitions is 15 years imprisonment, and it is not a defence to any of these offences that the human embryo clone did not survive or could not have survived.
Other prohibited practices
In addition to banning human cloning, the Act forbids a variety of procedures made possible by reproductive technologies, largely based on the unacceptable practices outlined in the National Health and Medical Research Council (NHMRC) Ethical Guidelines on Assisted Reproductive Development (1996). The following intentional acts are all offences under the legislation:
- Creating a human embryo by a process other than the fertilisation of a human egg by a human sperm, or developing such an embryo.
This provision means that techniques such as embryo splitting, somatic cell nuclear transfer and parthenogenesis are all banned. The main consequence of this prohibition is that therapeutic cloning (whereby a human embryo clone is created to derive stem cells that can be used for patient-specific cell therapies) is illegal. - Creating a human embryo outside the body of a woman, unless for the purpose of achieving pregnancy in a particular woman.
This provision specifically bans creating embryos for research purposes or to derive embryonic stem cells. - Creating or developing a human embryo with genetic material from more than two persons.
This means that cytoplasmic transfer, a new Assisted Reproductive Technology (ART) technique that may assist older women to achieve pregnancy is banned. This procedure involves the addition of cytoplasm from a donor egg into the patient's egg prior to fertilisation, and since cytoplasm contains small amounts of DNA, could mean that a third person's DNA is introduced into the embryo. - Developing a human embryo outside the body of a woman for a period of more than 14 days (excluding any period when development is suspended, such as freezing).
Human embryos created by ART must be implanted, stored or allowed to succumb if they are unsuitable or excess, before the 14th day of their development. However, the cut-off point of 14 days has been criticised as arbitrary, given the continuous nature of development. - Using precursor cells taken from a human embryo or a human foetus, intending to create a human embryo, or develop an embryo so created.
This prevents the use of cells taken from human embryos and foetuses that are precursors to gametes, in order to create a human embryo. This procedure has been banned because it could produce a child that has never had a living genetic parent. - Altering the genome of a human cell with the objective that such an alteration be heritable by descendants of the human whose cell was altered.
This prohibition essentially bans germ line therapy, whereby the genes of eggs, sperm and embryos are manipulated in order to overcome heritable illnesses and disorders. Germ line therapy may have great benefits in terms of overcoming heritable diseases, but has been banned because its long term effects are presently unclear. The prospect of germ line therapy also raises the spectre of specifically breeding so-called 'desirable' characteristics, such as strength and even intelligence. - Removing a human embryo from the body of a woman with the goal of collecting a viable human embryo.
- Creating a chimeric or hybrid embryo. A chimeric embryo is a human embryo into which a cell or any cellular component of an animal has been introduced, and a hybrid embryo is an embryo with a mix of human and animal cells. These prohibitions do not, however, apply to the creation of transgenic animals, which are regulated under the Gene Technology Act 2000 (Cth).
- Placing a human embryo into an animal or a human, other than in a woman's reproductive tract, or placing an animal embryo in the body of a human for any period of gestation.
- Importing, exporting or placing into a woman's body a 'prohibited embryo', which is defined to include an embryo created by any of the methods prohibited by the legislation.
The Act makes it clear that the wholesale export of prohibited embryos is not allowed. However, it is legal to export an ART embryo if a woman wishes to continue her treatment overseas. - Commercial trade in human gametes or embryos.
If a person offers, gives or accepts valuable consideration for the supply of a human egg, human sperm or a human embryo, they commit an offence. However, the payment of certain reasonable expenses relating to the supply of a human gamete or embryo – such as costs associated with collection, storage or transport – are not classified as constituting illegal valuable consideration. This provision is designed to ban the giving or receiving of money or other incentives for gametes or embryos.
The maximum penalty for violating any one of the above prohibitions is ten years imprisonment.
Application of the Act
The Commonwealth has no express power under the Constitution to legislate with respect to human cloning and the use of embryos, so the Federal Government has relied on a range of powers – including the corporations power and the trade and commerce power – to give effect to this legislation.
However, this Act may not apply to individuals. To cover this potential loophole, the states and territories agreed at COAG to introduce complementary legislation to ensure full coverage within six months of the Act coming into effect.
Consistent with this need to eradicate legislative loopholes, the Act specifically allows for the concurrent operation of State laws.
Future opportunities for review
The Act provides that the legislation must be independently reviewed after two years. This review must take into account developments in technology, medical and scientific research, and the potential therapeutic applications of such research. The person undertaking the independent review – to be selected by the Minister for Ageing and approved by each State – must also consider community standards, and the applicability of establishing a National Stem Cell Bank. The independent review of the legislation must be tabled in both Houses of Parliament and given to COAG within three years of the Act commencing.
The provision for such a review means that those who support cloning – particularly therapeutic cloning – will be able to argue their case. The review procedure highlights the dynamic nature of the legislation, and parliament's readiness to alter the Act to accommodate future scientific and ethical developments.
Conclusion
The Prohibition of Human Cloning Act 2002 (Cth) implements a national vision by banning human cloning and various reproductive procedures deemed unacceptable. The Act was passed unanimously by both Houses of Parliament, and its passage was informed by a wide range of concerns. These concerns included fears about the human dignity of the embryo, and the uncertainty surrounding the long-term well being of cloned subjects in a physical and psychological capacity. The danger that unregulated human cloning could provide a fertile ground for eugenicists, as well as the current lack of knowledge about the risks associated with therapeutic cloning, were also cited as disturbing by members of parliament when this legislation was the subject of debate. In addition, the apprehension that human cloning poses a threat to notions of individual identity and autonomy, so fundamental to our civilised society, was a major theme in parliamentary discussions.
Therefore, the Act makes human cloning – for any purpose – illegal, and it also prohibits a variety of undesirable and morally unacceptable practices in the sphere of reproductive technology. However, given the provision for a review of the legislation, the Act essentially establishes a moratorium on cloning, which may be lifted or altered if scientific advancements and community attitudes change substantially in the future.