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The amendment tabled by the noble Lord, Lord Alton of Liverpool, would ensure that a human admixed embryo was created or used if the research could not be achieved by any other means. At best, the amendment is unnecessary, because of provisions already in the Bill that ensure that research projects can be licensed only if the creation of the human admixed embryo is necessary. However, at worst, the amendment could force researchers down the route of using human embryos in preference to human admixed embryos. That would also mean that scarce human eggs would be used over animal eggs for some projects, and would be a significant obstacle to research.
A major issue in embryonic stem cell research is the shortage of human eggs to be used in the creation of embryos. Scientists and the Government have listened carefully to arguments from the scientific community about the need to create admixed embryos for research. As I said earlier, the matter has been closely scrutinised by parliamentary Select Committees, and voted on in the other place and in your Lordships House. An amendment tabled by the noble Lord, Lord Alton of Liverpool, concerning human admixed embryos was debated on the Floor of this House on Report and defeated by 268 votes to 96.
At present, the Human Fertilisation and Embryology Authority must assess whether the use of embryos or human-admixed embryos is necessary to achieve the purposes of research projects. The research must also be necessary or desirable for one of the statutory processes set out in Schedule 2. Amendment No. 2A would mean not only that the use of human-admixed embryos for the purposes of the research should be necessary, but that the research was unable to be achieved by any other method. This would be contrary to the purpose of using human admixed embryos, which is as a means of researching serious diseases while overcoming the problem of the scarcity of human eggs.
The noble Lord, Lord Patten, asked whether we are aware of such research leading to a cure anywhere in the world. We are in early days. As the noble Baroness, Lady Hollis, pointed out, if we do not do the research, we will not be able to find that out. The noble Lord, Lord Patel, eloquently referenced a number of promising early research results. The Government want to see research moving for all sources of stem cells. The country leads research in this field.
The noble Lord, Lord Alton, referred to a scientist who was leaving this country. For every scientist leaving, many have been attracted here to do research in this field, one of whom is Stephen Minger, who has come to the UK because of the legislative framework in place in the UK.
The noble Lord, Lord Alton, asked whether the HFEA has ever refused a licence. It has never done so, because the HFEA executive works with the licence applicant to ensure that the application is satisfactory before it can reach the licensing committee. At the same time, the HFEA requires the applications to be peer-reviewed to ensure that they are necessary and desirable, and meet the criteria.
Lord Alton of Liverpool: My Lords, I am grateful to the noble Lord, Lord Darzi of Denham, for the way in which he has responded to the debate. Indeed, I am grateful to everyone who has participated in it, especially to my noble friend Lord Tombs, who I am pleased to see back in his customary place. I am grateful also to the noble Lords, Lord Patten and Lord Bates, for their support for my amendment.
The House will be relieved to know that I will not detain noble Lords for long. I will briefly deal with some of the arguments raised. I have not, in this amendment, invited the House to return to the debate mentioned by the noble Lord, Lord Darzi, which we had nearly a year ago. This amendment would not prohibit embryonic stem cell research. It would not prohibit the creation of animal-human hybrids. It invites the House to require the Human Fertilisation and Embryology Authority to seek from every licence applicant, and from the licensing authority, an undertaking that, before using admixed embryos, alternatives had been explored.
I come to the point properly raised in our previous debates by the noble Baroness, Lady Hollis. I agree that this is not about trying to predict outcomes, but about methodology. It is not unreasonable in these changed circumstancesand they have changed even as we have considered this Bill, because we now have induced pluripotent stem cells, which are embryonic in nature, created from our own skin and do not require the creation of human embryosto say that this is a satisfactory alternative with which all of us can live. We should therefore require the authority simply to consider that question; not the creation and use, as the noble Lord, Lord Turnberg, said, of more eggs; not the creation of human embryos, as the noble Lord, Lord Darzi, said; but the use of adult stem cells, and, through them, the creation of induced pluripotent stem cells as a legitimate alternative to the manufacture of human embryos. I use manufacture not in a pejorative or rhetorical way, but I say to the noble Baroness, Lady Tonge, that 2 million human embryos have been destroyed or experimented on, either through IVF or experimentationthese figures were given earlier in the debatesince we authorised the creation of human embryos in 1990. If any Member of the House could say that this has led to cures, it might lend legitimacy to the argument. However, as the noble Lord, Lord Patten, and others have pointed out, it has not. It is not unreasonable, in 2008, to say that if this is still just about hope, it is not something on which we should place too much reliance.
