With this it will be convenient to discuss the following:
Amendment No. 41, page 3, line 26, at end insert—
'(5A) Regulations made under subsection (5) may not provide for an egg or embryo whose nuclear genetic material has been altered by genetic modification, or whose nucleus has been replaced by the nucleus of a somatic cell, to be a permitted egg or a permitted embryo.
(5B) In this section, "genetic modification" includes the alteration of the nuclear genetic material of an egg or embryo by—
(a) recombinant nucleic acid techniques which change the DNA sequence of nuclear chromosomes of the egg or one or more cells of the embryo, or
(b) the introduction into the egg or into one or more cells of the embryo of a stably-maintained artificial chromosome, virus or plasmid.'.
Amendment No. 47, in clause 4, page 4, line 37, at end insert—
'(f) an embryo created by combining pluripotent or totipotent human cells with amimal embryonic cells in which the latter have been altered so as to contain double the number of chromosomes, or in which the animal cells have been otherwise altered to become largely or entirely extra-embryonic tissue.'.
Amendment No. 50, in clause 68, page 53, line 19, at end insert—
'(2A) This section shall be subject to section (prohibition on placing human gametes into an animal).'.
Amendment No. 73, in schedule 2, page 58, line 42, at end insert—
'(4A) A licence under this paragraph may not authorise any activity the purpose of which is to develop techniques for creating a child by germ line genetic modification.
(4B) Regulations made by virtue of paragraph 3A(1)(c) may not provide for activities the purpose of which is to develop techniques for creating a child by germ line genetic modification.
(4C) For the purposes of this paragraph and paragraph 3A, "germ line genetic modification" means—
(a) altering the nuclear genetic material of an embryo, or of a gamete used to create an embryo, by—
(i) recombinant nucleic acid techniques which change the DNA sequence of nuclear chromosomes of one or more cells of the embryo or of the gamete, or
(ii) the introduction into one or more cells of the embryo or into the gamete of a stably-maintained artificial chromosome, virus or plasmid, and
(b) placing the embryo containing the genetic alteration in a woman, so that any resulting child could transmit the genetic alteration to its descendants.'.
New clause 24— Prohibition on placing human gametes into an animal—
'(1) The Secretary of State shall by regulations make it an offence to place any human gamete into an animal.
(2) Sections 3 and 4 of this Act shall not come into force until regulations under subsection (1) have been made.'.
As sufficient brickbats have been handed out so far, may I put on record that this emotive Bill was dealt with courteously and considerately in Committee?
The big debate is about whether it is right to extend the range of experiments involving the human embryo that may be carried out. The alleged goal is the extension of scientific and medical knowledge that could alleviate human suffering, especially, but not exclusively, that of a generic origin. For some hon. Members, no possible reduction in suffering, improvement in maternity or growth of knowledge can justify what they regard as the violation of human life and the interference with normal human development. Their position is unqualified. For many hon. Members in the Chamber, however, this is a case of balancing hope and fear. On the one hand, there is the hope that some day, terrible inheritable and cellular diseases will be conquered, and on the other hand, there is the fear that an increasingly casual approach to human life will denature our society and create possibilities that we would not wish. That balance is being played out in nearly every Member's head.
I suspect that we cannot know with any confidence whether those hopes or fears—or both—will be realised many years hence, so we all act on a kind of faith. Our position depends on whether we believe that the grounds for hope outweigh the grounds for fear, or vice versa. On Second Reading, that point was made most eloquently by Sir Gerald Kaufman, who is not in the Chamber; he said that he was more fearful than hopeful. That is the heart of the debate.
Whatever one's judgment on the main issue, my amendments Nos. 49 and 50 and new clause 24 do not affect it, because regardless of one's take on the Bill—for or against—we know that it was never intended that the Bill would authorise human genetic engineering or reproductive cloning, even through it repeals the Human Reproductive Cloning Act 2001. Nor was it intended that the Bill would allow scope for genetic engineering or reproductive cloning. The humane intention behind the Bill is to allow women whose eggs are encased in cytoplasm with disease-carrying mitochondria to transfer those eggs into healthy cytoplasm and avoid inheritable disease. I am sure that we all wish to avoid the transmission of inheritable disease.
The key point is that the Bill says that an egg or embryo for which mitochondrial disease is addressed is a "permitted" egg or embryo. It is an unquestionable, but ignored, fact that some mitochondrial diseases result from deficiencies in the nucleus, rather than arising from the cytoplasm or the mitochondria. The manipulation of the nucleus is thus—subject to regulation, of course—unintentionally permitted. Several amendments in the group, including Nos. 49 and 41, would address that by simply closing the door, or drawing the line, and restricting the law to what was originally intended.
Does the hon. Gentleman agree that the vast majority of genes in the mitochondria look after mitochondrial proteins, which apply across the human race? They would not contribute to a person's individuality, so he is exaggerating the problem of mitochondrial disease.
To exaggerate a problem is still to identify that a problem exists, and I do not think that it was intended that the Bill would generate such a problem.
Hon. Members may think that amendment No. 41 is more comprehensive than amendment No. 49, which I tabled, but my amendment would put the Bill back on track. The amendment would mean that the Bill would do what hon. Members, whether they support or oppose it, thought that it actually did.
May I offer my support for my hon. Friend's amendment No. 49, which is at the head of the group that we are discussing? I have no doubt that the regulations in the clause would stop nuclear modification to prevent cytoplasmic disease, and the Human Fertilisation and Embryology Authority would not, in any event, license such a procedure, but my hon. Friend is right: it is sensible for legislation to say what it means. There is no doubt that the Government mean the provision to deal only with cytoplasmic causes of mitochondrial disease in DNA. It is unfortunate that the Bill reaches us in this imperfect form, but my hon. Friend's amendment would improve it.
I thank my hon. Friend for that support. I see that we are in a holy, or perhaps unholy, alliance. We all have our views on the "slippery slope" argument, but slopes are certainly a lot more slippery if we do not examine carefully where we are treading and what exactly we are doing. Arguably, that is all my amendment seeks to do. We are talking about not an unintended consequence, but an unintended meaning to the Bill, which it behoves us to address.
Turning to new clause 24 and amendment No. 50, the legislation prohibits the placing of animal gametes or embryos in a human. My amendment mirrors that by banning the placing of human gametes in an animal for experimental purposes. Such an experimental procedure was carried out as recently as in 1984 in Australia. It, too, involved embryos. At the moment, such an act is covered, rather weakly, only by the Animals (Scientific Procedures) Act 1986.
Arguments against that simple, seemingly innocuous but important amendment are extraordinarily weak. They include the argument that so far, such experiments have been futile and uninformative—that is probably true—and the argument that scientists would not want to do such procedures anyway. The Department of Health argued that
"the development of a foetus or progeny is impossible", but that is disputed by Professor Millar of the Medical Research Council.
The Medical Research Council, the Association of Medical Research Charities, the Wellcome Trust and the Academy of Medical Sciences say that new clause 24 and amendment No. 49 would weaken invaluable research. What does the hon. Gentleman say to that?
As I understand it, some of the research that would be banned by my hon. Friend's new clause involves looking at the development of human gametes in the context of animals. It is not about creating embryos; it is about studying the development of human gametes in vitro. That is what his new clause would cut across. I do not think that it is the sort of frightening research that some would say it is, and I do not think that he is justified to seek to ban it when it is already regulated in other ways.
There is absolutely no reason that I can think of why such research should not be banned if people cannot state clearly the identifiable benefits that could be derived from it. That is quite apart from the question of whether humankind can be crossed with other primates—that, of course, is the scenario that most frightens people—and whether Stalin's scientists' dreams of creating a "humanzee" can be realised. That could all be science fiction.
I want to make two simple points. First, why should we legislators leave it to scientists to set limits on what is morally permissible? Scientists, bankers and MPs are all, in general, decent honourable folk. However, where there is an interest, I have limited faith in self-regulation for any of them. After all, in the Human Fertilisation and Embryology Act 1990, we outlawed placing a human embryo in an animal.
Secondly, would it not be a sight as monstrous as any hybrid creation to see hon. Members shuffle through the Lobby to preserve the right of scientists to put human gametes in animals' wombs? How would such an action be represented to their constituents? If hon. Members suggested and supported something that absurd and abhorrent, would not constituents think that hon. Members themselves had been transmuted into a flock of unreasoning sheep?
In many respects, I am pleased to follow the hon. Gentleman, because amendments Nos. 41 and 73, in my name and the names of a number of other hon. Members, are in the same vein. We wish to make it absolutely explicit, in the two amendments, that we are ruling out human genetic modification. I have always been pleased to try to do that in other areas, too. I have always been an opponent of the genetic modification of food, so it is unsurprising that I am an opponent of any attempt to allow it to happen to human beings.
I would like to think that I have the support of the Government, and of my right hon. Friend the Minister in particular. On a number of occasions she has made it absolutely explicit that the Government have no intention of allowing genetic modification of human beings. I think that the argument is about how the Government say that. However, the legislation could imply—I put it no more strongly than that—something slightly different. Amendment No. 41 basically tries to clarify that the Government cannot allow themselves, or a subsequent Administration, to use secondary legislation to do what should really come within the purview of this House—to clarify by clearly stating in legislation what should and should not be allowed. Amendment No. 73 basically says that if we do not have agreement and do not want to specify outcomes, it is meaningless to permit scientists to experiment in this field.
