Human Fertilisation and Embryology Bill [HL]

– in the House of Lords at 2:59 pm on 15th January 2008.

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Votes in this debate

Report received.

Clause 1 [Meaning of "embryo" and "gamete"]:

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

In moving Amendment No. 1, I shall speak to the consequential amendments. There are 96 amendments in total, but they all have one straightforward effect, which is to change the umbrella term "inter-species embryo" to a more suitable term, namely "human admixed embryo".

The research community and medical charities have made a considerable effort over the past 12 months to bring to the public and Parliament's attention the need for embryo research using embryos containing both human and animal material. In particular, concerns have been raised about the limited availability of human eggs for use in creating embryonic stem cells. That has led to calls for the ability to use animal eggs in their place, which are in much greater supply.

Both the pre-legislative scrutiny Joint Committee and the Science and Technology Committee of the other place have made inquiries into the ethical and scientific elements of this research. Both have made recommendations that this research should be permitted under regulation by the Human Fertilisation and Embryology Authority.

To enable promising avenues of research to be followed in this important field of embryonic stem cell research, we have set out in the Bill a framework of regulation for a number of embryo types which contain both human and animal material—embryos referred to collectively in the Bill as "inter-species embryos". However, questions were raised in the Committee stage of this House on whether the term "inter-species embryos" was the appropriate umbrella term for those part human, part animal embryos covered by the Bill.

A broad spectrum of entities can be created for research which contain both human and animal components. The Bill sets out a framework of regulation for those embryos defined in Clause 4 created using human and animal components where the resulting embryo in simple terms can be said to be towards the human end of that spectrum. That does not however cover the transgenic mice that are subject to Home Office regulation. It was suggested that an alternative term to "inter-species embryo" could be helpfully employed to make it clear that the Bill is not intended to apply to the whole spectrum of human, animal experimentation but only to those embryos that are predominantly human, resulting from modified human embryos or are the result of mixing human and animal gametes.

The term "human admixed embryos" has been suggested as a more accurate collective term to describe those entities, which the Bill seeks to bring clearly within the regulation of the Human Fertilisation and Embryology Authority. It was felt that the word "human" should be used to indicate that these entities are at the human end of the spectrum of this research. The term "mixed" was considered, but concerns were raised that such a term could be taken as referring only to those embryos that are a mixture of cells, such as chimera embryos, where the term also needed to include those embryos in which all the cells contain human and animal material but are genetically identical.

The term "admixed" is preferable as it does not lend itself to that sort of interpretation and is used in the chemical sciences to refer to a substance where two or more components are mixed in to each other. This term, developed in consultation with professional bodies such as the Academy of Medical Sciences, the Medical Research Council and the Wellcome Trust, allows for more focused debate on the research issues addressed in the Bill. This new term is more suitable by specifying that we mean human admixed embryos as opposed to animal admixed embryos, the use of which remains more appropriately within the regulatory oversight of the Home Office.

In addition, it was brought to our attention by the noble and learned Lord, Lord Mackay, that the drafting could be improved of the new Section 4A(1), which prohibits placing non-human embryos in a woman. In particular, the potential overlap between new Section 4A(1)(a) and new Section 4A(1)(b), as introduced by Clause 4, could cause confusion; an inter-species embryo covered by the prohibition in Section 4A(1)(a) is also an embryo other than a human embryo, as under Section 4A(1)(b). Whereas there is no legal problem per se, we agree on the further consideration that this could be clarified by a simple amendment. We have therefore tabled amendments to reorder new Section 4A(1)(a) for clarification. It is now clear that a human admixed embryo is a non-human embryo as far as the Bill is concerned, and is separately listed. The change removes any potential overlap, and so any confusion. Clause 4 continues to ensure that only human embryos may be placed in a woman.

I hope that these changes make our position clearer on the scope of what part-human, part-animal embryo research is subject to regulation under the Bill. I invite noble Lords to accept this amendment and I beg to move.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, this is a considerable improvement in the drafting of the Bill to make it clear that—as the noble Lord, Lord Darzi, made clear in his reply at Second Reading—it is not intended to cover the whole spectrum of inter-species embryos, but only what he described then, and again today, as the human end of that spectrum. The new phrase introduced by the Government in these amendments makes that clearer than before.

The noble Lord, Lord Patel, and I have tabled an amendment intended to encapsulate the phrase that the noble Lord, Lord Darzi, used about these being predominantly human embryos—in other words, not predominantly animal. We have put that in to fill in and cover the essence of the definition because at the moment, even with the change that the Government are proposing, there is no full definition. There is simply a list of four typical examples. The Bill would be improved if it were clear to the ordinary reader that it is talking about the predominantly human end of the inter-species embryo spectrum.

I am grateful also for the noble Lord's clarification on the relationship between the clauses. I think this an improvement in the clarity of the Bill, showing what it is really intended to deal with. It would be even further clarified were the further aspects of the definition, to which Amendments Nos. 17 and 18 refer, also incorporated.

Photo of Lord Tebbit Lord Tebbit Conservative 3:15 pm, 15th January 2008

My Lords, I should like to follow the remarks of my noble and learned friend Lord Mackay. Could the Minister give us, in short terms, a clear definition of what is a human admixed embryo and what is an animal admixed embryo? I do not like the expression of something being towards one end of a spectrum or towards the other end; I am interested to know where the spectrum changes. There must be a clear point. At the very least, the Minister should define it for the House, even if it cannot be included in a list of definitions in the Bill, although I think that perhaps it should be.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I support the point just made the noble Lord, Lord Tebbit, about the importance of clarity in terms of the definitions in the Bill. For instance, on the issue of full hybrids—raised by my noble and right reverend friend Lord Harries at earlier stages of the Bill—if an admixed embryo is 50 per cent human and 50 per cent animal, how can we truly describe that as "admixed"? Is that not rather nonsensical? So is this not an attempt to cover a multitude of sins for the reasons described by the noble and learned Lord a moment ago?

There are some serious legislative points to raise at this stage. We have had a full scrutiny committee of both Houses that examined these questions in great detail. We have also had a very extensive four-day Committee stage as well as a Second Reading debate. However, despite some of the finest minds in the country applying themselves to this issue—we can go back to the debates in Committee and read the comments of many of the most celebrated experts in the field from some of the most prestigious organisations in the country—they said that in the time available, just some six weeks ago, they did not think it was possible to come up with a definition that could work. So here we are with a rabbit pulled out of the hat—or at least I think it is a rabbit because it may now be something altogether different, perhaps an admixed hybrid. I understand that the noble Lord, Lord Darzi, is making a genuine attempt to address the issue, but we have here 100 amendments tabled at this stage in order to insert the phrase all the way through the Bill. Surely the Procedure Committee would have something to say if any noble Lord from the Back Benches were to produce on Report a tranche of amendments that fundamentally altered the understanding some of us had of the Bill. Indeed, I know from an earlier discussion with one of my illustrious noble friends on these Benches that he is deeply puzzled by the failure to bring clarity to this most central issue.

I am worried that we are creating a euphemism here to disguise the reality. I do not think that that will assuage public anxieties, a point we shall come on to later when we debate whether we should allow at all the creation of interspecies embryos. That is the expression that will be replaced if we use the phrase "human admixed embryo". As the noble Lord, Lord Tebbit, among others, has said and no doubt will say again, when is it an animal admixed embryo and when is it a human admixed embryo? Those questions will remain, whatever decision is taken by noble Lords today. I hope that when we come to the more fundamental debate on whether we should allow this at all, we shall pause very carefully for thought.

Photo of The Archbishop of Canterbury The Archbishop of Canterbury Bishop

My Lords, I begin by apologising to the House for the fact that I am obliged to leave the Chamber before five o'clock this afternoon. I want just to echo some of the anxieties that have been raised in the past few minutes. I share entirely the unease of the noble Lord, Lord Tebbit, about the phrase, "the human end of the spectrum", which seems to introduce a very unhelpful element of uncertainty. Given that some of the major moral reservations around this Bill, which have been expressed broadly both in the country and in your Lordships' House, pivot upon the concern that this is legislation which is gradually but inexorably moving towards a more instrumental view of how we may treat human organisms, any lack of clarity in this area seems fatally compromising and ambiguous. I hope that we can have some further clarity in this afternoon's discussion.

Photo of Lord Craig of Radley Lord Craig of Radley Crossbench

My Lords, I, too, find the phrase "human admixed embryo" confusing. Like other noble Lords, I have had a large number of letters expressing concern about the Bill and I do not think that replacing the phrase "inter-species embryo" with "human admixed embryo" clarifies the situation. I had not followed the detail of our debates closely enough to realise that the phrase "human admixed embryo" does not mean what I first took it to mean. The Bill has "Human" and "Embryology" in its title, so when I first read the phrase I assumed that it referred to a human egg that had been admixed with some animal cell input. As I read the Bill, it appears from Amendments Nos. 15 and 16 that the definition of the phrase "human admixed embryo", for the purposes of this Bill, will be a mixed animal and human cytoplasmic one or no more than a pure hybrid 50:50 animal-human one, starting from an animal egg. That suggests to me that the resulting embryo cannot be more than half-human, although I admit that I may not fully understand the science.

For members of the public who are concerned about mixing human and animal or other species in the creation of an embryo, the phrase "human admixed embryo" is unclear on what happens. It could mean, to the uninitiated, that a human embryo has had another species' material added to it. Did the Government intend that? It may be that the Minister can clarify the reasons for his amendments—and I listened most closely to what he said—but I wonder whether we have yet arrived at the right definition for this problem.

Photo of Lord Neill of Bladen Lord Neill of Bladen Crossbench

My Lords, I add my voice to the reservations and surprise that have been expressed today. I represent a category, which may not be limited to one Member of your Lordships' House, that finds this Bill quite difficult to understand anyway. On embryology I come from a sort of zero background, if that is possible.

I was astonished when I picked up the Marshalled List today. I found this change on its first page and then traced it through the rest of the amendments. It has a devastating effect throughout the Bill. My noble and gallant friend Lord Craig of Radley raised a serious question on whether the term is apt and easily understood by members of the public, and whether it truly describes what we are about in the best possible way.

I also share the doubts of the noble Lord, Lord Tebbit, about this image of the spectrum; like the rainbow, that presumably must have a mid-point. It is impossible to compare what is mainly at the human end with what is mainly at the animal end. As I understand it—although my knowledge, as I have confessed, is limited—we are covering organisms, if that is the right word, that are 50:50 animal and human. The stress in this new definition is, however, all on the human end.

Will the Minister consider not pressing ahead with these amendments, and treating today as if he has given notice that this is how he would like to see the final Bill? We could debate the amendments on that basis and come back on Third Reading to vote on them; that may provide time for a fuller discussion. I received no advance notice of the reasoning behind this or a letter from the Minister, although one or two colleagues in the House did. More time should be taken, and we ought not to be rushed into this today.

Photo of Lord Winston Lord Winston Labour

My Lords, may I interject briefly on the point raised by the noble Lord, Lord Tebbit? We have already crossed swords once in this debate and no doubt we shall do so again. However, the idea of the spectrum is not quite as simple even as it sounds. I say that because if you take the average mammalian embryo—the human embryo, for example—only a very small proportion of its cells end up being the foetus.

It is thought that in the human embryo, around 10 per cent of the cells will become the inner cell mass that eventually leads to the person, if it is allowed to develop. The rest is, essentially, the part of the foetus that we throw away at birth, or incinerate or dispose of in some way—the placenta or membranes. Whether you use the word "admixture", "hybrid" or whatever, there is a problem here with the definition of spectrum. The Government have tried very hard to find a sensible solution to this and I certainly support this amendment.

Secondly, I have a further concern in that, as I understand it, letters have been sent to Members of the House which seem scurrilously misleading. I have not received one myself so I may be wrong but this was reported to me. There seems to be a notion that such hybrids, such mixtured embryos, might be allowed to develop into an animal human being. That is a complete misconception, if I may use a pun for which I apologise. I did not mean to use it. That is untrue. It is very doubtful whether such organisms would be viable for more than a few days under any circumstances. In any case they would probably not be viable for longer than the length of time that the Act covers. As this is done for experimental purposes, we are really looking only at the first 14 days. In practice, we are looking only at the first six or seven days because that is as long as you can practically do the research and derive stem cells.

My third point is about stem cells. I mentioned this point in Committee and I believe that it is very important. The best way of defining the potentiality of a stem cell to develop into different tissues is to inject it into the embryo of an immune deficient animal, usually an immune deficient mouse, which cannot reject those cells as a result of its immune system. Pretty well all the experiments that have been done which have defined stem cells and their potentiality have eventually ended up with that experiment because that is the defining moment of finding whether you have a cell which is truly capable of development. If the mouse is allowed to develop, the following happens. When the mouse baby is humanely killed, one can see in which tissues the cells that have been transferred into the embryo still exist. Normally you would expect to see them in the brain, liver, heart and so on. That does not alter the quality of the mouse but you have demonstrated that the stem cells you have produced are genuinely pluripotent; that is, capable of developing into a wide range of tissues.

To my mind it is essential that we protect this research. So far as I am aware, there is no other test of pluripotentiality. Part of this research would not even be covered by this Bill. For example, if I derived a stem cell from the bone marrow of a human adult, I could legitimately inject such a cell into the mouse to define whether it was pluripotent. The paradox is that if it were an embryonic cell I could not do that because of this Bill. That seems foolish, if I may say so, and counterproductive to the human value of such research. Nobody in the scientific field in biology doubts that adult or embryonic stem cells—I know that the noble Lord, Lord Alton, and I disagree about this—are of huge value to human medicine, but we need to prove that they are capable of developing into different tissues without causing a cancer, and that requires that animal experiment.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I support this definition. There was much discussion and debate in Committee, and prior to that when we had the stem cell debate, about what we are trying to do here. It is important to understand what we are trying to do and why the human admixed embryo definition might be more appropriate. As the noble and gallant Lord, Lord Craig of Radley, said, the spectrum covers truly cytoplasmic interspecies embryos, where the component that comes from the animal egg is the cytoplasm in the egg of that animal from which the nucleus, and therefore the majority of the animal DNA, is removed.

It is important to understand why we are trying to do this and what the law currently allows. The law currently allows one to take a somatic cell, a skin cell, from a person suffering from a disease—for example, motor neurone disease—and insert the nucleus from that cell into a human egg from which the nucleus is removed and to produce an embryo from which to harvest stem cells that will carry the genes of that disease to be able to understand the progression of the disease and develop drugs to treat it. That is the main reason for doing this research. It is to help humanity—it is not to endanger humanity in any way.

Why do we have to use animal eggs? We need to use animal eggs because human eggs are not available. If you take a dead cow's egg and remove the nucleus, and take a somatic cell nucleus from a the skin of a person who is suffering from a debilitating, progressive and lethal disease, to produce a stem cell line, that stem cell line carries the gene of that disease. That will enable you to do the research necessary to cure that disease. Depending at what stage you harvest those stem cells, that stem cell line comprises 99.5 per cent human cells. It carries only 0.5 per cent or less of animal material and none of it is animal DNA. There is no intention to implant that in any human being or in any animal. It will be used for basic research, to find cures for diseases. Therefore, the term "human admixed embryo" is correct, because the embryo is at the human end—it is 99.9 per cent human.

Currently, there is no intention to use pure hybrids, which will end up as 50 per cent human and 50 per cent animal. We do not know, in research terms, when they use these cells to do exactly what the noble Lord, Lord Winston, has described in order to understand the subsequent development of cell lines, whether that will come later. But we recognise that any such development would require a Home Office licence. I hope that we understand the basis of these definitions and what we are trying to do. There was a discussion about the interspecies definition not being appropriate. Scientists have worked hard to explain what they are trying to do, and why it is important.

Photo of Lord Waddington Lord Waddington Conservative 3:30 pm, 15th January 2008

My Lords, I am sure that many people will feel that I should not intervene, but I am one of many who must be finding it terribly difficult to understand this debate. What we are talking about now—with respect to the noble Lord, Lord Patel—is not what those who wish to carry out these experiments are going to do in the future, but what this phrase "human admixed embryo" means. I still do not understand what it means. Does it, for instance, cover an embryo that is 51 per cent human and 49 per cent animal? Or is it only an apt description of an embryo that is 80 per cent human and 20 per cent animal? I simply do not understand.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, I think that what has been said by the noble Lord, Lord Winston, and by my noble friend Lord Patel leaves me with little to add, except these points. I think that the Minister raised this, and the Government proposed the term "admixed embryo", in a brave attempt to produce a more acceptable term than "interspecies embryo", which frightened many of the public into believing that if this Bill became an Act, it could ultimately result in the development and formation of monsters, or animal-human hybrids. That was never the intention, because these "admixed embryos" are viable, as the noble Lord, Lord Winston, made clear, only for three or four days at most and could never under any circumstances develop into actual animals or human beings. The Bill makes it clear that such structures could never be implanted into the egg of a female human being or indeed into an animal.

Having said that, let me stress the crucial point made by the noble Lord, Lord Patel, about the importance of stem cell research. Many people are saying that stem cell research has not as yet resulted in any improvement in human disease. There is in fact some evidence to suggest that stem cells have been able to ameliorate certain cardiac conditions and considerable evidence is now emerging—I speak as a patron of the Spinal Injuries Association—that crucially important work is going on that shows a very real prospect that stem cells may help to move towards repairing spinal cord damage in the paraplegic person. As yet, that is not a reality, but it is coming much closer.

