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If your Lordships prove sympathetic to this idea, it may well be that we should come forward on Report with an alternative means of providing for changes in the interpretation of parts of the Bill. I do not think
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Lord Winston: I rise briefly to support the amendment tabled by the noble Lord, Lord Patel. I declare an interest as an employee of Imperial College London, working in the Institute of Developmental and Reproductive Biology and as a director of a spin-out company which is involved in the modification of gamete cells.
I draw your Lordships’ attention to the prevalence of the kind of infertility that the noble Lord, Lord Patel, is addressing. It is now extremely common to see young women who cannot produce egg cells for one reason or another. Indeed, I think I have seen it written somewhere that it is now the fifth most common cause of anovulatory infertility—which is rising in a population that is tending to gain skills, get better education and leave child-bearing a little later. By the age of 40 a very large number of women have run out of eggs in their ovary and cannot conceive naturally, although they would be in a perfect position to have children were an egg to be available. As we know, the donation of eggs, which is dealt with elsewhere in the Bill, is a very fraught subject and not acceptable to all infertile couples. People would quite reasonably prefer to have their own genetic material, as I mentioned at Second Reading.
In the case of the male, testicular failure—the failure of germ cells to mature to produce sperm—is extremely common. It can occur as a result of many factors, some of which are unknown. A few factors are genetic, and some are due to injury. As we get better at treating diseases such as Hodgkin’s disease and cancer, we are also increasingly finding men with maturation arrest; that is, when the testicle is no longer producing sperm. These issues are extremely common and cause great distress to patients. They are important clinical issues. At present the only alternative available to these people is a donated gamete, a solution which all noble Lords agree is not ideal. Although we accept it within the legislation, it is, broadly speaking, much better if people can have their own genetic child.
As the noble Lord, Lord Patel, said, there is growing evidence of a research ability to produce gametes that are likely to be entirely viable in mice and other mammals, and it is very likely that this technology could be applied also to humans. Indeed, there have been suggestions that we can now develop viable animal embryos from gametes that have been matured from germ cells in viva. It would seem extremely cruel, in a Bill designed to help infertile couples, if that technology were prevented and that research was not allowed to continue in humans in Britain. The noble Lord, Lord Patel, is right to suggest that there are many issues in the clinical use of such matured gametes. We need to do a huge amount of investigation to make certain that the chromosomes, the genes, the development and the cell biology of these cells are normal before such an embryo is put back into the uterus. There are very few countries where this kind of research is possible,
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There is another issue. There are situations where we use primary germ cells and other cells without the intention of doing in vitro fertilisation or any infertility treatment. In my own laboratory we are trying to modify the male stem cells of pigs. We are doing it so that we will eventually, we hope, be able to transplant pig organs into the human safely without the pigs’ cell-surface proteins being recognised by the human system. As Members of the Committee will appreciate, a large number of people need heart transplants or other organ transplantation. This technology, which is the focus of the spin-out company to which I referred, is one example of where we could prevent such recognition.
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If we can develop this technology in the pig, important issues surrounding use of the same kind of technology in humans will arise—not to modify humans but to understand the science of germ-cell development, so that in future we might be able, for example, to treat male infertility much better by encouraging primary germ cells to go through better maturation to arrive at gametes. The problem with the Government’s proposed legislation is that research into human tissue would be difficult and would need a licence. I do not think that a licence should be required because there is no intention to produce a pregnancy, simply an intention to understand the cell biology. Any use of these gametes would thereafter of course be subject to law—as they should be—under the Government’s proposals.
There is a risk of unwitting restriction which could prevent and inhibit research that is quite properly required and is not threatening. I do not believe that any member of the public, even those with fairly strong religious convictions, would see this as a problem. The issue is not much more than one affecting the use of human tissue. I therefore hope that the Government will look favourably on the amendments tabled by the noble Lord, Lord Patel.
