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What has now happened is that the Government have not come forward with another catch-all provision but have taken refuge in a power to add to the list of things which amount to an interspecies embryo,
Whatever you have to say about that, it is a fairly all-embracing kind of definition; the regulation-making power does not seem to be extremely restricted.
When we are talking about interspecies embryos, as many Members of the Committee were doing earlier, it is essential to know what it is we are talking about. The interspecies embryos that the Government are seeking to capture, if that is the right word, in the Bill were described by the noble Lord, Lord Darzi, in his reply at Second Reading as the
I think that that was his phrase—of interspecies embryos. That immediately suggests that there is more to the spectrum than is intended to be captured by this definition—and, of course, we do not have far to go to find some examples.
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I had understood, rather vaguely, that the Secretary of State for the Home Department regulated this, but, with the great help that I received from officials of the noble Lord’s department, I have examined this issue a little more fully. It seemed to me that if we could not get a catch-all provision, we could have a general provision and then extract from it what had already been given to the Secretary of State for the Home Department. That would make a perfectly reasonable type of definition also and I was anxious to see how that could be fitted into the scheme.
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The answer is that it does not fit at all. The Animals (Scientific Procedures) Act 1986 proceeds by requiring licences for animal experimentation that causes distress, pain or harm to the animals that are the subject of the legislation. The embryo of an animal does not come under the protection of that legislation until it is half-way along the gestation period for that particular animal, unless it be an animal that does not have that kind of characteristic and then it is when it first qualifies for independent feeding. So it is not captured by the Home Office legislation unless and until it is of a half-gestation period and only if it is an animal embryo.
I believe that an interspecies embryo which starts off being an animal embryo and has human material inserted into it in some way or other is no longer the embryo of that animal. If that is right—and that, I think, was the hypothesis of the answer given to the Joint Committee to which the noble Lord, Lord Alton, referred—the result is that interspecies embryos are not regulated at all if they come from that end of the spectrum. They might of course attract regulation if they were to be implanted in an animal, as that would be a part of the procedure which would require a licence, but if nothing like that happens, then as far as I can see there is no regulation of these at all. I do not find that a very satisfactory situation.
The split between what I might call “the human end of the spectrum” and “the animal end of the spectrum” is rather hard to define. When the working group of the association met to consider these matters it decided that the Bill with which we are concerned should aim to capture human embryos treated with animal material, leaving out animal embryos treated with human material. That was its broad definition, and basically that is what was reflected in the draft Bill and in the Bill before us. However, it is not satisfactory. Indeed, in some ways, we are in a position rather like the one we were in before the 1990 Act became law. Everyone felt that the embryo research and in vitro fertilisation should be the subject of control and there was unanimity that some regulation was required. The only dispute was what that regulation should be. In particular, the main dispute was whether research on the embryo up to the 14-day or primitive-streak stage should be allowed.
The noble Lord, Lord Alton, and those of a like mind who have spoken in the previous debates on these ethical issued would think it right that this area of interspecies embryos should be regulated, but the question is what that regulation should be. From what
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We have had some communication with experts in this area and my noble friend Lord Jenkin of Roding will speak about that. The parts of the scientific community that are interested in this field have seen the problem and are seeking to address it. They are better qualified than I am to provide an answer, although we tried to do so in the Joint Committee’s report. We realised that it was not perfect, but then no research is. As we have just heard, you cannot say it is perfect in advance; you can only do that once it has happened.
We did our best, but the Government felt that that was not good enough and have proposed this route instead. It is not right to leave this important area of regulation in this vague state, with a ministerial power to say what the definition really is. The noble Lord, Lord Darzi, said at Second Reading that that gave flexibility. I entirely accept that it does, but flexibility is inappropriate at the point of definition. When you want to regulate something, I submit that it is vital that the area to be regulated is clearly defined. It is about as mad to have flexibility in that area as it would be to have flexibility in a fence around an animal enclosure. Flexibility is very useful, and Ministers—myself included—have often invoked it in support of powers of various kinds, but I respectfully suggest to your Lordships that it is not appropriate when it comes to defining an area of concept and research as important as this, where there are ethical principles to be followed that are already in the 1990 Act and will be continued in the licensing of this type of interspecies embryo, should it be allowed under provisions similar to those in the Bill. I beg to move.
The Deputy Chairman of Committees (Viscount Ullswater): I must advise your Lordships that if this amendment is agreed to, I will be unable to call Amendment No. 9 because of pre-emption.