One other point is very important. Stem cells derived from adult tissue such as bone marrow, stem cells derived from the umbilical cord and stem cells derived from other tissues may in fact be invaluable for the treatment of disease. The problem is that the cells, when injected into another individual, produce an immune response. If that treatment is to work, they require the suppression of the immune response of the individual in just the same way as suppression of the immune response is required in renal transplantation, heart transplantation and others. The great virtue of what has been called the interspecies embryo, to which my noble friend Lord Patel referred, or as the Government now wish to call it, the admixed embryo, is that if you take a skin cell from a human being suffering from one of these devastating diseases and, if it were available, take a donor female ovum—which is very rare and difficult to obtain—and take out the nucleus of the donor ovum and transplant into it the nucleus from the skin cell of the individual with the disease, you can then create from that structure a series of stem cells that are immunologically compatible with the host from whom that skin cell has been removed. That is a major development of great importance.

The reason for using the admixed embryo is to take the animal egg, remove the nucleus, put in the skin cell from the human subject—the same technique that was used by Ian Wilmut in creating Dolly the sheep—and to create from that a generation of stem cells that are 99.95 per cent human. The animal component is simply the capsule in which that nucleus has been implanted. That is a very minor component, so it is properly called a human admixed embryo. That technique has enormous prospect for the amelioration of human health and, if the Bill goes ahead—as I very much hope that it will—it will be of great importance to the future of many people with inherited diseases such as diabetes, Alzheimer's and other conditions that could be greatly helped by the derivation of those cells.

Ian Wilmut said that he was not going to go on with this technique of cloning because of another technique that is being developed; but that other technique, which is being carried out in the United States, requires the use of an oncogene, which is a cancer-producing gene. I know that that is now being modified, but the problem is that stem cells derived in that way, which Ian Wilmut says is worthy of further exploration, are liable to produce malignant growths. That is one of the problems. The so-called interspecies embryo, or, as the Government now prefer to call it, the admixed embryo, is capable of producing generations of stem cells that are compatible with the individual and which do not produce an immune response, which is of enormous value in the treatment of disease.

Photo of The Countess of Mar The Countess of Mar Crossbench

My Lords, can we get back to the nuts and bolts of the amendments? We are talking about changing the name of the embryo; we are not talking about the ethics of the use of the embryo. In so far as the definition is concerned, Amendments Nos. 15 and 16 to Clause 4 adequately suit the purpose.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, we are getting into a misapprehension here. I did not believe that we were debating the good or ill, or success or failure, of matters to do with stem cell research. I thought that we were debating a particular term that we did not understand. It is as simple as that. Surely it is not unreasonable to wish to see clearly what we mean when we set down wording in a Bill. Everything else can wait for other debates. We have wasted a good deal of time on matters that do not actually refer to these amendments. I wish that we could get back to them.

Photo of Baroness Jay of Paddington Baroness Jay of Paddington Labour

My Lords, regarding the terms of these amendments, I am a complete lay person in following the scientific arguments. However, I listened with some care to the full Committee stage debate on the definitions of embryos and to the concerns raised by the noble and learned Lord, Lord Mackay of Clashfern, about the phrase "interspecies embryo", about which, I must say, I was not personally concerned. I have also received the letters that suggested a more scurrilous—to repeat the word used earlier—application of this term. I understand why many of the issues have been raised.

I found the explanations given by the noble Lords, Lord Patel and Lord Walton, and by my noble friend Lord Winston helpful in explaining the nature of the admixed embryo. However, it is not, as suggested by the noble Lord, Lord Walton, a government proposal, although it is a government proposal for the purposes of the Marshalled List. I understand that it is a result of lengthy discussion with the scientific community, as suggested by the noble and learned Lord, Lord Mackay, in agreeing with the change of term. Therefore, while I did not feel the apprehension that existed at the Committee stage about the phrase "interspecies embryo", I feel extremely reassured by what the noble and learned Lord, Lord Mackay, has said about his reaction to this new expression and would be happy to accept it.

Photo of Baroness Warnock Baroness Warnock Crossbench

My Lords, if it were possible to bring the definition of human admixed embryo, to be placed in Clause 16, further up to the very beginning—to the first page—of the Bill, some of today's expressions of bewilderment would be allayed because that is a good definition. The problem is that the Bill necessarily contains a large number of expressions, not just this one, that are unfamiliar to people who are not familiar with the science. The latter can be learnt if the Bill is read with its definitions carefully. That would put an end to a lot of the trouble but I do not know whether that is possible.

However, if the definition was moved to the beginning, the need for a definition of where exactly on the spectrum a human embryo changes to an animal embryo would be unnecessary. What is referred to as a human admixed embryo is clear and means nothing except what is to be found in the definitional clause later on. Therefore, it is just a matter of saying it earlier.

Photo of Lord Harries of Pentregarth Lord Harries of Pentregarth Crossbench

My Lords, will the Minister think again about a suggestion I made at an earlier stage? Widespread hesitation has been expressed in the House today about the question of definition on the one hand and there has been strong defence by our scientifically qualified noble Lords of the need for a particular type of research on the other. Indeed, we seem to have so many distinguished noble Lords in the House that I wonder whether, equivalent to the noble and gallant and the noble and learned, we need a noble and scientific Lord? The point is that the noble and scientific Lords have defended research on cytoplasmic hybrids. It has been given extensive consideration by the HFEA, both by its ethics committee and in its legal advice—of which the latter is that this is a human embryo from the standpoint of the 1990 Act.

There are research scientists banging on the door wanting to get on with this kind of research for the type of reasons that have already been given. Research on other forms of admixed embryo is not yet in the offing, as I understand it. So it would be possible for this Bill to make it quite clear that it is approving cytoplasmic hybrids, with perhaps a regulating power to consider other forms of admixed hybrid when the occasion arises, and when research scientists want to do research in that area. If there is total deadlock on this issue, perhaps I may ask the Minister to consider that way of proceeding.

Photo of Lord Patten Lord Patten Conservative 3:45 pm, 15th January 2008

My Lords, I certainly do not fall into the category of noble and scientific; I fall into the category of noble and confused about the meaning of these terms. I wish to make two points: the first is on meaning and the second is on process. We have a brand-new meaning and, as I think it is very important, I would be grateful if the Minister could find time, in his wind-up, to say when exactly this phrase "human admixture" was coined. Was it coined by the Minister? When did the Minister first hear of it? That must be on record. It is an extremely important point in this debate.

Noble Lords:

Why?

Photo of Lord Patten Lord Patten Conservative

My Lords, noble Lords ask why. The answer is that the Bill has been subjected, quite properly, to long pre-legislative scrutiny and to close examination at Second Reading and in Committee when we were debating a partially different definition. It is important to know whether this phrase was considered earlier and rejected and, if so, why. The Government are now clearly in some trouble about the meaning and I suspect that, if the phrase survives this place, it will go to another place where it will have even closer scrutiny, which it may not survive.

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".

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.

Photo of Lord Winston Lord Winston Labour

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—

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

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.

Photo of Lord Winston Lord Winston Labour

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.

Photo of Lord Patten Lord Patten Conservative

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.

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.

Photo of The Bishop of Winchester The Bishop of Winchester Bishop

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.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

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, 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.

Photo of Lord Tebbit Lord Tebbit Conservative

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.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

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.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendment No. 2:

Clause 1, page 1, line 10, leave out "an inter-species embryo" and insert "a human admixed embryo"

On Question, amendment agreed to.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

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 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.

Clause 3 [Prohibitions in connection with embryos]:

Photo of Lord Patel Lord Patel Crossbench

moved Amendment No. 4:

Clause 3, page 3, line 29, at end insert—

"(5A) Regulations may provide that—

(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.

(5B) Any regulations under subsection (5A) must provide that any sperm be developed from one or more cells of a genetic male and any egg be derived from one or more cells of a genetic female."

Photo of Lord Patel Lord Patel Crossbench

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.

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

"How ironic that one of the few reproductive novelties the Government wants to ban is the very one that CORE could make a case for".

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.

Photo of Baroness Tonge Baroness Tonge Spokesperson in the Lords, Health

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.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

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 during his remarks, I raised a question with him then about the use of gametes. He has very kindly 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.

Photo of Baroness Jay of Paddington Baroness Jay of Paddington Labour

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.

I follow the noble Baroness, Lady Tonge, in drawing the House's attention to one particular group of patients affected by this who I think would be very properly helped—people who have had cancer. I am sure the noble Lord has had his attention drawn, as I have, to the slightly disturbing report published today by the Royal Colleges of Physicians, Radiologists and Obstetricians and Gynaecologists about there being no national policy or funding for techniques for people who have, as a result of cancer treatments, successfully survived but become infertile. I am sure that many of us know that many young people have survived into adulthood precisely because of the advances in cancer treatments, particularly for paediatric leukaemia and so forth, but then face an infertile adulthood. These techniques, as I understand it, would be very helpful to them. I believe that around 11,000 patients between 15 and 40 years of age are diagnosed at this stage every year. This group could be helped by this technique, and the Minister should be aware of that when considering whether to accept the amendment.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 4:15 pm, 15th January 2008

This is new and very exciting work, and the amendment would take the issue very much further forward. This, after all, is adult stem cell technology, and progress has been made in animal models and in laboratory studies of human cells in generating gamete precursor cells from bone marrow cells. Many leading research groups in the UK are now working in this field, not least those at Newcastle University to which my noble friend Lord Patel referred. One intention behind the work is to look at the possibility of attempting to restore fertility in young men who have undergone chemotherapy, but many other potential developments are arising out of this work.

The Bill in effect places a ban, which it would require a whole new Bill to overturn, on ever using such gametes to treat patients. Amendment No. 4 proposes a regulation-making power, which is reassuring, through the affirmative procedure, to permit the HFEA to consider applications to apply this new technology to treat infertility if it is satisfied that it is safe enough, if there is sufficient evidence of effectiveness, subject to the usual provisions of carefully designed ethically approved clinical trials, and following any public consultation that may be necessary. It is also open to the Government to carry out a consultation prior to promulgating any regulations. This is a very important amendment, which I warmly support.

Photo of Lord Winston Lord Winston Labour

The most important group of patients has probably not been mentioned, so perhaps I might mention it. The noble Lord, Lord Patel, mentioned the importance of this for male infertility, and the noble Baroness, Lady Tonge, mentioned female infertility in certain cases. However, we live in a changing society in which more and more women are taking education, gaining skills and leaving child-bearing rather late. There is now a huge section of women in their late 30s and early 40s—these are not old patients or people who would be regarded in any way as undesirable mothers, no matter what kind of spin one places on that—whose ovaries have run out of eggs. The prospect of making an artificial egg in due course from a stem cell would help a vast number of women and would be a great cause of happiness in our society. Therefore anything that we can do to alleviate the situation and promote that research is to be welcomed. I really value the speech made by the noble Lord, Lord Alton, who has shown his humanity this afternoon. I think that many people will have found his interjection on this point extremely welcome.

Photo of Earl Howe Earl Howe Shadow Minister, Health

I agree with noble Lords who have spoken. The noble Lord, Lord Patel, has made a powerful case and I support him. I do, however, have a technical question about the approvals process. If the amendment were accepted, will the Minister confirm that it would cover research only? If there were any question of the technique being applied to treat an individual patient, which regulatory body would license it? Would it be the HFEA, or would it be the MHRA, bearing in mind that we would suppose by that stage that the technique had been developed to a sufficient stage to enable it to be applied in the field? In other words, would regulations passed under the Bill as amended enable patients to be treated?

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

My Lords, the Bill seeks to prohibit placing in a woman any embryo, sperm or egg other than a permitted embryo, sperm or egg. New Section 3ZA defines permitted embryos and gametes. With respect to gametes, this means that only an egg produced or extracted from a woman's ovary or sperm produced or extracted from a man's testes can be used in treatment. I would like to make it clear that nothing in the Bill prevents the creation or use of other types of gamete for the purpose of research. Natural gametes, matured or grown in vitro, can still be used in treatment, due to the nature of the definition of gametes found in the Bill.

In response to the Science and Technology Committee in another place, we accepted that, in future, artificially created gametes could offer new fertility treatments for people unable to produce sperm or eggs. Amendment No. 5 introduces a regulation-making power that will allow the definitions of permitted eggs and sperm to be expanded to include eggs and sperm that have been developed from one or more cells of a woman or man as part of a prohibited process to treat infertility. These gametes are often referred to as artificial gametes and, on our current understanding of the science, would be gametes derived from somatic cells—that is, not naturally derived from the germ cells residing in the testes or ovaries, but derived from cells in, for example, the skin or blood.

As noble Lords have said, research on this is being undertaken around the world in the hope of creating a non-invasive form of IVF. It is hoped that this research will help those people unable to produce gametes naturally to have children who are genetically related to them. It is also theoretically possible that this technology could be used for the purpose of enabling same-sex couples to have children who are genetically related to both parents.

This is an exciting development. While we are keen to see research continue, the application and safety of developments in this area are not known, which makes it difficult for any power to include the necessary safeguards on how this is exercised in the future. I realise that the scope of this amendment is not as wide as the one moved in Committee and that many concerns have been removed. However, issues of discrimination have to be considered, including, for example, whether it may be possible for same-sex couples to use this technology to create children using their combined genetic material and whether it would be proportionate to prevent them benefiting from this treatment in the future.

It is important that all these factors are known at the time of discussion in Parliament. To date, the Government have not believed that this is the right time for the House to decide whether it should be possible to enable this use of technology through secondary legislation. On balance, the Government decided that such a significant and potentially far-reaching development should be subject to full parliamentary debate and consultation when further data on the techniques are available. That is why there is no such provision in the Bill.

However, I have listened carefully to the debate this afternoon. The fact is that support—albeit qualified support—is coming from all parts of the House. Therefore, I would like to take this amendment back. There is nothing further that we can do with it in this House because Third Reading follows Report stage so quickly. There is no way in which the Government could consider this issue in depth, as we would have to, before Third Reading. Therefore, I ask the noble Lord to withdraw his amendment, on the understanding that we will look at it further in the other place. I cannot give a commitment that we will move on it in the other place, but I am certainly prepared to discuss this issue further with colleagues and to see where we go from there.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I thank the Minister for her reply. I am, of course, disappointed; I hoped that we could have resolved this issue more firmly today or on Third Reading. I reiterate that this amendment is about obtaining eggs for research from a cell from a woman and sperm from a male; it does not apply to same-sex couples. This leaves me in a quandary, but I shall wait to see what the Government intend to bring in. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 4 [Prohibitions in connection with genetic material not of human origin]:

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendments Nos. 5 to 7:

Clause 4, page 4, leave out lines 4 and 5 and insert—

"(a) a human admixed embryo,(b) any other embryo that is not a human embryo, or"

Clause 4, page 4, line 9, leave out "an inter-species embryo" and insert "a human admixed embryo"

Clause 4, page 4, line 10, leave out "an inter-species embryo" and insert "a human admixed embryo"

On Question, amendments agreed to.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

moved Amendment No. 8:

Clause 4, page 4, leave out line 11

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, it was said earlier in our proceedings that the privilege of serving as Members of this House has enabled us to be on a very steep learning curve as the various stages of the Bill have taken place. I echo that remark because it is an extraordinary privilege to hear some of the contributions that have been made from learned Members of your Lordships' House and to understand the technologies that are moving at such a galloping pace. Whether the rest of us can keep up either with the ethics or, indeed, with an understanding of those things is altogether another matter.

Some of your Lordships may feel that I have laboured this point a lot. I did so in 1990 in another place when I opposed the creation of human embryos for experimental purposes; I did so in your Lordships' House when I divided the House back in 2001 on the proposition that we should not create cloned human embryos; and, during Second Reading and, indeed, in Committee, I made clear my opposition to the creation of animal-human hybrid embryos, now to be called "human admixed embryos" in the legislation.

The reason why I oppose those developments is not because I am opposed to good science—quite the reverse—and not because I believe that we should leave people in suffering and pain; again, quite the reverse. I think that we should make every possible progress to alleviate sickness. It is always a privilege to hear my noble friend Lord Walton of Detchant speaking about these things. There is no disagreement between us about the importance of doing all that we can to remedy disease. However, we always have to weigh in the balance the nature of what we are doing to achieve that. Sometimes I fear that the science becomes instrumentalised and that we march ahead without proper consideration to where either Parliament's or, indeed, the public's opinion lies on some of these things.

My amendments would not affect existing animal-human embryo research such as animal transgenic and animal chimeric research, or research such as the Down's syndrome mouse; they would simply ban the new types of interspecies embryos that would be permitted by the Bill.

It is perhaps worth mentioning to your Lordships, as I did at earlier stages, that taken together the embryos that we have created since 1990—primarily for IVF cycles, but also those that we have created for experimental purposes—now number some 2.2 million. I do not think that it is unreasonable in debates of this kind for any Member of your Lordships' House to ask how many more we need, where this science is going and what has been achieved so far. I just register the point again, as I did at an earlier stage, that so far all the scientific developments in terms of existing therapies have been achieved through adult stem cells—nearly 80 worldwide, with some 350 clinical trials under way using stem cells. There is not a single therapy, as my noble friend Lord Walton confirmed, anywhere in the world—maybe there will be, but there is not now—that uses embryonic stem cells. One of the reasons for that is often rejection. The beauty of adult stem cells is that they are taken from the patient themselves; that is why many hold that they will be the cells used in therapies in future rather than for experimental purposes, which is what the Bill permits.

