Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Deben Excerpts

Tuesday 24th February 2015 Lords Chamber

Moved by

[Lord Deben]

To leave out from “that” to the end and insert “this House declines to approve the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 laid before the House on 17 December 2014 and calls on Her Majesty’s Government not to lay new draft regulations until a joint committee of both Houses has been established and has reported on (1) the safety of the procedures permitted by the draft regulations, (2) the compliance of the draft regulations with European Union and domestic law, and (3) the key definitions used in the draft regulations”

[Lord Deben (Con)]

My Lords, first, I have to say that I am in favour of mitochondrial donation. I am not opposed to it in principle. I tabled this amendment because otherwise it would have passed through this House—in the Moses Room—without the kind of concern that we now have. The numbers present show it to have been right to discuss this matter very carefully. It is right because we are dealing with something of incredible importance to the families concerned: the fathers and mothers who can produce children but cannot, because those children will, almost certainly, carry this terrible disease. They deserve all the care that we have expended on them. The fact that some suggest that there are not that many of them is nothing: if there were but one we should be as concerned about this as we are.

I yield to no one in my determination to try to do what is right in this area and I do so for a personal reason, which is that I am thankful every day that my wife and I produced four children who in that sense—though perhaps in no other—are perfect. Those of us in this situation have a particular need to be concerned. We should be concerned with the parents; we should be concerned with the wider community; and we should be concerned with the children who would be born in these circumstances. My concern is that the Government have approached this in a way that is very unhappy. Because there are so many of us who would find the movement of a spindle from a non-diseased egg to a diseased egg something that we could accept, there was a basis for a commonality of understanding and support. That was there. All we needed, therefore, was to be assured that the procedure was safe and legal.

My noble friend—and he is a noble friend; he was one of my Ministers, and we worked closely together—has carefully covered his view of the law. I think that the law is very often an ass. I am certainly not one who would demand that lawyers should decide what we should want. I say sorry to the noble Lord, Lord Pannick, who looks unhappy at that comment. However, I believe that we should obey the law and it is quite clear that there is considerable disagreement—I put it simply like that—about whether this action is legal under European law. Although my noble friend gave the best account that he could, it is worth saying that many others take a different view. What is more, the two law officers, the Attorney-General and the Lord Chancellor, voted against these regulations. The Attorney-General has said clearly that he did so on legal grounds, so it cannot be said that those of us who suggest that the legal arguments are at least uncertain have an entirely unreasonable position.

Many who are present will have been sitting through the last part of the previous debate on ticketing. I had taken a particular view on that but felt that the House had heard enough of me without intervening on that occasion. But it may be within the memory of the House that the Government fought very hard not to take action on ticketing until they were absolutely sure about the legality, under European law, of what was being proposed and that there was a proper investigation of it. I had expected my noble friend to say that he had been to outside experts and to the European Union itself to be assured that he was not going to find himself in court were this passed. He has not done so. The only legal advice that has been presented to this House is the internal advice of the Department of Health. I do not find that satisfactory.

[Lord Willis of Knaresborough (LD)]

I am grateful to my noble friend for giving way. Does he accept that the Wellcome Trust has published and given to all Members a legal position which has all the authority of its own lawyers and which backs up the position of the Minister?

[Lord Deben]

The Wellcome Trust has certainly done that but I was referring at that moment to the ministry and the Minister. However, the Wellcome Trust has not gone to experts in European law; it went to an expert that it chose. I am perfectly happy about that but it is only one of a series of opinions, which are contrary one to another.

I started with this point because of my concern about the families. It seems that it would not be a good beginning for this change if, immediately afterwards, the large number of Members of the European Parliament —from the right to the far left—who have said that they would see this as so clearly contrary to European law seek to refer it to the courts. That would not start this off very well. The real question is why the Government have not taken the steps which would enable us all to accept that this was legal. I do not understand why they have not done that, so my first questions to my noble friend are: why was that not done and why, even after we asked for it, did the ministry not go out and see that it had exterior and clear European advice, so that we would know where we were?

