My Lords, I am extremely grateful to be able to follow the noble Lord, Lord Patel. I am also grateful to the noble Earl for setting out the issues so carefully at the beginning. I listened with great attention to the eloquent and persuasive speech from the noble Lord, Lord Deben, but I am afraid I was not persuaded. I cannot go along with the idea that we should put this regulation on hold for the time being. My reason is the awful position parents find themselves in when they have a child severely affected by one of these dreadful mitochondrial diseases. They are desperate to avoid having more children with the same disease. The noble Lord, Lord Deben, started from the same position but I believe that we are now in a position to move forward.
We have all been bombarded with information about mitochondria to the extent that few of us can be entirely ignorant of what they are and what they do.
Yet there is still considerable room for confusion, at least according to some of the correspondence I have received. References to GM crops and cloned animals are way out of line. Suggestions that mitochondrial transfer techniques are a form of cloning when they are nothing of the sort, or that they are on the slippery slope to genetic manipulation and designer babies when there is no conceivable link between them, are very unhelpful and not part of any reasoned discussion about the issues. I could elaborate on that but will leave it for the moment to concentrate on what I think are the more rational arguments that have been and will be made today.
The noble Earl discussed the safety issues, as did the noble Lord, Lord Patel. The suggestion has been made that the techniques may not yet be safe enough. Let me take this a little further. The basic animal experiments have been going on since the 1980s and the specifics of maternal spindle and pronuclear transfer have been very fully researched for the last seven years. We have heard about the three thorough scientific reviews by expert panels set up by the HFEA. In each, further research that needed doing was suggested and each time the research has been actively and successfully pursued. On the last occasion, in 2014, they clearly stated that there were no major safety issues remaining. It is true that they suggested some further tests—and they are all under way, as we have heard—but they pointed to the fact that at the end of the day there will be no substitute for trying it in humans who carry the abnormal mitochondria.
In vitro studies in the test tube with human embryos after mitochondrial replacement have revealed no problems, and experiments with macaque monkeys—yes, they have been done—and maternal spindle transfer are all reassuring. It is interesting that monkeys are not suitable models for pronuclear transfer techniques because research shows that pronuclear transfer in vitro fails in monkeys but works perfectly well in human studies. The only way in which safety can be finally tested is in humans since no procedure or drug can be certainly safe without that. We have gone almost as far as we possibly can before that step is taken. We have heard some issues about the China syndrome, which I believe the noble Lord, Lord Patel, has dealt with perfectly well. Clearly, that was quite something else and not relevant to our discussions today.
Equally important is that these regulations do not simply allow human trials to start now—they do not; they allow the HFEA only to examine applications made to it for full assessment. It will then decide if the science is persuasive enough, that those proposing to do it have sufficient experience and capacity, and that the patients being put forward are clearly those likely to benefit. Remember that the HFEA is no pushover. It has in its membership not just three scientists and a clinical geneticist but three patients who have gone through IVF, a barrister, a professor of philosophy, a bishop and a national security adviser. That is quite an interesting mix but not one likely to be easily moved by faulty argument. It is they and their scientific advisory panel who will be assessing applications when these regulations come into force in October.
Other anxieties have been expressed that we will be disrupting the relationship between the nuclear and mitochondrial genes: the nuclear genes carry the information that determines all the characteristics that make us human, and the mitochondrial genes provide the energy supply for cells. This argument was discussed at great length in the HFEA’s scientific report in 2014 and was found wanting, not least because half the genes in a fertilised egg are derived from the father and are therefore already foreign to the mitochondria, yet they do not interfere with each other. Furthermore, mitochondrial genes are pretty well conserved between different individuals because they perform a limited number of functions, while there are large differences between the nuclear genes of different people, each of whom is made up of a mixture of DNA from a mother and a father.
5.30 pm
You might expect problems to occur all the time in normal people if there was a problem of interrupted communication between nuclear and mitochondrial genes, but the fact is that we do not see any miscommunication problems arising. On top of all that, there is no detectable direct interaction between the genes or the DNA in the nucleus and the mitochondria—only indirect actions through protein products and RNA, as between any cell activities. Nor, incidentally, is there any evidence whatever that mitochondrial genes contribute to any of the features that one might consider to be human characteristics.
The worry is sometimes expressed that we are messing with the germ cell line and that what we do to the first offspring will be handed on to her daughters and so on. However, what will be handed on will be only normal mitochondria and none of the egg donor nuclear genes. The mitochondrial donor does not contribute anything to the nuclear genetic pool, which is all derived from the original mother and father. The next daughter after that will have a quarter each of what will then be the original genes of the grandmother and grandfather—I hope that noble Lords are keeping up—and half from her new father, but she will still have normal mitochondria despite this dilution of her nuclear gene pool down the generations.
A number of questions have been raised about the legality of pressing ahead with these regulations, as the noble Lord, Lord Deben, said—most notably by my noble friend Lord Brennan, who I know is sitting behind me. I would not dream of crossing legal swords with my noble friend but I have to say that I have been convinced by the Department of Health’s legal opinion and more recently by the opinion obtained by the Wellcome Trust from Mr Thomas de la Mare QC. These reassure me that the regulations do not in fact contravene any of the provisions of the EU clinical trials directive, the human tissue directive, the HFE Act or the EU charter or European Convention on Human Rights. It is worth noting, incidentally, that the Nuffield Council on Bioethics could find no ethical reasons to object to mitochondrial transfer techniques being used. Both it and the HFEA confirmed that their public opinion exercises had revealed considerable support among the general public.
Finally, there is a most difficult question which has not been raised: the religious conviction of some that manipulation of embryos is basically wrong and against God’s will. I am afraid I have no answer to that; I am not privy to God’s will. However, I know that parents who have watched affected children suffer and in turn have suffered themselves are hoping and praying—yes, they are praying—that they will be able, some day, to have a child who is normal. What a boon that would be, and I very much look forward to us passing these regulations today.