The Bill is therefore utterly wrong to allow licences to be granted to create true hybrids. I come back to the point that I made in my earlier intervention: we can call them "human admixed embryos", but a true hybrid can be 50 per cent human and 50 per cent animal as well as other kinds of human interspecies embryo. My noble and right reverend friend Lord Harries made that point earlier in his interesting comment about the difference between cytoplasmic and true hybrids in relation to these definitions.

We react, quite rightly, against the notion of placing a human interspecies embryo inside a woman. That point was made eloquently by the noble Lord, Lord Winston. I agree with him: it does no one any service when they misrepresent the nature of what is being proposed. I most certainly have never suggested that we are trying to grow embryos on. This Bill explicitly forbids the growing on of human embryos, whether they are mixed or singular, into something beyond that. That is why we opposed reproductive cloning. We were united in the House about that in 2002 and I think that we are united in our opposition to the growing on of an animal-human hybrid—whatever our feelings about their initial creation—beyond the 14 days under this legislation. Why is it that we oppose that? Why would we not want to see it created? If we do not want to see it implanted, is it so lacking in logic and is it so contradictory to argue that we should not be creating it in the first place?

If Members of your Lordships' House believe that the reason for prohibiting a true hybrid from being implanted and born is that that crosses the line between human and other species, and if the problem is that this disturbs our sense of what it is to be human—a point made earlier by the most reverend Primate the Archbishop of Canterbury—we should surely, if it is so important to our common humanity and the basis of our ethics, tread very warily before permitting the creation of an animal interspecies embryo in the first place.

As the elusive question about definitions stalks our debate again today, we need to ask ourselves precisely what species this embryo is. The line will have been crossed; the species will have been crossed. Among those who are looking for funding and exploring every angle, no one really believes that the long-term prospects for stem cell research lie with cybrids or these new types of interspecies embryos. This is leading us into another blind alley. It is a scientific sideshow. Our first instincts were to ban it; those were the Government's first instincts, too, and they were the right ones.

We know that this will not in the long term give us the means to get useful stem cells from adults. The noble Lord, Lord Patel, made this point just a moment ago, on the use of adult stem cells in fertility treatments. That is more likely to come from groundbreaking work from men such as Professor Shinya Yamanaka at the Institute for Frontier Medical Sciences at Kyoto University, whose breakthroughs in this area have developed even while the proceedings on this Bill have been taking place. In an interview in New Scientist on 15 December, he described how reprogrammed adult skin cells have been turned into cells akin to human embryonic stem cells. New Scientist said that,

"the method, which involves inserting genetic material that makes the cells' development run backwards, opens the door to stem cells specific to patients, which could be used to repair damaged organs or fight diseases such as Parkinson's and diabetes—crucially, all without the need to destroy human embryos".

That extraordinary development illustrates why, whatever the result of the vote today, the argument has been lost for investing more public money and primary legislation in such redundant techniques as making cloned interspecies embryos to try to investigate and treat disease. As we have heard, it was famously abandoned by Ian Wilmut, who produced Dolly the sheep.

Last month, the journal Science reported that Professor Rudolf Jaenisch successfully treated a mouse with a humanised version of sickle cell anaemia, using induced pluripotent stem cells—that is, iPS cells. In 2002, Jaenisch attempted treating another blood disorder in mice by therapeutic cloning. The experiment failed. To cut a long story short, it worked only when adult stem cells were used. Nevertheless, it was hailed as a proof of principle for therapeutic cloning.

Earlier, when my noble friend spoke movingly about spinal injuries, I was struck by what I had heard in our Moses Room a few months ago, when I organised a seminar that was attended by many noble Lords. We heard an extraordinary account—it was the basis of a BBC television programme, "Miracle Cell"—by Professor Carlos Lima from Portugal, who has always disavowed the use of human embryonic stem cells. He told us of more than 100 treatments—not in the future, but treatments that have already taken place—using olfactory cells in the treatment of spinal injuries. He has produced real treatments; he showed us pictures to illustrate his talk. I was powerfully moved by that and I hope that my noble friend Lord Walton will have a chance to meet him in due course.

Professor Jaenisch stated in the journal Cell:

"Our results raise the provocative possibility that even genetically matched cells derived by therapeutic cloning may still face barriers to effective transplantation for some disorders".

That was confirmed by Professor Ron McKay's group, which stated in the journal Developmental Cell:

"Jaenisch addressed the possibility that ES clones derived by nuclear transfer techniques could be used to correct genetic defects ... However, the donor cells, although derived from the animals with the same genetic background, are rejected by the hosts".

One proposition that we seem to agree on is that the problem with embryonic stem cells is rejection. If that is so with embryonic stem cells, I simply ask as a lay man how much more rejection there will be where we mix any degree of animal material with human material. It does not seem to be well argued from a scientific point of view, let alone an ethical one.

Last month, Professor Jaenisch's group had striking success in treating mice with iPS cells from the mice's own skin where no similar success had been achieved using embryonic stem cells from cloned embryos. Science Express stated:

"The correction of sickle cell anaemia described in our experiments indicates that harnessing autologous iPS derived cells for therapeutic purposes recapitulates several of the promises offered previously by somatic cell nuclear transfer ... This demonstrates that iPS cells have the same potential for therapy as embryonic stem cells without the ethical and practical issues raised in creating embryonic stem cells".

Most tellingly, one of Professor Jaenisch's co-authors of the article on treating humanised sickle cell anaemia in mice, Professor Townes, commented in ScienceNOW last month that he and Jaenisch initially collaborated on a project that used nuclear transfer to make corrected stem cells; that is, therapeutic cloning. But he revealed that the experiments failed because nuclear transfer was inefficient in producing the needed cells. The iPS cell technique, Professor Townes stated, "is amazingly efficient".

Of course, one should acknowledge that the direct reprogramming of skin cells is not going to cure everything tomorrow either, as there are still potential risks that need to be eliminated. Nevertheless, there is currently no reason to believe that such risks are any more of a barrier to future clinical use than those already apparent with embryonic stem cells. Moreover, the remarkable progress made with a technique initially reported less than two years ago clearly surpasses the claims of therapeutic cloning, for which the relevant technologies have been around for over a decade.

Let me come to a conclusion. As Parliament is dazzled with misleading claims about therapies and cures, there have been none anywhere in the world. We have stubbornly refused to celebrate the life-giving qualities of adult stem cells, which are already being used and which pose none of the ethical dilemmas that this kind of legislation holds for so many of us. Instead of concentrating our efforts on their development and application through things such as the routine collection of cord blood cells, we are instead being invited to cross the Rubicon. If we permit the creation of these predominantly human interspecies embryos and full hybrids, we will be crossing an important ethical line—crossing human and animal. But for what? For the sake of a technology that we know will not be the future.

As it stands, the Bill permits not only the licensing of the 99.9 per cent human cybrids that we hear so much about, but also the licensing of true hybrids, which, as the noble Lord said, may never be used but which are what this Bill provides for—50:50 hybrids, really crossing human with animal. True hybrids are the most perplexing, the most disturbing and the most extreme examples of human interspecies embryo. They are not a potential source of stem cells of obvious clinical benefit. They have no suggested clinical benefit whatsoever. A line needs to be drawn somewhere and it should be drawn to prohibit the creation of these new types of human interspecies embryo that have been proposed in the Bill. I beg to move.

Photo of Lord Patel Lord Patel Crossbench 4:30 pm, 15th January 2008

My Lords, I do not know where to begin in challenging my noble friend Lord Alton. He makes a case for adult stem cells. I think that there is some legitimate reason to do so, but not as much as he claims. He does not feel that there is a need for so-called interspecies or human admixed embryos. Rather, he makes a case for reprogrammed adult stem cells and cites Professor Yamanaka and Professor Sir Ian Wilmut as people who have abandoned human embryonic stem cell research. None of this is true.

Let us rehearse the whole argument. What are reprogrammed induced pluripotent stem cells? I have said in this House twice before that it is the holy grail for all stem cell scientists one day to have no need to use human embryos or any form of admixed embryos for research, but to take an adult skin cell and reprogramme it to be a cell that truly behaves like an embryonic stem cell. They want a cell that is able in its totality to behave like a human embryonic stem cell. What have we got? We have the most fantastic research that has been announced in the past six to eight weeks where it has been possible to take a human adult somatic cell and reprogramme it to a cell that looks and seems initially to behave like an embryonic stem cell.

That has been achieved using what we call viral vectors, initially by using one viral vector that is a powerful oncogene—a substance that produces cancer. When that vector was used in a mouse model, it did exactly that by producing extensive teratomas in the mice. That vector has since been removed, but others still remain. When the cells are examined, each has a minimum of 20 injections of such vectors. We have to learn how to remove those vectors from every cell before they will be available for therapy. That research is, of course, exciting more and more stem-cell scientists. More and more of them will thus turn their attention to working on induced pluripotent stem cells because, in the long run, that may offer the greatest advantage.

Let me use an analogy; we have found a yellow metal that looks like gold and, initially, seems to behave like gold. Yet we do not know whether it is gold, and the only way to test that in totality is to test against the gold that we know—the human embryonic stem cells. Furthermore, none of this work would have been possible if we had not allowed the initial research on such stem cells. That research produced the science that made it possible to use viral vectors to induce pluripotency in adult cells. If the noble Lord, Lord Alton, wants to challenge me to examine the science on that, I will take that challenge.

Adult stem cells have delivered a lot, particularly in the treatment of hematopoietic diseases. The noble Lord referred to a register; there are lots of registers from trials of adult stem cells, but some of them have produced successes. It is sometimes difficult to assess those registers, because if you look at them just putting "stem cell" produces several types. None the less, I accept that adult stem cells have produced therapies. The problem is that those cells do not have the capacity to differentiate into all the cell types. Adult stem cells are not stable and, often, the treatment is for a particular patient and cannot be expanded to the large majority of patients. Those cells are not useful for developing certain therapies, particularly for degenerative diseases.

Is there a reason to support embryonic stem cell research? Yes, as a much larger number of patients can, potentially, be treated due to the indefinite self-renewal of human embryonic stem cells. For instance, the so-called Edmonton protocol uses islets from two or three cadaveric donors for each diabetic patient treated. That would be possible for many more patients using embryonic stem cells. Eight to 10 foetuses aborted between six and eight weeks from gestation are also required to treat each Parkinson's patient.

Embryonic stem cell research is often criticised for having failed to deliver after so many years. In reality, although human embryonic stem cells were derived in 1998, access to them was very limited for several years because of strict licensing, arrangements related to material transfer, and the logistics of expanding the existing characterised cell lines that were particularly imposed by laws in the United States. The first person to get the lines from Jamie Thompson in Wisconsin—the researcher mentioned by the noble Lord, Lord Alton—who identified and developed the induced pluripotent cells in humans was Peter Andrews at Sheffield University; most of the labs did not have access to human embryonic stem cell lines until 2003. Indeed, the first HFEA licence to derive human embryonic stem cell lines was not granted until 2003.

Normally, the time from discovery of a small molecule to its development into therapeutic use is anywhere between 20 and 40 years. For example, monoclonal antibodies took 20 years to be developed in the United Kingdom. We abandoned that research. The United States took it up and it is now a £2 billion business for treating patients. Given that and even in the light of the previous existence of Murai ES cells, the development of potential therapy from human embryonic stem cells is progressing well.

The first clinical trial using human embryonic derived stem cells could commence later this year in the United States to treat spinal cord injury with human embryonic stem cell derived oligodendrocytes—neuronal cells that repair spinal damage. UK scientists have said that they are within three to five years of a clinical trial. It is possible that a trial might be started in the United Kingdom within two years for the treatment of age related macular degeneration—some noble Lords may understand what that means—

Photo of Lord Patel Lord Patel Crossbench

Or possibly sooner, as my noble friend Lord Winston suggests. Three million people in the United Kingdom alone suffer from this condition. The advantage of a therapy that is developed from embryonic stem cells is that it will be more widely available. There will be problems, as the noble Lord, Lord Walton, said, with regard to immune rejection, but we hope that we will be able to study that and dampen it down. It might even be possible to take a cell from a person who has a disease, which will alleviate the need to use immunosuppressive drugs.

I hope that I have made a case for embryonic stem cell research, adult stem cell research and research involving reprogrammed adult cells and induced pluripotent cells. I hope also that I have explained why that research is so exciting but why we still need to learn a lot. That learning will come from studying human embryonic stem cells as the gold standard.

Is there a need to use interspecies embryos to create stem cell lines? We have a problem in not being able to create stem cell lines that carry the genes of a disease that we want to study in order to develop therapies or drugs or to do drug trials. We have that problem because to create such lines we need human eggs, ideally fresh human eggs, and they are not readily available. We can do the research without using fresh human eggs by taking fresh animal eggs; for instance, from dead cows. The stem cell lines created will be 99.5 per cent human and, more importantly, will carry the genes of the relevant disease such as motor neurone disease, Parkinson's disease, diabetes, muscular dystrophy and so on, that we wish to study to discover why some cells that eventually become damaged brain cells or produce muscular dystrophy behave differently. Are they programmed to do so from very early on? If so, can we manipulate them so that that programming is removed? You do not get a disease unless you have a disease specific gene. Normally, most disease genes are multifactorial. When a gene is switched on, mostly to express protein, you get a disease. We can learn how to switch off that expression and how to test drugs earlier in these cells so that we do not have to test more powerful drugs on humans and end up with a disastrous result, as happened last year in Northwick Park when three young people were severely damaged. So I hope that I make a case for the need to carry out studies using so-called interspecies or admixed embryos.

All the scientists who have worked hard to produce this science of induced pluripotent cells have said repeatedly that they do not believe that work on embryonic stem cells should stop. Every scientist today believes that work should continue on every different stem cell type—adult, cord blood, cord, embryonic, induced pluripotent, bone marrow—because we do not know at this stage which cell type will deliver the most cures, and what cures will be delivered by what stem cell types. I hope that I have made the case for allowing all forms of stem cell research to continue.

Photo of Lord Winston Lord Winston Labour

My Lords, correct me if I am wrong, but I think it was about five years ago that this House voted overwhelmingly in favour of continuing embryonic stem cell research. The vote was also carried in another place by about a two-thirds majority. It is true, as the noble Lord, Lord Alton, says, that embryonic stem cell research has not produced much clinical benefit. It has produced scientific benefit, unquestionably, and I do not think he disputes that. Although we think of science progressing very rapidly, in fact science does not progress very rapidly—it takes a while. It took about two years for the HFEA to grant any research licences, because it was so cautious. So in practice, in this country, the research has been relatively short-lived. It would be utterly wrong for this House, after such deliberation—which was so welcome to so many people, and so widely praised, not only in this country, but all over the world—suddenly to turn around and nip this work in the bud, just at the time when we are beginning to develop the tools to see what we can do with embryonic stem cell research.

I do not want to go through the arguments of five years ago, but the noble Lord, Lord Alton, has produced a bit of a blunderbuss attack. There are undoubted problems with adult stem cells that are widely accepted in the scientific community. Firstly, they come from an ageing person. Therefore, they are likely to be different in the way they propagate, and also in whether they are capable of continuing to live after transplantation. Secondly, as the noble Lord, Lord Patel, said, they may be subject to producing cancers. I do not want to exaggerate this, but the transplanting of any stem cell, either embryonic or adult, could theoretically produce a cancer. It is essential for scientists to look at this—one reason for doing embryology research is to see whether these cancers can be prevented.

There is also the question of transplantation. What is rather forgotten in this debate is that stem cells are very slow to divide in culture. Therefore, if you are an adult with a medical condition, and stem cells are taken from you, because they will be immune compatible, grown and then transplanted back into you, your degenerative process may be so advanced that your stem cells cannot catch up and you die before the stem cell transplantation can help you. That is why we need pools of stem cells and one reason why embryologically derived stem cells may be so valuable in future.

There are other issues. There has been confusion here about nuclear transplantation and the risk of immune incompatibility. I do not think that this is relevant to this debate. Any further manipulation of these cells reduces their viability, whether they are embryonic or adult stem cells—that remains a significant problem. One thing that we have to consider carefully is that transplanting adult stem cells is different from transplanting embryological stem cells. If I am an adult patient and I receive my own stem cells that have been grown, those stem cells will be programmed with potentially the same genetic defects that I already have, and which caused my disease in the first place. The brilliant advantage of an embryonic transplant is that you would be using a fresh pool of genes which would not be prone to that defect; that is one of the promises of such transplants.

Of course scientists, like anyone else, are fallible; there is no question about that. But 95 per cent of the biological community, with all honesty, firmly believes that embryonic stem cells are an important area of research. I understand that the noble Lord, Lord Alton, has difficulties with in vitro fertilisation, but at a time when so many human embryos are literally discarded after in vitro fertilisation because they cannot be transferred back to the patient, not to use those embryos seems to me to be an ethical problem for us. In my view it must be ethically far superior to use that material which would be discarded to produce stem cells, rather than simply discarding it.

