Human Fertilisation and Embryology Bill [Lords]

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Dr. Harris: Does my hon. Friend accept that there has been some debate on this in recent years? There was debate both outside and inside Parliament, on the White Paper and on the draft Bill. Under the Bill as proposed, there would have to be further debate in Parliament and outside when regulations were brought allowing the manipulation of eggs or embryos to tackle the problem of mitochondrial disease. There has been a lot of debate, and there is plenty of scope for more.
Dr. Pugh: I would be much relieved if I thought the fine detail of this were going to be examined by elected Members, but I do not think that that is the case. I think it is more likely to be the object of appreciable debate in the HFEA and nowhere else. It will simply happen. Even so, it is clear that we must know what we are doing and what the Bill encompasses. Matters are as simple as that.
11.30 am
The broad clause prescribes circumstances and processes for which regulations may provide. I am unhappy about such an approach. Had we moved amendment No. 21, I would have drawn attention to that. Elsewhere in the provisions that we have dealt with so far, clause 1(5) allows the Secretary of State to redefine key terms such as “gamete” and “embryo”. There are genuine anxieties about that. If fundamental concepts of legislation can be redefined on the hoof, concern will be expressed. We must be fairly clear about what is happening. It is not as though any of the learned papers that I have read so far about the provisions establishes a clear, moral consensus. That does not exist. We have blank cheque legislation. I used that expression on Second Reading, and do not repent doing so.
The more positive way in which to express matters is used by advocates of the Bill as it stands. They talk of future-proofing legislation. Future-proofing is a more positive way in which to describe what I referred to as blank cheque legislation. It is fine. I am all for future-proofing legislation. I do not have a fundamental difficulty with the concept per se, as long as we future-proof against a set of principles and moral ideas that we all clearly understand and we know where they are heading.
Mark Simmonds: I just wish to assist the hon. Gentleman and clarify the intentions of amendment No. 2. It would strike out the Secretary of State’s regulation-making power because the decision to allow the mitochondrial research would be inserted into the Bill. As a result, lines 19 to 24 of clause 3 on page 3 of the Bill would become superfluous.
Dr. Pugh: I am comforted by that explanation and anything that would make the Government’s intentions more clear in the Bill and leaves discretion where it should be. A clear moral consensus about what may or may not be done would make me feel more comfortable about the Bill as a whole. However, if we look at it from the point of view of the parliamentary draftsman, we must say that it leaves the door wide open to all sorts of things that the Committee has not even envisaged.
Mr. Streeter: I am delighted to serve in Committee under your chairmanship, Mr. Gale. I rise to support the last two speakers. Whereas the Bill takes great pains—to the credit of the draftsman—to prescribe and regulate tightly activities that may or may not take place, we find suddenly in subsection (5), the subject of amendment No. 2, which I support, that the Government may make regulations in the future to deal with something that is not permitted under the Bill at present. To correct the hon. Member for Southport, I must say that the regulations would be made not by the HFEA but by the Government.
Robert Key: By Parliament.
Mr. Streeter: The regulations would be made by the Government tabling a statutory instrument before Parliament. We know the extent of scrutiny that that can involve—perhaps 90 minutes of debate which, first and foremost, would be within the Government themselves. There would then no doubt be a short debate in Parliament.
I want to ask the Minister whether the wording of subsection (5) is as tightly drawn as it might be. Reading with my legal eyes on, I agree that it could well become a loophole in the hands of future Governments—obviously not in those of this Government, who are sensible, moderate and regulatory and who we are thrilled are in place at the moment. We could even have a coalition Government; the hon. Member for Oxford, West and Abingdon could be the Secretary of State for Health. We do not know what might happen in future.
The clause is capable of a wide interpretation and I will explain why. If we read it as it might be drafted without its sub-definitions:
“Regulations may provide that—
(a) an egg can be a permitted egg, or
(b) an embryo can be a permitted embryo,
even though the egg or embryo has had applied to it—”
—in circumstances set out by regulation, a process also set out by regulation, which is—
“designed to prevent the transmission of serious mitochondrial disease.”
Control over the process and circumstances is entirely in the hands of the people who write the regulations. As I understand, that could be far wider than the issue that my hon. Friend the Member for Boston and Skegness referred to, which is at the back at the Government’s mind. That is the process by which we take a little bit from one egg, mainly the mother’s, and make an egg which is free from genetic diseases. Who could argue with the desire behind that? However, in my opinion the wording of the clause goes far beyond that. As technology develops, it could allow regulations to be made that take us well beyond that in terms of circumstances and processes that regulate what egg and what embryo.
I hope that the Government will look again at that point. Many people are concerned that new section 3ZA(5) is a loophole, probably unintended, but a loophole nonetheless. It could end in permitting the kind of reproductive cloning or genetic manipulation that the Government have rightly set their face against. I hope that when the Minister responds, she will not brush such concerns aside as they are held by a number of people. The point is more about drafting than ethics or science. The drafting of subsection (5) must be looked at again.
Dr. Harris: I rise to support the Bill as drafted and to follow up the point made by the hon. Member for Salisbury. I am delighted to see the amendments tabled by the hon. Member for Boston and Skegness. They press for a more permissive approach on the question of permitted embryos than the Government envisage. The idea behind them is that we should not need further regulations, and that there is enough information to show the likelihood that the technique will be both effective and safe enough to trial under informed consent. In addition, we have enough confidence in the regulator to ensure that those two provisions are policed with regard to effectiveness, safety and consent, so that we do not need Parliament to approve specific regulations. Those arrangements could be designed by the HFEA.
