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So far we have unanswered questions about exactly what the term means and exactly what the “human end of the spectrum” means. No amount of wordplay, semantics, rebranding, rebadging or downright spinning can disguise the fact that embryos, in the end, will be used in these processes. It cannot be denied that any embryo is an embryo of something. We can understand what an embryo is only if we know what it will be when it grows up, if it grows up. It is an animal embryo, a human embryo or a mixed human and animal embryo; it will lie somewhere on the spectrum about which my noble friend Lord Tebbit was searching for an explanation. No amount of spinning of the word “admixture” can disguise the fact that it is nothing new, save a new name for an old meaning, the old name being “interspecies embryo”.

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I am fearful that this argument, as played by both sides to the outside world, is causing great concern. Unless it is clarified in an acceptable way, it may cause great damage to relationships between science and the general public. I believe that it is already doing that; the social contract between society and science can easily be damaged. I think that it was as long ago as 1904 that HG Wells, in his novel The Food of the Gods, referred to an iron curtain—incidentally, I think that that was the first use of the phrase—coming down between the scientist and what he termed the outside world. We must not have an iron curtain and it is extremely important that explanations are clear. If the average Peer in the street cannot understand exactly what is going on, what chance has the average person in the street? Clarification of meaning is vital.

Secondly, on process, there might be an important constitutional issue that may be gripped around the throat in the other place.

Lord Winston: My Lords, I am grateful to the noble Lord for giving way. He talks at length about an embryo growing up and being either an animal or a person or a mixture of the two. I hope that he will take it in good faith that I am speaking honestly when I say that these embryos, if derived, will be subject to the law as it already exists; that they could not survive beyond 14 days under the law and, in practice, will not survive beyond seven days; that they cannot be transferred to a uterus either of a human female or an animal female; and that there can be no possibility whatever of viability. That seems to me to be a very important point. There seems to be a mythology going around that in some way the scientists want to create monsters. I think that we do engage with society. Indeed, one of my great missions has been to engage with society. I have consistently done this with many of my colleagues and I think that we are doing it very well. I think that society understands these issues quite well, but there is—

Baroness Royall of Blaisdon: My Lords, forgive me. I believe that noble Lords may interrupt to make a specific point, but they are not able to make another speech. This is the Report stage of the Bill.

Lord Winston: My Lords, my apologies. The issue then is the viability of these embryos. I would be grateful to put on record the fact that these would not be viable.

Lord Patten: My Lords, I am grateful to the noble Lord, Lord Winston, for his intervention. He has a particular understanding. Alas, I do not think that the Minister has satisfied the House on the points made by the noble Lord, Lord Neill of Bladen, and others about what this term means, let alone what the phrase “the human end” means. Different interpretations have doubtless been given by the scientific community, but this is not the scientific community’s Bill; it is the Government’s Bill. The Government owe it to this House to have absolute clarity, because this House should not legislate about that which it cannot define.

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I return to my second point. On parliamentary process, we seem to be going quite a long way from the 1990 Act. We do not have this phrase in the 1990 Act. It has not been subject to parliamentary scrutiny. There are constitutional issues about the way in which these amendments have been introduced. These issues will be discussed in this place and another place. However, I end as I began. I would be grateful to know when the Minister first coined or knew of the phrase “human admixture” in the context of the Bill.

The Lord Bishop of Winchester: My Lords, I do not know whether I am the only Member of your Lordships’ House who, after this 45 minutes, and after helpful explication of the language of the “human admixed embryo”, is left thinking that the previous phrase, “interspecies embryo”, was clearer for the man or woman in the street, the church or the mosque, than what we now offer.

My second point is equally brisk. It is of course true, as the noble Lord, Lord Winston, and others have said, that some of those who have been writing letters to many or all of us have this vision of the creation of a monster. However, we would be wrong to suggest that that is what most people who are anxious about this phrase and this entity, the interspecies embryo, have in mind. I do not believe that the vast majority of those who are concerned about this point—we shall test that concern later—are worried about the creation of monsters; they are worrying about the point that the most reverend Primate the Archbishop of Canterbury made earlier.

