Lockhart review backs therapeutic cloning

The independent stem cell legislation review committee chaired by former Federal Court judge John Lockhart has given its support for somatic cell nuclear transfer (SCNT), sometimes known as therapeutic cloning.

The committee handed its findings to the Australian government yesterday after six months, in which it reviewed more than 1000 written submissions and heard personal presentations from more than 100 people on the Prohibition of Human Cloning Act 2002 and the Research Involving Human Embryos Act 2002.

"The committee believes that it is important for Australia to maintain its role as a leader in the advancement of high quality and ethically sound scientific research and medical practices," said Lockhart in a statement. "To this end, we support the continued use of both adult and embryonic stem cells under existing guidelines for research and do not recommend that any additional legislative restrictions be applied."

The Lockhart Committee, which also included Nobel laureate Barry Marshall, lawyer and ethicist Loane Skene, neuroscientist Peter Schofield, clinical neurologist Pamela McCombe, and clinical ethicist Ian Kerridge, made 54 recommendations in relation to the two Acts.

"We think the Lockhart committee has done an excellent job in consultation and balancing the views of different parties in society and the recommendations that they've come out with will be helpful to stem cell scientists in Australia, if they're accepted by parliament and become legislation -- which is the step yet to be taken," said Australian Stem Cell Centre CEO Hugh Niall.

AusBiotech CEO Anna Lavelle welcomed recommendations to allow SCNT and called on state and Commonwealth governments and federal parliamentarians to accept the outcomes of the review with bipartisan support for appropriately amended legislation when it comes before parliament.

Unequal footing

As well as recommending that SCNT -- where an embryo is created by removing the nucleus of an egg and replacing it with the nucleus of a donor somatic cell -- be permitted, the committee also recommended that human embryos created using the genetic material from more than two people also be permitted.

"The inability to carry out somatic cell nuclear transfer experiments -- which is still the case -- puts Australian scientists on an unequal footing with their counterparts in, say, the United Kingdom," said Niall.

Megan Munsie, the scientific development manager of privately-held company Stem Cell Sciences, said she was pleased that an independent body had seen the merit in the use of SCNT for research. "The implication for us is that now we'll be able to pursue our areas of interest, provided we have appropriate license and the recommendations are accepted."

The committee recommended that human reproductive cloning remain prohibited and that an embryo created through the fertilisation of a human egg by human sperm should only be used for infertility treatment.

"The clarity of comment regarding the distinction between SCNT for research and the necessity to prohibit reproductive cloning -- to prevent the implantation of any embryo generated by SCNT -- was really clear and well articulated," said Munsie.

Egg donation for such practices as SCNT should be strictly managed, the committee said, and to reduce the need for human eggs the committee also recommended that the use of animal eggs (oocytes) be permitted so long as it was under license and the embryos were not implanted into a woman.

"The Lockhart committee makes clear the motivation for [using animal eggs] is to reduce the need for human eggs," said Niall. "There's also reference to experiments involving mitochondrial preparations from different animal sources that could lead to a better understanding of mitochondrial diseases."

Changed definition

The committee also recommended that the definition of human embryo be changed to a slightly later stage in the fertilisation process, namely the first cell division (cleavage).

"The committee thought that the revised definition fitted with the broad public understanding of what a human embryo is," said Niall. "It simplifies matters and that simplification will allow clearer debate about the kind of experiments that can and can't be done."

The use of excess IVF embryos should continue to be permitted under licence, the committee said. Also, such embryos not suitable for implantation should be permitted to be used for research, training and improvements in clinical practice rather than discarding them.

"We don't want to lose sight that this legislation covers the use of embryos in research, and that research is a very important aspect -- particularly in developing optimum and improved techniques for IVF and also for stem cell research," said Munsie.

Ongoing review

In another recommendation that could reduce the need for ongoing review of the Acts, the Lockhart committee said that so long as the licensing committee reported in detail to the NHMRC and parliament, it should be able to provide rulings on the interpretation of practices that are currently prohibited under the Acts. Also, the licensing committee should be able to grant licenses for research that is not expressly permitted but within the tenor of the Acts, said the committee.

Niall said that he believed this recommendation had been included as "an insurance policy against there being some quite unexpected breakthrough in technology... I would not expect it to be used with any frequency and it may well not be used at all," he said.

"There's a direct feedback into parliament so it's not as though they'll be giving researchers carte blanche to go an do what ever they want," said Munsie. "There will still be a necessary and essential regulatory framework to ensure that this work is done but done in an appropriate fashion.

"The licensing body has operated very well to date, in ensuring that only projects that can be demonstrated to have merit get a license and that must continue," she said.

Commercialisation OK

The Lockhart committee also recommended the import and export of human embryos and human embryonic stem cells should be permitted.

Commercialisation of human stem cell research should be supported, said the committee, "in order to ensure that potentially beneficial products can be developed for therapeutic use".

The committee also recommended that a national stem cell bank be established and that further public education and consultation programs are needed in the area of stem cell research.

"We've certainly been promoting that our MEL cells should be widely available and we welcome the establishment of a national stem cell bank so this valuable resource can get out to as many researchers as possible," said Munsie. "These stem lines have been donate altruistically by patients and they should be available for researchers both in an academic and commercial setting."

Where to now?

The recommendations made by the committee will be considered by parliament next year in what is expected to be a heated debate. As yet it is unclear whether parliamentarians will be allowed to vote according to conscience, as was the case in 2002 when the Acts were originally passed.

"We certainly want to be engaged in the debate, and will be available and will be actively calling on state and federal parliamentarians to see the merit in this technology," said Munsie.