As I said in Committee, and we have gone a bit further now, we have written the scientific paper and are about to present it to a journal. Recently in my laboratory we found that embryos that are not clinically viable and which we as clinicians would not consider suitable for transplantation to the human uterus seem potentially capable of producing embryonic stem cells. If the amendment prevented that research, we would kill the huge potential benefit to patients. That seems wrong.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, it would take courage for a non-scientist to intervene in this debate. I admit that I am truly confused, and I would be very grateful if the debate would turn itself a little to what appear to be the established facts of the situation.

During the debate in 2001 on the regulations for the HFEA, a number of claims were set out for embryonic stem cells. Those claims unquestionably referred to such degenerative diseases as Alzheimer's, multiple sclerosis and others. If you look back at that debate, you will see evidence of highly promising results in a relatively short period as a result of the use of embryonic stem cells. In the discussion that we have just had, the noble Lords, Lord Patel and Lord Winston, have both said in very strong terms that the great majority of the biotechnological community are strongly of the view that embryonic stem cell research is still absolutely essential. I admit that I was a bit thrown, having done a good deal of research as a lay person in this subject, to find strongly stated opinions that appear to be rather different. With the leave of the House, I will refer to some of those, but I will not take long. Let me mention a few.

The House will be familiar with the fact that Professor Wilmut, the designer and producer of Dolly the sheep, the first cloned mammal in this country, has already said that he will not pursue cloning and will now turn over to largely adult stem cell research as the basis for his research and investigations. Let me quote a few more.

Dr Lanza, chief scientific officer for Advanced Cell Technology in Massachusetts, said:

"It's a bit like learning how to turn lead into gold".

He was referring to adult stem cell research. Perhaps more to the point, in my own university of Harvard, a huge amount of investment has been made into the discussion of embryonic stem cells. Professor Douglas Melton, the head of that project, said:

"There was a prejudice, now shown to be wrong, against the very idea that you could take an adult cell and reprogram it back into an embryonic-like state".

It is very difficult, if you read back to the discussions of that earlier period, not to deny that there was such a fundamental prejudice against the idea that adult stem cells could have the results that they have now been shown to have.

James Thomson, head of a Wisconsin-Madison research unit which has done a great deal of interesting work in the field on stem cells, says, "The world has changed." Our own Nobel prize-winning professor, Martin Evans of Cardiff University, says:

"The writing is on the wall for destructive embryonic research".

It is quite difficult to put those quotations from recognised scientists—in one or two cases, very senior scientists—alongside what has been said earlier in this debate. As it is vital to try to get to the heart of the matter, perhaps I may ask a few questions as a lay person—I repeat, layperson—who shares the strong desire that we should address degenerative diseases and find ways of healing them, but who also believes that we should not do so by giving or raising false hopes of the kind that are extremely disappointing and discouraging.

I understand that the shortage of eggs—mentioned by the noble Lord, Lord Winston, for whom I have the greatest respect—is one difficulty in dealing with this field of research. Responsibility therefore surely falls on us to try to reduce the need for such human eggs as far as possible; in other words, to ensure as far as possible that the research we follow is not dependent on embryonic stem cell research unless it is unavoidable. I still want to hear about the extent to which it is unavoidable.

The second argument for adult stem cell research is that it does not raise the issue of immune reaction because the stem cells come from the same host as the one in whom they are intended to work in a curative capacity. Therefore, the second question I need to ask, and it would be very helpful to have a direct reply to it, is how far the immune reaction can be excluded on the basis of cells that are themselves based on embryonic cell research, and how far that continues to be a problem.

The third issue—it is not one that I fully understand although I listened closely to the noble Lords, Lord Patel and Lord Winston—is how far adult stem cells are replicable for embryo stem cells. The argument that the noble Lord, Lord Winston, put forward, if one hears and considers it carefully, was based much more on expectations and hopes of what might come from embryonic stem cell research than on actual evidence of clear therapies that have emerged, the most recent example of which is sickle cell anaemia and adult stem cell research.

The noble Lord, Lord Winston, like another noble Lord at an earlier stage, referred to the possibility of cancer-carrying genes when he indicated certain dangers with adult stem cell research. Again, it is hard for a layman to make a judgment. Professor Yamanaka told us a few weeks ago that he had managed to exclude genes carrying the possibility of cancerous developments from his own attempts to reprogram adult stem cells. He announced the results of that experiment a few weeks ago. However, I rather got the impression that the noble Lord, Lord Patel, nevertheless felt that still to be a real and serious factor. Does that mean that we have not yet had enough experiments to make it clear that the danger of cancer-carrying reprogrammed cells can be excluded, or does it mean that the noble Lord does not particularly believe that the experiment was valid and justified?

My final point is very important. In a situation where adult stem cells are largely though not totally replicable for embryonic stem cells—the noble Lord, Lord Winston, referred to embryonic stem cell research as a form of reference or a golden standard—should we take the view that if, as has happened in the past few months, more research in the field more frequently indicates that adult stem cell research is a fully adequate and non-dangerous alternative to embryonic stem cell research, then the Government should honour their own commitment? That commitment was made both in another place and in this place by the noble Lord, Lord Hunt, for whom we all have great respect. In the Official Report for 22 January he said:

"the 1990 Act already provides the answer to the question of what happens if and when research into adult cells overtakes research using embryos".

I had raised the question of whether the point we seemed to have reached was clear, and the noble Lord went on to say that, in that case,

"embryonic research would have to stop because the use of embryos would no longer be necessary for that research".—[Hansard, 22/1/01; col. 120.]

The Minister in another place went even further, saying that the HFEA,

"must satisfy itself that there is no other way of doing the research, avoiding embryo use".—[Hansard, Commons, 19/12/00; col. 214.]

Adult stem cell research has undoubtedly progressed in leaps and bounds since then, so I would like to ask the noble and scientific Lords, as we now know them, what is their own assessment of the advances made by adult stem cell research in very recent years? Do they believe that the argument about genes carrying possibly cancerous materials still holds up in the light of Dr Yamanaka's most recent research, or are they waiting for more such experiments? Finally, if embryonic stem cell research proves to have been overtaken in the next 10 years by the results and therapies from adult stem cell research, will the Government ensure that they take steps to bring the matter before the House again so that we can move from one to the other at the earliest possible scientifically acceptable point? I have a very strong sense that, as my Harvard colleague indicated, there is a prejudice in favour of embryonic stem cell research and that that prejudice must be questioned. I am sure that none of us has a desire to continue using embryos if it can possibly be avoided.

Photo of The Bishop of Winchester The Bishop of Winchester Bishop 5:00 pm, 15th January 2008

My Lords, we have heard a series of distinguished speeches, which have been hugely educative, but perhaps I may take the House back to what I take to be the main thrust of Amendment No. 8.

I am warmly supportive of the amendment. I also believe that I understand, I say with great temerity, why the noble Lords, Lord Patel and Lord Winston, concentrated on some of the major parts of the speech of the noble Lord, Lord Alton, but not on the point that he was seeking to make. I understand that the thrust of Amendment No. 8 concerns the mixing of human and animal matter and whether that is called an interspecies embryo or a human admixed embryo. That seemed to be the point that the noble Lord, Lord Alton, was making. Perhaps he somehow hid that thrust within the many other interesting things that he had to say, and which drew from the noble Lords, Lord Patel and Lord Winston, the hugely instructive material that they produced. However, it seemed to me that neither of the two noble Lords addressed the ethical admissibility of interspecies embryos. Although they made a case for the need for the work that they and many others are doing, they did not address that question. I think that that was the question that the noble Lord, Lord Alton, was trying to put before us, and that is the plain meaning of his amendment—which, as I understand it, seeks to remove the six words,

"except in pursuance of a licence", and which would leave new Section 4A(2)(c) as a negative.

My view and the view of many others, including many who have written to us from all kinds of philosophical and religious perspectives, and the point that I think the noble Lord was trying to make, and he used this language, is that the use of such interspecies embryos—such human admixed embryos, with the mixture of human and animal matter—crosses a fundamentally important line. It is a fundamentally important line on which I had understood the 1990 legislation was predicated. However great the advantages of crossing that line, we human beings have mostly judged—both out of the major religious traditions and for other reasons, too—that a unique status and respect must be afforded to the human being, the human embryo and human reproductive material. The point at issue is not one of those made by the noble Lords, Lord Winston and Lord Patel, it is whether Parliament should permit that line to be crossed. I understand that the purpose of this amendment is to test that view. My own judgment is that it is a view that I should support.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, I am not going to rehearse again the views that I expressed in debate on an earlier amendment—to the effect that the prospect of using an interspecies embryo, or should we call it an admixed embryo, which contains the nucleus of a human somatic cell and, surrounding it, the capsule of an animal egg can produce very many stem cells which are 99.95 per cent human and only 0.05 per cent animal. These embryos can therefore produce an enormously valuable source of stem cells which would be immunologically compatible with the individual from whom that somatic cell was removed. That is still the crux of this argument.

There is a vast scientific literature on all aspects of stem cell research. This is a field in which the United Kingdom, for a variety of reasons, is in some respects leading the world. There are other parts of the world, particularly the United States, where, through private funds and not government funding, some research of this importance is continuing. There is no doubt that adult stem cells have a value and can be used for potential treatment of disease. This relates equally to umbilical cord cells, which are significantly less mature. However, as most scientific experts will say, those cells are much more difficult to program and manipulate in order to produce kidney cells, brain cells, nerve cells, heart cells, muscle cells and the other kinds of cells that are ultimately needed for the treatment of human disease. On the other hand, embryonic cells have a much greater pluripotential and can readily be manipulated to produce that kind of tissue.

I hope that this is taken in the correct way, because I have no doubt about the total sincerity of my noble friend Lord Alton, with whom I have had many interesting and important arguments over the years. However, some of the attitudes of those writing in the medical and scientific press criticising the use of embryonic cells for research have been conditioned very much by religious beliefs. Many centuries ago in the Roman Catholic Church, St Thomas Aquinas, that great theologian, averred that life did not begin until the foetus was capable of independent existence outside the womb, but a pope in the middle of the 19th century laid down the edict that life began the moment the sperm entered the egg. In consequence, people of the Roman Catholic faith, ever since that time, have believed firmly that they should oppose all aspects of embryonic research.

I have to say that I am a Christian, a lifelong member of the Methodist Church. I attend an Anglican church in Northumberland because there does not happen to be a Methodist church in the village where I live, but I firmly adhere to Christian beliefs and understanding. As regards the views of those in the Roman Catholic Church on embryonic research, I also have to point out that there are others of their own faith who do not agree with the complete ban on embryo research. I remember that when we debated the legislation in 1989 and 1990, I quoted the reverend Professor Norman Hunt, a distinguished Roman Catholic theologian from Australia, who took the view that it was perfectly proper to consider experiments on the human embryo up to 14 days after fertilisation, at which time the primitive streak is the first appearance of a human nervous system. It is on that basis that I have consistently supported embryonic research.

I say to my noble friend Lord Alton in passing that the world leader in the use of olfactory ensheathing cells for the treatment of spinal cord injuries is Professor Geoffrey Raisman of the national hospital, Queen Square, and University College. He is absolutely outstanding in this field. In addition, there is no doubt that stem cell research is beginning to show an additional factor over and above the use of olfactory ensheathing cells for the treatment of spinal cord injury. That is important.

In the scientific community world wide, there are those with the views which have been expressed who are bitterly opposed to all kinds of embryo research. Because of that belief, they oppose the idea of the admixed or interspecies embryo as well. But the great majority of world-wide research workers, as noble Lords will find if they care to consult papers produced by the Royal Society, the Medical Research Council, the Wellcome Trust, the British Medical Association or the Academy of Medical Sciences, believe that the use of the admixed embryo for the development of stem cells for the treatment of human disease is a major development, and that embryonic stem cells have a far greater potential for the treatment of human disease than the adult cells derived from cord blood or other areas. With every possible respect to my noble friend Lord Alton, while I appreciate the total sincerity of his views, the amendment must be rejected.

Photo of Lord Rea Lord Rea Labour 5:15 pm, 15th January 2008

My Lords, I listened carefully to the speech of the noble Lord, Lord Alton, and wrote down verbatim some of the things that he said. One of them was that human admixed embryo research was,

"disturbing our sense of what it is to be human".

The right reverend Prelate put something of the same feelings into his speech. Implied in that statement is the real reason for the noble Lord's opposition to this procedure, which is moral abhorrence. We should respect his feeling and all those who share it, but the noble Lord knows that the human admixed embryo which will be created will be destroyed before it develops into a recognised organism. The legislation requires this. My noble and professional friends have explained extremely clearly how these embryos are to be used: purely for research purposes to increase our knowledge of all aspects of human development. Application of this knowledge may be useful later on for therapeutic purposes, but this research is not, as the noble Lord, Lord Alton, put it, "a scientific sideshow", a "blind alley" or a technology which will not have a viable future. The House has heard enough to put those statements in their place.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I shall address myself to the question raised by the right reverend Prelate about crossing the boundary between human and animal species. The right reverend Prelate will have seen the discussion in Committee about the extent to which animal embryos mixed with human DNA are used. They have been used for a long time already, so that boundary, if treated generally, has already been crossed. The material in that area, if regulated at all, is regulated by the Animals (Scientific Procedures) Act. There is a question about whether embryos in that area are regulated at all because the Act refers to the embryo of an animal, but if an embryo has human material mixed with it, it may no longer be the embryo of that animal. If that is the case, it is not regulated as an embryo, although there is regulation if it were to be implanted in an animal. So that boundary was passed a long time ago and is why using the phrase "interspecies embryo" in the Bill was very easy to understand, except that it does not properly reflect what is being regulated as the Bill says that if you start with the human embryo and puts animal DNA in it, within limits, you should treat it with the same respect as you accord to a human embryo.

In 1990, there was a considerable debate about whether human embryos should be used for research at all. The Government of that day gave a free vote on that matter to everyone who took their Whip. There was a free vote about it in this House. The House decided by quite a substantial majority to allow research on human embryos under specific conditions, including one that looks quite like what the noble Baroness, Lady Williams of Crosby, quoted from the noble Lord, Lord Hunt, speaking at that time, I think, for the Government as Minister for health. That clause is in the 1990 Act, and it is reproduced to a considerable extent in the present Bill.

What is proposed by the Government and was supported by the Joint Committee, of which I am a member, is that if the human embryo is modified or admixed with animal DNA material, it should be accorded the respect as a embryo that is accorded to the human embryo by the 1990 Act, but with prohibitions that do not apply to the human embryo, generally speaking, under the 1990 Act; namely, that it is not to be allowed to exist for more than 14 days and is not to be implanted in a human being. The idea of the Bill is to take this extension of the human embryo and treat it for practical purposes of regulation in the same way as an ordinary human embryo would be treated with those additional restrictions. That is what it is about.

If you do not believe that embryo research is right at all, that has a certain consequence. If you do believe that embryo research is right, subject to the conditions of the 1990 Act, you have the additional question of whether this admixture makes all the difference. Considering what has happened with animal embryos, to which I have referred and which was discussed in considerable detail in Committee, that problem may be resolved for you by the experience of what has happened already. The important thing is whether these admixed human embryos—I believe that is a more accurate expression: it may not be quite as simple as interspecies embryo but accuracy is sometimes better than simplicity in a situation such as this—should be permitted if there are benefits to be gained. The licence conditions require that, so a licence should not be granted unless the specified conditions are accepted.

For my part, although I understand perfectly the arguments that the noble Lord, Lord Alton, and the right reverend Prelate have raised, in the present circumstances, I feel that it is right for Parliament to allow these matters to be considered for licensing. Of course, there is a very important question about the utility of the research, and so on, but that is for the licensing authority to consider on a particular application.

Photo of Baroness O'Cathain Baroness O'Cathain Conservative

My Lords, I tremble to join this debate, but I want to support the noble Lord, Lord Alton. I have been deeply encouraged to do so by the speeches of the noble Baroness, Lady Williams of Crosby, and of the right reverend Prelate the Bishop of Winchester.

I had a great many points to raise on this amendment but I will not raise them because it would just be repetitious and we do not need that. However, certain statements were made during the course of the debate. One was that 95 per cent of the biological community supports embryonic stem cell research, even though it has limited, if any, therapeutic benefit at the moment. Why do they carry on wanting that when, already, adult stem cell research has resulted in more than 70 proven therapies?

We were then told that macular degeneration would be cured by embryonic stem cell research. Would not macular degeneration be cured by further adult stem cell research? We are also told that embryonic stem cell research has had private funding in the US and elsewhere. Have there been any positive results from that, because we have not heard of any?

Above all, bearing in mind the comment about the 95 per cent of the biological community in support of embryonic stem cell research, I gently draw to the attention of noble Lords that, in an ICM poll for the Human Fertilisation and Embryology Authority published in July 2007 about research on hybrids and chimeras—what we are talking about, analogue human research—half the population was opposed to it. No one has mentioned that, out there, an enormous number of people have deep ethical concerns. It is not the religious faction; it is not the Roman Catholics; it is people who probably do not understand, but the scientific community has not done a great deal to try to make it simple for people to understand. We keep being told that adult stem cell research has resulted in more than 70 proven therapies and that embryonic stem cell research has not resulted in one proven therapy. No wonder people are concerned.

