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Biotech News Stem cell legislation - A jurisdictional comparison In brief: Recent claims of successful human cloning and ever advancing research tools and techniques prompt international bodies to continually review human cloning and associated stem cell research legislation. Lawyer Melissa Foong compares current legislative measures enforced by different jurisdictions. By AAR Lawyer Melissa Foong. |
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Background
On 12 February 2004, South Korean researchers reported that they had successfully extracted stem cells from cloned human embryos. The researchers later, however, promised to suspend experimentation with human embryos due to ethical concerns. This situation highlights the ethical and moral dilemmas faced by regulators and the need for a global consensus on human cloning. There have also been a number of reports in the international press of pregnancies of cloned humans but little hard evidence has been provided in this regard.
On one hand, embryonic stem cell research (using stem cells sourced from human embryos) is an area of great promise, and may eventually provide cures to currently incurable diseases. On the other hand, most people find the idea of human clones morally repugnant and some even consider cloning to be an offence against human rights. Governments and international bodies have responded by either declaring moratoria on all experimentation with human cloning, banning reproductive cloning, banning therapeutic cloning or by simply taking no action. This article examines the variety of approaches taken by different jurisdictions.
Australia
In Australia, therapeutic cloning, reproductive cloning and inheritable genetic modification is prohibited under Commonwealth law, but stem cells may be obtained from excess embryos created by assisted reproductive techniques (ART). For a review of the current status in Australia, please refer to our feature article by Caroline Ryan in the January 2002 issue of Biotech News. If Korean scientists had created cloned embryos in Australia, they would have committed a criminal offence under the Prohibition of Human Cloning Act 2002 (Cth). The Act also prohibits the implantation in a woman, import or export of a cloned human embryo and human embryos that have been genetically modified. It is also an offence to give or receive valuable consideration for the supply of a human egg, human sperm or a human embryo. Penalties of up to 15 years imprisonment or fines of up to $495,000 for a corporation or $99,000 for an individual may apply for breach of the legislation.
The Research Involving Human Embryos Act 2002 (Cth) permits use of excess ART embryos produced after 5 April 2002 under license from the NHMRC Licensing Committee or for an 'exempt' use (storage, removal from storage, transport, allowing the embryo to succumb, observation or diagnostic investigation). Embryos that are not excess ART embryos may only be used as part of an ART program carried out by an accredited ART centre. It is also an offence to use an embryo created after 5 April 2002 for research that will damage or destroy the embryo (which includes techniques that clone by removing the nucleus of an embryo). Penalties of up to 5 years imprisonment or fines of up to $165,000 for a corporation or $33,000 for an individual may apply for breach of the legislation.
At this stage, a number of license applications have been submitted to the NHMRC, but the approvals process has not yet been completed. A review of the legislation is scheduled to begin in December 2004.
The Commonwealth legislation overrides previous legislative bans in South Australia, Western Australia and Victoria on research likely to damage or destroy excess ART embryos.
The United States of America
Regulation of human cloning in the United States is far from uniform. At the federal level, in August 2001, President Bush authorised funding of stem cell research using stem cell lines existing before 9 August 2001. Such use could only receive federal funding if researchers obtained the consent of donors, the embryos had been created for reproductive purposes and not research purposes, and no financial inducement had been made to donors. However, there is no limitation on private funding of human cloning research.
The House of Representatives voted in 2001 to outlaw therapeutic and reproductive cloning. A companion bill and other bills dealing with cloning were introduced into Senate but were not passed.
At a state level, however, only a number of states have passed legislation prohibiting human reproductive cloning.
Europe
In continental Europe, 29 countries have signed the Council of Europe Protocol prohibiting the cloning of human beings. The European Parliament has also adopted a Resolution on Human Cloning, which states that human cloning is a grave violation of fundamental human rights which cannot under any circumstances be justified or accepted. Australia, Denmark, France, Finland, Germany, Hungary, Iceland, Norway, Russia, Spain, Sweden and the United Kingdom have prohibited reproductive cloning.
The approach taken by the United Kingdom to human embryo research is similar to that of Australia, with the important difference that therapeutic cloning is permissible under license from the Human Fertilisation and Embryology Authority in the UK. Research licenses will only be granted if the use of human embryos is necessary or desirable to promote advances in the treatment of infertility, to increase knowledge about the causes of congenital disease, to increase knowledge about the causes of miscarriages, to develop more effective techniques of contraception or to develop methods for detecting gene or chromosome abnormalities in embryos before implantation. Further, the creation, storage, handling and use of human embryos outside the body can only be undertaken in licensed facilities.
International
Several international bodies, such as the World Health Organisation and UNESCO have stated their opposition to reproductive cloning of humans on the basis of human rights-based international law. In August 2001, a convention to ban reproductive cloning (to be followed by a treaty addressing research or therapeutic cloning) was proposed by France and Germany. This initiative was supported by 75 countries. The United States of America, Spain, Australia and other countries opposed the convention on the basis that it did not prohibit therapeutic cloning. In November 2003, the United Nations voted to suspend debate on the proposed convention until late 2005, due to the inability of member nations to reach a consensus.
Conclusion
Since the creation of Dolly the cloned sheep was made public in 1997, the possibility of human cloning has loomed large in the public imagination. The response has varied between nations and internationally, with some countries (such as Australia) taking a conservative approach, some declaring moratoria, and others choosing to allow cloning without limitation. Despite the apparent lack of progress in reaching a consensus, it will be interesting to see whether agreement can be reached about a technology that has as much potential to dehumanise as to help humanity.
For further information on the issues raised in this article please contact Richard Hamer +613 9613 8705 .