My hon. Friend may be confusing the issue. For example, if somebody has cystic fibrosis, it is possible now to attempt to introduce genes, by various mechanisms, into the lung cells to prevent what we call somatic disease. However, a disease could also pass into the gametes, and be passed on from the person who is being treated to their children, should they be fortunate enough to have children. It is then in the genetic line. Part of my brain can see why we ban such research at the moment, but another part says, "Perhaps one day we'll get lucky." In other words, perhaps we will be able to knock out genetic disabilities. Many genetic diseases—250 or 300 of them—could then be completely knocked out. We should not throw the baby out with the bath water.
I hear what my hon. Friend says, but we have to deal with what we are faced with today. The amendments are carefully phrased. We are looking at mitochondrial opportunities to deal with diseases that someone might carry, but the amendments would make it absolutely clear that that should not be done through human genetic modification. There is a dividing line, but I hope that the Government are clearly on my side, and that of other hon. Members.
I have written to my right hon. Friend the Minister on the subject; unfortunately, I have not had a reply. I refer to the letter sent by my right hon. Friend Mr. Meacher, my hon. Friend David Taylor and me. We wrote to the Government in the hope that the point would be clarified before Report, given that in Committee I tried to draw attention to what some of us saw as a particular problem. To refresh everyone's memory, we are talking about proposed new section 3ZA to the Human Fertilisation and Embryology Act 1990, which, to many of us, is the key part of the Bill before us. It goes to the essence of what human fertilisation and embryology is all about. Those of us who wish to shut down genetic modification will draw attention to any loophole that will result from the Bill becoming law.
As I said in reply to my hon. Friend Dr. Gibson, I have no problem with the Government's aim of helping people with mitochondrial conditions. The problem is that proposed new section 3ZA(5) is so broadly worded that it would allow a future Government to permit absolutely any technique—including genetic modification or even reproductive cloning—to prevent transmission of mitochondrial conditions. We want the Government to respond to that issue.
We feel that the Government have to clarify their position, because although there is an opportunity for Parliament to scrutinise in respect of permitting any technique that requires the passing of regulations, that is not the same as primary legislation. Views will change, and as has just been said, matters may pass on. As Dr. Pugh said, unless the legislation is clear from the outset, there will be the slippery slope about which some of us are very concerned.
The Minister cannot have it both ways. If the Government are coming down against the genetic modification of children, that needs to be stated in the Bill and we should not need to go to secondary legislation. If that does not happen, the Government will effectively be supporting a loophole that would permit such modification to happen in due course. There is an argument that my amendment might interfere with the techniques for mitochondrial donation. However, according to people far more scientifically knowledgeable about these issues than I, there are other ways in which such donations can be made. From my philosophical point of view, those are very preferable to genetic modification.
I agree with the hon. Member for Southport. We have had a listening Government and open-minded discussions. What happened before is different, but to me that is a slightly different issue. I hope that the Government will respond. The problem is that if we do not get things right with amendment No. 41 at this stage, that will be the law, even if there is a subsequent attempt to provide more control through the regulatory process. Some of us are nervous about that, because attitudes change and 90 minutes—at best—is not a good length of time in which to discuss such huge philosophical issues.
Amendment No. 73 clearly links to amendment No. 41, and through it we are asking why the Government, if they wanted to will the end—not allowing genetic modification in respect of the creation of children—were not prepared to rule out the means. As it is currently constituted, the Bill will allow scientists to continue to experiment in this area. That is problematic for two reasons. First, this country is an outrider on this issue in the world, and certainly Europe. Many European countries have ruled out the process. I am quizzical about why, in saying that they want a degree of restrictiveness in this area, the Government have not signed the relevant convention. That has been discussed in Committee and on Second Reading. Even if we want to be at the front end of scientific progress, why are we out on our own? Some of us do not want to go to certain places.
If our view is that we wish to make genetic modification in respect of the creation of children illegal, shutting down scientific research on the issue would seem perfectly reasonable. If it is not shut down, scientists in this country or elsewhere will work on the issue. If we believe that science will eventually find answers, such scientists—whether mavericks or the most genuine members of the scientific community—will push through that door. We will then be faced with the dilemma of what to do with that research—sorry about the pun, but the genie will really be out of the bottle.
I have explained why amendment No. 73 is vital. It would not interfere with the basic research, because other forms of research dealing with all manner of genetic imperfections would be allowed to carry on. The problem is that unless we are clear that we are not encouraging research through genetic modification, somebody somewhere, if the legislation retains its current wording, will go on with it.
I hope that the Minister will give a good response and that the House, if asked to vote, will come clearly down against genetic modification, which I am sure everyone in the House is against. The argument is about how best to be against it. If amendment No. 49, tabled by the hon. Member for Southport, is pushed to a Division, I will support it. However, I hope that my more comprehensive amendment is taken seriously and seen as a way of helping the Government, who, I am sad to say, have listened but not acted as some of us would have wished. They have not been comprehensive in clarifying their views on human genetic modification.
It is a pleasure to follow the hon. Members for Southport (Dr. Pugh) and for Stroud (Mr. Drew), and I support their amendments. Many of us opposed in principle the prospect of human admixed embryos, but we had a vote on that principle and the House decided to go ahead with it. Many also opposed the practical results proposed by the Government; indeed, during discussion of the programme motion today, the Minister again alluded to the prospect of treatment for Alzheimer's disease and other debilitating conditions. Many of us applaud that fine motivation, but are concerned that the Government are marching us up to a false summit. Many of us sought to oppose the move because we felt that there were ready alternatives that are producing therapeutic treatments and offer great prospects of further cures to such debilitating illnesses.
I wish to speak to amendment No. 47, tabled in my name and those of other right hon. and hon. Members. It is not a wrecking amendment; it does not seek to oppose the principle of human admixed embryos, as we have to accept the previous will of the House. Nevertheless, there will obviously be a fundamental vote on Third Reading. Our amendment seeks to do something important: plug a gap that has exercised the minds of many. The Minister has mentioned that there have been 80 hours of deliberation and many of those have been taken up in discussion of whether the definitions of human admixed embryos in the Bill are adequate. Amendment No. 47 is significant, and I will want to press it to a Division.
"My Lords, the issue of defining human admixed embryos has long vexed all those who have tried to tackle it. It was probably the topic that the Joint Committee of both Houses that scrutinised the draft Bill spent most time considering."
Like other hon. Members here, eighteen months ago I was a member of that ably chaired Joint Committee. We sought to be as constructive as possible to assist the Government to come to an appropriate definition. The House of Lords Science and Technology Committee also undertook an inquiry specifically into the issue of definitions, which is a matter that has led us down many different paths. Indeed, I pay tribute to the noble Lord Mackay, who gave particular consideration to the issue, both in the Joint Committee and in the other place, with Ministers and others, to try to help us come to a definition.
As a lawyer, I would perhaps tend to look to definitions as an important part of any Bill. It is therefore quite right that we should begin our considerations this afternoon with the issue of definition. If we cannot get the definitions right, that does not hold out much hope for the Bill's practical application. Notwithstanding all the results that we want to achieve, it should concern us all in the House if we cannot get the definition right. I therefore hope that my amendment No. 47 will attract widespread support from those who, despite being vehemently for or against human admixed embryos in principle, whatever I say, are concerned that the definitions in the Bill should be comprehensive.
The noble Lord Darzi said on Third Reading:
"We are now facing what we hope will be the final steps in this journey."
Those final steps led to an essentially catch-all definition, which he described in that debate in terms of clause 4, which includes a
"regulation-making power to extend the definition of human admixed embryos if necessary."
"It has been included to ensure that if someone comes up with the type of human-animal embryo at the human end of the spectrum that is not captured by the definition, there is a power to extend the definition to catch it. This is a future-proofing mechanism."
It is for this House to try to ensure to the best of our ability that we get the definitions right, so that they are fully comprehensive and so that everyone out there—the scientists and the public—is clear about what we mean by human admixed embryos. We should not simply devolve the issue to future delegation or a future-proofing mechanism. That is not satisfactory.
The gap in the current definitions needs to be addressed properly. My amendment No. 47 seeks to do that. The gap is crucial—it is the gap in the law between the Bill and the Animals (Scientific Procedures) Act 1986. The amendment standing in my name addresses that gap, by adding another type of chimeric embryo to the definition of "human admixed embryo" in clause 4, which would otherwise remain unregulated.
The science behind the creation of such embryos is complex—one would perhaps need a hot towel on one's head to understand it fully—but it is important not to be blinded by that complexity, because the concept is very simple. Indeed, the noble Lord Darzi put the issue in its proper context, again on Third Reading, saying that the Government's intention was for the Bill to ensure that the Human Fertilisation and Embryology Authority
"regulates human-animal embryos at the human end of the spectrum."— [ Hansard, House of Lords, 4 February 2008; Vol. 698, c. 853- 4.]
That is the context that my amendment No. 47 seeks to address.
That principle was reinforced in Committee on
"contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal...but in which the animal DNA is not predominant."
Hon. Members need to ask themselves today whether that provides sufficient clarity or whether there are any circumstances that would lead to a lack of regulation of a key area of research.