Not for that reason alone, but in the main for that reason, I support the noble Lord, Lord Alton.

Photo of Lord Tebbit Lord Tebbit Conservative

My Lords, I must say that it is a privilege to have listened to the debate today in this House. I cannot think of anywhere else where any of us would have heard people with such erudition as the noble Lords, Lord Patel and Lord Winston. I do not want to upset the noble Lord again—I know that I did in Committee—but I find myself instinctively more in sympathy with the right reverend Prelate the Bishop of Winchester. I am not a Roman Catholic. I understand that he is not either. I am probably only a fellow traveller on his train, rather than an active driver. But we treat humans and animals differently and I think we would all agree that we should treat humans and animals differently. Once we get into the business of creating entities which are halfway, or somewhere along that spectrum, between animal and human, we have a deep ethical dilemma. Arguments for the different treatment of humans and animals begin to be undermined and I find that a worrying feature. I am also worried about the attitude of the scientific community which, while it is always willing to accept that there should be limits placed on it on ethical grounds, always seems to assume that the limits should be somewhere just beyond what is scientifically possible and what it wants to do and those limits keep moving.

The matters we are discussing are more of ethics than of technology. Because it is scientifically possible to do something does not mean it should be done. Because it might bring great benefit to particular people does not mean that it should be done. If we accept arguments of that kind, we are essentially accepting the argument that the end justifies the means. I am not sure that the noble Lord, Lord Alton, is absolutely right. It is very difficult to decide where we should go from where we are, but I would much rather go in the direction which the noble Lord, Lord Alton, wants to go in than that which we are told the scientific community wants to go in. There is an ethical element to this which is understood broadly by most people in or out of the scientific community and which relates to the unease of creating things which are neither human nor animal and then justifying in some way that we should continue to treat animals and humans differently.

Photo of Baroness Warnock Baroness Warnock Crossbench 5:30 pm, 15th January 2008

My Lords, I will reply to one point that the noble Lord, Lord Tebbit, has just made. It cannot be said that scientists are always thinking that what can be done should be done or is permissible. I vividly remember, after the publication of the report on embryology and fertilisation, taking part in a television programme with Bob Edwards, who was partly responsible for the first IVF birth, where he said, "What I would really like to do is to keep an embryo alive in the laboratory for more than 14 days but I am a law-abiding man." I nearly killed him for saying that because we were facing a very hostile audience at the time and I had envisaged saying that nobody would want to keep an embryo longer than 14 days. But he said he did want to and he could not. There may have been many other scientists who would have liked to conduct research on embryos older than 14 days, but as far as I know nobody has. That is a case where the law has laid down a regulatory barrier beyond which lawyers say nobody may go and everybody has kept to it.

Photo of Lord Patten Lord Patten Conservative

My Lords, I fully support what the noble Lord, Lord Alton, said and I greatly admire his growing scientific expertise. He is beginning to fall more and more into the category of noble and scientific that his noble and right reverend friend Lord Harries of Pentregarth referred to earlier. I do not know whether he has been taking private tuition. I certainly do not have his scientific grasp and therefore I shall not attempt to repeat his arguments. I shall simply make two points, one economic and the other ethical.

Without attempting to run the argument that the free market is about to come to the rescue of embryonic stem cells, it is interesting to know what great interest there is in the investment community in adult stem cell research and how very little interest there is in the venture capital community—I have no interest to declare in this matter—in embryonic stem cell research. Markets are not always right and investors do not always make the right decisions but it is very telling, as has been pointed out by Forbes magazine and others.

The second point I wish to make is the ethical one. I am relieved that we have not heard on Report some of the arguments put forward in Committee. These admixtures, as we must now learn to think of them, are very small and invisible and because they are so small and invisible to the naked eye, they are not really important. Lots of things are invisible. Good and evil are invisible to the eye. It is only when the outward manifestations are reached that we see that something has happened that should not have happened. So I am very relieved that no one has tried to put forward the housemaid's baby argument again that this was just a little admixture, not a large one. The right reverend Prelate the Bishop of Winchester was right in saying that this is where the line should be drawn. In response to an earlier debate, the noble Lord, Lord Alton, said that he felt people might look back to some of our debates and say they were old-fashioned and ancient history. On this occasion I think they will look back to what has been said by the noble Lord, Lord Alton, and the right reverend Prelate the Bishop of Winchester and say they were absolutely right ethically.

Photo of Lord Sutherland of Houndwood Lord Sutherland of Houndwood Crossbench

My Lords, the amendment before us is one that will close a door to certain forms of research. If we are to do that, we must take note of two or three different points. The first is that this is a well regulated door already and in the Bill there is additional regulation. I was very grateful to my noble and learned friend Lord Mackay of Clashfern for spelling out the details of which doors were still open and which were not. This is a well regulated door and we would have to have very good reason to close it. I can think of two possible reasons. My concern in this debate is that they have been intertwined sometimes in unhelpful ways.

One reason is ethical, based on a strong metaphysical or theological foundation. I have not heard views expressed and arguments put forward that would persuade me to change my own metaphysical and theological beliefs in a way that would lead me to support this. Such arguments there may well be but I have not heard them put forward today. The other possible reason is that we do not think that the kind of research which will be allowed if this door is opened will be productive. On that—and I speak as many others have done as a non-scientist—I have to defer to the opinion of those whom I respect and whom their colleagues respect. We have all of us, I am quite sure, had circulation of a note representing the major scientific institutions with an interest in this area. They are quite clear about the possibilities and again I have not heard arguments which will overthrow the conviction they have shown that the weight of opinion is that this door is worth keeping open. Are we trying to predict as a group of largely non-scientists whether either embryonic or adult stem cell research will be the most successful? I do not think most of us are in a position to do that. Having said that, if we were to shut this door, we would be shutting a door of real possibility, according to the views of many of my scientific colleagues here and elsewhere.

The last point I will make is that public opinion is very important but it is not and cannot be the final way of resolving some of these questions. Consider, for example, the debates over the death penalty and what public opinion might have done in that respect. So I stand with those who do not accept the amendment.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, I have two simple points to make that have not been made so far in this debate but which I think are important. Throughout our consideration of the Bill at all stages, the issue of how this House uses and refers to scientific research and scientific opinion will recur. It is important right from the outset that we get into the habit of referring accurately to the scientific information and research as it is presented to us.

A number of noble Lords in this debate have pointed out that Professor Ian Wilmut, the famous creator of Dolly the sheep, announced in December that he would in future pursue research only on adult stem cells. No one has added that he also stated in December that, although he had taken that decision, he was very firmly of the view that it was important that embryonic and other types of stem cell research should be funded and continue, because only if all avenues were pursued would the scientific community, drawing as it does from knowledge gained in the different disciplines, get to the eventual end point, which is therapy. I make that point because my noble friend Lady Williams of Crosby quoted a number of professors from America. I am not in a position to evaluate those statements because I do not know well enough the context in which they were made. For now and for the rest of the debate, however, I wish us to take great care in how we use the information that is presented to us.

I know that my noble friend, who presented the case very cogently in Committee, is concerned that there is fashion in science research and that it may be that embryonic stem cell research, as opposed to adult stem cell research, continues to be in fashion. I reiterate that we on these Benches agree with her that when government come to take funding decisions about research, they should continue to ensure that there is adequate funding for all forms of research. That funding may have to take into account the point made by the noble Lord, Lord Patten, that commercial resources may go to particular types of funding rather than to others and that government may have to balance that out, but it is important that we should say in this House not only that these different types of research should continue to be important but that funding should follow them. Therefore, for those reasons, we on the Front Bench in this debate do not support my noble friend, although we do understand the important basis of her argument.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, the amendments seek to prevent the creation, keeping and use of interspecies—or, as we now intend to call them, human admixed—embryos in any research, including into understanding and treating serious diseases and medical conditions. As science has moved forward since then, our understanding of embryo development and embryonic stem cell research has increased significantly. However, new challenges have arisen as our understanding of stem cells has increased. It is now clearer than ever that the challenges facing embryo researchers are more complex than at first perceived, but we are also more confident than ever that at the end of this research there will be new treatments for serious diseases and medical conditions.

The research community and medical charities have in the past 12 months made a considerable effort to cite the need for human admixed embryo research. The shortage of human eggs in particular for use in refining the process of embryonic stem cells has led to calls for the ability to use animal eggs, which are available, as most of us know, in much greater numbers, to create human admixed embryos. This was further reinforced today by a publication from the Academy of Medical Sciences, the Medical Research Council, the Royal Society and the Wellcome Trust, and supported by the Association of Medical Research Charities. In Annexe A, they eloquently highlight the role of different sources of stem cells: embryonic stem cells, foetal stem cells and adult stem cells.

I also remind the House that the granting of peer review funding for stem cell research is equal if you look at embryonic stem cell research versus adult stem cell research. That is extremely important. Peer review funding in this area is highly competitive. There is a strong cohort out there, an international scientific community, which truly believes that there is a tremendous and rich future for research into embryonic stem cells. The joint pre-legislative scrutiny looked at this with the Science and Technology Select Committee of the other place, and both have held inquiries into the ethical and scientific considerations regarding human admixed embryo research. Both have recommended that this research be permitted under the regulation of the HFEA.

The noble Lord, Lord Tebbit, also raised a very important issue about the unnatural nature of research in this area. I agree that there is an unnatural process here. However, we need to remind ourselves that many scientific discoveries are unnatural. That does not necessarily mean that they are bad. A true example, as highlighted by the noble Baroness, Lady Warnock, is IVF. There is nothing natural about IVF, but it has saved many lives.

Photo of Lord Tebbit Lord Tebbit Conservative 5:45 pm, 15th January 2008

My Lords, the Minister is not distinguishing correctly between discoveries and the advance of technologies.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I am grateful for that intervention. I was trying to get at limiting scientific discovery in relation to the unnaturalness of the process. I agree that there are ethical issues about this. As far as they are regulated, as highlighted in the Bill, I feel that we should be supporting this. Within the context of the regulatory framework that we have put in, I remind the House that there is an absolute time limit of 14 days and an absolute prohibition about the implantation of a human admixed embryo in a woman or any animal. Such research will, as I said, be permissible only with a licence from the HFEA and only in circumstances where the HFEA deems the research necessary for one of the statutory processes. In taking such decisions, the HFEA will be required to take into account all other available avenues of research that may achieve the same end. I invite the noble Lord to withdraw the amendment.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I hope that anyone who doubts the worth or the value of your Lordships' House will read the Hansard record of today's debate, because whatever positions we come from—we are deeply divided on this issue—they will see that the high quality of the debate and the many informed contributions from those on all sides give the very reason why this House should exist. It is impossible in another place—I served there for 18 years—to have debates of this kind, and regardless of our differences, we have been able to explore and to give justice to something that people would expect us to have an intelligent and informed debate on and to be willing to vote on.

Although I do not offer my noble friend a theological opinion—I am not a theologian—I have always believed passionately that life begins at conception, and I do not believe that we should destroy life after that unnecessarily. I know that that is an old-fashioned view that does not commend itself to everyone, but, without the value of Thomas Aquinas, to whom my noble friend referred, the 38 Anglican, Catholic, Reformed and Orthodox theologians who submitted evidence to the retrospective Select Committee that we established in your Lordships' House in 2002 also argued the point about the sanctity of human life.

It was Lord Rawlinson of Ewell, who contributed to the debate here in 1990, who said at the time that it must be 14 days after something. That is the fundamental question—the metaphysical and theological point to which the noble Lord, Lord Sutherland, referred—that divides us. Many of us are of the view that this is human life and that therefore we should not do these things to it. However, that is not the amendment before the House today. The amendment before the House today deals specifically with a prohibition on the creation of animal-human hybrids—or human admixed embryos, as we are now going to call them. The noble Lord, Lord Rea, said in his intervention that this legislation requires it to be destroyed. He had put his finger on it. "It" must be something and it is going to be destroyed at 14 days. What is it that we are destroying, 14 days after something? We must at least ask ourselves that question.

The noble and learned Lord, Lord Mackay, whom I enormously respect, said, quite rightly, that many lines had been crossed in the past. Is this another line that we should be crossing? That is the question we need to ask. We have come a long way from the report of the noble Baroness, Lady Warnock, which said that we should show respect to the human embryo and accord it human status. I recall the noble Baroness saying to us a couple of years ago that she wished she had not used those words in her report, because when you are flushing something away down a drain, it is hard to accord respect or status. I am not misquoting the noble Baroness; she said that.

That is where we are now. The issue is whether we take that argument further. The noble Lord, Lord Patten, talked about the importance of understanding science. I agree with him. We must comprehend the science, but we do not always have to follow it. I despair when I hear Ministers saying, in order to defend their points, that we have to follow the science. We do not always have to follow the science. We need to inform ourselves, even if we are mere laymen without the expertise that some of those who come to our debates bring.

If theological opinion is divided, as it will be, and if lay opinion and metaphysical opinion are divided, so is scientific opinion. Here I want to say something to those who have implied that it is not, as the noble Lord, Lord Winston, did earlier when he said that 95 per cent of the scientific community was united. I think he was talking more generally about embryonic stem cells, but I want to get back to the amendment for a moment and remind the House of what was said by those scientists who came to the Joint Committee. The noble Lord, Lord Jenkin, and the noble and learned Lord, Lord Mackay, among others, were members of that committee. Dr Lovell-Badge said:

"I cannot think of a good experiment to do now but I am sure someone will think of a good experiment".

Professor Bobrow said:

"We are also not aware of any pressing scientific reasons at the moment for creating such entities, but who knows what tomorrow might bring?"

Professor Smith said:

"At the present time we have not been able to identify such a particular reason"— to make true hybrids—

"but that does not mean that they do not already exist and that there are not people already in the scientific community who would have appropriate grounds or that they would come along in the future".

That is not exactly overwhelming evidence. I remind the House of what the new Nobel Laureate, Sir Martin Evans, who originally discovered mouse embryonic stem cells a couple of decades ago, recently said:

"The writing is on the wall for stem cell research that depends on using human embryos".

Let me end by reminding the House of what Sir Liam Donaldson, our Chief Medical Officer, said in his evidence to the Joint Committee on the draft Bill on 6 June 2007, concerning true hybrids:

"There was no clear scientific argument as to why you would want to do it, and, secondly, a feeling that this would be a step too far as far as the public are concerned".

It is a step that we should not take and I wish to seek the opinion of the House.

On Question, Whether the said amendment (No. 8) shall be agreed to?

Their Lordships divided: Contents, 96; Not-Contents, 268.

Division number 1 Private Parking: Ports and Trading Estates — Human Fertilisation and Embryology Bill [HL]

Aye: 94 Members of the House of Lords

No: 266 Members of the House of Lords

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Resolved in the negative, and amendment disagreed to accordingly.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat 6:09 pm, 15th January 2008

moved Amendment No. 9:

Clause 4, page 4, line 12, at beginning insert "Subject to sub-paragraphs (6)(a) and (6)(b) of Schedule 2 to this Act,"

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I hope that it will be accepted that, while I move Amendment No. 9, it stands in the place of Amendment No. 41 and that any vote on Amendment No. 9 would constitute a vote on Amendment No. 41.

I recognise that the hour is growing late and I do not wish to detain the House for long, but let me distinguish clearly between this amendment and the previous amendment, as there is some overlap in the debate. The purpose of Amendment No. 8, moved by the noble Lord, Lord Alton, with regard to what I still call mixed species because I find it hard to remember the phrase "admixed species", was to refuse any longer to accept trans-species research. The proposal in this amendment very straightforwardly says that a licence should not be granted by the HFEA except where it is clear that there is no alternative to embryonic cell research. The amendment would not rule out embryonic cell research. It accepts that for some purposes embryonic cell research may be absolutely essential, but it proposes a definite requirement in the award of any licence that there has to be peer review and research evidence to show that embryonic stem cell research is necessary. In other words, we would give a preference to adult stem cell research over embryonic stem cell research and that preference would clearly be built into the licensing process.

The reason for that is clear. When the 2001 regulations were debated in this House, a view was taken that adult stem cell research would probably not be a very exciting or creative line of research and that therefore embryonic stem cell research was bound to be the central theme behind the processes of stem cell research in general. My view, which is shared by many, is that you have to make out the strong case for embryonic cell research because of the ethical objections to it. That means that licences should be tightened up and should be awarded for embryonic cell research only where no other form of cell research can be shown to be effective. This would require two changes in HFEA licensing: first, evidence to show the efficacy of such research and that it was needed; secondly and crucially, evidence to show that it was the one way forward. We believe that embryonic cell research should be left to where it is the absolutely required factor where other forms of research would be likely to be unsuccessful.

In his response to my speech on the earlier amendment, the Minister was kind enough to say that there had been or was now an almost equivalent expenditure under the HFEA between adult stem cell research and other forms of cell research, particularly embryonic cell research. He is absolutely correct in what he says. Yet it is also true that in the six years since 2001, when the House passed the regulations, there has been a steep increase in expenditure on adult stem cell research, which was not true at the beginning of that process when little money was found for it because the scientific community had little faith in it.