I will be happy to give these papers that have been passed to me to the noble Lord, Lord Winston. I can give him a copy of a briefing produced by Professor David Prentice, in which he lists, as the noble Lord, Lord Tombs, has done, more than 70 different conditions that have been successfully treated using adult stem cells. It is true that some treatments have been by bone marrow, but there have been other examples, too. I chaired a briefing in the Moses Room of your Lordships House in which Professor Carlos Lima came from
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The noble Lord, Lord May, agreed with methere is common ground herethat none of us should overhype the potential of these cells, whether they are from embryos or adult stem cells, because there are many people suffering from debilitating conditions for whom this must seem like a tantalising solution, when it is still probably a long way off. I will be happy to share that information.
The noble Lord, Lord Winston, and others made a point about the comparative amounts of money allocated by the Medical Research Council to these two areas of research. I have the figures here and am happy to share them. In 2005-06, £17.4 million was made available by the Medical Research Council, of which 43.6 per cent was spent on adult stem cells and 56.4 per centsignificantly moreon embryonic stem cells. I say to my noble friend Lord Patel that, instead of the trend being in that direction, the reverse is true. In 2006, the figure was 46 per cent spent on adult stem cells and 54 per cent on embryonic stem cells. There is every indication that the work that Professor Colin McGuckin has undertaken at Newcastle has, as he said, been discriminated against. I think that we should take that seriously, but those are not the arguments that your Lordships are being asked to vote on this evening.
Therefore, it would be down to the person applying for the licence and for those sitting on the licensing authority to satisfy themselves of those facts before they proceeded to issue such a licence. I think that this is a moderate amendment and I hope that noble Lords will be prepared to support it. I wish to seek the opinion of the House.
(e) any embryo not falling within paragraphs (a) to (d) which contains both nuclear or mitochondrial DNA of a human and nuclear or mitochondrial DNA of an animal (animal DNA) but in which the animal DNA is not predominant.
Lord Darzi of Denham My Lords, I beg to move that the House do agree with the Commons in their Amendment No. 3. I shall also speak to their Amendments Nos. 5 and 30. These amendments follow discussions in this House and relate to human admixed embryos.
The Bill sets out a clear definition of human admixed embryos and ensures that all such embryos are regulated and may not be created without a licence. Government Amendment No. 3 amends the definition of human admixed embryos. The Bill uses the term human admixed embryo as an umbrella term for all four embryo types containing human and animal genetic material. These range from those that are, in simple terms, 99 per cent genetically human through to those that are 50 per cent genetically human. The Bill also contains the power to amend these categories of human admixed embryos should new scientific advances be made.
However, by not providing a catch-all definition of human admixed embryo, the Bill raised concerns as it passed through this House. In particular, the noble and learned Lord, Lord Mackay of Clashfern, tabled
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thereby giving a clearer idea of the range of entities caught by the Bill. This new category will replace the existing regulation-making power to create new categories of human admixed embryos. However, as there is an additional regulation-making power introduced by Amendment No. 2 to amend the existing categories in the light of scientific advances, this will not impede future flexibility. Amendment No. 5 would make consequential amendments to ensure that the power to amend the categories of human admixed embryos applies to the new catch-all provision. Amendment No. 30 is a consequential amendment to the removal of the regulation-making power.
(f) such other embryo not falling within paragraphs (a) to (e) which contains both human and animal nuclear or mitochondrial DNA as may be specified in regulations.
The noble Earl said: My Lords, I begin by doing something that the Minister may not necessarily expect of meexpressing my appreciation for government Amendment No. 3. At earlier stages of the Bill, my noble and learned friend Lord Mackay, with his characteristic succinctness, expressed considerable misgivings about the wording in Clause 4(5)(e) which was designed as a catch-all provision, but which seemed to him and to many of us unsatisfactorily vague and inappropriate in terms of the language that it employed. Government Amendment No. 3 is a distinct improvement on the original wording and I thank the Minister for having considered the matter so constructively.