Does my hon. Friend agree that, despite the Prime Minister writing in an article in The Observer on
Certainly the issues are complex and certainly there has been a desire at an early stage for clarity. Whether we have all been swept along by that complexity is perhaps for others to judge. There is certainly a need for clarity, however, particularly in the definitions.
I would like to give some examples of where that lack of clarity poses potential dangers that need to be dealt with. As the Minister will no doubt remind me when she responds, the Government's intention in adding a catch-all category to the definition of human admixed embryos in the Bill was, as she explained on a previous occasion, to provide
"further clarity of the scope of the term", adding:
"In addition to the four precise scientific definitions already in the Bill, that will ensure that all new forms of embryos that may be developed that contain both human and animal DNA will, where the animal DNA does not predominate, fall within the regulation."— [ Hansard, 18 May 2008; Vol. 476, c. 59.]
That is the test that we have to hold that catch-all category up to. Does it provide further clarity? Does it ensure that all new forms of embryos that we are aware of are captured? The Government's approach was that the human end of the spectrum referred to any embryo containing both animal and human DNA, where the human DNA was more than 50 per cent. of the total, and that all such embryos should and would be regulated under the Bill.
The Joint Committee, of which I was a member, considered the matter and reported on it. The issue exercised our minds; indeed, letters were written to the Department of Health and the Home Office, given their twin responsibilities. In our conclusions, in paragraph 163, on page 47 of the report, we said:
"The second issue centres on the human-animal boundary and which entities should be regulated as human embryos and which should be regulated under the Animals (Scientific Procedures) Act 1986. We have received a lot of evidence suggesting that there is no principle, as such, which underpins the Government's choice of 50 per cent. as a cut-off point for whether an entity is sufficiently human to merit regulation by the HFEA, or whether it is more appropriately regulated as an animal by the Home Office. The 50 per cent. rule intended to be embodied in subsection (e)", as it was then—it has since been amended—
"is essentially an arbitrary attempt to draw a line between what qualifies as human and what as animal."
There can perhaps be few more important issues than what qualifies as human and what as animal.
The Joint Committee continued, in paragraph 164:
"We heard evidence arguing that the issue as to what proportion of the entity is human and what proportion is animal is not clear-cut."
"For example, Professor Martin Bobrow, Chair of the Academy of Medical Sciences"— reference has already been made to that august body—
"working party on interspecies embryos, told us that what makes an entity human rather than animal is not easily measured in DNA terms, although, if a line in the sand had to be drawn, he saw no reason why it should not be drawn at 50 per cent."
The report continued:
"Professor Sir Richard Gardner, Edward Penley Abraham Research Professor of the Royal Society in the University of Oxford, raised the more technical issue of what the 50 per cent. actually refers to—for example, when calculating the relative quantities of mitochondrial DNA (which may come from a cow egg) against quantities of nuclear DNA (which may come from a human skin cell), different answers would result according to whether you measured the mass or the number of genes."
Those are the experts who say that the issue exercised their minds.
I draw attention to the evidence given to the Committee by Professor Robin Lovell-Badge in response to my question, which was:
"In terms of definitions and in terms of inter-species embryos would you want there to be a definition to cover animal chimeras starting with an animal embryo and a set of human cells, whether that should come into the ambit of an inter-species embryo, tetraploid complementation processes and the like"— we will come to that definition—
"whether that should be subject to the Bill?"
Dr. Lovell-Badge responded:
"Again, you have got yourself right into a difficult position again because 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 off with an embryo which is 20 per cent. human and end up with something which is 60 per cent. human or vice versa."
The challenge from the Minister to provide further clarity of the scope of the definition of what is animal, what is human and what should be subject to regulation is surely put to the test by the very nature of the subject. We must ask ourselves a serious question about clause 4—whether it contains the definitions needed for the public to understand, for us to understand and for the scientists to work with.
The subject of amendment No. 47 is the case of embryos created by a process called tetraploid complementation. If the results were to be the same in experimentation with human-animal embryos as they are with mice, the potential exists for the embryos to end up completely or almost completely human. In tetraploid complementation, pluripotent stem cells are combined with an embryo that has been altered in such a way that the cells in the embryo have double the number of chromosomes. The cells are then tetraploid and develop into an extra-embryonic tissue such as placenta, while the pluripotent stem cells develop into the foetus. However, this specific class of embryos would not fall within the ambit of the Bill. That is the issue that my amendment seeks to address.
My hon. Friend has been demonstrating how complex these questions are. Is it not true that one has a simple question to ask as well—that is, what would the general public, on whichever side they happen to be, expect us to do in trying to deal with these questions? Would they not expect us to make sure that the examples that my hon. Friend has given came within the ambit of the legislation and did not fall outside? That is how they would understand, as well as they could, the very detailed arguments that he puts forward.
I am grateful to my right hon. Friend. That is the least the public would expect of us. They may or may not agree with the principles and the practical results, but at the very least they would expect the Bill to cover researched examples of animal-human embryos. It is important that we do not leave that to a foolproof clause regulating future embryo research.
In tetraploid complementation, pluripotent stem cells are combined with an embryo that has been altered in such a way that the terms of Bill would not properly apply. Under the Animals (Scientific Procedures) Act 1986 those embryos could be legally implanted into an animal and taken up to mid-gestation without requiring a Home Office licence for the research project—it is this part of the process that causes concern and is not subject to proper regulation—other than an implementation licence, which is an unrelated animal welfare issue.
That goes against the principles behind clause 4 as described by the noble Lord Darzi in the other place. Those principles are also reflected in the new sub-paragraph (e) which is intended, as the Minister said, to capture all hybrid embryos in which human DNA is predominant. The embryos that I am describing would be similar to the type of chimeric embryos described in section 4A(6)(d) of the 1990 Act. They would be, as defined in the Bill, a mixture of human and animal cells, rather than transgenic embryos or cloned embryos. However, they would remain outside regulation, and I shall spend a few minutes explaining why they would fall outside the ambit of the Bill.
First, the chimeric embryos referred to in section 4A(6)(d) are human embryos to which animal cells are added. However, the chimeric embryos in the example that I am putting forward would be animal embryos to which human cells were added. As confirmed by Lord Hunt of Kings Heath in a written answer on
"Chimera embryos created by the addition of human cells to an animal embryo are not within the regulatory framework set out in the draft Bill. These chimeras, made using animal embryos, are regulated under the Animals (Scientific Procedures) Act 1986 at such time as they become a protected animal under that Act. Any embryos not considered to be a protected animal do not come within the Animals (Scientific Procedures) Act."— [ Hansard, House of Lords, 25 June 2007; Vol. 693, c. WA101.]
The second reason why there is a need for amendment No. 47 is that the chimeric embryos that I am describing would not be captured by new sub-paragraph (e), as embryos created by tetraploid complementation would start as predominantly animal, with very little human DNA contribution. They may develop to have predominantly human DNA only after the first 14 days of development. In the examples that the eminent experts discussed in the Joint Committee, the human or animal definitions could not easily be applied.
This argument may seem to have no relevance to the Bill. Dr. Harris, with whom I have debated the matter on many occasions, may suggest that. However, since those embryos would fall under animal legislation, the 14-day rule and the no-implantation rule, which I concede are in the Bill, would not apply, so the embryos would not be permitted to be implanted into an animal womb. Thus, their development would continue to the stage where human DNA would potentially overwhelmingly predominate in the developing foetus.
The third reason is that although clause 3 of the Human Fertilisation and Embryology Act 1990 bans the implantation of an entirely human embryo in an animal—we would all unite and agree on that—and, as we know, the ban is retained in the Bill, if an embryo created by the mechanism of tetraploid complementation were to be implanted, it would not be entirely human at that stage. That is the crucial issue. At the pre-implantation stage it would be defined as not human, and it would not fall within the remit of the Bill. It would then supposedly come under the auspices of animal legislation. My point is that it would not; it would tend to be unregulated. Even if the particular embryo were subsequently to develop into an entirely human embryo, it would escape the ban. That is why the issue is crucial.
I am following the hon. Gentleman's argument with interest. Will he explain whether it is his understanding that if such an entity were implanted into animal, a licence would be required from the Animal Procedures Committee?
I am grateful for that intervention. If the hon. Gentleman bears with me, I shall come shortly to the issue of the licence.
The fourth reason for the amendment is that proposed new section 4A(4) bans the implantation of human admixed embryos in an animal. Since the embryos in question are not defined as human admixed under current definitions in the Bill, implantation into an animal could not be banned under clause 4. The embryos would thus fall under animal legislation, potentially allowing a human foetus with an animal placenta to develop in an animal womb up to mid-gestation, without the requirement—this relates to what the hon. Member for Oxford, West and Abingdon said—to obtain a research licence from the Home Office. The research project would require a licence only if the research was intended to take the foetus beyond mid-gestation. If that was the intention, a licence would be required.