We have put forward this proposal not to completely rule out embryonic cell research but to indicate that it should always be, as it were, the residuary factor: the requirement must be very clear. One reason for this was exemplified by the remarks about the shortage of human eggs, which was one of the reasons why we argued for a—I am sorry that I keep using the old phraseology—mixed-species form of embryo. Such research is necessary because, as the noble Lord, Lord Winston, said, there is a great shortage of human eggs. Yet you would not require so many human eggs if you relied much more on adult stem cell research than on embryonic stem cell research, because most such research that could be done in either way would be primarily done by adult stem cell research.

That is the reason for Amendment No. 9, which would tighten up the licensing system of the HFEA, indicating that, although the licensing system does not rule out embryonic stem cell research, such research is the lesser preference. The first preference should be adult stem cell research. This would balance a situation in which, until recent years, adult stem cell research has tended to be somewhat disregarded.

I should perhaps say "human admixed embryos" and apologise for having used the old terminology. I am referring throughout to human admixed embryos, the term that the House has passed and which it is a requirement for me to respect.

There is now extremely exciting evidence of the remarkable achievements in adult stem cell research. It is growing in all directions. It is probably growing in other countries even more than here. It is a way forward that leaves out some of the great drawbacks of embryonic cell research, not just the ethical issues but also issues of supply and immunity. I will not detain the House long, because we had this debate earlier, but in moving this amendment I also stress the need to build in this element of preference.

Finally, I must apologise to the House. I rose to the challenge when the noble Lords, Lord Winston and Lord Patel, spoke because they addressed the alternatives of adult stem cell research and embryonic cell research. I was so carried away by the desire to put the other side of the case that I made that case largely on the last amendment and I should have made it on this one. I was not unique in that, because the noble Lords, Lord Winston and Lord Patel, made the same point, but I ask people in deciding how to deal with this amendment to recall the debate on the last amendment, too. I beg to move.

Photo of Lord Harries of Pentregarth Lord Harries of Pentregarth Crossbench 6:15 pm, 15th January 2008

My Lords, I do not suspect the intentions of the noble Baroness, Lady Williams, but what she proposes in her amendment was what the House intended in the regulations approved in 2001 and 2002 and, indeed, in the 1990 Act. The HFEA's licensing procedure is already tight and I am not persuaded by what she said that these amendments would make it any tighter.

At the moment, when a research application comes to a licensing committee of the HFEA, it has already gone to a local ethics committee and must have received the approval of two peer reviewers, who have to go through a substantial form answering some of the questions that the noble Baroness has put down in her amendment. For example, the form asks whether the research could be achieved using means other than embryos, whether it is really necessary, how many embryos are likely to be used and whether it is likely to be successful.

There is a reference to whether there are enough significant research papers and whether enough significant research has been done, for example, on animals. All this has to be considered first by the peer reviewers, after which the application comes to the licensing committee, which again considers all those questions. At the end of every meeting on a research licence application, there is a formal decision tree to which the chair of the committee must go to ensure that these questions really have been faced and answered satisfactorily. While I entirely respect the intention of these amendments, I believe that the procedure is already tight and I am not convinced, were these amendments to be approved, that it would be any tighter.

Photo of Lord Neill of Bladen Lord Neill of Bladen Crossbench

My Lords, my respectful view is that the noble and right reverend Lord, Lord Harries of Pentregarth, is approaching the matter from an entirely mistaken perspective. I think that everyone would agree that there must be conditions restraining the circumstances in which embryos and—let me get the language right—human admixed embryos can be used. This amendment seeks to include in the Bill some of the most pre-eminently important conditions that would have to be satisfied. I wish that the House would listen to the point—perhaps it is already listening—that people outside are listening to and watching what we are doing. In the light of the last vote, it is extremely important that we should say, "Yes, these embryos can be used, but we are specifying what strict conditions have to be met".

I say with great respect to those who sit on the authority that what they do in their routine business is completely unknown to the outside world. I do not suggest that it is not knowable; I am simply saying that it is not known. Why should we not state these conditions? The first one comes straight out of the provision in the 1990 Act, at paragraph 3(6) of Schedule 2. It uses the same language, saying that,

"any proposed use of embryos or inter-species embryos is necessary for the purposes of research".

The only addition is the words "inter-species embryos", now to be "human admixed embryos". Amendment No. 41, as noble Lords who have their Marshalled Lists to hand can see, uses exactly the same words as those used since 1990 with the exception of the new term. So it is hard to see that there could be any conceivable objection in principle.

Proposed paragraph (6)(b) goes on to demand,

"cogent evidence, which must include published, peer-reviewed scientific data".

I was heartened by the reference to this made by the Minister, the noble Lord, Lord Darzi, when talking about peer-reviewed financial grants in aid of research proposals. That is what goes on, but to the lay man it is significant to be told that there will be peer-reviewed research available for other scientists, supporting the matters that I will now enumerate.

The first is that the research has been undertaken successfully in animal embryos of one or more species. Again I admit to my own lack of knowledge in this field, but my understanding is that, almost invariably, animal work will have been carried out and it will have been successful. The only suggestion that I picked up on the first day in Committee indicating a difficulty to the contrary is that there may be some diseases on which there is a wish to carry out research but where it is not possible to make use of animal testing. If that is correct, one can either read paragraph (6)(b)(i) as not extending to a case of impossibility—evidence would not be required on a point where it was impossible to produce it—or, if necessary, one could add qualifying words such as, "save where it can be demonstrated that relevant animal testing is impossible". I should have thought in any event that that was implicit.

Proposed paragraph (6)(b)(ii) requires that,

"the research proposed on human or inter-species embryos is likely to achieve its specified purposes".

That is a moderated version of a condition proposed by my noble friend Lord Alton in his Amendment No. 7 in Committee. The language used then was that,

"the research method proposed is most likely to produce satisfactory results".

That amendment was criticised on the basis that it set the bar too high and was unnecessarily and impossibly rigid. Here the language has been moderated to,

"likely to achieve its specified purposes".

Perhaps I may remind those noble Lords who have had to deal with inventions in universities or at places of work of the problem of whether the invention belongs to the institution or employer or to the man who made it. The relevant provision of the Patents Act 1977, Section 39(1)(a), states,

"the circumstances ... were such that an invention might reasonably be expected to result from the carrying out of his duties", where "his" means the employee's. We have contemplated in legislation that circumstances could arise where an invention could reasonably be expected to result. It seems no more than a parallel case to someone forming a judgment, here the authority, that the proposal is likely to achieve its specified purposes, in all the circumstances of which the authority would have full knowledge. I commend this condition as well.

Finally, and I think that this is probably inherent in that everyone has mentioned it, the third condition, in paragraph (6)(b)(iii), is that,

"it is not reasonably practicable to achieve the specified purposes of the research without using human embryos or inter-species embryos".

The authority would expect to be told that resort was being made to embryos because the research team could not see a way of using any other form of material. Indeed, we discussed earlier today the other types of material that can be used for experiments that do not involve an embryo. The condition ensures that researchers would have to demonstrate that the use of another material was not possible.

In following the noble Baroness, I ask noble Lords to accept the amendment and to take the view that it is perfectly reasonable, in the situation in which we find ourselves, to put in the Bill these conditions to apply whenever permission is sought to use one of these embryos.

Photo of Lord Winston Lord Winston Labour

My Lords, I fully respect the reasons for this amendment moved by the noble Baroness. I refer to the notion of trying to do animal research before human research. The poor scientist is in rather a difficult position. Often he is told by the animal rights people that animal research bears no relationship to human research and therefore we should concentrate on human research. Now we are being told that we must use animal research first. The fact is that research has to be tailored to the circumstances in which you are working. On mammalian embryology, the reason why I have to say that this amendment is not reasonable, unlike the noble Lord, Lord Neill, is that there are many situations that are specific to the species with which you are concerned. In this case, for example, specific aspects of human embryos are different from those of all other animals.

For example, let us consider the culture media. In some species, the use of glucose is not particularly deleterious, but for others the use of glucose in the medium turns out to be completely poisonous and will destroy the embryo within two days of fertilisation. Certain embryos require particular growth factors while others do not. That is why the species that you are dealing with is so important. In the human, we have a particular issue when we are looking at individual genes that we might want to identify in the embryo and, more important, the string on which the genes are arrayed: the chromosomes. Human chromosomes are unique to humans. If we wanted to image a chromosome in the embryo, we would have to go to the human embryo because no other animal species would give us that information.

There is also a difference, as I mentioned before, in the proportion of cells: the inner cell mass that will become the true embryo and the outer cell mass that will become the placenta. Perhaps the nearest model to the human is the primate, and a higher monkey at that—a menstruating monkey. That represents even more of a problem, because even monkeys do not fully represent the human and the notion of doing this kind of work in monkeys would, practically speaking, prevent the research from going on. It would be hideously expensive, terribly complex, and in some ways I doubt the ethics of subjecting sapient primates to research that can be done, quite justifiably, on discarded human embryos.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I am sorry to interrupt the noble Lord. Surely those are exactly the arguments that one would use in applying for a licence as the reasons why you had to continue with human embryos. The purpose of the amendment is to indicate that that should be a last resort, but that the last resort is not excluded.

Photo of Lord Winston Lord Winston Labour

My Lords, I suppose that it is in part a question of the wording used in the amendment. As the noble and right reverend Lord, Lord Harries, pointed out, the HFEA takes cognisance of this issue already. I know that it has done so with my research applications—indeed, I have felt, perhaps rather unreasonably, that it might have taken rather too much cognisance. But then there was a difference of opinion, which of course the HFEA was perfectly entitled to have under the legislation. I need say no more.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, the noble and right reverend Lord, Lord Harries, pointed out that this is the way in which the HFEA already works. I think that it would help in reassuring people if we decided to include this amendment in the Bill. However, proposed paragraph (6)(b)(i) is really shown to be inappropriate as it is expressed. As the noble Lord, Lord Winston, pointed out, it is rather difficult to know whether we should be doing this work on animals or humans first. It depends very much on the type of work. I wonder, therefore, whether the noble Baroness would be prepared to reconsider the wording of that paragraph in the hope that this amendment can otherwise do no harm, as it describes what is done anyway. It might do some good, as the noble Lord, Lord Neill of Bladen, was saying, to show that we are pretty keen to make sure that this type of work is properly regulated.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench 6:30 pm, 15th January 2008

My Lords, the House will be aware that I would obviously have preferred the earlier amendment on prohibition to have been passed. I accept and understand the result, despite having concerns that such an issue should be a conscience question. Sometimes I despair that even after such an extraordinary debate as we have had here, there are Whipped votes. I am sorry that the precedent of 1990, when the original legislation was introduced and free votes were allowed throughout on these matters, has not been followed today.

We have before us an amendment that does not ban animal-human hybrids, embryo experimentation or scientific research. It requires the Human Fertilisation and Embryology Authority to do such things as my noble and right reverend friend Lord Harries has said that it would normally do anyway. The noble and learned Lord, Lord Mackay, has just told us that it would nevertheless do no harm—with, perhaps, some alteration in a part of the amendment—to have this belt-and-braces provision in the context of the legislation. I strongly agree with him.

Without entering into that argument on the HFEA which we had in Committee, my noble and right reverend friend Lord Harries nevertheless knows of my concern that the authority has never turned down an application. As he said in Committee, it would be very difficult for anyone to be appointed to it while holding the sort of views that many of your Lordships hold. It is therefore a pity that no members of the HFEA are there to argue in favour of concerns for the human embryo. I serve on my university's ethics committee; we sometimes look at the kind of animal experiments to which the noble Lord, Lord Winston, referred a few moments ago. In the case of my university, they only ever involve mice, but I am glad to say that there is serious consideration of issues such as duplication and replication before even they are ever used.

This amendment only really asks that the licensee and the licensing authority should both have to demonstrate that no alternatives can be used before human embryos are used in any of these procedures. As the noble Baroness, Lady Williams, said in her excellent speech and when intervening on the noble Lord, Lord Winston, the kind of issues that he raised would be precisely those that would be placed before the licensing authority when such a licence application were made—as the noble Lord himself has had to do in the past.

If this amendment were carried, there would be a requirement to take seriously what the noble Lord, Lord Hunt, said to us back in 2001; that human embryos should not be used in circumstances where it could be demonstrated that alternatives were available. Whether or not your Lordships have been convinced by the argument that there are alternatives, at least those who make the application would in future have to demonstrate it, which seems a moderate and thoroughly reasonable proposition.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, I want to intervene just for two minutes. I have been listening carefully to what has been said, and I cannot for the life of me see why we should not underscore and underline something that makes the Bill more safe. It would also be better regarded by people outside, who are watching us very carefully, and show that we are minded of the seriousness of the matters being discussed in this legislation. I cannot see why we should not make a clear observation within the Bill that shows how seriously we undertake this matter.

I am rather appalled to hear what the noble Lord, Lord Alton, said about conscience; if we cannot have a conscience regarding our votes and our work in this House then we are not really worth much. If we must always do what our party tells us, no matter that our conscience opposes it, we are then poorer representatives of the people of this land. I am shocked because the Government ought to see that the more they put a Whip on, the less effective is the figure of the final vote. It is then not an expression of people's genuine feeling, but a case of saying, "Yes, sir, no, sir, three bags full, sir. I will go through this Lobby, because I have been told to". That worries me. We all ought to be able to vote as our conscience tells us. Why do the Government disagree with that? Why cannot we be crystal clear that, with this amendment, we recognise the seriousness of what we are doing in this Bill?

Photo of Baroness Hollis of Heigham Baroness Hollis of Heigham Labour

My Lords, I have been triggered by the comments of the noble Baroness, Lady Knight, to lay a possible canard to rest. After this debate and the previous Division, the suggestion just might go out from this House that the vote was Whipped instead of being the result of reflection, judgment, information, interest and passionate attention to the arguments that were put before us today. I would not like it to be spun in such a way, to use a phrase from a previous discussion.

As far as people like me are aware, this is a Government Bill which was properly scrutinised in a pre-legislative committee; there is thus an expectation that the Government will, broadly speaking, get their legislation through. But I am confident that if any members of my party on these Benches felt that they had an issue of conscience that diverged from the Government Bill, they would go to their Chief Whip and absent themselves. If they felt exceedingly strongly, they might even vote in the opposing camp, as I have done on occasion—I do not doubt that that raised the eyebrow of my Chief Whip—having given him that information. That is how this party works; it is an honourable, decent and proper way to conduct legislation.

Photo of Lord Patten Lord Patten Conservative

My Lords, I fully support what was said by the noble Baroness, Lady Williams of Crosby. I will not reiterate her arguments; I, too, was lined up as a fellow traveller during the last Division with the noble Lord, Lord Alton. Like him, my noble friend Lady Knight, and others, I feel that, notwithstanding what we have just heard from the noble Baroness, Lady Hollis, it is very sad that on issues where there are such strong feelings, Government Whips have to be applied.

As I walked through the Lobbies, rather threateningly, two Labour Peers came up and walked either side of me. They had what you might call a good fulminate about how a three-line Whip had been put in; I think that the Teller saw them going through beside me. They were concerned that conscience issues were not being taken properly; I simply report what was said in the privacy of the voting Lobby where, rather as with the privacy of the confessional, one does not name people.

This is a great pity and I think the Government will rue it. I am absolutely convinced that being allowed a free vote, taking conscience into account, as Members of parties which do not have Whips can do, is the correct and grown-up way to go. That is the progressive way—not the rather old-fashioned heavyweight Whipping that has clearly been going on.

Secondly, I want to make a point on the HFEA: its fitness of purpose, its membership and how, generally speaking, applications proceed. I fully understand the argument, which I respect but do not agree with, that unless people are fully signed up to the work they should not be there. I do not think that that is right because I think that an open, progressive and transparent HFEA would welcome outsiders being present, albeit in a carefully modulated minority. I respectfully suggest that it should look for that greater openness. I should like to ask the Minister if, in putting forward—

Photo of Lord Harries of Pentregarth Lord Harries of Pentregarth Crossbench

My Lords, I should say as a matter of fact that appointments to the HFEA are public appointments, which are advertised. There is an interview process and the successful candidates are appointed by the National Health Service Appointments Commission.

Photo of Lord Patten Lord Patten Conservative

My Lords, the question I was going to ask the noble Lord, who is a DHSS Minister, was exactly on that point. Would someone applying to go on to the HFEA who, for example, was strongly in favour of sex selection or full reproductive cloning be acceptable as a name to go forward? I look forward to the Minister's response.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I have difficulty understanding the purpose of this amendment. I suppose that it might be to try to exert influence as regards embryonic stem cell research. Why do I say that? I do so because we heard the noble and right reverend Lord, Lord Harries of Pentregarth, say that the HFEA applies the most stringent scrutiny when considering any application for a licence to carry out embryonic stem cell research.

Adult stem cell research is not regulated in any way. Anyone can carry it out. If an application meets the required standards, funding for adult stem cell research is granted as it is for embryonic stem cell research. We have heard that the MRC—to mention one grant-giving agency—delivers about a 50/50 allocation of money to adult stem cell research and embryonic stem cell research respectively.