Lord Darzi of Denham: My Lords, I am grateful for the contributions that have been made. I will start with the remark of the noble Lord, Lord Patten, about when I knew, and whether there was any spin, about the change in terminology. As a point of record, spinning might be a technology used in the creation of an embryo in a laboratory, but it was certainly not used in the creation of the term “admixed embryo”. That term was the result of the deliberations that we had in Committee, and I am grateful to the noble and learned Lord, Lord Mackay of Clashfern, and others in the House who put in a significant amount of time with the Government and with the scientific community, including the Academy of Medical Sciences, in coming up with a better description than “interspecies embryo”, as debated by your Lordships in Committee.

This is not a change of definition. The definition is exactly the same as it is in the Bill in front of us. The terminology that has changed is the title—the nomenclature—so that “interspecies embryo” is replaced by “admixed embryo”. This relates to the Government’s attempt to clarify what we mean by the human end of admixed embryos. A broad spectrum of entities can be created in research, as we are fully aware, that contain both human and animal components. However, the ability objectively to separate the structural and functional components of the created embryos, as described by my noble friend Lord Winston, is an impossible task. We must remember that not all DNA is functional; in fact, a large proportion of human and animal genome,

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according to our current understanding, has no functional role in development. However, our understanding in this area, as suggested by some noble Lords, is far from complete.

As I said earlier, “human admixed embryo” has been suggested as a more accurate collective term to describe those entities that the Bill seeks to bring clearly within its regulation. The new term is more suitable because it specifies what we debated in Committee: the human admix is nearer to the human end as opposed to the animal admixed embryos. I am grateful for noble Lords’ contributions reminding us that we are talking about the title, not the definition. The amendment will improve the Bill.

Lord Tebbit: My Lords, the Minister seems to have glossed over the question that I asked him 40 minutes ago. I do not object to this expression. Why should I? I understand—fairly well, I think—what it means. But when the Minister talks about one end or the other of the spectrum, I find myself at a loss. If he says that certain matters relate only to human admixes at the human end of the spectrum, he must be able to define that in some way. I accept entirely what the noble Lords, Lord Winston, Lord Patel and others, say: part of the DNA is not functional. Of course I understand that, but it does not get away from the fact that the Minister has identified two things: the animal admix and the human admix. He has introduced the concept that they are not entirely separate but they are at opposite ends of the spectrum. All I and other noble Lords ask is that the Minister should say where along that spectrum the change from animal to human comes.

Lord Darzi of Denham: My Lords, “human admixed embryo” refers to interspecies embryo as defined in the Bill. The confusion may have arisen with the addition of the “animal admixed embryo”, which is not part of the Bill, but I would be more than happy to define that separately. The definition in the Bill of “human admixed embryo”, which we are discussing today, is that of “interspecies embryo”, as defined in Clause 4, at paragraphs (a) to (e) in new Section 4A(5).

On Question, amendment agreed to.

Lord Darzi of Denham moved Amendment No. 2:

On Question, amendment agreed to.

4 pm

Lord Darzi of Denham moved Amendment No. 3:

The noble Lord said: My Lords, I will also speak to the related Amendments Nos. 21, 22, 139, 141 and 167. The definition provided in paragraphs (a) to (d) of new Section 4A(5) of the 1990 Act is designed to ensure that all necessary categories of interspecies embryos or, as we intend to call them, human admixed

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embryos, are brought within the regulatory remit of the Human Fertilisation and Embryology Authority. To ensure that admixed embryos proposed to be created by novel techniques not captured by the definitions in paragraphs (a) to (d) of new Section 4A(5) can be regulated in the future, the Bill contains two regulation-making powers so that secondary legislation can bring any such embryos under regulation. The first power, inserted by new Section 4A(5)(e) of the 1990 Act as inserted by Clause 4, allows secondary legislation to add new types of entities to Section 4A(5) and thereby bring them within the regulation. The second power, inserted by new Section 4A(7), permits secondary legislation to alter the existing definitions or to repeal those definitions. These amendments relate to the second power.