The difference, as I understand it, between requiring a licence for a research project and requiring one for implantation is an unrelated animal welfare issue—not something that falls within the intention of animal legislation. As the hon. Member for Oxford, West and Abingdon knows, animal legislation is designed to ensure that animals are not butchered by incompetent or uncaring technicians or researchers who do not know what they are doing or do not care if animals suffer unnecessarily. In relevant cases, the researchers would need an implantation licence because the animal to be implanted would be classified as a protected animal. That is the crucial issue. In my example, the foetus developing inside would be an unprotected animal until mid-gestation. That is the gap that I am seeking to plug. Hence a licence would not be required for the research project unless the intention was to develop the foetus beyond mid-gestation. That might sound like a far-fetched scenario; some may even say that it is a science-fiction scenario.
For the sake of clarity, will the hon. Gentleman say whether he is referring to mid-gestation in the species into which the implant has been made?
Let me give an example. The procedure has been used in mice since the early 1990s, and it is routinely used to make entire mice from embryonic stem cells, which are being aggregated with tetraploid embryos. When used in this way, the procedure is considered a gold standard for testing, where researchers have isolated genuine, fully functional embryonic stem cells to make every cell type in the body rather than just many cell types. Since the tetraploid cells would make tissue outside the embryo, such as placenta, the inserted embryonic stem cells would have to make every cell type in the animal. If anyone is interested, I have research papers here on that very procedure.
Currently, researchers use a far less rigorous type of test for human embryonic stem cells. It is called the teratoma test, as was mentioned earlier. Teratomas are a specific type of tumour generated by embryonic stem cells, which consist of various stem cell types. However, it is a much less comprehensive test than tetraploid complementation, since relatively few cell types are generated in this way.
I am listening very carefully to what the hon. Gentleman is saying. His basic argument relates to something falling outside the current prohibitions in the Bill. However, does he not agree that the definition of human admixed embryos, already discussed in the House, covers tetraploid complementation so that the Bill's prohibitions would apply? The embryos could not therefore be placed into an animal, which is the fear that he is expressing. The Bill therefore deals with the problem.
It will probably not surprise the Minister to hear that during the 20 or so minutes of my speech, I have been seeking to make the very point that the definitions are not covered, which is why we need amendment No. 47 to plug the gap. That follows on from the relationship with animal legislation— [Interruption.] The Minister may well like to talk rather than listen to my response, but this issue should not be taken for granted. This research and testing is taking place, and the issue of the mid-gestation period, which presently falls within the ambit of the Home Office and animal legislation, needs to be dealt with properly at this stage, through the opportunity presented by the Bill. That is important as we seek to define human admixed embryos and to deal with regulation in respect of animal-human embryos.
If we assume that the Minister is right, it must be perfectly reasonable to agree with my hon. Friend as well. All he is doing is ensuring that those who fear that the Minister may not be right can be reassured by his amendment. If the Minister is right, she must be able to accept his amendment, because she has suggested that its content is already in her Bill. It seems to me that this is an opportunity for Members on both sides of the House to agree. If, on the other hand, the Minister does not really want this provision, she is trying to avoid the strength of my hon. Friend's amendment by suggesting that everything is all right anyway.
As always, I am grateful to my right hon. Friend. I want to be reassured by the Minister telling me that tetraploid complementation is fully covered by the definitions in the Bill, but according to a written answer given by Lord Hunt, that type of chimeric embryo is not covered. He said at one point that the position following mid-gestation is covered by animal legislation, but before he had said that it was not, so there is a discrepancy. I hope to be assured that all these matters will be fully covered by regulation under the Bill, but if they will not be, as I believe, all Members should unite in supporting amendment No. 47.
During a public hearing on hybrids and chimeras on
The Committee also heard from Professor Blakemore, who gave evidence on
"to the point of organogenesis", although not to term. At a public hearing of the Joint Committee on the Bill on
"take human embryonic stem cells, insert them into a primate blastocyst and take that blastocyst to midgestation or maybe to birth, or maybe to ten years of age."
There is no indication that any of those scientists had tetraploid complementation in mind, although the creation of chimeric embryos to test totipotency, not just pluripotency, may indicate that it had been considered by one or two researchers. However, the scientists may have been referring to a very similar procedure whereby embryonic stem cells are inserted into normal diploid embryos rather than tetraploid embryos. In such cases, the resultant human-animal chimeric foetuses, or creatures, would contain various proportions of cells from both species. Many of us agree that that carries great concerns of its own—for example, the potential development of human gametes or of a large proportion of human brain cells in an animal. However, as the Bill is currently drafted, both those types of chimera would fall within the more permissive animal legislation. I therefore ask the Minister to consider very carefully why there should not be legislation containing proper, clearer definitions.
Amendment No. 47 is restricted to dealing with tetraploid complementation.
I am still a little confused, because there are two issues here. First, is the tetraploid complement embryo actually human at the point at which the hon. Gentleman envisages it would be implanted, bearing in mind that the embryo itself does not include the animal-derived trophectoderm that forms the placenta, in which case the Minister is right and it would be covered? I see the Minister nodding. In any event, does the hon. Gentleman accept that in order for appropriate implantation, there would have to be a close species match? Would that not require a licence from the Animal Procedures Committee that it would be extremely unlikely to give? Is not the hon. Gentleman's amendment therefore unnecessary in both those cases?
As always, I am grateful for the hon. Gentleman's intervention and for his expertise in this matter. However, he raises the question of whether the embryo would be human, but as he has heard during questions to the experts, they themselves have not been able to agree on that. They have said that there is not a defined point, and they have talked in vice-versa terms on the issue of going from human to animal. When one follows through this process within the ambit of animal legislation, it is apparent that at the time before mid-gestation there is potential for the process to be unregulated, unless a licence has been applied for where there is an intention to go beyond mid-gestation point. There is a gap that I feel needs to be properly plugged, at the very least for the reassurance that we have it covered. After all, everyone is concerned that all forms of animal and human embryo that we are aware of should be properly covered.
Is this not fairly simple? There is not a scientific consensus on the definition. There is, therefore, not a consensus among practitioners, and if there is no consensus on the definition, the Minister cannot rely on the definition in the Bill unless it is fully clarified.
I am grateful to my right hon. Friend for her comments. Similar points were made in the other place. It is absolutely crucial that, at this late stage, we can have clear definitions. This issue has been raised by the media. Reference has been made to the media being dominated by the issue of abortion, but there have been other debates as well, and awareness of the issues has grown. Many of us are concerned that the awareness of stem-cell therapy should lead to greater support for, and investment in, adult stem-cell therapy that is producing the treatments that we all want.
Earlier this year, The Independent reported that a senior cloning scientist, Dr. Lanza, had warned that some might wish to use tetraploid complementation to create cloned babies by inserting human-induced pluripotent stem cells into human tetraploid embryos. It was reported that he had said that
"studies on mice have shown that it is possible to produce fully cloned offspring that are 100 per cent. genetically identical to the adult. This was achieved by using a type of defective mouse embryo with four sets of chromosomes instead of the normal two.
This 'tetraploid' embryo only developed into the placenta of the foetus and when it was injected with a reprogrammed skin cell, the rest of the foetus developed from this single cell to become a full clone of the adult animal whose skin was used.
None of the scientists working on cell reprogramming to produce induced pluripotent stem (iPS) cells—as the embryonic cells are known—plan to use it for human reproductive medicine. Their main aim is to produce (iPS) stem cells (from adult cells) for the therapeutic treatment of conditions such as Parkinson's, Alzheimer's and stroke."
We note the great progress made in that regard.
The Independent stated that
"Dr Lanza said that the mouse experiments his company had done demonstrated how easily the technology could be used to produce cloned or chimeric babies", and he went on to say that we are opening up a "can of worms." We want to close that can of worms and ensure that the gap created is properly plugged. Dr. Lanza said that the technology
"could be used to produce cloned or chimeric babies by inserting iPS cells into early human embryos. This is not banned in many countries, where legislation has not kept pace with scientific developments."
He also said:
"In addition to the great therapeutic promise demonstrated by this technology, the same technology opens a whole new can of worms".
Does the hon. Gentleman not accept that he is talking about scientists opening a can of worms by developing the technology, while the Bill will close a can of worms by regulating and limiting exactly the things that he is talking about? My right hon. Friend the Minister has assured us of that.
The purpose of my amendment No. 47 is to deal with the can of worms that is already out there. It is not science fiction about a theoretical area of research. The matter needs to be properly regulated and defined, and it is currently not. That is the purpose of the amendment, for which I seek the Government's support.
If Ms Keeble is right, is it not true that all she need do is support the amendment, because it merely reinforces what the Government have done? If she is wrong, we will want to support the amendment to see that the hole is plugged. Surely we do not need to have this argument, because it is so obvious that both sides agree.
I am grateful to my right hon. Friend, whose repetition of the point makes it ever better and more compelling. It is important that the Minister deals with the issue. The response in the other place was, "Well, we have a foolproof guarantee; we will ensure that we cover new forms through regulation and powers." However, the reality is that we have a gap, and for the sake of reassurance and ensuring that we have a comprehensive definition, the amendment should be accepted.
I am following with great interest my hon. Friend's speech, which shows his great knowledge on the subject. Is it not correct that if we pass the Bill as it is, we will rely on secondary legislation to protect us? The protection against reproductive cloning should be in primary legislation.
No, I shall make a bit more progress now.
