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Stem cells – gateway to 21st century medicine

Box 1 | How has stem cell research been legislated in Australia, the US and the UK?


Australia

In December 2002, Australia passed two pieces of federal legislation to regulate cloning and embryonic stem cell research The first, Prohibition of Human Cloning Act 2002, outlawed any form of human cloning, whether it be to generate tissues (therapeutic cloning) or a new human being (reproductive cloning). The second, Research Involving Human Embryos Act 2002, allows researchers to access surplus human embryos, under strict conditions.

A major objection to stem cell research, from both religious and non-religious groups, is that it devalues human life because it uses embryos as 'a means to an end'. For that reason Australia's legislation ensures that embryos cannot be created for the sole purpose of harvesting their stem cells. The only embryos that can be used are surplus embryos that were available at the time the legislation was drafted in April 2002. These can only be used if the embryo donors give their consent. 

Researchers who want to use such embryos are legally required to obtain a government licence. To get such a licence they must show that their research will lead to new knowledge that can't be obtained by other means. Applications must first be approved by the in-house ethics committee of a researcher's institution, and then by a National Health and Medical Research Council Committee made up of scientists, lawyers and ethicists.

United States

In the US, government-funded researchers are not allowed to make stem cells from spare human embryos. But there is no criminal law against it, as there is in Australia; so researchers in private companies do not have the same constraints as researchers receiving government funding. But it is government-funded scientists who carry out the vast majority of research in the US, and they say the US effort is falling behind because of the restrictions on them. 

At present, these government-funded researchers have access to only nine embryonic stem cell lines. (Five of which came from Australia.) Scientists think that more cell lines are needed for a number of reasons. For example, additional cell lines would provide more genetic diversity, they would be a source of replacements in case problems develop with existing cell lines, and they could serve as sterile lines for future cell-based therapy. US researchers are lobbying President Bush to revise his ruling of 2001.

United Kingdom

The House of Commons (December 2000) and the House of Lords (January 2001) voted in favour of permitting research using human embryonic stem cells and approved the creation of embryos for specific research purposes. Under strict licensing the relevant legislation allows research involving human embryos that have not exceeded the fourteenth day of their development. The Human Fertilisation and Embryology Authority has regulatory responsibility and will not licence any research that has reproductive cloning as its aim.

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Posted October 2003.

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