The Delegated Powers and Regulatory Reform Committee recommended changes to the Bill concerning the second of those regulation-making powers. It raised specific concerns that the power was too wide and should be more limited. Having accepted that recommendation, we are proposing to remove the regulation-making power contained in new Section 4A(7) and to introduce a new power under what will be new Section 4A(13)(a). This power will be limited so that it can be exercised only to amend and not to repeal the current definitions of human admixed embryos in paragraphs (a) to (d) of new Section 4A(5) as inserted by Clause 4. We have also introduced a condition that the power can be exercised only in the light of scientific developments. This mirrors the limits on a similar power already in the Bill in relation to alteration of the definition of human embryo in new Section 1(6) as inserted by Clause 1. Both regulation-making powers are subject to affirmative resolution.

The regulation-making power still ensures that, should any new method of creating human admixed embryos come to light, secondary legislation will continue to ensure that it can be brought within regulation. At the same time, this amendment ensures that the law cannot be so scientifically changed as to remove the regulation of recognised types of admixed embryos altogether.

In addition, these amendments will remove the existing regulation-making powers contained in Section 4A(7) to amend the definitions of “eggs”, “embryo” and “gametes”. The regulation-making power under new Section 1(7) to amend those definitions following changes to Section 1 is also removed. This could cause problems. If, for example, the meaning of “gamete” for the purpose of Section 4A(5) was amended, it might not be possible for the equivalent amendment to Section 4A(1) to be made in relation to prohibitions. That would clearly not be desirable.

This amendment introduces a new Section 4A(13)(b) to provide a general regulation-making power to amend the definitions of “embryo”, “eggs” and “gametes” for the purpose of Section 4A in its entirety. This power is again subject to developments in science and medicine and to affirmative resolution. The power to make consequential amendments to Section 4A(6) following changes to Section 4A(5) remains unchanged. I invite noble Lords to accept the amendment. I beg to move.

On Question, amendment agreed to.

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Clause 3 [Prohibitions in connection with embryos]:

Lord Patel moved Amendment No. 4:

(a) an egg can be a permitted egg, or(b) a sperm can be a permitted sperm, even though the egg or sperm has been developed from one or more human cells in a prescribed process designed to treat infertility.

The noble Lord said: My Lords, this amendment relates to a regulation-making power by affirmative regulation to allow Parliament to approve the potential use of stem-cell-derived gametes in treatment. I tabled this amendment in a different form in Committee, and I have now removed the concerns expressed at that time. I have specified that we are talking about using stem-cell-derived gametes—eggs from a woman and sperm from a man—to treat infertility problems and nothing beyond that.

Thousands of patients suffer from the inability of their gonads to make gametes—either sperm or eggs. New technology offers the promise for such patients that their infertility can be treated by the generation of new gametes from stem cells. That is adult stem cell technology. For those who are concerned about using embryonic stem cell technology, this is especially favourable to adult stem cell technology. It is adult stem cell technology that has made progress in animal models and in laboratory studies of human cells in generating gamete precursor cells from bone marrow cells.

Several leading groups in the UK currently carry out such research. One is led by Professor Nayernia of Newcastle, who has derived sperm from mouse embryonic stem cells and used it to fertilise mouse eggs, and who has previously derived early-stage sperm cells from human bone marrow. The research in this field seems very promising. There is also the prospect of generating new gametes from embryonic stem cells derived from an embryo created from the patient by therapeutic cloning using SCNT, but most progress has been made using adult stem cells.

The Bill effectively places a ban that will require a whole new Bill to overturn on ever using such gametes to treat patients. That is despite the Bill permitting the use of gametes that have been grown and matured from gamete stem cells derived from the testes and ovaries, and despite the Bill continuing the regulation-making power to allow the use of embryos created from eggs that have been manipulated by nuclear transfer to treat mitochondrial disease.