Human-human chimeric embryos will be banned under clause 3, but the issue to consider is the definition of what is animal and what is human in the tetraploid complementation process. The amendment would close up a legal loophole between the Bill and the Animals (Scientific Procedures) Act 1986. It would ensure that chimeric embryos created by tetraploid complementation that had the potential to result in a completely or almost completely human foetus with an animal placenta would not come under animal legislation, and would therefore not be allowed to develop inside an animal womb.
One need only examine research and journals, as many will already have done, not least the 2007 article by Professor Jaenisch in Science, to see that the injection of IPS cells into tetraploid embryos needs to be addressed properly. The amendment would bring those embryos within the ambit of the Bill, preventing them from being developed beyond 14 days or from being implanted. It is important to establish that prohibition in primary legislation, and it is consistent with the Government's intentions throughout the Bill.
This issue should not divide those who are in favour of using embryonic stem cells and those who are against it. It is an altogether separate matter, and I hope that hon. Members can see that it potentially applies equally to adult stem cells and induced pluripotent stem cells. The Government's position is that they do not want to permit the implantation of embryos, to use the noble Lord Darzi's phrase,
"at the human end of the spectrum".—[ Hansard, House of Lords, 4 February 2008; Vol. 698, c. 854.]
As the Bill is intended cover all such embryos, I hope that all Members will join me in supporting amendment No. 47, which would close a rather unusual and technical but extremely important loophole on the definitions of what is human and what is animal. It would ensure that there is clarity in the Bill.
I rise to support new clause 24 and amendment No. 50. In my opinion, the issues that they deal with are serious, sinister and ultimately ridiculous. Members of the general public listening to this debate might find it difficult to understand what we are discussing, and I should like to begin by making it clear which issue the new clause and amendment are trying to resolve. If the Bill as it stands is passed, it will allow the insemination of human gametes into an animal—that is, the insemination of human sperm into an animal. I find it difficult, as many members of the public doubtless will, to understand why the Bill is allowing this to take place, as it would be incredibly simple for a clause to be inserted prohibiting this, as was said.
Dr. Pugh described how the Bill completely fails to prohibit the placing of human gametes in an animal, and has questioned why we cannot address this issue. Given that the Bill has been put together so inefficiently, perhaps we should be thankful that the Government have been alert enough to prohibit the insertion of an admixed embryo into an animal, and the placement of non-human gametes in a woman. What have the Government been playing at, given that this loophole was pointed out to them a long time ago? What would it take for them to make this amendment? Why do we need to deal with an issue so basic, and which has been pointed out so frequently to the Government?
Of all the experimental possibilities debated during consideration of the Bill, surely none is quite as utterly repulsive as seeking to inseminate animals with human sperm. Yet despite all the Government's fervent assurances about safeguards and regulations, this procedure remains entirely untouched by the Bill's prohibitions. The Department of Health has argued that the insemination of animals with human sperm could never lead to a viable foetus. How can it know? Surely the nature of science and scientists is that they are incredibly experimental and inquisitive and constantly attempting to push back the barriers. How do we know what this would lead to in one, five or 10 years' time?
My hon. Friend might be interested to know that when we debated the Warnock report in 1984, I drew attention to this very question. Of course, I was treated with complete ridicule and contempt, because it was regarded as ridiculous nonsense that anyone would try to do this. However, I had read articles in obscure journals in the Californian medical field indicating that scientists were doing exactly the experiments that my hon. Friend has described.
I thank my hon. Friend for illustrating the point far better than I could. Who would have thought only a few years ago that attempts would be made in an underground tunnel in Switzerland to re-create the big bang? That is happening today, but we would have thought it ridiculous a few years ago—that it would not be possible. However, as I said, the Department of Health is arguing that the insemination of animals with human sperm could never lead to a viable foetus, and that therefore there is no need to legislate. It is just not an issue, the Department says. I think that it is a huge issue, as do many people.
The hon. Member for Southport asked what our constituents will think of us when we shuffle through the Lobby today to vote for some of the Bill's provisions. I would find it very difficult to justify to my constituents why I had voted to allow human sperm to be inseminated into an animal. If a constituent asked me "Why did you do that?" I would find it very difficult to explain my motives. When a Bill purporting, as we heard the Minister say today, to set global standards of regulatory efficiency fails to mark out such a fundamental ethical boundary, that is a very serious matter indeed. Moreover, it is a sinister matter.
That does not excuse the situation at all. The provision to which the hon. Lady refers prohibits the placement of a human admixed embryo in an animal and the placement of non-human embryos or gametes in a woman, but it does not prevent human gametes from being implanted into an animal.
Do we not come back to exactly the same thing? If Ms Keeble is right, it does not matter if we repeat things. If she is wrong, it does matter that we say so. Some in this Chamber want to include in this Bill something that is not explicit, so we need to insist on the amendment to which my hon. Friend Mrs. Dorries is referring.
I thank my right hon. Friend for that clarification. I wish to ask Ms Keeble why we should not clearly state in the Bill that it prohibits the insemination of human sperm into an animal. What is the problem with including such a provision in the Bill? [Interruption.] No, the Bill prevents things from happening the other way round, but, as I said, the hon. Lady can make that speech herself.
The point that my hon. Friend Ms Keeble made was raised in error, because the new subsection to which she referred does not ban the activity she mentions, but licenses it. It would be banned
"except in pursuance of a licence."
Those were the words that she failed to mention. The new subsection states in full:
" No person shall—
(a) mix human gametes with animal gametes,
(b) bring about the creation of a human admixed embryo, or
(c) keep or use a human admixed embryo, except in pursuance of a licence."
It licenses the very activity that my hon. Friend is trying to say is not permitted by the Bill.
That makes my point even more coherently for me. Perhaps we need to legislate to ensure that this activity cannot happen even in pursuance of a licence. I cannot believe that anybody in this House believes that inserting human sperm into an animal would be a good thing to do, so why do we not clearly state in the Bill that it will not be allowed to happen? This argument is not a surprise to the Government, because it has been pointed out over and over again that the Bill would allow this activity to take place in the seeking of a licence. One has to ask why they have not addressed the issue.
This is a sinister matter, because of the connotations. It is impossible to discuss insemination of animals with human gametes for very long without considering the infamous Soviet hybridisation trials of the 1920s. There are a huge number of historians on the Conservative Benches—I do not know how many there are on the Labour Benches—and one of the great pleasures for me, since becoming an MP, has been listening to some of those amazing and learned historians. I am sure that they will forgive me if I get anything wrong in the following paragraph.
At that time, the Soviet authorities were struggling to rebuild Stalin's red army after it had suffered many deaths and huge defeats. Stalin told his top scientist, Ilya lvanov, to turn his skills to breeding an ultimate soldier by crossing human beings with apes. Stalin told him to breed a soldier who would not be fussy about what he ate, who did not feel pain and who was invincible. Stalin told Ivanov to use all his scientific knowledge and know-how to cross apes with humans and breed that soldier for him.
Many people in this House might think that it is ridiculous my even mentioning what Stalin did in the 1920s, but his ideas found credence among many in the scientific community and even became quite popular among evolutionary biologists in America; as my hon. Friend Mr. Cash said, the idea that perhaps we could cross humans with apes and thus have almost a "humanzee" took root.
The hon. Lady does her case no favours when she goes down this hysterical line. Over the past few weeks, we have celebrated the 10,000th birth of an in vitro fertilisation baby. If she reads the Hansard record from the time when IVF was being introduced to this place, she will see that the debate was exactly the same. It was about breeding animals, hybrids and everything else. We should stick to the debate and the issues, and hon. Members should stop being hysterical.
I am terribly sorry, but it is historical not hysterical. If the hon. Gentleman wishes to rewrite the history books and what happened in that era, he is at liberty to do so, but I am citing factual history. Stalin said that he wanted an invincible human being, insensitive to pain and indifferent to the quality of food he ate. That is what his scientists went off to do, and that is what took root in scientific thought in much of the western world in the 1920s.
In Ivanov's proposed research, there was never any consideration of the potential ethical problems of such experiments. Far from condemning his proposals, Ivanov's western colleagues and patrons were fascinated by them—and that is the point that I am trying to make. The Department of Health says that what we do today will never be abused or subject to experimentation in the future, but I would not be so sure. By their very nature, thank goodness, scientists push back the boundaries of research, and they may decide to see what would happen if they put human gametes into animals. They may see that as a valuable line of research.
Would my hon. Friend be interested to learn that the United States had a commission to study ethical problems in medicine in 1982, and in its report "Splicing Life" it called into question the issue of human-animal hybrids? It asked whether genetic engineering could be used to develop a group of virtual slaves, partly human, partly lower animal, to do people's bidding, so that is not as fanciful as some Labour Members seem to think.
I thank my hon. Friend for his valuable intervention.
I am not for one moment suggesting that the Government intend to follow the example of Stalin in the 1920s. I am not suggesting that they will select a team of experts and dispatch it to inseminate chimpanzee females with human sperm to obtain, if possible, a hybrid of the two species. I do not believe that it is the Government's intention to do that. However, let me point out several important comparisons with the Soviet experiments.
Ivanov's experiments were legal. I suppose that should hardly surprise us—he was working under one of the most brutal totalitarian regimes the world has ever known, at the personal behest of one of history's bloodiest dictators. He was allowed to experiment with humans and chimpanzees. Soviet scientists had precious few personal freedoms in the 1920s—they could not buy their own homes or shop for the food that they wanted—but they enjoyed the legal freedom to carry out experiments involving placing human gametes in animals.