I have great sympathy with that approach. I have always pressed for a more permissive approach, given that we have an authority that everyone says is wonderful and adept at making the regulations. I know that the approach proposed by the hon. Member for Boston and Skegness was proposed in the House of Lords by Lord Walton, who has connections with Newcastle university where much of this work is being done by Doug Turnbull’s group. Although I have a huge amount of sympathy with the hon. Gentleman’s approach, one would have to have regulations to prescribe and circumscribe what we want. In the end, I can see no other way than to provide for the regulations, although I have sympathy with what he is doing. It is important that the House indicates very clearly that we want to be able to translate research—which is currently permitted in this area—into the clinic, and that we signal very strongly that we are minded not to oppose the concept of regulations, but to ensure that further scrutiny is of the regulations, not the principle. I am glad to see that there appears to be widespread support from all sides of the House for this sort of approach. I hope in the separate clause stand part debate to identify another area where we need to ensure that research that does not come under mitochondrial disease can be translated from the clinic to clinical therapies for patients.
My hon. Friend the Member for Southport was not really supporting the approach I just set out. He was arguing that we cannot simply leave it to regulations, because regulations would be a simple one and a half hour debate in both Houses under the affirmative procedure, as set out later on in the Bill. Clearly, whenever we agree to a regulation-making power, we limit the amount of amendments that can be made to the regulations. So I hope that the Government would agree, insofar as they can for this Government—because it may not be in the time scale of this current Government—that if they do propose to introduce these regulations, they will produce them in draft for consultation. After that, the regulations could be reconsidered and brought back again without having to be formally withdrawn. That would be considered quite a big step in this place: one rarely sees regulations that are laid in draft withdrawn, so I hope that the Government will take a consultative approach to the drafting of the regulations.
I would say again to my hon. Friend the Member for Southport that there was considerable debate about this during the consultation period, considerable debate around this in the White Paper, and considerable debate on the draft Bill. It was considered by a Joint Select Committee of both Houses and I think there has been plenty of public, as well as parliamentary, debate.
Dr. Pugh: The point that I made that my hon. Friend has not addressed was in connection with the different ways in which one could tackle mitochondrial disease, either by doing something with the nucleus or by cell transfer. One represents a clear step in the direction of genetic engineering; the other, one could argue, does not to the same extent. My hon. Friend may not see that distinction, but other people do. If there is that kind of moral divide—it is a significant moral divide, though it may not be significant for everybody—would it not be more appropriate not to regulate but to tighten the legislation sufficiently to circumscribe what the legislation intends to facilitate?
Dr. Harris: I accept that point and I wanted to come on to it, along with the point made by the hon. Member for South-West Devon, because there is a small problem—which I admit I did not notice during the Bill’s passage through the Lords—with the phrasing of subsection (5). I just wanted to finish the point that I was making on the amendments more broadly.
Mitochondrial DNA, which causes some mitochondrial disease, represents about 0.5 per cent. of the genes that humans have. The DNA in the mitochondria do not code for any human attributes. These are genes that have been preserved through evolution from bacterial inclusions in cells, and therefore are common across many species, though they will differ between species.
On that basis, if one accepts that it is possible to change the DNA in mitochondria without its being considered germ-line gene therapy or germ-line gene engineering, because we restrict that to nuclear DNA, then I would argue that it is probably not appropriate to have the same consent arrangements for donors of mitochondria as for donors of nuclear DNA. So I question whether amendment No. 33, even within the construct that the hon. Member for Boston and Skegness has put, is appropriate, because it gives a status to the mitochondria in respect of consent that they do not deserve because they do not pass on recognisable human attributes, which is the basis for the very strong consenting arrangements that the Minister has proposed.
I would be grateful if the Minister could clarify that, as at the moment it is not clear whether there is, or needs to be, any difference in the consent arrangements for the donor of mitochondrial DNA. Clearly donors must consent to the donating of the tissue, but it is not clear whether that is done under the strong and strict consent arrangements that exist under the Human Tissue Act 2004, or whether the Government envisage going further and introducing regulations to raise the status of that donation. I am not convinced that we need to raise the status, as it is a tissue donation. I would not want it to be seen as a donation of a genetic attribute, as that would make it more difficult for us to defend what the Government are doing, with my support, in the Bill.
11.45 am
As this has been raised, it is appropriate to speak about subsection (6). However, we will come that in the next debate, so I will not mention it now. On the issue raised by my hon. Friend the Member for Southport and the hon. Member for South-West Devon, there may be a problem. I have seen a document from Human Genetics Alert—an organisation with which I generally disagree in principle and in practice—that points out this issue. Some mitochondrial diseases, including serious ones, are transmitted by nuclear DNA coding for some of the proteins in the mitochondria. The argument would be that the current wording of subsection (5) would permit in the regulations a process by which the egg or embryo could have nuclear transfer as the prescribed process, or at least gene transfer into the nucleus designed to prevent the transmission of serious mitochondrial disease. The Government have already said that that is not their intention and I do not believe that it is the intention of the researchers working on this in Newcastle university and elsewhere. They have made that absolutely clear. I do not believe that any Government would produce regulations permitting that, or that the HFEA, even if it could, would issue a licence for it. However, if that is the case, perhaps the Government would consider making that clear in subsection (5) of proposed new section 3ZA, which sets out what the regulations may provide. They might for example, at the end of the section
“even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease”
add “transmitted by DNA in the mitochondria”.
As I said, the two hon. Members who spoke before have raised a valid and fair point and I would be grateful if the Minister could address that in her response.
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