Amendment No. 4 proposes a regulation-making power through the affirmative resolution process to permit the HFEA to consider applications to apply this new technology to treat infertility, if the authority is satisfied that it is safe enough, if there is sufficient evidence of effectiveness, subject to the usual provision of carefully designed, ethically approved clinical trials being carried out, and following any public consultation that it may feel necessary. It is also open to the Government to carry out consultation prior to promulgating a solution.

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I could produce more evidence. It is interesting to cite Josephine Quintavalle of CORE—Comment on Reproductive Ethics—who said:

So even CORE would support it.

I hope that I have said enough to rest my case that this is about treating infertility. It is not about using embryonic stem cell science but about treating infertile patients, especially men who cannot produce sperm because of chemotherapy, cancer, infection, or any other damage—mostly, it affects men rather than women. I beg to move.

Baroness Tonge: My Lords, I support the noble Lord in his amendment. Frequently during the passage of the Bill, I have felt a sense of real excitement about what is going on out there. I am a medical doctor, but I am not a medical scientist. I know that medical scientists have the same view of humanity as doctors, which is to do the very best for people that they can and to research for the benefit of mankind.

The amendment refers to something that I thought could never happen. Earlier, the noble Lord, Lord Winston, told us very graphically how his infertile patients feel that their immortality is being taken away from them. They cannot have their own children so their genes will not be passed on to grandchildren and great-grandchildren. This amendment refers to work which will rectify that. It means that an adult man who has had mumps orchitis, for example, and is infertile as a consequence will be able to have sperm created from his own body, from his own stem cells, to produce his very own child. Likewise women—I do not know whether I am right but noble Lords will tell me—with polycystic ovaries who have very great difficulty in conceiving and sometimes never succeed could also undergo this technique.

As the noble Lord, Lord Patel, has said, sperm could only come from male adult stem cells and an egg could only come from a female. In fact, a female cannot produce a male because we do not have Y chromosomes. This is so exciting. There are patients who, if they knew we were discussing this in the Chamber today, would be cheering—they would be filled with such joy that something in the future may be able to help their particular cause of infertility. The Bill of course covers treatment for infertility.

I hope there is no opposition to this. There should not be any because although embryo stem cells can be used in this research, this technique will use adult stem cells, of which we have heard such a lot from some of the people who feel very uneasy about many other aspects of the Bill. So I hope that the amendment will be supported. This is one of the most exciting things in this Bill and one of the most exciting bits of medical research we have heard about.

Lord Alton of Liverpool: My Lords, the amendment that my noble friend moved earlier is a development of the amendment which he brought before your Lordships in Committee. As he said, I raised a question with him then about the use of gametes. He has very kindly

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thought further about it and removed that part of the amendment in this recomposed amendment before us today. I very much welcome that. I have substantial agreement with a lot of what he has said today and with what the noble Baroness has just said. Where adult stem cells are used, I do not think there can be anything like the same ethical arguments—although there are some—used in dealing with embryonic stem cells. Later we will have further discussion about the application of adult stem cells.

Let me share this thought with the noble Baroness. In the future, some of our debates on these proceedings may well seem like ancient history because if the real developments take place that we have been hearing about using adult stem cells, clearly there can be a coalescing of good ethics and good science and the reservations that some of us would have about embryonic stem cells may simply melt away. No one would more pleased about that than I.

So where therapies can be developed that are absolutely licit—and I too have seen those comments by Mrs Quintavalle from Comment on Reproductive Ethics—I think it would be perfectly proper for us to examine those proposals and to incorporate them in legislation. My noble friend has tabled this amendment today. We have not had the chance to consider all its implications. If it specifically ruled out the use of human embryology, as he has done in his speech, then I do not think there could be any difference between us and should not be. Even if the Government are unable to give it the green light today, I hope that they will give it further consideration and that maybe at later stages—because this Bill will go on to another place—we can find absolute agreement on it.

Baroness Jay of Paddington: My Lords, I very much hope that my noble friends on the Front Bench in the Government will hear the remarks made by the noble Lord, Lord Alton, and follow the argument of the noble Lord, Lord Patel, about the way in which he has amended the amendment that he tabled in Committee. I think he dealt very properly with some of the ethical issues raised.

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