It is also necessary to understand better adult stem cell research and to apply the experience and knowledge gained. To make it more successful in terms of developing treatments you may have to undertake some preliminary embryonic stem cell research. As regards adult stem cell research, including induced pluripotent cells that behave like embryonic cells, it might be necessary to downregulate those cells to the point of creating a blastocyst. That blastocyst is no different in embryo status from an embryo derived from human beings. One needs to test that blastocyst to see whether adult stem cells will behave in exactly the same way as the embryonic stem cells. The HFEA should clearly understand its regulatory powers. We need to be assured that both embryonic and adult stem cell research will continue and that no amendment made to the Bill will detract from that.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health) 6:45 pm, 15th January 2008

My Lords, these amendments seek to place strict criteria upon the requirements which must be satisfied before an embryo or human-admixed embryo research licence can be issued for any research project.

We have set out in the Bill a framework of regulation for human admixed embryos, which is equally as robust as that in place for human embryos at present. There will be an absolute time limit banning the keeping of embryos beyond 14 days' development and an absolute prohibition upon the implantation of a human admixed embryo in a woman or an animal.

Amendments Nos. 9 and 41 seek to change the criteria by which the HFEA considers applications for a research licence. Such research will be permissible only with a licence from the HFEA, and only in circumstances in which the HFEA deems the research necessary or desirable for one of the statutory purposes, and the creation of embryos is necessary. In making such decisions the HFEA will be required to take into account other avenues of research available which may achieve the same end, according to the criteria already imposed in the legislation.

The HFEA has for nearly two decades licensed embryo research. In that time it has, through the provisions of the 1990 Act, been given the flexibility to form and utilise its own tests on whether the use of embryos is necessary in each licence application. The extra criteria which this amendment seeks to impose on the HFEA do not need to appear in the legislation. The authority already considers each of the new criteria stated, as part of its interpretation of the test of necessity.

In addition, the requirement that research should already have been successfully attempted using animal embryos is appropriate in some, but not all, cases. Any application to undertake embryo research should have a firm evidence base upon which the detail of the research project is founded. The evidence base may include information gained through animal embryo research, or could equally be data from research conducted through other means. Human and animal physiology and genetics are close enough for animal embryo experimentation to provide a good model upon which to test research methodologies. However, we need to recognise that the differences which are present can mean that research which works in an animal model does not work in humans, as highlighted by my noble friend Lord Winston. This principle also works in the other direction, and research may fail to get satisfactory results in animal models, where clear successes occur in human models.

Animal research is clearly vital for better achieving success in human embryo research. However, research using human embryos must not be strictly limited to being undertaken only in cases where animal models have shown success. The authority has effectively made decisions on the necessity of using human embryos in research, and will always look to animal-based evidence in deciding whether a research project application is valid. It should retain the flexibility, however, to be able to license research in those cases where evidence from animal embryo experimentation is not available or not relevant.

Regarding the requirement in the amendments that the research should be likely to produce satisfactory results, I should point out that this approach is undertaken by the authority through the peer review process for each research licence application, as highlighted by the noble and right reverend Lord, Lord Harries.

Lastly, as regards the requirement that the research cannot be satisfactorily achieved by means other than through embryo research, adult stem cell research, embryonic stem cell research, and reprogrammed stem cell research each hold out promise to the sufferers of many wide-ranging diseases and medical conditions, as we heard. The sufferers of these diseases should not have valid avenues of research, such as embryonic stem cell research, limited because of the possibility that a treatment may be developed in the future by other means. Until diseases such as these, and many others, have a clear treatment available it is only right that we allow all avenues of research to proceed—I stress under regulation—in the hope of cures being developed as soon as possible.

A rigid framework of criteria set out in legislation would seriously limit the research which the HFEA can license, which would surely be a great loss to those suffering from serious medical conditions, who are hoping that cell-based therapies will be developed and used within their lifetime.

As regards the point made by the noble Lord, Lord Patten, on the appointment of HFEA members, a wide range of criteria is used to determine the type of members appointed. These take into account the skills and expertise that the HFEA requires at that particular time. It would obviously be difficult for someone to be appointed to the HFEA who, for example, fundamentally disagreed with IVF.

I invite the noble Baroness to withdraw the amendment.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I listened very carefully to what the noble Lord, Lord Darzi, said. It was clear from the first part of his remarks that he understood exactly the purpose of the amendment. I refer that to the noble Lord, Lord Patel, but I think that the amendment's purpose is pretty clear; namely, that the preference should lie with other than embryonic stem cell research if—I repeat this—it is evident that other forms of research would be equally efficacious for the purposes for which the research was originally demanded.

It is also the case in the example given by the Minister of people with serious degenerative or other diseases who are waiting for a cure. I fully understand and sympathise with that view. The further argument is that, until now, those cures have largely come from adult stem cells, rather than from embryonic stem cells, and that we are trying to correct a bias in the system. The noble Lord, Lord Patel, pointed out that when one looks at the pattern of grants given by the HFEA since 1990, decisions in the earlier stages largely—indeed, almost entirely—favoured embryonic stem cell research over other research. It is now true that, largely on the basis of its results, adult stem cell research has become much more substantial and accounts for nearly half the financing made available. That is a considerable change in recent years and reflects the fact that the scientific community now recognises the potential of adult stem cell research.

The main point of this amendment was the one referred to by the noble and learned Lord, Lord Mackay of Clashfern. That is, if we are all agreed that the HFEA effectively works in a way that reflects what my amendment asks for—though I do not think it has built into it quite this element of special preference for non-embryonic forms of research—it is reasonable to say that that should be clearly in the Bill. The noble Baroness, Lady Knight, made the same point. It is a way of saying to the public that we take their concerns seriously, that the HFEA takes them seriously and that those concerns will be taken into account by a House of Lords that reflects, to some extent, public concerns. At the moment, as the noble Lord, Lord Alton, said, the public have very little awareness of the criteria that the HFEA employs. It works largely in private. It is not widely understood what concerns people have, and how far those concerns are reflected. Therefore I propose not to ask for the opinion of the House now, because I take very seriously the remarks of the noble and learned Lord, Lord Mackay of Clashfern. I will go back and look at sub-paragraph (b). I will see whether it should be redrafted in the way that he suggests. But I will bring back this amendment at Third Reading, with whatever correction is needed to address the point made by the noble and learned Lord, because many of us believe that this would be a very useful addition to the Bill. I beg leave to withdraw this amendment.

Amendment, by leave, withdrawn.

[Amendment No. 10 not moved.]

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendments Nos. 11 to 15:

Clause 4, page 4, line 12, leave out "an inter-species embryo" and insert "a human admixed embryo"

Clause 4, page 4, line 16, leave out "inter-species embryo" and insert "human admixed embryo"

Clause 4, page 4, line 17, leave out "inter-species embryo" and insert "human admixed embryo"

Clause 4, page 4, line 19, leave out "an inter-species embryo" and insert "a human admixed embryo"

Clause 4, page 4, line 21, leave out "an inter-species embryo" and insert "a human admixed embryo"

On Question, amendments agreed to.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendment No. 16:

Clause 4, page 4, leave out lines 22 to 29 and insert—

"(a) an embryo created by replacing the nucleus of an animal egg or of an animal cell, or two animal pronuclei, with—(i) two human pronuclei,(ii) one nucleus of a human gamete or of any other human cell, or(iii) one human gamete or other human cell,(b) any other embryo created by using—(i) human gametes and animal gametes, or(ii) one human pronucleus and one animal pronucleus,"

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, the Bill seeks to bring within legislation certain types of part-human, part-animal embryos, which in the Bill are referred to as "interspecies embryos". It is now intended that these will be called "human admixed embryos". The definition of "human admixed embryos" found in new Section 4A(5), as introduced by Clause 4, breaks down into four components, representing the four methods of creating a human admixed embryo.

New Section 4A(5)(a) represents those embryos created by the fertilisation of a human egg with an animal sperm, or an animal egg with a human sperm—or other techniques that create the same type of embryo. These are commonly referred to as "true hybrid embryos". New Section 4A(5)(b) represents embryos created by cell nuclear replacement—a technique used in cloning, which combines human cells and animal eggs. They are commonly referred to as "cytoplasmic hybrid embryos" or "cybrids". New Section 4A(5)(c) represents embryos created by genetically modifying the cells of a human embryo using animal DNA. These are commonly referred to as "transgenic human embryos". Finally, new Section 4A(5)(d) represents embryos created by attaching one or more animal cells to a human embryo. These are commonly referred to as "human-animal chimera embryos".

On the introduction of the Bill to the House, it was brought to our attention that the definition of "cytoplasmic hybrid embryos" in new Section 4A(5)(b) contained a loophole. As drafted, the category expressly excluded the use of human cells of the female and male germ line, which can be used to create cytoplasmic hybrid embryos. Germ cells are the cells of the body that lead to the formation of gametes and the gametes themselves. Amendments Nos. 19 and 20 therefore remove this express exclusion. In addition, to ensure that it is clear that germ line cells are covered, new Section 4A(5)(b) is amended to include the use of human gametes. Gametes are defined as including cells of the female or male germ line. These amendments ensure that cybrids created using any human cell types will be caught under the Bill.

Much of the debate regarding the human admixed embryos has centred on getting the correct definitions. This amendment ensures that the Bill will bring all the necessary entities within the regulation of the HFEA. I invite noble Lords to accept the amendment. I beg to move.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I support this amendment—but then I would, wouldn't I, because I raised this issue in Committee? I welcome the amendment because it addresses the main practical issue relating to the definitions of "gametes" and "germ cells" and removes the only cause for concern that the definition would adversely affect research.

On Question, amendment agreed to.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

moved Amendment No. 17:

Clause 4, page 4, line 35, leave out paragraph (e) and insert—

"(e) such other embryo, not falling within subsections (a) to (d), which contains the DNA of a human and the DNA of an animal, in which the DNA of an animal does not predominate throughout the period of its keeping or use."

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, Amendments Nos. 17 and 18 are intended to complete the definition of "admixed human embryo". In new Section 4A(5) of the Bill, paragraph (e) refers to,

"such other thing as may be specified in regulations".

Most of us would agree that this is a not particularly felicitous way of looking forward to some scientific development yet to occur which might show some other way of producing an admixed human embryo. The other point is that it is not at all clear in summarising the character of paragraphs (a) to (d). "Such other thing" is really not a particularly good gathering up of what went before. When this Bill was originally presented in draft to the Joint Committee, the Government had a paragraph that was intended to be a catch-all provision. It specified the proportion of animal and human material that would be required to constitute what was then described as an "interspecies embryo" and is now more accurately described as an "admixed human embryo". That paragraph did not have any percentage at all to start with. The percentage was added in ink, which suggested it was a slight afterthought, and the scientists who gave evidence found it impossible to understand, because the percentage depends on what you are measuring and the effect depends on more than mere proportion. The Joint Committee was anxious to produce a definition that would clarify the issue and also tie the whole paragraph together. We made a suggestion in the report that was taken up by the Government but apparently they failed to produce any improvement, and it was ultimately given up in favour of "such other thing".

Following the Committee stage, the noble Lord, Lord Patel, kindly arranged for us to meet some of the leaders of the scientific community to see whether we could produce an effective definition that would "catch all" and that would also be illustrative of the point that we are not regulating all interspecies embryos, but only some interspecies embryos. After discussion, we came up with the view that this could be clarified by an amendment along the lines of Amendment No. 17, which the noble Lord, Lord Patel, and I have tabled, with the help of those scientists. It uses as the fundamental measuring word the word "predominate", which enables a judgment to be made on the various factors that could be used to estimate the degree to which animal material and human material were present in the embryo. When the noble Lord, Lord Darzi, was opening the debate on Amendment No. 1, he used that word, which suggested to me that so far no one has thought of a better word. Therefore, this is a much more illuminating provision for proposed new Section 4A than "such other thing", to which I have a certain degree of animosity.

The amendment would be an immediate answer to the question asked by my noble friend Lord Tebbit on Amendment No. 1. We say in the amendment that the human end of the spectrum of interspecies embryos ends where the amount of animal material predominates in the embryo. That means that roughly the 50 per cent or equal category would be caught as a human embryo and would have the regulation and protection of the human embryo, leaving the embryos in which animal material predominates to be regulated, if at all, by the Animals (Scientific Procedures) Act.

As I said earlier, it is not absolutely clear that it regulates embryos, but it regulates what you can do with animal embryos after six months, and it regulates putting into animals materials of any kind that might cause them harm or pain. There is an element of regulation there, but there is no actual regulation of a non-animal embryo in the Animals (Scientific Procedures) Act, so far as I can see in my study of it. That is not an essential point. The essential point about the amendment is that it clarifies what we mean and what the Government mean by "human admixed embryo". It is therefore an element in clarification of the scope of the Bill as a whole and replaces the inaccurate description that was in the Bill originally and which has now been replaced by the Government in this House. I beg to move.

Photo of Lord Patel Lord Patel Crossbench 7:00 pm, 15th January 2008

My Lords, I am very pleased to add my name to the amendment, which I strongly support. I would not attempt to try to make it clear in legal terms what the noble and learned Lord has in his usual way made absolutely clear. The amendment captures the important factor in such a decision as to whether an embryo will need to be accorded the same status as a human embryo or should be treated as an animal embryo.

It has been widely discussed in the scientific community and it is supported by all the eminent stem cell scientists. As the noble and learned Lord said, the use of "predominate" moves away from simplistic counting of the proportion of DNA and allows a more qualitative assessment to be made. It refers to the whole period of use, not in the expectation that this could be checked constantly but in recognition of the fact that the relative amount of DNA may alter with time when animal and human materials combine. That must be considered in any new construct.

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

My Lords, my noble and learned friend Lord Mackay has really got his teeth into this one. He did so in the Joint Committee, he did so in the Committee of this House and he has done so again tonight. The question of how you can wrap up a definition in a way that includes everything that you want to include but excludes the things that you do not want to include has proved very difficult. My noble and learned friend drew on the word "predominate", which apparently emerged from scientific discussion of how to do this. My difficulty comes after reading the evidence that we heard in the Joint Committee from Dr Robin Lovell-Badge. He made the point:

"It is very hard to come up with any strict definition saying this is 50 per cent human and 50 per cent animal, therefore it falls into this category rather than this one, because things change as well. You may start with an embryo which is 20 per cent human and end up with something which is 60 per cent human or vice versa".

Because the licence has to come at the beginning of the process, before the research is done, how do you decide whether you are going to be dealing with an entity that requires a licence? It may be only 20 per cent human, but by the time you are finished it may end up being 70 per cent or 80 per cent human. I am not sure that we have solved that problem, but I warmly congratulate my noble and learned friend on what is obviously an extremely brave try.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

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.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I ought to have mentioned that we submitted this amendment to Professor Martin Bobrow, the chairman of the working group of the scientific community in this area. He says that he has the text of this amendment and that he is content that it is as accurate and clear as anything in this field can be. He says that he prefers this definition to the original Government version because of the emphasis on these being essentially modified human embryos as opposed to constructs originating in animal material. He wishes us well, I might add.

The whole point of using the word "predominant" is to deal with the difficulties of judgment about ratios and so on, to which the noble Lord referred. We are not seeking to destroy the ultimate power to alter the definition of admixed human embryos, because that remained. We are taking out the one that I object to but the power to amend the whole definition is left in, should people want to do that.

Our proposal clarifies what is meant by an admixed human embryo in a way that is not possible without it. It leads to clarity in reading and understanding of the Bill. It is possible for almost any definition to be held up as producing difficulties which are thought up not so much by the scientific community as by those who are concerned with drafting. This is a practical definition which scientists should understand. The noble Lord, Lord Patel, is a pretty distinguished exponent of that particular art. I gather that the noble Lord, Lord Winston, would not object to this definition either. The point is that this definition is not immutable. Therefore, I propose—

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I am grateful. I had not intended to press the amendment as it is a practical matter of drafting. However, I commend it for further consideration. On that basis, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 18 not moved.]

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendments Nos. 19 to 22:

Clause 4, page 4, line 38, leave out from "embryo" to "and" in line 40

Clause 4, page 4, line 42, leave out from "embryo" to end of line 43

Clause 4, page 4, line 44, leave out from beginning to end of line 6 on page 5

Clause 4, page 5, line 19, at end insert—

"(13) If it appears to the Secretary of State necessary or desirable to do so in the light of developments in science or medicine, regulations may—

(a) amend (but not repeal) paragraphs (a) to (d) of subsection (5);(b) provide that in this section "embryo", "eggs" or "gametes" includes things specified in the regulations which would not otherwise fall within the definition.

(14) Regulations made by virtue of subsection (13)(a) may make any amendment of subsection (6) that appears to the Secretary of State to be appropriate in consequence of any amendment of subsection (5)."

On Question, amendments agreed to.

Clause 8 [Power to contract out functions etc.]:

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendment No. 23:

Clause 8, page 7, line 23, leave out "inter-species embryos" and insert "human admixed embryos"

On Question, amendment agreed to.

Clause 11 [Activities that may be licensed]:

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

moved Amendment No. 24:

Clause 11, page 8, line 28, leave out "inter-species embryos" and insert "human admixed embryos"

On Question, amendment agreed to.

Photo of Lord Patel Lord Patel Crossbench 7:15 pm, 15th January 2008

moved Amendment No. 25:

Clause 11, page 8, line 29, at end insert—

"(b) after subsection (1)(c) insert—"(d) licences under para 1A of that Schedule authorising activities in the course of providing therapy."."

