Lisa Jardine, chair of watchdog HFEA, warns that coalition plans will scrap the special status restricting use of embryos
The human embryo may be in danger of losing the special status that guards it against use in anything other than important and necessary research, under proposals due out next week.
The law, which followed recommendations from the 1984 report by Lady Warnock, carefully shelters human embryos from routine experimentation, with research allowed only in carefully vetted circumstances. The Warnock report concluded that “the embryo of the human species ought to have a special status and that no one should undertake research on human embryos the purposes of which could be achieved by the use of other animals or in some other way”.
But the Human Fertilisation and Embryology Authority (HFEA), which currently must approve any research application on human embryos after lengthy consultation, fears a government-ordered review may in effect scrap the special status granted to the human embryo under the Human Fertility and Embryology Act.
Professor Lisa Jardine, chair of the HFEA, said: “My worry is that to achieve a consistent approach to research licensing, the safeguarding of the ‘special status of the embryo’ will be lost – that fundamental principle laid down in the Warnock report, which provides special protection in law for the human embryo and embryonic material outside the body.
“I very much doubt that the general public, let alone those groups who are fundamentally opposed to such research on moral grounds, would wish to see this happen without full debate.”
The review, which will be published on Monday, is designed to speed up approval for research applications, including clinical trials. There have long been complaints from scientists that UK regulation is tied up in too much red tape. Drug companies wanting to conduct clinical trials of new medicines have also been critical.
The review was commissioned last March from the Academy of Medical Sciences by then health secretary Andy Burnham and is chaired by Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence. The review will focus on a number of potentially controversial issues, including the use of human tissues and the use of patients’ data and consent.
The HFEA was among many organisations to submit evidence to the review and has been notified that there will be recommendations relevant to its work. It is also on the list of bodies that the current health secretary, Andrew Lansley, has said he was minded to scrap or amalgamate.
The concern at the HFEA, which will be shared by religious groups and ethicists, is that its role in vetting human embryo research will be stripped away and given to the new clinical research regulatory body that the Rawlins review is expected to recommend.
Critics will say that human and animal embryos must be treated differently – and that a new, streamlined set of procedures for obtaining research approval will not be adequate to safeguard the human embryo’s special status.
Debate around the use of human embryos is always fraught. Some scientists involved in embryo and stem cell research, attempting to find causes and cures for genetic diseases and treat infertility, are impatient with the delays involved in the HFEA’s approval processes. But the outcry when some issues are made public clearly show why careful vetting and wide consultation is necessary, says the HFEA.
Among the issues that have made headlines have been the creation of human-animal hybrids. In January 2008, the HFEA allowed a team from Newcastle University to insert human DNA into the egg of a cow. Scientists hope the cells from such embryos, grown for just a few days, will help them investigate diseases such as Alzheimer’s and motor neurone disease. Animal eggs have been used because of a shortage of donated human eggs.
The HFEA has also to deals with applications to create embryos specifically for research purposes – the law allows it, but the regulator decides whether to approve on a case-by-case basis. Also sensitive is “therapeutic cloning” – creating embryos by inserting an adult cell into an egg which has had its nucleus removed. The intention is not to clone a human being but to produce embryonic stem cell lines which are a genetic match to particular parents.