Such was life in Stalinist Russia, but of course no enlightened 21st-century western democracy would ever countenance allowing such things in law. Of course it would not, because its Government would ensure that they learned a key lesson from history and what happened in the 1920s, and would legislate to ensure that it could not and would not happen again. I am using the example of those 1920s experiments to say that that is what we should do today. We should legislate today to ensure that such experiments will never be legal.
The Department of Health insists that inseminating chimpanzees with human sperm could never produce hybrid offspring, and therefore no scientist would ever try, but the Ivanov episode shows that there is just enough hypothetical possibility in such a proposal to entice a certain kind of scientist. The chromosomal differences between some animals that can mate—such as goats and sheep—is greater than between humans and chimpanzees. There has been reference to a press article in which scientists speculated whether inseminating chimps with human sperm could produce offspring, and predicted that were it legal, some of their less squeamish colleagues were bound to try it. So we actually have members of the scientific community saying that if this is allowed to go through today, some of their colleagues will try it. The scientists are saying that themselves—
The hon. Gentleman is shouting "Rubbish" from a sedentary position. He is not saying that I am talking rubbish, but that the scientific community is talking rubbish. There are those in the scientific community who have said that their colleagues will try to use this loophole if it is allowed to remain in the Bill. It is not I who say that, but the scientific community.
Members of the scientific community said that some of their less squeamish colleagues were bound to try to insert human sperm into an animal. The reporter was even able to find a professor of applied philosophy at a UK university who claimed to see no ethical objections to the creation of "humanzees". A professor in a UK university used that terminology! Mr. Devine can shake his head as much as he wants. I despair to think that a scientist would believe there were no ethical objections to such behaviour. Like many people, I applaud scientists for their inquisitive nature. Thank goodness they exist and experiment constantly. However, the role of the House, the Government and Parliament is to legislate to curb that enthusiasm and that inquisitive nature. That is why the Bill should and must close the loophole to protect us all from the creation of "humanzees", as the professor calls them.
When it comes to placing a human admixed embryo into an animal or of a non-human embryo or gametes into a woman, the Government have taken the wise steps of ensuring that such procedures remain strictly hypothetical, because they are banned by law. If the placement of non-human embryos or gametes into a woman is to be prohibited by the Bill, why are we allowing this loophole to go through? Whether there are any budding Ivanovs working in Britain's research facilities becomes irrelevant if new clause 24 and amendment No. 50 are passed. For that reason, I hope that the House will have the opportunity to divide on them.
In conclusion, I cannot help reflecting on the farcical nature of the topic under discussion. We are in the midst of the remaining stages of what is supposed to be benchmark legislation of impeccable ethical and technological integrity, but Members such as I have to support a new clause as basic and ethically uncomplicated as the one before us. Plenty of intricate and huge ethical issues are as yet not satisfactorily resolved in the Bill—the subject of saviour siblings will not even reach the light of day. How ludicrous it is, in those circumstances, that we are debating the placing of human sperm into an animal. How absurd it is that the Government, by failing to close the loophole, have allowed themselves to stand shamed by direct comparison with the most distasteful ethical excesses of Stalin's Russia.
I thank the hon. Member for Southport for his good sense in tabling new clause 24 and supporting amendment No. 50. I hope that I have the opportunity to vote on them in due course.
I rise, briefly, to speak against new clause 24 and amendments Nos. 50 and 47. I was involved with the 1990 Act when it came through the House, and I sat through the first two and a half hours of the debate thinking that things had moved on in some areas. The presentation that we have just had from Mrs. Dorries has knocked me back 17 years in terms of how we compare modern-day science and get it into context. As legislators, we have a responsibility to do that.
Comparisons to Stalin's Russia and to what Hitler did have never helped this debate from a scientific point of view in the years that I have been a Member of this House—including in debates on private Members' Bills and other legislation. Saying that the scientific community is on one side or another is not a helpful case. If there are two scientists in a room, they are likely to hold three different opinions. In a sense, it is the same with politicians. Over the years, I have listened to many scientists give evidence to the Health Committee, and other Select Committees also sometimes call in eminent scientists to put their arguments. However, we must accept that there will never be a consensus among scientists.
If it is well known that scientists never agree, does not the onus then fall on Parliament to ensure that there are no loopholes in legislation? The law must provide the boundaries that scientists who disagree with each other cannot cross.
I was about to explain why I oppose amendments Nos. 47 and 50 and new clause 24. Earlier, I intervened on Dr. Pugh, who is not in his place at the moment. In the past 48 hours, all hon. Members will have received a short briefing from the Medical Research Council. The text was agreed by the Academy of Medical Sciences, the Association of Medical Research Charities, the Wellcome Trust and the MRC itself. There is a consensus on different issues among those organisations that we, as legislators, have accepted for many years. I know that various hon. Members have sat on some of those bodies, as lay or other members, and that they have brought their experience back to the House. We have a duty to recognise what the collective voice of the scientific community says about different pieces of legislation.
The scientific community has said that it believes that the two amendments and the new clause to which I have referred should be rejected. I do not know what my right hon. Friend the Minister of State thinks about that recommendation—we will have to wait and see—but I am happier to accept the advice in that brief than the advice in some of the other briefs that have been read out in this debate. I would not always accept the argument put forward by these organisations, but I shall briefly explain why I accept it today.
The brief states:
"We oppose the amendments which would have the effect of limiting valuable research which can be undertaken using human gametes in animals...While we recognise that gametes are special, in that they are cells involved in reproduction, the reasons for studying human gametes in the context of an animal is to learn more about how gametes develop and function."
Many reasons are given in debates such as this for looking at different areas of research, but the briefing note says that this particular research
"is important in the study of male infertility."
Time constraints today mean that we will not be able to discuss male infertility, but it remains a major issue in society. I have been very lucky in my life to be able to have children and grandchildren without ever having to worry about whether I could be a father, but many of our constituents go through the torture of infertility. Some of them, unfortunately, find it hard to afford treatment in the private sector, and Ministers will know that over the years I have spoken about the deficiencies of NHS infertility provision. However, the most important thing is that scientists should continue their research into these matters, as that is how they can help citizens who have not been as lucky as I have been when it comes to having a family.
I agree with what the right hon. Gentleman is saying. Another example of the sort of research to which he has referred is the process by which ovarian tissue, for example, is engrafted on to an animal and then tested for the effects of chemotherapy. That is impossible—or at least very difficult—to do in vitro, without that sort of animal model. For good reasons, the Bill defines gametes as cells in the ovary or the testes at any stage in their development, including their very early stages. That is why banning the placement of human gametes in animals would prevent research, currently being done in this country, that involves research into the effect of chemotherapy on those cells' development. Clearly, that research would play into the issue of infertility.
I am grateful to the hon. Gentleman for that intervention. Obviously, with the professional knowledge that he gained before he came to this place, he has a deep understanding of the scientific complexities and the need for these procedures.
The briefing from the scientific community continues:
"Research of this nature is sufficiently regulated under existing human and animal legislation, and the creation of 'human admixed embryos' is already covered under licence provisions. Procedures directly involving animals are already licensed by the Home Office and therefore do not need to be covered by this Bill."
I move on briefly to amendment No. 47. Several hon. Members intervened on Mr. Burrowes, who admitted in one of his early utterances that the science is complex. Indeed it is. He then went on at great length just to give us an example of how complex it is, and I am grateful that he did. If I may say so, we have here a conflict with what the scientific community think about the effect of amendment No. 47. I will wait to hear what the Minister says. The Government believe that the intended effect of the amendment is covered by clause 4 as it stands. I will not enter into a dispute about that with Ministers, although other hon. Members have been prepared to do so this afternoon.
If, however, it turned out from the right hon. Gentleman's own standpoint that the argument being advanced by my hon. Friend Mr. Burrowes was correct, and that the Government's protection in this case was not enough, would he be minded to support amendment No. 47?
When I first stood up, I said that I was minded not to support it, because of the scientific voice that expressed itself in the briefing that was sent to us and to other legislators from those four eminent areas of science. I was half hoping that Mr. Gummer, who has held high office in the House and must have taken many Bills through Parliament, would tell us whether, as a Minister, he ever accepted an amendment from anybody on the basis that the content of the amendment was in the Bill anyway, and it would just strengthen that message. I am not too sure about that.
The question before us is such that I do believe that I would have accepted such an amendment on it, for this reason. If there is a sufficiency of concern about a matter as serious as this—which in my case has been increased by the speech of the right hon. Gentleman, who would not give an affirmative answer to my right hon. Friend Mr. Duncan Smith—then I would, as a Minister, wish to make it clear that the Government whom I represented were against the kind of cloning that we are talking about. Therefore I would of course have received and accepted such an amendment.
I do not know whether the right hon. Gentleman actually held any health portfolios, but that is a very brave thing for an ex-Minister to say from the Back Benches. I have never heard a Minister advocate that from the Treasury Bench in response to such a suggestion. I served on the Opposition Front Bench for many years, and did not get that type of acceptance for anything.
On that point, it is clear that the scientific community whose brief I quoted is happy with the situation. It is covered by regulation anyway.