Lord Walton of Detchant: My comments on the amendment will be brief. The future makes it possible to create eggs or sperm from stem cells. These are known as in vitro-derived or artificial gametes. I prefer to use the term “gametes”. Those cells, artificial sperm or artificial eggs derived from stem cells may make it possible for individuals not able to produce mature eggs or sperm to have a child. That is a prospect for the future which should be supported. For that reason I strongly support the amendment.
Lord Alton of Liverpool: It would be surprising if Members of the Committee were not dazzled by the scientific acumen of noble Lords such as the noble Lord, Lord Winston, and my noble friends Lord Walton and Lord Patel. The noble Lord, Lord Elton, put the matter well; I have no difficulties with some of what my noble friend Lord Patel said earlier, and I
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We are being asked to do different things. The amendment of my noble friend Lord Walton asks us to remove all regulation and to allow what he would like to do to proceed in a wholly unregulated way. On the other hand, my noble friend Lord Patel suggests a form of regulation. I suggest in my Amendment No. 2A that we should reserve to Parliament the right to decide on these complex and sometimes controversial issues.
The amendments in the group deal not only with the questions already alluded to but with reproductive cloning, mitochondrial DNA, and immature human and animal gametes, expanding their use into interspecies embryos. That is a phenomenally wide group of issues to consider in one group of amendments. It is also a phenomenally complex group of issues for any lay person to deal with.
We are having a rather back-to-front debate very late in our proceedings. Probably tomorrow or perhaps next week, we come to Amendments Nos. 66 and 67, tabled by the noble Lord, Lord Brennan, which urge on us the creation of a national bioethics committee that is outside Parliament and capable of giving informed opinion to Members of both Houses before decisions such as this are taken. In many ways, I wish we could have had that debate at the head of our consideration of the Bill in Committee.
My noble friend Lord Walton seeks in Amendment No. 4 to remove the need for regulation. The practical effect would be to allow licence holders to modify an egg or embryo for mitochondrial reasons without further regulatory requirement. If that were to permit reproductive cloning to prevent the transmission of mitochondrial disease without having to go through the affirmative procedure, we would have entered a brave new world without so much as a parliamentary grunt. Many of us who admire scientists and science nevertheless believe that Parliament has a right and a duty to insist that good science and good ethics march hand in hand. I doubt that I am alone in wearying of the political mantra, “We will follow the science”. Parliament’s job is surely to inform itself; arrive at wise and just judgments; and to lead, not to follow. We should be deeply suspicious of any attempt to remove regulation and simply place that power in the hands of the Secretary of State, however esteemed they may be.
To sleep-walk into provisions that might have irreversible effects, and to do so in the absence of a legislative, ethical and regulatory framework, would be a dereliction of our duty. So, too, would the failure to close a route to reproductive cloning. As we are seduced and subverted by the dazzle of these various proposals, I am reminded of CS Lewis’s prophetic polemic, The Abolition of Man, published in 1943, and of his futuristic work, That Hideous Strength, published in 1945. He foresaw what he described as
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“I went on with this research just the way it led me ... I have never troubled about the ethics of the matter”.
He was not subject to regulation.
Instructively, Lord Feverstone, the creator of the National Institute for Coordinated Experiments in That Hideous Strength and a fictional Member of your Lordships’ House, says that his aim is:
“Quite simple and obvious things, at first—sterilization of the unfit, liquidation of backward races ... selective breeding”.
All this was futuristic, speculative writing, but it is fast becoming reality because of the extremely permissive flexibility of provisions in Bills such as this. It is clear that the desire of the scientific lobby, to which my noble friend Lord Patel referred earlier, and evidenced in arguments for deregulation, is that the Bill embrace all future technological developments without wasting time coming back to Parliament for approval. Even when specific restrictions are stated in the Bill, they are usually accompanied by provisions to permit further change, with a minimum of scrutiny or accountability. I hope that when the Minister replies, he will reiterate that the provision of the conscience clause in the 1990 Act will continue to apply, thus protecting those scientists who do not wish to be corralled into work that in other European jurisdictions would carry a prison sentence.