Lord Jenkin of Roding: I do not need to add a great deal to what my noble and learned friend has said about the purpose for which we tabled our amendment. We did so not necessarily with a view to removing the power, but to open up the discussion about the apparent conflict between the procedures under the Bill and those under the Animals (Scientific Procedures) Act 1986. The purposes of the two bits of legislation are entirely different. Whereas we are concerned with protecting the human embryo and regulating the circumstances in which it can be used, whether for therapeutic care, therapy or research, the Home Office legislation is concerned with animal protection, animal welfare, good husbandry and so on. Of course it envisages that there may be transgenic experiments, but, as my noble and learned friend has explained, the regulation comes in only at a
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“You are quite right, we have produced this definition for our purposes, that is what we are here for. We are also working in conjunction with the Home Office to make sure that the two bits of legislation do butt up against each other and do not contradict each other. There may be more work to be done on that”.
I think we would all agree with that. Mr Webb highlighted a problem in response to another question from my noble and learned friend:
“Lord Mackay of Clashfern: What is the requirement so far as using embryonic material to implant into animals is concerned?
Anyone who has been in government and has had to deal with the Home Office will recognise that completely. The Home Office has always had a strong instinct to defend its boundaries. That has been its culture. I suspect that the noble Lord, Lord Darzi, will find that for himself if he has to try to sort out how we will deal with this in the context of the Bill.
As my noble and learned friend has said, I have been in touch with one of our principal witnesses, Professor Martin Bobrow, who chaired the committee of the Academy of Medical Sciences and gave us valuable evidence on how the medical scientific world views this difficulty. In answer to my noble and learned friend, Professor Bobrow said:
“The idea of a single, general definition is very attractive. The problem for me in this area is that we do have this bifid system where we regulate animals and things that come from an animal in one way and things that start as human in another way. We are trying to deal with the meeting of it”.
He then went on to comment on the amendment that my noble and learned friend had put to him.
It is clear that at the moment we are in a difficult and unsatisfactory situation. My first proposition is that it is for the Government to sort this out. If the Bill says “the Secretary of State”, the convention is that that means any Secretary of State—including, of course, the Home Secretary—not just the Secretary of State for Health. That is the pattern of the legislation. It rests firmly upon the Government to find a solution to the problem, otherwise the regulators will find great difficulty, as my noble and learned friend has said, in knowing what to regulate.
Professor Bobrow, with whom I have had a long discussion today, said that the Academy of Medical Sciences has been sympathetic to a suggestion, made some while ago, that early in the new year a workshop should be convened, followed by a new working party to consider the status of animal embryos with some human admixture. That would allow widespread debate and perhaps deliver some new thoughts into the discussion about the definition of what constitutes a human embryo. That, of course, is the question. What is “human”? We are very concerned to defend humanity in this. The reason why we attach such importance to the embryo is that it is human. The profession is now going to sit and work on that. It will not be just the academy; it will be the Medical
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Lord Alton of Liverpool: I have a brief question for the noble Lord, who has made a hugely important point. Given his own experience in government, which he has alluded to, if this is not resolved, what does he think should then happen with this Bill? Should it proceed in an unamended form or should it be sent back in its entirety?
Lord Jenkin of Roding: It is too soon for me to express an answer on that. I intend to keep in touch with the scientists, as I have no doubt others will. If the Bill contains this regulation-making power, this may have to be the mechanism by which one can resolve it, but we are not nearly there yet.
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Lord Winston: The noble and learned Lord, Lord Mackay, raises an important issue with his amendment. I draw the attention of the Committee to one aspect of this in the research area. True stem cells, at best, are totipotent; that is, they can develop into any one of numerous cell types—in the case of the human body, it is about 220 different cell types. There are various degrees of potency. Some stem cells are pluripotent, which means that they can develop into many tissues, but not all. Some stem cells—mostly, it seems, from adult sources—have even more limited potential and can grow only into certain tissue types.
There are many ways of assessing a stem cell’s potency for further development. One can look at the genes which the cells produce and get some idea of how they are likely to progress if allowed to differentiate into different tissues. One can look at the tissues which are produced in vitro in the laboratory, to see whether one is developing nerve cells, muscle cells, heart cells and so on. However, one of the best tests—it is almost the prime test, and the one that has been most used in the literature and the most valuable—is to mix stem cells with an animal embryo, usually that of a mouse, to see what happens to the human cells during that animal’s development, which is then sacrificed either before gestation has finished or shortly afterwards.
The classic experiments have allowed it to be established that good stem cells, which one really might want to use, can be incorporated in a wide range of tissues—liver, spleen, kidney, brain, heart and so on. This is without doubt an extremely valuable test. The question is whether it would continue to be a viable possibility for experimenters in this country who look at stem cells in the future. It would seem to me very important that it does; there
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Lord Harries of Pentregarth: The noble and learned Lord, Lord Mackay, and the noble Lord, Lord Jenkin, raise crucial points. In light of what they said, I wonder whether the Government are right to have accepted the recommendation of the Science and Technology Committee that all forms of human-animal hybrid should be brought into the Bill.