On Second Reading—it seems such a long time ago—I said that the 1990 Act was not especially descriptive. There was no consensus outside or inside the House on many areas, so things were left out of that Act that people thought, rightly or wrongly, should have been in the legislation.
As I said on Second Reading, the 1990 Act has served this country and Parliament well, because it has allowed an open-minded approach and has supported the areas that have been difficult to debate on the Floor of the House. Support has been given by regulations and regulatory bodies such as the Human Fertilisation and Embryology Authority. I am confident in saying, both in the House and in my constituency, that we as legislators have a duty to bring about this way of improving medical science and research into such scientifically complex areas. However, we also have a duty to ensure that our regulations may cover any areas in which we are concerned that something could happen in the future so that if something does happen, regulations can take care of it.
I support amendment No. 41, to which Mr. Drew ably spoke, and which is the only amendment in the group that deals with a most significant ethical issue. Proposed new section 3ZA(5) of the 1990 Act constitutes a significant drafting error. When the Minister responds to the debate, I will be grateful if she addresses that error, which could undermine the very principle that the Government have always insisted is fundamental to the Bill: strict and comprehensive regulation.
Subsections (2) to (4) of proposed new section 3ZA say that there can be no alteration of the nuclear and/or mitochondrial DNA of a permitted egg, sperm or embryo. They say that eggs must have been
"produced by or extracted from...ovaries" and sperm
"produced by or extracted from...testes".
They say that an embryo may not have other cells added that are not the "embryo's own cells", and that an embryo must have been created by fertilisation. So far, so good; one would think that the provisions were pretty clearly written.
Proposed new section 3ZA(5), however, could overturn every one of those safeguards. It says that to
"prevent the transmission of...mitochondrial disease", regulations could make provision for "permitted" eggs and embryos that had had alterations to their nuclear and/or mitochondrial DNA, and need not have been created by fertilisation. Permitted eggs might not need to have been obtained from ovaries, nor sperm from testes, and permitted eggs and embryos might be allowed to be created using material from two women, and to have other cells added to them that were not the embryo's own cells.
This is not a narrow, technical drafting point. When one reads the two sets of provisions, an important hole opens up in the Bill. Proposed new section 3ZA(5) could, albeit in particular circumstances and subject to secondary legislation—I shall come to that in a moment—completely undermine every one of the stringent safeguards built into subsections (2) to (4) of the proposed new section, which are clear provisions that should reassure anyone reading the Bill.
This is important because clause 3(6) repeals the Human Reproductive Cloning Act 2001, which established the United Kingdom's complete ban on human reproductive cloning. If there is one thing on which all hon. Members agree, it is that we want the ban on human reproductive cloning to continue.
If we provide for regulations that would allow any method of preventing
"the transmission of...mitochondrial disease"— that is in proposed new section 3ZA(5), which I read out—we could create a loophole, through which a human reproductive cloning procedure could become permissible in law. Given how important this matter is, I am not sure whether that loophole should exist.
The regulations, which would have the stated aim of avoiding the transmission of mitochondrial disease, could allow the nucleus of any cell from a "parent" with diseased mitochondria to be placed in a donated egg. The resulting child would be a clone. In one instant, the United Kingdom would move from having a clear ban on human reproductive cloning in primary legislation—we have had such a ban since 2001—to having the option to permit a form, albeit only a form, of reproductive cloning. And that would happen through secondary legislation. In other words, the Government would not have to come back to the House with primary legislation.
As I understand it—of course, when the Minister sums up, she can reassure me on this point—the clear ban on human reproductive cloning in the 2001 Act is being replaced by an ambiguous situation in which the Secretary of State has power to introduce a form of reproductive cloning by regulation if he or she so desires. Given that we have waited 20 years for the Bill, and that we will almost certainly have to wait another 20 for the next, that is a dangerous situation.
In their initial review of the Human Fertilisation and Embryology Act 1990, the Government stated that they
"did not intend to reopen debate on those fundamental aspects of the law that are widely accepted in our society or which have been recently debated and conclusively resolved in Parliament. These include the...prohibition of human reproductive cloning".
"maintains this position while superseding the provisions of the Human Reproductive Cloning Act 2001."—[ Hansard, House of Lords, 2 June 2008; Vol. 702, c. WA11.]
That was the claim, but clearly—without the 2001 Act, which was clear, and under proposed new section 3ZA(5)—regulations could allow any method of avoiding the transmission of mitochondrial disease, including a method that uses somatic cell nuclear transfer. That is what worries me, and some people outside the House.
The Government reassure the House that they have no intention of changing their view, and I accept that. I make this concession: I accept that at the moment, the Government have no intention of passing regulations in a form that would open up the loophole and allow the human reproductive cloning ban to be circumvented. However, it would be useful for the Minister to restate that. Section 3ZA(5) grants the same regulation-making power to future Secretaries of State. The Government simply cannot speak for future Secretaries of State; that is why we have primary legislation. If ever the Government want to change their policy in this area, we want them to come back to the House—to the elected representatives—and we want a chance to say, "No, we don't want to leave this extraordinarily vital ethical issue in the hands of a future Secretary of State."
Why is the Secretary of State so sure that secondary legislation initiated under proposed new section 3ZA(5) will close the loophole? Have the regulations been drafted already? Are the Government that far ahead of the game? I suspect not. Perhaps a copy of the regulations could be placed in the Library so that we could read it and have our fears put to rest. I suspect that no copy is available, and that it will not be placed in the Library. I suspect that we will pass the Bill without ever having had a chance to read the regulations. Far better to make sure that any alteration to the human reproductive cloning ban can be made only after the closest scrutiny by the public, and by parliamentarians acting on their behalf, in primary legislation.
If the Government are serious about maintaining the ban on human reproductive cloning, as they have repeatedly claimed—I accept that—why should they not support an amendment that enshrines that prohibition in their flagship primary legislation? That would at least be a signal that they could give the many of us who are worried about the Bill. They could make the situation absolutely clear in the Bill, as it was in the 2001 Act, and ensure that the ban could not possibly be tampered with by secondary legislation. Why can we not have that? Perhaps the Government will take this opportunity to state publicly why such an amendment would be detrimental to the spirit and intentions of the Bill. I do not think that it would be. Amendment No. 41 is not a wrecking amendment. It is completely in line with everything that the Government have said. I would have thought that the Minister could support everything that I have said so far.
If the amendment is not to be regarded as detrimental, surely the Government are prepared to commend it for identifying and rectifying a serious drafting error that threatens to make a mockery of their oft-repeated assurances that the foundational intention of the Bill is the creation of a rigorous regulatory regime encompassing all existent and hypothetical reproductive technologies. We all know that creating such a regime will be very difficult, but there is one issue on which both sides of the argument want absolute assurance from the Minister: there should be no loophole in the Bill through which some form of reproductive cloning could in future emerge. We are entitled to have that assurance from the Government because this ethical area is so vital.
Amendment No. 41 removes only that which the Government have insisted repeatedly they do not want: a means of permitting a form of human cloning for reproduction. The amendment retains that which the clause is specifically intended to permit—mitochondrial donation techniques. Amendment No. 41 also rectifies a further blunder caused by the dangerously loose wording of proposed new section 3ZA(5), which I have read out to the House. In replying, the Minister may wish to explain this problem. By providing for regulations allowing any—I stress, any—method of preventing the transmission of a mitochondrial disease, 3ZA(5) also opens up the possibility of legally altering human nuclear DNA as a means of preventing future transmission of mitochondrial disease. That, of course, would be germ-line genetic engineering—that is, human genetic modification. People should be concerned about that.
Clearly, the only appropriate vehicle for dealing with an issue of such magnitude would be primary legislation; I hope that we can all agree on that. The idea that such a serious issue could be dealt with sufficiently by affirmative resolution is ridiculous. Even the Bill's supporters have acknowledged that a significant problem exists because of the wording of proposed new section 3ZA(5), and that, in overturning the ban on mitochondrial DNA alteration, subject to regulations, the proposed new section—unintentionally, I accept—overturns a ban on nuclear DNA alteration. They say that the issue should be dealt with at a later stage. Here we are, at a later stage; in fact, it is the last stage. So far, however, the Government have refused to address the obvious discrepancies in the wording of the proposed new section. The House must rectify the Government's failures by amending that glaring fault in the Bill; that is what amendment No. 41 would do.
I am going to finish my speech in a moment, but before I do I should apologise for having been somewhat technical. I have had to read out closely what is in the various clauses of the Bill. However, I want to end with my personal view, and why I feel passionately about this issue. At the heart of all the debates on the Bill and of the technical arguments about these amendments appears to lie a point of view that in this country we are treating human embryos as things. I believe that human embryos are emphatically not just blobs of cells; they have the entire genetic make-up of a human being. I believe not that they are potential human beings, but that they are human beings with potential. Of course, they are microscopic—a grain of sand—and that is perhaps why we can view them as a spare part. However, when I thought of them as a microscopic grain of sand, as it were—as something that was not in any way recognisably human—I was reminded of this passage from Dostoevsky, the greatest poet of human nature. In addressing the brothers Karamazov, the prior of the monastery says:
"Love all God's creation, the whole and every grain of sand in it. Love every leaf, every ray of God's light. Love the animals, love the plants, love everything. If you love everything, you will perceive the divine mystery in things. Once you perceive it, you will begin to comprehend it better every day. And you will come at last to love the whole world with an all-embracing love."