It may be very unfashionable to say this, but there are tens of thousands of desperately unhappy children who are orphans and who would desperately love to be in a loving home. Adoption has gone out of favour, and I noticed in a reply to a Parliamentary Question which I tabled recently that, in the whole of last year, only 165 babies were available in this country for adoption. Of course couples who wish to prevent the transmission of disease to their children should, as the noble Lord, Lord Winston, has said, be given every support possible if they want to adopt an orphaned child, instead of going to extraordinary lengths and using cell nuclear replacement procedures to create children who may turn out to have some other unexpected disorder resulting from the very artificial procedure used to create the embryo.
Adoption would also be better than creating three genetic parents. At Second Reading my noble friend Lord Walton said that to be able to prevent the transmission of mitochondrial disease:
“One can take a donor ovum from which you have removed the nucleus and put the nucleus into that donor ovum, which has normal mitochondria in the cytoplasm, and then allow that to be fertilised by the partner’s sperm, thus allowing these women to have normal children”.—[Official Report, 19/11/07; col. 709.]
This means that you can carry out a technique to insert the nucleus of an egg from the woman with mitochondrial disease into the egg of an egg donor
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If we simply insert an adult somatic cell from the woman with unhealthy mitochondria into the enucleated egg instead of inserting the nucleus from her egg, would that not be reproductive cloning after activation instead of IVF? What precisely in the Bill would prevent this, as permitted eggs and embryos are allowed to have alterations in their mitochondrial and nuclear genes if it is for the treatment of mitochondrial disease, and do not have to have been created by fertilisation as new Section 3ZA(5) can override the prohibitions in new Section 3ZA(2) and (4) which would otherwise have prohibited implanting embryos created by altering DNA and embryos that had not been created by fertilisation?
Paragraph 2(3) of Schedule 2 on page 54 also specifies that licences can be given where the nuclear and mitochondrial DNA of embryos to be implanted has been altered for the purpose of mitochondrial disease. These eggs and embryos are also specifically permitted to have material from two women according to new Section 35A on page 30. All this would seem again to permit reproductive cloning as one of several possible ways to prevent transmission of mitochondrial disease.
With the Bill as it stands in new Section 3ZA(5), both this and the procedure suggested by the noble Lord, Lord Walton, would be subject only to affirmative resolution. However, if the noble Lord’s Amendment No. 4 is approved, then neither procedure would be required to go through Parliament for affirmation. This means that reproductive cloning would be legal as one method to prevent transmission of mitochondrial disease without ever having come back to Parliament. We must not allow this law of unintended consequences to happen.
Baroness O'Cathain: I agree with the noble Lord, Lord Alton, in showing concern about the groupings in the Bill. I feel the groupings are far too wide. For example, in the first grouping, it may appear as though the amendments have a great deal in common but, in reality, there are basic differences which lead to various different outcomes. Unless it is properly understood, we are in danger of passing the Bill to the House of Commons without proper scrutiny of the possible—or, indeed, probable—unintended consequences to which the noble Lord, Lord Alton, has referred. After all, the danger of any new legislation is unintended consequences, and we have had a long history of looking at this over the years.
As has already been said, the science involved is dazzling, and for a lay person to get involved in this might seem like utter stupidity. On the other hand, there are underlying issues in the Bill to which I referred at Second Reading. The Bill concerns an enormous number of people who have no idea of the basic science. When we hear people stating that the great public out there have no problem with the issues, of course they have no problem because they do not understand the issues. When you are asked a question
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We are now determined that we are going to be so leading edge in this area, where there is no guarantee of therapeutic success. In case noble Lords are not aware of the issues that were raised at Second Reading—I have not read them—I repeat that over a period of some 17 years there have been attempts to undertake this type of research and, during that period, there have been no positive results, whereas we have more than 70 proven therapeutic treatments directly attributed to the ethical adult stem cell research.
I shall address Amendment No. 1, in the name of the noble Lord, Lord Patel, in particular. Will the Minister—or indeed the noble Lord himself, if he wishes to come back—give me some satisfaction on some of the issues the amendment raises? Does it necessarily mean that no licence under Clause 4(1)(a) will any longer be needed to store or use immature eggs? Will no consent be required any more under Schedule 3 for the use of immature eggs? Immature eggs derived from adult ovarian tissue could be used without consent for cloning experimentation and so on. Immature foetal eggs derived from abortion could be stored and used without any need for a licence, while no restrictions would exist any longer on the use of immature eggs derived from born persons for treatment purposes. A licence-free environment in which immature eggs could be used for experimentation without any control is, I suggest, not the right way to go.