My concern is that the government amendment before us, although it is undoubtedly a step forward, may not be quite good enough. Noble Lords may remember that in Committee I pointed out a lack of legal clarity in relation to the interface between this Bill and the Animal (Scientific Procedures) Act 1986. There appeared to be an unsatisfactory grey area in terms of whether human/animal admixed embryos were covered by one piece of legislation or the other. The noble Lord, Lord Darzi, has just put the issue very well, as he did at Third Reading, when he said
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The wording in Amendment No. 3 attempts to encapsulate that idea. However, as my noble friend Lord Jenkin of Roding pointed out in Committee, science is not always as simple as we might sometimes like it to be. The difficulty here relates to the way in which hybrid embryos can develop. My noble friend quoted part of Professor Robin Lovell-Badges evidence to the Joint Committee. The professor said:
We need, therefore, to deal satisfactorily with those cases where the human DNA might only comprise a minority proportion of the total DNA at the beginning of the life of the embryo but would end up predominating.
I am not clear that the wording of government Amendment No. 3 would cover an embryo of this type. Such an embryo would evade regulation under the Bill, because it would not have predominantly human DNA within the first 14 days and could, therefore, in theory and perfectly legally under the 1986 Act be implanted into an animal, and perhaps be taken to mid-gestation without even requiring a licence for the research project. The additional words that I propose at the end of new paragraph (e) would bring under the ambit of this Bill all embryos deliberately created whereby it could be reasonably predicted that the animal DNA would not ultimately predominate. However, if such an embryo were implanted and, under the 1986 Act, allowed to develop in an animal, and be found subsequently to be predominantly human, all future such embryos would come under the ambit of the HFEA, because the ultimate outcome would be known.
My second concern is slightly different. We could imagine a situation, as science moves on, whereby an animal embryo is created with a predominantly or entirely human brain. The DNA of the entire embryo could still be predominantly animal. However, Parliament might wish in the future not to permit the creation of a human-animal embryo of this kind. Rather than leave this and other unforeseeable scenarios to the mercies of the Home Office, it would be preferable to leave the opportunity open to Parliament to take a decision in specific cases that are particularly ethically sensitive.
The role of the Home Office would not be interrupted. However, in exceptional cases, should there be objections among the general public or in Parliament to a particularly sensitive type of chimeric creature, such as a non-human primate or large animal with, for example, a largely human brain, the second part of my amendment would provide a regulation-making power to deal with that situation. I am sorry that in the process of improving this part of the Bill the Government decided to jettison the regulation-making power.
Lord Mackay of Clashfern: My Lords, I should, first, thank the Minister and his colleagues for the further consideration that has been given to this matter since the Bill left this House for a somewhat prolonged sojourn in another place. Here it is back with us with an amendment in almost the same terms as the amendment that I originally proposed.
When the draft Bill was before the committee examining it, it contained a catch-all clause after listing the four examples that remain in the Bill. Unfortunately, none of the experts that gave evidence to our committee could understand the clause. If they could not understand it, we thought that on the whole it was not adequate for the purpose of defining the entity that we had in mind.
When the Bill ultimately came to your Lordships House, that portion had been deleted altogether, and in its place had been put a regulation-making power of somewhat ambiguous import. In other words, the Government had given up the idea that they could define in a catch-all way what they meant by this type of embryo. I felt, as did other noble Lords, that that was not satisfactory and we should do what we could to agree to a satisfactory catch-all definition that would not interfere with the four examples in the Bill, but demonstrate in essence their characteristics, as an explanation of the concept of an admixed human embryo.
I should perhaps have mentioned that originally a different phrase was used. The phrase admixed human embryo was adopted during the passage of the Bill through this House. It is not a self-evident expression. An ordinary person will have some difficulty understanding the phrase. I believethis may be the general view in the Housethat it would be useful to produce what, in effect, is an explanation of the phrase at the same time as a catchall.
There are a number of ways of approaching the matter. One is to say that everything that is not caught by the Home Office would be caught here, but unfortunately the approach of the Home Office in the Animals (Scientific Procedures) Act 1986 is quite different: it concerned pain to animals. If human material is involved, there does not seem to be any particular criterion about the importance that that extra fact confers on the embryo. Therefore, here we have successfully defined the human end of the spectrum of mixture.
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