The House of Commons Science and Technology Committee's report, 'Government Proposals for the Regulation of Hybrid and Chimera Embryos', is its response to two related events: firstly the UK Government's intention to outlaw the creation of such entities, announced in December 2006 in its White Paper (1), and secondly the Human Fertilisation and Embryology Authority (HFEA)'s decision in January this year to delay a ruling on licence applications from two teams that wanted to pursue work on particular forms of such embryos under the existing law.
The Committee is critical of both the Government and the HFEA. It believes the Government based its proposal on a knee-jerk reaction to a poorly conducted public opinion survey. To block important research on these grounds is 'unacceptable', says the Committee. It believes that the HFEA, working under current law, should have reached an immediate decision, both on whether the particular hybrids - created by cell nuclear replacement of a human nucleus into an enucleated animal egg cell (which it calls cytoplasmic hybrid embryos) - fall within its remit, and on whether, if they do, the researchers could proceed under licence.
The support the Committee has given to researchers in this area is to be welcomed. However, in my opinion there is a problem with the report's treatment of human-animal cytoplasmic hybrid embryos, which relates to the broader question of how this field ought to be governed.
What is a human embryo?
Rightly, the HFEA is taken to task for delaying a decision. But the Committee goes further than this. It believes the HFEA is also wrong to have doubts about whether it has the power to license work using cytoplasmic hybrid embryos. The key question is what is a human embryo. The answer depends in part on whether we are concerned to answer this from first principles, or from the point of view of the current law. Regarding the former, I liked Professor Martin Bobrow's thoughtful response during the 5 February evidence session: 'the definitions of humanity that I know about all apply to things that walk upon the earth rather than things that live in the bottom of the Petri dish, and I am not sure that there is a very straightforward answer'. But regarding whether the HFEA has the power to license research in this area, this hinges on the definition of human embryo in the law as it stands.
Human embryos under the HFE Act are embryos created by fertilisation of a human egg by human sperm. In 2003 a House of Lords judgement (Quintavalle v. Secretary of State for Health) broadened the definition to include embryos created by cell nuclear replacement of a human cell into a human egg - 'therapeutic cloning. It did this by including within the definition of a human embryo the potential to develop into a live-born human being, of the kind that Martin Bobrow and the rest of us would recognise, if placed in the right environment, namely a woman's uterus.
On this basis, the HFEA has its doubts about whether human-animal cytoplasmic embryos are human embryos under existing law. Whatever the rights and wrongs of this particular argument, why is the Science and Technology Committee, given its general desire to reduce the burden of regulation on researchers, so concerned that these embryos should be specifically regulated by the HFEA? And why does the Committee want all use of human-animal hybrid and chimera embryos to be subject to licensing under a new law, akin to the way human embryos are regulated under existing law? All they say on the broader issue is that it is useful and necessary to reassure the public concerning the creation of half animal-half humans (paragraph 91). Public fear, it would seem, is 'unacceptable' when the Government uses it to argue for a ban but acceptable when used to justify strict regulation.
In his evidence to the Committee during this inquiry, Robin Lovell-Badge relates that he had hoped that human-animal cytoplasmic embryos might have been viewed as an experimental research tool that didn't require a specific licence. Considering the profound doubts about their potential for development as embryos, the ease with which human cell nuclei and animal egg cells can be obtained and the existing prohibitions on implanting such embryos into a woman, it was a reasonable hope. But it has been overtaken by events, including this inquiry's recommendations.
Stifling the liberal impulse?
In its major report into the area in 2005, the Science and Technology Committee pushed for a more liberal regulatory regime for both fertility treatment and embryo research, one which would allow researchers and clinicians greater freedoms, both in terms of what they are allowed to do and in terms of the regulatory burden under which they work. In this they were, tentatively, supported by some scientists. The Committee proposed a slimmed-down and faster system of regulation, with a greater emphasis on trusting professionals to follow the law absent detailed regulation. Indeed, in principle the Committee suggested that there might be no need for a regulator specific to the field and that the law itself could be changed so that research using embryos should be broadly permitted except for specific prohibitions (to be decided) (2).
Two years on, keen for the regulator to license cytoplasmic hybrids under the current law and for Government to legislate for the regulation of the many other forms of hybrids and chimeras under a new law, the Committee runs the risk not just of burdening a particular form of research with regulation but also, more broadly, stifling the liberal impulse that it helped to initiate.