I remind your Lordships that a number of scientific research projects are banging on the door and wanting permission to use cytoplasmic hybrids for the reasons which we have discussed previously; that is, taking out the nucleus of an animal egg and replacing it with the nucleus from an adult human cell. The HFEA has received scientific and legal advice that this is a human embryo from the standpoint of the 1990 Act. It is very different from the other kinds of human-animal hybrids—the so-called true hybrids—which have all been brought together in this definition. I wonder whether a way forward might not be to ensure that the question of cytoplasmic hybrids should be in the Bill so that the House’s opinion on it can be tested. Scientists would welcome the opinion of this House and the House of Commons. The suggestion of the noble Lord, Lord Jenkin of Roding, of a workshop to look into other forms of hybrids should be pursued, because, as two other noble Lords have suggested, we have not yet had a proper moral compass on them. As far as cytoplasmic hybrids are concerned, the HFEA has received scientific and legal advice that they are human embryos from the standpoint of the 1990 Act.
Lord Alton of Liverpool: Does my noble and right reverend friend believe that it is right, if the report in today’s Times is to be believed, that on 5 December—that is, later this week—the Human Fertilisation and Embryology Authority will consider whether to grant one of these licences? Does that pre-empt not only the points that have just been made so well by noble Lords, but also the debate on this Bill in your Lordships’ House?
Lord Patten: I strongly support the amendment argued by my noble and learned friend Lord Mackay and my noble friend Lord Jenkin of Roding. I have only two, rather simple points. First, any practitioner of the ministerial arts—being a Minister is probably more of an art, sometimes black rather than white, than a scientific practice—is always wise to have as much wriggle room as possible and, in taking legislation through this place and another place, to have opt-outs, opt-ins and the ability to put things in and out by regulation. It would be helpful to know at this or some later stage of these considerations in Committee whether the noble Lord, Lord Darzi, sees the regulation-making power that he proposes as having to be debated regulation by regulation in your
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Secondly, although I am no expert in these medical and ethical issues, it strikes me that if the noble Lord has his way and line 35 appears on the statute book when the Bill passes into law, it would be possible for him or one of his colleagues in the Department of Health to come forward with a regulation in some future year, notwithstanding the fact that there has been an enormous amount of regulatory angst and philosophical discussion about the ethical position of this or that outside your Lordships’ House.
Lord Patel: I have much sympathy with what noble Lords have said. My professional friend, the noble Lord, Lord Winston, spoke about the tests. The test of a stem cell’s pluripotency would apply also to induced pluripotent cells. They would have to be tested for efficacy by using that kind of test—and that is the standard test. One cannot conduct such chimera tests in humans; they have to be done in animals, using human stem cells.
I agree with my noble and right reverend friend Lord Harries of Pentregarth that what scientists are seeking is to use cytoplasmic hybrid embryos. As I said previously, the transfer of a somatic adult cell nucleus into an animal egg from which the nucleus is removed—it might even be possible to remove mitochondria, but that is a separate discussion—and removal of the stem cells from early blastocysts is 99.9 per cent, if not 100 per cent, human DNA. In that respect, as my noble and right reverend friend said, it could be regarded as a human embryo. To produce stem cell lines that carry the disease genes that occur in humans, but not in animals, is what scientists are seeking to do. These stem cells are useful in testing how these diseases developed and how to change these chromosomes by genetic manipulation. They are used also in future drug development. Avastin was developed by using such experiments, as my noble friend Lord Winston described.
Lord Walton of Detchant: I, too, feel uncomfortable about the definition in new Section 4A(5)(e), which refers to “such ... thing”. That seems rather a curious definition in any legislation coming before your Lordships’ House. However, I should draw to your Lordships’ attention the views of the Wellcome Trust, the Academy of Medical Sciences, the Medical Research Council, the Royal Society of Medicine and the Association of Medical Research Charities, which support the inclusion of a definition of interspecies embryos of the two hybrids, the cytoplasmic embryos, the transgenic embryos and the rest. One thing that has been postulated, although I think that it is very far into the future, is that with the creation of such hybrid embryos—about which I feel I have a somewhat sneaking feeling of discomfort—by inserting human genes into an animal embryo you might be able to create an animal that would be a source of organs for transplant. People have been trying to use pig livers for transplant, for example, due to a shortage of organs for human transplantation. The problem with that was a viral
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The group of important bodies to which I referred supports the inclusion of a regulation-making power in new Section 4A(5)(e) to make adjustments to the definition of interspecies embryos in light of the difficulties of defining all the types of such embryos that might be created in future. They believe that to be an important and sensible approach to future-proofing of legislation. I pass that suggestion on from these bodies as something that they have made clear in their views.
Earl Howe: 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
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