---

Human Fertilisation and Embryology Bill [HL]

I shall speak to Amendments Nos. 19 and 20 in this group, which I have tabled for the very reason set out so well by my noble and learned friend Lord Mackay of Clashfern. It is highly unsatisfactory that in debating a subject as sensitive and difficult as interspecies embryos we have no clear idea of what kinds of embryo are capable of falling under that heading. Like my noble and learned friend, I am distinctly uncomfortable about giving the Secretary of State a broad order-making power to widen the scope of new Section 4A, even under the affirmative procedure. It would be better to omit that provision altogether than to have the current lack of clarity about the definition, difficult as it may be to come up with such a definition. At the same time, I am conscious that the creation of interspecies embryos is permitted, and has indeed been authorised, under the Animals (Scientific Procedures) Act 1986. As my noble friend Lord Jenkin pointed out, the thrust of that Act has little to do with embryology as such; it is about minimising suffering in animals that are used for medical research. The Act, almost by default, allows for a wide range of experimentation involving animal embryos to which human genetic material has been added. It appears also to regulate only those procedures involving so-called protected animals, which are defined in the Bill. Animals that do not fall within the scope of this definition are not subject to regulation when it comes to research. The question of when an animal embryo ceases to be an animal embryo and becomes human is equally not addressed in the Act. It leaves us as bereft of a definition of interspecies embryo as does this Bill. That cannot be satisfactory in an area of law as important as this. I am particularly worried about the scope that there appears to be in the 1986 Act to authorise research that involves bringing hybrid creatures to maturity inside the womb of an animal, a process that this Bill would explicitly ban in relation to an interspecies embryo in any of the forms listed in new Section 4A. We have read about transgenic mice that are bred using human genetic material, including the mouse on which a human ear was made to grow. I am not condemning that kind of experiment, which may well carry the potential for enormous good, but it takes us close to an area with which most of us would, I think, feel decidedly uncomfortable if, for example, there was any question of replicating a human-like brain inside an animal. I have no idea whether that is technically possible, but the issue that should concern us is whether it is currently legal or capable of being allowed. What is the acceptable time limit for propagating animal-human hybrid embryos in the laboratory? For hybrids that are at least 50 per cent human, this Bill says that the limit should be the earlier of 14 days or the appearance of the primitive streak. But for animal-human hybrids—that is to say, hybrids that are predominantly animal but partly human—the current law is a lot less restrictive, especially for animals that do not fall within the definition of protected animals. What are we to think about that? These are major questions on which we currently have no guidance at all. The report of the Joint Committee said: "““There is no principle, as such, which underpins the Government's choice of 50% 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% rule is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal””." That indeed is the nub of the problem and, to be frank, it does not make life any easier to be told by the Government that the definition of interspecies embryo proposed by the Joint Committee will not do because it would sweep up within it various sorts of scientific procedure currently overseen by the Home Office. The retort to that is surely that the regulatory structures ought to follow the ethical principle rather than the other way round. If it is not possible to distinguish the ethic status of something that is 99 per cent human from that of something that is 49 per cent human, we are bound to question whether the dual arrangement for research approvals makes proper sense. The Government’s adherence to the dual arrangement would be more tenable in practice were it possible to predict in advance that an entity would be, say, 20 per cent human on the basis that it begins as 20 per cent human. But, unfortunately, as Dr Robin Lovell-Badge told the Joint Committee, things are not as neat as that, since, in his words, you may, "““start off with an entity which is 20% human and end up with something that is 60% human or vice versa””." It seems fairly clear that if in legislation we doggedly stick to the artificial distinction between entities that are more than 50 per cent human and those that are less than 50 per cent human, yet fail to define in the legislation what we mean by interspecies embryo, there are bound to be categories of entity that do not fall to be regulated by either the 1986 Act or this Bill. We have to deal with that, and the Government and Parliament need to approve a legal architecture that would straddle all types of interspecies embryo—an architecture that rests on the foundations of ethics and science and which has clear guidelines but which allows for a sensible degree of autonomy by the regulator in taking decisions. We are nowhere near that position at the moment. I hope that the Minister will take seriously an issue about which I and my noble friends share very considerable concerns.