US bioethics Council releases ART recommendations

President Bush's Council on Bioethics has released wide-ranging recommendations calling for greater regulation of assisted reproductive technology (ART). The report, entitled 'Reproduction and Responsibility: The Regulation of the New Biotechnologies', advises that the American federal government should become more involved in the regulation of fertility clinics. It says the fertility business is rapidly increasing in the US, but at present is largely unregulated.

The recommendations were originally released in draft form in November 2003, and the final wording of the draft version was approved in January 2004, after some amendments. They form part of the Council's continuing project on 'US Biotechnology and Public Policy and the Biotechnologies Touching the Beginnings of Human Life', which began more than a year ago and is looking at a wide range of issues in assisted reproduction 'from consumer protection to research regulation'. The latest recommendations form the final version of the report that will be sent to the President for approval.

In the report, the Council also says that Congress should, for the moment, set aside the divisive issue of human embryo cloning for research and quickly ban other embryo experiments where there is consensus that they are unethical. These include limiting research on human embryos to a maximum of 10 to 14 days after fertilisation, the creation of human-animal chimeras, transferring IVF embryos to the womb for purposes other than reproduction, creating embryos from fetal cells and gestation of human embryos in animals. It also proposes that 'attempts to conceive a child by any means other than the union of egg and sperm' should be prohibited, which would have the effect of banning human reproductive cloning. A statement from five Council members, attached to the report, says 'we believe that this language provides a way for Congress to ban reproductive cloning while agreeing to disagree on the question of cloning for biomedical research'.

The 'Reproduction and Responsibility' report also examines the converging fields of fertility treatment, human genetics and embryo research and says that the Council found an 'ethically unstructured world in which the lines between science, medicine and human experimentation are unclear'. It calls for an input of federal funds to expand data collection from fertility clinics - particularly on the use of genetic tests that can help parents select the sex and other traits of their children. These techniques involve the removal of a cell from an embryo, and the long-term consequences of this, if any, should be studied. It also calls for a long term study to help resolve lingering concerns about the health effects of various assisted reproduction techniques on patients and their offspring.

Dr Leon Kass, chair of the Council, said that it was their hope 'that public spirited members of Congress might see fit to embrace these matters', adding 'with the field moving very rapidly - and no existing oversight, never mind regulatory mechanisms, in place - I think it is urgent we set down some markers on which everyone can agree while continuing to argue about those things that still divide us'. But despite amendments made to the original wording of the report, some people remain sceptical. 'The Council appears to have struck a more balanced tone', said Pamela Madsen from the American Fertility Association, but added 'we will have to watch this very carefully' when it comes to writing legislation. A spokesperson for the American Society for Reproductive Medicine said that it was good that the original report had been altered in response to comments from patient and professional groups and that there is 'much in this report that we can support'. It was also good, they said, that some of the more 'technical' aspects had not yet been included, as even the most carefully worded legislation could be affected in debates and end up as 'bad law'.