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Human Fertilisation and Embryology Bill [HL]

My Lords, first, I thank the noble and learned Lord, Lord Mackay, for his tremendous interest in this area and for his intellectual rigour in identifying a proper definition. However, the amendment seeks to replace the regulatory-making power under proposed new Section 4A(5)(e) of the 1990 Act as inserted by Clause 4, which would permit regulations to extend the list of interspecies embryos and replace it with a provision aiming to capture all forms of embryos that are predominantly human in their genetic make-up. As we have heard, there is always a difficulty in adopting a broad definition that leaves scope for interpretation, particularly in cases such as this one. The Government, working with professional bodies such as the academy, the Royal Society, the Medical Research Council and the Wellcome Trust, endeavoured to put together a catch-all definition that would ensure that, should a new form of human admixed embryo come to light, there would be the scope for it to come within HFEA regulation. However, a definition attempting to cover different entities such as chimera, hybrids and transgenic embryos, where such a definition is easily interpretable by scientists in the HFEA and which is also practically sound, has proven elusive. The Bill therefore includes a regulation-making power to extend the list of human admixed embryo at proposed new Section 4A(5)(e). The amendments introduce a more limited provision to ensure that any embryo will be regulated if it contains both animal and human DNA and throughout the period of its keeping and use of the animal DNA does not predominate. The practical application of this definition may leave both the regulator and scientist in difficulties. The definition seeks to ensure clarity, but we do not believe that it achieves it. For example, if on any day of its gestation the embryo is considered to be more human than animal in terms of predominance of DNA, it falls under the regulatory remit of the authority; but would it not fall under its remit beforehand? Does this mean that the scientists can culture it before that point without a licence or would they need one because it would break through the 50 per cent barrier on a different day or if a scientist destroyed it at 10 days, when at the 11th day, it would, if it had been kept, become predominantly human? The definition also refers to the predominance of DNA, including nuclear and mitochondria. In some cases, the predominance of DNA would shift throughout the keeping of an embryo. When assessing an embryo on day 13 that contains hundreds of cells—some of which may be human, some animal, some hidden and some even hybrid—it would be difficult for the researcher to make a sensible estimation of the proportion of DNA which is human and the proportion which is animal. Let us not forget that the functionality of that small content also might be different. Does this researcher have to estimate the number of mitochondria found in each cell and how this affects the balance? Does the researcher count the number of genes or the physical quantity of DNA? We also know that not all DNA is functional. In fact, large portions of human and animal genomes, according to our current understanding, have no functional role in the development. However, as we all know, our understanding in this area is far from complete. For these reasons, I believe that, although I share with the noble and learned Lord, Lord Mackay, the wish for a straightforward definition without the need for regulation-making powers, the task is not possible without adversely affecting the scientist or the HFEA or, in some cases, both. New Section 4A(5)(a) to (d) captures all the entities that we currently predominate the human end and are deserving of regulation by the authority set up to license human embryo research. We believe that at this time, the list is robust. However, should new technologies come to light, we have the power to bring them within legislation through the regulatory-making power in new Section 4A(5)(e), following appropriate debate in Parliament. I reassure noble Lords that the process of taking a hypothesis to a laboratory takes time, research ethics approval and funding. The HFEA and the Government will continue to monitor developments in this area of science. I am sure that, if needed, regulations would be in place well before the researcher had the appropriate clearance to begin work. I invite the noble and learned Lord to withdraw his amendment.