Human Fertilisation and Embryology Bill [Lords]

Certainly the issues are complex and certainly there has been a desire at an early stage for clarity. Whether we have all been swept along by that complexity is perhaps for others to judge. There is certainly a need for clarity, however, particularly in the definitions. I would like to give some examples of where that lack of clarity poses potential dangers that need to be dealt with. As the Minister will no doubt remind me when she responds, the Government's intention in adding a catch-all category to the definition of human admixed embryos in the Bill was, as she explained on a previous occasion, to provide"““further clarity of the scope of the term,””" adding:"““In addition to the four precise scientific definitions already in the Bill, that will ensure that all new forms of embryos that may be developed that contain both human and animal DNA will, where the animal DNA does not predominate, fall within the regulation.””— [Official Report, 18 May 2008; Vol. 476, c. 59.]" That is the test that we have to hold that catch-all category up to. Does it provide further clarity? Does it ensure that all new forms of embryos that we are aware of are captured? The Government's approach was that the human end of the spectrum referred to any embryo containing both animal and human DNA, where the human DNA was more than 50 per cent. of the total, and that all such embryos should and would be regulated under the Bill. The Joint Committee, of which I was a member, considered the matter and reported on it. The issue exercised our minds; indeed, letters were written to the Department of Health and the Home Office, given their twin responsibilities. In our conclusions, in paragraph 163, on page 47 of the report, we said:"““The second issue centres on the human-animal boundary and which entities should be regulated as human embryos and which should be regulated under the Animals (Scientific Procedures) Act 1986. We have received a lot of evidence suggesting that there is no principle, as such, which underpins the Government's choice of 50 per cent. as a cut-off point for whether an entity is sufficiently human to merit regulation by the HFEA, or whether it is more appropriately regulated as an animal by the Home Office. The 50 per cent. rule intended to be embodied in subsection (e),””" as it was then—it has since been amended—"““is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal.””" There can perhaps be few more important issues than what qualifies as human and what as animal. The Joint Committee continued, in paragraph 164:"““We heard evidence arguing that the issue as to what proportion of the entity is human and what proportion is animal is not clear-cut.””" To pick up on the intervention that my hon. Friend the Member for Stone (Mr. Cash) made, the issue is a complex one that has exercised the minds of great experts. The Joint Committee continued:"““For example, Professor Martin Bobrow, Chair of the Academy of Medical Sciences””—" reference has already been made to that august body—"““working party on interspecies embryos, told us that what makes an entity human rather than animal is not easily measured in DNA terms, although, if a line in the sand had to be drawn, he saw no reason why it should not be drawn at 50 per cent.””" The report continued:"““Professor Sir Richard Gardner, Edward Penley Abraham Research Professor of the Royal Society in the University of Oxford, raised the more technical issue of what the 50 per cent. actually refers to—for example, when calculating the relative quantities of mitochondrial DNA (which may come from a cow egg) against quantities of nuclear DNA (which may come from a human skin cell), different answers would result according to whether you measured the mass or the number of genes.””" Those are the experts who say that the issue exercised their minds. I draw attention to the evidence given to the Committee by Professor Robin Lovell-Badge in response to my question, which was:"““In terms of definitions and in terms of inter-species embryos would you want there to be a definition to cover animal chimeras starting with an animal embryo and a set of human cells, whether that should come into the ambit of an inter-species embryo, tetraploid complementation processes and the like””—" we will come to that definition—"““whether that should be subject to the Bill?””" Dr. Lovell-Badge responded:"““Again, you have got yourself right into a difficult position again because it is very hard to come up with any strict definition saying this is 50 per cent. human and 50 per cent. animal, therefore it falls into this category rather than this one, because things change as well. You may start off with an embryo which is 20 per cent. human and end up with something which is 60 per cent. human or vice versa.””" The challenge from the Minister to provide further clarity of the scope of the definition of what is animal, what is human and what should be subject to regulation is surely put to the test by the very nature of the subject. We must ask ourselves a serious question about clause 4—whether it contains the definitions needed for the public to understand, for us to understand and for the scientists to work with. The subject of amendment No. 47 is the case of embryos created by a process called tetraploid complementation. If the results were to be the same in experimentation with human-animal embryos as they are with mice, the potential exists for the embryos to end up being completely or almost completely human. In tetraploid complementation, pluripotent stem cells are combined with an embryo that has been altered in such a way that the cells in the embryo have double the number of chromosomes. The cells are then tetraploid and develop into an extra-embryonic tissue such as placenta, while the pluripotent stem cells develop into the foetus. However, this specific class of embryos would not fall within the ambit of the Bill. That is the issue that my amendment seeks to address.