Australian embryo research laws: time for change?

Sarah Chan, Murdoch Childrens Research Institute, Austalia and Centre for Social Ethics and Policy, University of Manchester, UK

Progress Educational Trust

27 November 2005

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[BioNews, London]

The regulation of research using human embryos is one of the most ethically complex areas of law in any country. Since 2002, in Australia, research on human embryos, including creating human embryonic stem (ES) cells, has been governed by the Research Involving Human Embryos Act and the Prohibition of Human Cloning Act.

These laws provide for the use of 'spare' IVF embryos (that is, IVF embryos that are excess to the parents' reproductive requirements and have been donated) in research, including for the purpose of producing human ES cell lines, under a licensing scheme administered by the National Health and Medical Research Council (NHMRC). 'Human cloning' in the form of creating or implanting a human embryo clone is banned, as is creation of embryos for any purpose other than assisted reproduction.

Provisions for review of the legislation are included in the Acts themselves. This review 'must consider and report on the scope and operation of [the] Act[s]' with respect to developments in technology and community attitudes, and make recommendations as to amendments to the legislation. With only a few weeks until the Lockhart Review on the two Acts, currently in process, is due to report to Parliament (on 19 December), it is timely to consider what effect the existing laws have had on Australian research, and what changes may be needed.

The current legislation has had some notable benefits for Australian research. Firstly, it created a unified national framework for the regulation of embryo research in Australia. Previous inconsistencies between state laws produced a climate of uncertainty, impeding research and raising ethical problems. The new legislation removed these difficulties, provided public certainty and allowed research to proceed at a national level.

By specifically permitting embryo research, the laws facilitated the progress of Australian research. The three years since the introduction of the Acts marked significant developments in Australian ES cell research, including the establishment of the Australian Stem Cell Centre, the production of several new ES cell lines and further growth in biotechnology investment and commercialisation. These achievements will continue to benefit Australia locally and in the international arena.

However, the existing legislation is far from problem-free. Criticisms have been levelled at the law from many quarters, both those in support of and opposed to embryo research. A commonly acknowledged problem is that the law is unclear ethically. Much of the debate surrounding the introduction of the Acts centred on the moral status of the embryo. Parts of the legislation (such as the temporary moratorium, now expired, on the use of embryos created after 5 April 2002) appear to be an uneasy compromise between two conflicting ethical perspectives rather than a sound legislative remedy. On controversial issues such as this, however, perhaps such legal fence-sitting is to be expected.

More serious is the complaint that the legislation is itself unclear about what is permitted. For example, the Acts do not contain any definition of what constitutes an embryo. Previous state legislation defined an embryo as the product of fertilisation between an egg and sperm. However, this fails to cover embryos created by nuclear transfer (if such entities are indeed embryos). Although the creation of a 'human cloned embryo' is prohibited by the law, there is no clear definition as to what exactly constitutes such.

Another criticism is that the laws lack the flexibility needed to keep pace with rapidly changing technology, instead relying on the slow-moving vehicle of legislative change to keep up with scientific progress. Since 2002, science has made dramatic advances such as the first successful creation of nuclear transfer human ES cells and the production of artificial gametes from mouse ES cells. The legislation was enacted when these techniques were only a possibility; in light of their subsequent realisation, it is clear that the laws should be re-assessed.

What outcomes can we hope to see from the Lockhart report? Perhaps the following recommendations for change may be hoped for. Firstly, further clarity in the law is required so that scientists can pursue their work in an atmosphere of confidence in research, both what is permitted and what is not. This is best done through a mechanism that allows flexibility, to take account of recent and potential future scientific developments.

One model to which Australia might look for guidance is the UK system of regulating embryo research. Their Human Fertilisation and Embryology Authority (HFEA) operates in a similar manner to the NHMRC licensing scheme, but with much broader jurisdiction and hence greater scope to consider new technologies in light of all current ethical and scientific thought. Although the operation of the HFEA itself is now under review, it has successfully regulated research in the UK for the past decade and a half, allowing substantial advancement of science in that country. If Australia is to keep pace with the rest of the scientific world, it is clear that we should look for means to facilitate research through the law rather than impede it.