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Lord Walton of Detchant: As it appears that we are now discussing this whole group of amendments, it is appropriate that I should comment on my Amendment No. 4, which was referred to in detail by my noble friend Lord Alton. The purpose of the amendment is quite simple: to remove the need for research on the prevention of mitochondrial disease to be subject to regulations made by both Houses of Parliament, simply leaving the responsibility for licensing such research with the Human Fertilisation and Embryology Authority. I shall come to that in just a moment.
I remind your Lordships that mitochondrial disorders are a cruel class of inherited disease— life-threatening conditions coupled with great unpredictability about how future children will be affected. They can include fatal liver failure, stroke-like episodes, mental retardation with intractable epilepsy, muscle weakness, diabetes and deafness. All cells in the body contain between 1,000 and 10,000 mitochondria in the cytoplasm that surrounds the nucleus. They are tiny energy-producing structures, or organelles, vital to cell function. If they malfunction, organs will eventually fail.
Because there are no mitochondria in sperm but only in the ovum cytoplasm, when mutations occur in the mitochondrial genes, causing these devastating diseases, those mutations are transmitted by the female who has those genes to all her children of either sex. They are therefore inherited only from the mother. Mitochondria carry only a very small number
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The Human Fertilisation and Embryology Act 1990 permits laboratory research into human cytoplasmic transplantation. Such a research licence was granted by the Human Fertilisation and Embryology Authority to a team at Newcastle University in 2005, and the laboratory studies are ongoing. The team is working on animal studies in which it is carrying out the procedure, to which I referred in detail at Second Reading, of taking an ovum, removing the nucleus from it and transplanting the nucleus from another ovum into it so that that nucleus will contain 99.5 per cent of the DNA of the donor nucleus but will also contain the normal cytoplasm.
The proposal that we are discussing now is the next step—when safety has been assured and when all the evidence, scientific and otherwise, has accumulated to make it clear to the Human Fertilisation and Embryology Authority that this is a practical possibility—which is to be able to take an ovum from a women carrying these devastating mitochondrial abnormalities in her cytoplasm, take the nucleus containing 99.5 per cent of her DNA and transplant it into a donor ovum from which the nucleus has been removed but which has normal cytoplasm.
The decision to allow that to happen is hinted at in the Bill, which allows regulations to be introduced in the future in respect of the clinical application of the current animal research to prevent the transmission of mitochondrial disease. This amber signal is welcome, but is it not just introducing yet another stage of bureaucracy in allowing the research to proceed? The decision to introduce this technique as a clinical treatment must be based on whether researchers can produce convincing evidence of safety and efficacy. The decision to grant a licence for such new clinical treatment involving embryos and gametes ordinarily rests with the HFEA. Similarly, there is a strong case for the HFEA to be allowed to determine whether to license cytoplasmic transplantation in human subjects. It will be ideally placed to assess the safety and efficacy of each case and to incorporate detailed scrutiny by members of the scientific community with appropriate expertise. There is a need for such research to progress to therapeutic application for the prevention of such serious, life-threatening diseases.
The idea that the resulting child has three parents is nonsense. The DNA in mitochondria carries no information that defines any human attributes whatever, so it cannot be parental in any way either. On this reasoning, one might well claim that people with a kidney transplant have four parents; indeed, that is a stronger claim, as the kidney carries nuclear DNA from the donor and not just cytoplasmic DNA.
This treatment is not the same as reproductive cloning, which describes the situation where any baby created would be genetically identical to a donor through the transferring of a nucleus from that donor into an egg from which its own nuclear DNA had been removed. Reproductive cloning is, and must remain, illegal in the UK. However, in mitochondrial disease treatment, there is in effect the exact opposite:
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