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This argument may seem to have no relevance to the Bill. The hon. Member for Oxford, West and Abingdon (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.
Dr. Evan Harris: 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?
Mr. Burrowes: 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.
Mr. Robert Flello (Stoke-on-Trent, South) (Lab): 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?
Mr. Burrowes: 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.
The Minister of State, Department of Health (Dawn Primarolo): 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.
Mr. Burrowes: 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.
Mr. Gummer: 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.
Mr. Burrowes:
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 31 January 2007, of the Select Committee on Science and Technology, of which I was not a member, although I note that others present were, it was stated that a number of scientists had informed the Committee that at some point researchers might wish to go beyond the teratoma test and generate chimeras to demonstrate totipotency and pluripotency—Members are nodding, which suggests that they remember that comment—using human embryonic stem cells, which would clearly involve breaching the 14-day and no-implantation rules, to which we all hold. It was pointed out that that would apply to adult as well as embryonic stem cells.
The Committee also heard from Professor Blakemore, who gave evidence on 5 February 2007. In answer to questions 234, 239 and 265, he said that some scientists would eventually wish to test the multipotency of human adult stem cells and also induced pluripotent stem cells—which, as many Members know, are derived from ordinary adult cells, and which many of us believe hold great prospects for the future—by inserting them into the blastocyst of an animal embryo, implanting them and allowing them to develop. Professor Blakemore suggested that those chimeras could be allowed to develop
“to the point of organogenesis”,
although not to term. At a public hearing of the Joint Committee on the Bill on 20 June 2007, Dr. Stephen Minger said in answer to question 646 that scientists would soon want to
“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.
Dr. Evan Harris:
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?
3.30 pm
Mr. Burrowes: 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.
Miss Ann Widdecombe (Maidstone and The Weald) (Con): 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.
Mr. Burrowes: 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.
“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.”
“In addition to the great therapeutic promise demonstrated by this technology, the same technology opens a whole new can of worms”.
Ms Sally Keeble (Northampton, North) (Lab): 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.
Mr. Burrowes: 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.
Mr. Gummer: If the hon. Member for Northampton, North (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.
Mr. Burrowes: 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.
Mr. Peter Bone (Wellingborough) (Con): 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.
Mr. Burrowes: I am grateful to my hon. Friend. That is the point—we need to be clear in primary legislation.
Ms Keeble: Will the hon. Gentleman give way?
Mr. Burrowes: 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”.—[ Official Report, 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.
Mrs. Nadine Dorries (Mid-Bedfordshire) (Con): 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.
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