Photo of Lord Patel Lord Patel Crossbench

My Lords, I am in a slight difficulty because if we are to continue with this amendment, it will not be over in the next 15 minutes. I need guidance, if that is possible.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

My Lords, it is probably the will of the House that we continue with this amendment. We might not finish until shortly before eight o'clock, but I am sure noble Lords would be comfortable with that.

Photo of Lord Patel Lord Patel Crossbench

My Lords, thank you. There are two particular issues of concern. One is related to licence to create storage and to use embryos for therapeutic purposes and the other is that of related regulations. I have left aside what I was going to say, because the letter that was circulated, addressed to the noble Lord, Lord Darzi, from the Association of Medical Research Charities, covering the Genetic Interest Group, Muscular Dystrophy Campaign, Parkinson's Disease Society and Progress Educational Trust, puts it in simple terms that can be clearly understood. The association supports this amendment and says:

"Many avenues of research which target the conditions supported by the signatories of this letter hold significant potential. For some of these conditions, there is currently no cure or effective long-term treatment available to patients. On-going research projects are therefore the subject of much hope for patients with these conditions, who have the opportunity to be treated with specific cell types (such as skin or nerve cells) that have been derived from embryonic stem cells. These will replace the cells that are not functioning correctly, or which have died, and ultimately may provide a cure for the illness. It is vital that this research continues at the exciting pace that it currently shows.

"The HFE Bill, as it stands, has no provision for the granting of licences for the creation, storage and use of embryos in order to provide treatments derived from embryonic stem cells. Like the1990 Act, the Bill only provides for the creation, storage and use of embryos for research purposes. Therapies derived from embryonic stem cells that will require such licences for their creation will hopefully be with us soon; an estimate of five years for some treatments is not overly optimistic. Indeed, a California company, Geron, is in dialogue with the US Food and Drug Administration to initiate a clinical trial with human embryonic stem cells in 2008 for acute spinal cord damage. A number of UK, US, European and Asian academic research groups and companies are testing human embryonic stem cell populations in animal models of Parkinson's disease, diabetes, multiple sclerosis, heart disease, retinal disorders, and many other serious human conditions, with the goal of translating this important research to the clinic as quickly as possible. It would be very unfortunate if the application of these therapies has to be delayed due to the passage of further legislation".

It is also the view of these organisations,

"that this barrier to the development of therapies through these research avenues will impede investment and slow the pace of research. The worst case scenario, of course, is the development of a save, viable treatment that is then forced to languish unused for years whilst new legislation is drafted and debated, and the HFEA develops a new system to grant licences. This would seem to be a perverse undermining of the core objective of putting this legislation on the statute book in the first place.

"The use of embryos for such therapies was clearly envisaged by Parliament in 2001 when both MPs and peers voted overwhelmingly to allow therapeutic cloning research to take place as that was part of the justification for extending the research purposes to include developing treatments of serious disease. It is also reflected in the terms of the EU Human Tissues and Cells Directive and the EU Advanced Therapies Medicinal Products Regulation, both of which explicitly cover the use of stem cell therapies".

On the regulations, which are rather complex, I have some comments about the context in which the amendment is tabled. The amendment would permit embryos to be created, stored and used for purposes of therapy rather than just, as at present, for infertility treatment and research. There has been extensive debate and consideration of how best to regulate the use of stem cell therapies and that is reflected in the existing body of law and policy. An additional category of licences for therapies should not be seen as a step into the unknown, but an amendment to bring the legislation into line with the wider context of regulation in this area.

There is already a considerable body of regulation relating to cell-based therapies in the UK, with which we would have to comply in order to take a cell-based therapy from the laboratory to clinical practice. The research licence granted by the HFEA represents only an early step in an ongoing process, which is now dominated by the regulation of advanced therapies, including stem cell therapies. However, HFEA licensing is an important initial stage, not least because good manufacturing practice facilities' requirements will track back to ensure that the correct regulatory requirements have been met at each stage. I shall demonstrate that with an example.

If the HFEA had granted a licence for research purposes to carry out research on an embryonic stem cell line that was created, and that line was subsequently taken for treatment purposes, it will help us to go for an initial clinical-phase trial, which will be carried out in animals. If it progresses to being used for therapy in humans, it will require the approval of the MHRA, and it will have to comply with the Human Tissue Act and the European Union directive. I could go into a lot of detail about that. In effect, it would not be recognised by those directives and a new line would have to be created under GMP facilities, which would have to be tested again in a first-phase trial in animals before it could go to clinical trials. That process in itself might take up to two years, so that much time will be lost as regards trials for human therapy if we do not allow the creation of embryos and storage for therapy purposes.

In this country, both the MRC and the NHS have invested in upwards of five departments, each costing more than £1 million, providing facilities for good medical practice. To allow those departments to carry out in vitro fertilisation, embryos are created in that environment and, therefore, stem cell lines are also created in those GMP facilities. We also have a stem cell bank, with an investment of nearly £3 million a year, to maintain stem cell lines in appropriate condition, not only for research, but to characterise them, to improve them, to make them the best available lines in the world and to make those lines available for therapy. To this day we have no line that can be used for therapy in a bank which has 48 lines. Others in the world have lines that are usable for therapy; some of them are commercial and they will charge a lot of money. If it were permissible under the regulatory authority, our scientists are considering forming a consortium, and those lines would be available for both research and treatment subsequently. It is not necessary that they lie dormant until a therapy is found—they could be used for research. Importantly, they will meet the regulatory directives of the MHRA, the tissue authority and the European directives.

When one thinks about it, it seems rather foolish that, when we are about to embark on many clinical trials, we do not have such lines for therapy. It is only a matter of agreeing whether that should be allowed and that the HFEA should have regulatory powers to deal with it. I am trying to be brief, but I hope I have convinced the House that there is a need for such lines. I am pleased that others have put their names to the amendment. I beg to move.

Photo of Baroness Tonge Baroness Tonge Spokesperson in the Lords, Health

My Lords, I support the amendment. The major reason for my support is that embryo research has huge potential for the treatment of diseases. I know that there are many other reasons for doing this work, but for me the idea that we could crack diseases such as Parkinson's, diabetes, stroke and some cancers is just so attractive that we must do anything possible to encourage this research.

Looking to the future, I believe that the possibilities are exciting. This Bill is mainly concerned with research and not treatment, except infertility treatment, which, of course, is of great benefit to the individual but not usually to society as a whole. As we have heard from the noble Lord, Lord Patel, much regulation relating to cell-based therapies already applies to the UK. I have discovered that there are many European Union directives: the European Union directive on human tissue and cells, the European Union directive on clinical trials, and many more. The UK Human Tissue Act 2001 and even the OECD regulations apply to cell-based therapies in the UK. A long time has to elapse and many hurdles have to be jumped before a cell-based therapy can be taken from the laboratory into clinical practice.

That is one side of the coin. The other is that licences granted by the HFEA are only a very early step in research towards treatment. They extend only to cover the creation, storage and use of embryos for research and the treatment of infertility—nothing else. However, if a cell line was developed under licence that was found to be useful for treating, say, diabetes, replacing the pancreatic eyelet cells with functional ones that produce insulin—just imagine that—and it is feasible, researchers under current law would have to go back to square one and create another cell line to comply with the directives that I mentioned. You could not carry on with a cell line that you had already created. Valuable time—as the noble Lord, Lord Patel, said, two years or more—would probably be lost before clinical trials on humans were permitted.

We are suggesting in this amendment that we provide a missing link in the legislation to allow treatment to be developed and, if it proves successful, to move forward into the final stages of approval, ending in clinical application. As the noble Lord said, surely the use of embryos for therapies was part of the reason why, in 2001, both Houses voted to allow therapeutic cloning research to take place. We must include in this Bill permission for research towards treatments using embryo cell technology.

There is a lot of support among the general public for embryo research if it will lead ultimately to cures for terrible and common diseases with which every family is familiar. It would be tragic if this new legislation did not recognise this and did not allow the Human Fertilisation and Embryology Authority to grant licences or research into treatment on the same cell lines developed for research purposes.

J

A minor typo - 'pancreatic eyelet cells' should read 'pancreatic islet cells'. Islet cells contain the insulin producing beta cells, and stem cells perhaps could be grown to replace these.

However there is still the challenge of the underlying autoimmune disorder in Type 1 diabetes (which caused the specific destruction of the insulin-producing beta cells in the first place) that needs to be overcome before insulin-producing stem cells could be used effectively as replacement cells in transplants.

Jo Brodie
Senior Science Information Officer &
Islet Project Coordinator, Diabetes UK
islets@diabetes.org.uk

Submitted by Jo Brodie

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 7:30 pm, 15th January 2008

My Lords, I, too, warmly support this amendment. I was heavily involved in the discussions on the original Bill in 1989 and 1990. At that time, the Human Fertilisation and Embryology Bill was directed towards establishing the Human Fertilisation and Embryology Authority, deciding on mechanisms that could be used to improve the treatment of human infertility and moving towards mechanisms that could prevent the birth of children suffering from serious genetic disease. No clause in that Bill made it possible to use embryonic cells. The experiments were licensed for up to 14 days after fertilisation, but no clause in the Bill allowed any derivative cells produced from such experiments to be used for the treatment of disease.

However, in 2001, we debated the regulations to allow therapeutic cloning. I had every belief that, when those regulations were passed by a very large majority, they would enable stem cells derived from embryonic research to be used for the treatment of human disease. I was surprised to find that that was not the case and that, although research leading to therapeutic development was allowed under the Act and the regulations, the use of stored embryos and the stem cells derived from them for treatment of human disease was not.

As my noble friend Lord Patel and the noble Baroness, Lady Tonge, have said, once you derive cells for treatment, a whole series of regulatory mechanisms has to be examined: the European regulations, the Medicines and Healthcare Products Regulatory Agency regulations and others. The amendment is crucial to make certain that cells derived from stored embryos can be used for treatment, subject always to the regulations that follow. I am surprised after the 2001 vote on therapeutic cloning that this is not possible under the existing Act. It is therefore important that the amendment should be included in the Bill.

Photo of Lord Winston Lord Winston Labour

My Lords, I, too, support the amendment, albeit briefly because of the lateness of the hour. It would be a valuable addition to the Bill. It would be rather ironic, given the accusations that embryonic stem cell research has not benefited anybody so far, to find it impossible for it to benefit anybody in the United Kingdom, so I certainly support the amendment. I am in rather a peculiar position. If the BBC will allow me to say this, I am planning to film a patient going overseas to get stem cell therapy of one kind. It would seem to me far better if patients could get stem cell therapy, or any kind of therapy, done under properly controlled and regulated procedures in this country after proper manufacturing practice, which is expensive, has been implemented.

Photo of Baroness Finlay of Llandaff Baroness Finlay of Llandaff Crossbench

My Lords, I support the amendment. I would like to explain to the House that good manufacturing practice is not good in the sense of being the baseline; it is actually the gold standard. It is extremely difficult to reach that standard. We have made an important investment in it. These cell lines are very fragile. This is not something that can be done anywhere. It is already carefully controlled, but there is a deficit at the moment, which would be rectified by this amendment.

Photo of Earl Howe Earl Howe Shadow Minister, Health

My Lords, I strongly support the noble Lord, Lord Patel, in the objectives that he is trying to achieve through these amendments. However, I need to ask the same question that I asked during the debate on Amendment No. 4. If treatments are developed of the kind referred to by the noble Lord, which we all hope may emerge from the research, would it potentially be for the HFEA to license those treatments or would it be for the MHRA? If it is the MHRA, is it for this Bill to deal with the matter? I hope that the Minister will cover that point when she replies. If we are, through this amendment, changing the remit of the HFEA, we need to know that we are doing that, and we need to decide, and appreciate, how this impacts on the role and work of other regulators.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, I will make just a brief interjection. It is my understanding that the licensing of any therapy would have to be done by the MHRA, working in consultation with the Human Tissue Authority and the HFEA. Those bodies have already foreseen the possibility that they will have to do just that. They have begun to work—I am not sure how far they have got—on an agreed process by which approval would be gained.

The noble Lord, Lord Patel, and I tabled this amendment because, although the upstream work—the licensing of research—is well and truly covered by the matters being discussed under this Bill and the downstream work that needs to be in place to bring about the licensing of any therapy is in place, the middle part is missing. That has to start in this Bill, because it involves the licensing of a piece of research on a stem cell line for both research and therapy. We are in effect putting into place a missing middle link in a process and that missing link has to originate, as I understand it, in this Bill. Perhaps the noble Baroness could comment on that in her reply.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

My Lords, these amendments are clearly motivated by the desire to see the rapid translation into practice of treatments for serious diseases. That is a laudable aim and one that the Government, of course, share. The debate is largely one of ways and means rather than of principle. These amendments would extend the remit of the HFEA to enable it to license the creation, keeping and use of embryos for non-reproductive, therapeutic purposes—for example, the creation of embryonic stem cells for implantation into a person to treat a disease or a medical condition, as we have heard this evening.

Much of the support for embryo research is in part due to the potential for such research to develop therapies for currently incurable conditions. Our decision not to make provision in the Bill for the creation of human embryos for the purpose of therapy was made not because we did not want to support potentially revolutionary therapeutic interventions such as embryonic stem cell-based therapies. I hear the evidence in relation to the timing cited by the noble Lord, Lord Patel, and others. The Government are—perhaps were—of the opinion that this technology is not yet ready for use in the treatment of patients, although the potential is huge and is rightly being explored with vigour.

It is not possible to know at this time the answer to questions such as how many embryos would be needed to provide an effective treatment, or how many conditions such a treatment could cover. In the Government's view, it is also not possible to fully understand at this time the scope of the treatment for which these therapies could be used. These debates would be better placed once all the facts are available; Parliament would then be able to frame the rules and regulations. This is not just about switching licences for therapy. Many noble Lords, including the noble Earl, Lord Howe, have raised the important question of regulation. The regulation of the creation of therapeutic interventions would, of course, go wider than the HFEA.

I am grateful to the noble Baroness, Lady Barker, for her explanation. I am sure that it is absolutely correct. I cannot confirm it officially, but I will come back to noble Lords. The safety of treatments would need to be examined and the techniques by which they were created would need considerable oversight. Without having a full policy on when and how licences for therapy should be granted, it would not be possible to anticipate all the changes that would be needed to make the 1990 Act ready to enable proper regulation and licensing. This means that a regulation-making power would also be needed to make changes to the Act at the appropriate time. Such a regulation-making power would need to be very broad, enabling changes to HFEA licensing procedures, licence conditions, storage and consent.

It is absolutely right that research into treatment should continue. The 1990 Act does, and will continue to, permit the creation of embryos for research. This means that embryos can be created for pre-clinical research trials and beyond, as long as the creation is still for research purposes. The Government believe that we would perhaps be better placed to consider informed and appropriate new primary legislation to permit this technology to be used in future therapy at a later date. I have listened carefully to all the arguments put this evening and would not want to mislead noble Lords into thinking that we could bring back our own amendment at Third Reading. We could not. This is an important and wide subject. While we are grateful for the amendment as tabled, it would need considerable work. However, I am sure that my colleague the Minister responsible in another place would be prepared to look at it again and that she would return to the issue in the other place. I hope that, with that, the noble Lord is willing to withdraw his amendment.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I thank the Minister for that answer and I thank all noble Lords who have supported the amendment. It clearly has widespread support in the House.

Let me answer one or two points raised by the noble Earl, Lord Howe—I cannot answer them fully, because of time. It is important to understand that the use of ES cells in patients will be regulated by the MHRA, not the HFEA. However, all the cell lines currently made in this country are made from embryos licensed to be used only for research, not for therapy purposes. There might therefore be difficulty in using these cell lines for therapy purposes. The EU directive requires that the EU ask whether the cell lines were created in an environment of which it would approve: the GMP facilities. Hence the need to allow under licence the creation of embryos for storage and the creation of lines at GMP facilities so that we are ready to have them.

On the number of lines required, that might again be a decision that the regulators, such as the MHRA and the EU directive, must make on the basis of a therapy. But it could be that we require only one stem cell line. Embryonic stem cell lines, when kept under proper conditions, are immortal. You can produce vats of cell lines from one stem cell line. It is not rocket science to know how many lines. The maximum that we require for our population might be 15, even for some kind of tissue-matching purposes; that would depend on the immunogenicity, but I would not go there.

I am slightly concerned by the Minister's response that this matter will be taken back to another place to be, perhaps, amended. I hear that it is not that easy to bring forward such an amendment. I hope that the Minister will suggest that we have a discussion before Third Reading, so that we know exactly what will happen.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

My Lords, of course we will certainly continue to have discussions with noble Lords before Third Reading. Should it not be possible to do something before Third Reading—as I sadly suspect—I know that my colleague in the other place would wish to continue having discussions with noble Lords in this place who tabled this amendment.

Photo of Lord Patel Lord Patel Crossbench

My Lords, I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 26 not moved.]

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Government Whip

My Lords, I beg to move that consideration on Report be now adjourned. In moving the Motion, I suggest that Report begin again not before 8.45 pm.

Moved accordingly, and, on Question, Motion agreed to.