There is something very dangerous in what we will undoubtedly do today. We are making ourselves less than human, in a sense, by viewing one part of human creation as a thing, a spare part, which I believe is extraordinarily dangerous.
First, we have amendment No. 49, which is in the name of my hon. Friend the Member for Southport. It would add the words "via cytoplasm" to the provisions of clause 3, and it touches on the issue raised by Mr. Leigh. The hon. Gentleman is correct: there is no longer an absolute ban in primary legislation on some of the things that the Government clearly intend to ban, because it requires the secondary legislation to be written, as I am sure that it would be, in such a way as to allow only those forms of treatment of mitochondrial disease that are caused by cytoplasmic factors, and only in such a way that there is no breach of the provisions and policies enunciated by the Government, namely that there will be no human reproductive cloning, or germ-line nuclear genetic amendment.
I have already said in an intervention on my hon. Friend the Member for Southport that it would be better for the primary legislation to state what it intends in purest terms. It is unfortunate that the Government have not found a way to do that. I believe that the Government said in Committee that they had tried to draft the legislation so that such practice would be restricted in such a way. I do not see why a phrase such as "via cytoplasm" or something similar would not be acceptable, at least to narrow the issue. I do not accept for a moment that the current wording opens the door to those things feared by my hon. Friend, but given the battle we have had to get to this stage, in which we have had to overcome people whipping up fear about what might happen—we have heard some rather dismal examples today—it would be better if the legislation were clear. It is unfortunate that it is not, and for that reason, I would support amendment No. 49.
The second issue relates to new clause 24, in the name of my hon. Friend the Member for Southport and others, which would ban the placing of human gametes into an animal. This was dealt with in Committee, thanks to my hon. Friend, and the Minister wrote a letter to him explaining why it is not considered necessary or appropriate to include such a provision. I agree with what the Minister said in that letter—I will not go into it because she may be planning to do that. In 1990, it was not considered necessary to include measures in legislation to ban the practice of inserting sperm into animals. That procedure is not part of science, and it is not appropriate for it to be dealt with in the Bill.
Moreover, valuable science is being done, as the Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust and the Association of Medical Research Charities have said, involving the use of early germ-line cells in animal models to explore how they develop in a in-vivo system—in a living system. We cannot do that in humans for all sorts of ethical reasons, but we permit the practice, under tight regulation, in animals. We do so to explore what causes infertility and, for example, what the impact of certain types of chemotherapy might be on infertility. The Bill's drafting means, for good reasons, that "gametes" includes germ line cells at any stage of their development, including immature germ-line cells found in the ovary and the testes, which are subject to such experiments. One could list—but I will not do so—papers that have been published in peer review journals using such work, and I have no doubt that such work is being done in this country. My hon. Friend's new clause would prevent that work, and he accepted in Committee, on the record, that that would be an unintended consequences of what I describe as an unnecessary step. I hope that the House is reassured that the amendment is unnecessary, but if that does not make the argument, the speech that we heard from Mrs. Dorries put the fact that it would be inappropriate beyond any doubt.
The third point is about the interesting issue that the hon. Member for Enfield, Southgate raises in amendment No. 47. We must accept—I hope that the Government will accept this—that it has not been possible to produce an exhaustive list of admixed embryo types. I do not believe that it is possible to do so; indeed, the Academy of Medical Sciences accepts in its paper that it is probably not possible. The Government have made the best attempt that they can and it is only right that we should accept that the list is not guaranteed to be exhaustive.
The hon. Gentleman's amendment is a good example of some of the debates that we could have, but that is why we have the HFEA. It is there to ensure that scientists understand that there is a need to fall within the regulations where at all possible. I cannot imagine any scientist in this country seeking to identify types that would not come before the HFEA, so that they could argue in a court of law, "Well, it's not human enough at the point at which we were seeking to implant it to be covered by the HFEA." That is not how science works.
To pursue that line of argument, does the hon. Gentleman not agree that exactly the same kind of argument that he is presenting was presented to me when I suggested that we would move into research into animal-human hybrids? That was 25 years ago, and now we are where we are. Does he recognise that because people have an enormous amount of knowledge, it does not follow that they will not later do things that are unacceptable to society as a whole?
It is certainly possible, but it is also possible that new primary legislation could be brought before the House if that was felt necessary, as happened over human reproductive cloning. In that case it was felt necessary to reassure the public through primary legislation that something that was not envisaged and not possible would also be illegal. So, we are not in an "It's now or nothing" situation.
Let me also deal with the issue of definitions. A huge amount of effort has been put in, especially by Members of the House of Lords and the Government Bill team, to try to find an appropriate definition. A tribute must be paid to Lord Mackay in particular, who has struggled, even though he was not necessarily a huge fan of the legislation to start with, to find a way to deal with the issue. The Government have engaged on the subject and done the best that they feel they can.
It would not be appropriate for the Government to argue—indeed, I hope that the Minister does not argue—that the list is definitive. However, it is as good as one can get while preserving the ability of scientists to do the research in a way that will be regulated. There is no scientist in the country who does not understand that such research will have to apply to the HFEA under one of the categories set out in the Bill.
There are two potential gaps, one of which the hon. Member for Enfield, Southgate mentioned. Proposed new section 4A(6)(e) talks about an embryo that does not fall within paragraphs (a) to (d) which
"contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal...but in which the animal DNA is not predominant."
The key question, however, is at what point we are talking about the animal DNA not being pre-dominant, because that could vary. The hon. Gentleman rightly said that the scientists pointed that out in evidence to the Committee. That is not a secret, which is why it would be appropriate for the Government not to recognise that the list is not perfect. Indeed, it cannot be perfect, but I argue that it is good enough.
That is one problem. The second problem is that even if the hon. Gentleman is right that the tetraploidal complementation process that he mentioned falls outwith the provisions, his amendment does not solve the problem. It is quite possible to have complementation that does not involve tetraploid cells. One could inject into a more developed, normal diploid embryo a less developed human embryo, which would then predominate, causing the original embryo to become the extra-embryonic endoderm and the trophectoderm—the stuff that forms the placenta—as has been done in mice. His amendment does not refer to such an entity, however. So the hon. Gentleman is merely demonstrating that the clause is never going to be perfect, but it is clear that anyone attempting to implant an entity which arguably does not fall within the definition in clause 4 will have to apply for a licence to the animal procedures committee to implant it.
When I spoke to the hon. Gentleman outside the Chamber, he conceded, I hope it is fair to say, in answer to my question, that if one created an entity with human cells in an animal envelope—I do not believe that that is likely outside HFEA regulation in any event, for reasons that the Minister will explain—a licence would still be needed to implant it into an animal. One cannot just grab a pig from a farm, drag it into a lab and implant something into it without a licence.
As somebody who was responsible for that animal legislation, may I suggest to the hon. Gentleman that animal legislation is designed to protect animals and their welfare. One of our concerns must be, therefore, that it is not reasonable to use that legislation to deal with the problems under discussion. He may be right that that is not necessary, but it does not seem sensible to say that animal legislation of the kind that we have properly covers these circumstances. Surely if we find some gaps in the law, we might deal with those and make the law that much better. There may still be other gaps, but why is he not willing to accept that the gaps that have been identified should be covered now, rather than left to the organisation outside or to secondary legislation?
I am in almost 100 per cent. agreement with the right hon. Gentleman. It is possible that there are gaps in the definition. I hope the Minister will accept that that is the case and that it is necessary for ongoing work to be done. The academy has indicated a willingness to continue to do that work so that if, down the line, something that is not covered by these definitions is felt to be useful and therefore needs to be covered by the HFEA legislation in order not to fall completely outside or under animal procedures, amendments can be made to the legislation. That is a mature, sensible approach.
If amendment No. 47 closed all potential gaps, I would recommend supporting it. I have already demonstrated that it does not even close its own potential gap because it does not cover diploid complementation, as just one example. The Minister said in an intervention that the specific example that the hon. Member for Enfield, Southgate cited was covered by the Bill, presumably because at the relevant point the entity would not be predominantly animal—the embryo would be human and the animal cells would form the non-embryonic part of the entity. It would therefore fall under subsection (6)(e).
I am grateful to the hon. Gentleman for allowing an intervention. An application to the HFEA for a licence would have to be made at the outset if it was believed that the human DNA would become predominant, so it would be covered. Whether that was predominant at the start or whether its development would lead to its becoming predominant, a licence from the HFEA would be needed before the process started.
I leave that to stand. I would also say that if a scientist wanted to avoid a criminal charge, it would be wise to apply for a licence. Even if the scientist felt that the circumstance would not be covered by the definition, if it turned out to be covered, he would be liable under the Human Fertilisation and Embryology Act, as amended, which contains stiff penalties.
Although I have some sympathy with the broad point made by the hon. Member for Enfield, Southgate, his amendment No. 47 is not comprehensive, it does not deal with the gap that it is intended to cover. I will not support amendment No. 47, but I hope the Minister will agree that ongoing work is needed in order to ensure that if gaps emerge, they can be covered. That is what the scientists want and, as I understand it, that is what the Department of Health seeks as well.