That is of course only the first part of it; the second is a question of safety. I have said that if we talked about transferring the spindle from one egg to another, I would not have any ethical objection. Indeed, it would be the opposite; I would want to support it. I ought to say that, because one noble Lord, who I know is going to speak later on, at an earlier meeting said, “Well, he only says all those things because he’s a Roman Catholic”. I think I will face that. Those Members of your Lordships’ House who took part in the proceedings on the Marriage (Same Sex Couples) Bill will remember that I spent a good deal of time supporting the Government’s position on that.

--- Later in debate ---

[The Deputy Speaker (Lord Geddes)]

I assume the noble Lord would like to move his amendment.

[Lord Deben]

I beg to move.

[Lord Patel]

My Lords, I am sorry for rushing in, but the noble Lord, Lord Deben, excited me so much with the comments he made that I have to answer some of his points, particularly on safety. I hope that noble Lords will have patience, because I need to go through each of the points he has made on safety, as I have no doubt that they will come back again in subsequent debate.

It is important that I put down some ground work. What are we talking about? We are talking about a mitochondrial DNA disease that commonly affects multiple different organs. Symptoms include severe muscle weakness, diabetes, heart problems, cardiac failure and sudden cardiac death, as well as central nervous system problems, which include dementia, epilepsy, stroke and such other horrible conditions. It results in death, which can occur early in childhood or after a prolonged period of incapacity and pain that can last for years.

It is important to have some facts about mitochondrial DNA genetics and inheritance. Mitochondrial DNA is strictly inherited maternally, via the egg. The mitochondrial DNA copy number and the number of mitochondria vary between cell types, with more than 200,000 in the egg and early embryo down to perhaps as few as 10 to 20 in many cells of the two to three-week old embryo, and hundreds to thousands in most cell types in adults, where the number tends to correlate with energy demand. Cells can have a mixture of two or more types of mitochondrial DNA sequence, a condition referred to as heteroplasmy, in contrast to homoplasmy, where each copy has the same sequence. More than 300 distinct mutations of mitochondrial DNA have been found in patients with mitochondrial disease. Although some mutations are far more common than others, if an individual is heteroplasmic, with a mixture of mutant and normal mitochondrial DNA, the proportion of the former determines whether they show symptoms of mitochondrial disease. Some women at risk of transmitting mitochondrial disease to their children are heteroplasmic and may have levels considerably below the disease threshold, but their eggs can have very high levels of mutant mitochondrial DNA or even be homoplasmic. This can be explained by the so-called bottleneck, which I will not go into in detail, but, during the development of the egg, only a certain number of mitochondria go into fertilisation, and that causes a bottleneck that sometimes results in only the mutant mitochondria getting through.

It is estimated that at least one in 200 children in the UK is born with some faulty mitochondrial DNA—so quite a lot of them may well have some faulty mitochondrial DNA. It is estimated that one in 6,500 babies goes on to develop serious mitochondrial disorders. The severity varies from mild to extremely debilitating and may result in early childhood death. Almost 2,500 women of child-bearing age in the UK are at risk of transmitting mitochondrial disease to their children. Estimates based on this figure suggest that between 100 and 150 births a year in the UK risk passing on mitochondrial disease to the child. If today we were discussing cancer or dementia, and how we could modify those diseases with some form of genetic or mitochondrial manipulation so that people would not get it, everybody would be in favour of it; but as mitochondrial disease affects 100 to 150 people a year, we do not take it so seriously—or so it seems.

I will now go on to what the noble Lord, Lord Deben, said about the two techniques that we are likely to be discussing—the maternal spindle transfer, which the noble Lord prefers, and pronuclear transfer—and I will say why I believe it is necessary that currently the HFEA, as a regulator, is allowed to decide which method might be appropriate for a given patient in a given centre. We do not know which technique is the more efficient and safer, despite what some others may believe. In fact, they may not be equally efficacious in every woman.

Pronuclear transfer has been used successfully in animals for more than 30 years with no evidence of adverse effects. On the other hand, maternal spindle transfer is a newer technique, which is likely to result in less carryover of mitochondria but has a higher risk of chromosomal abnormalities. That is an important point: pronuclear transfer may have more carryover of mitochondria but maternal spindle transfer has a higher risk of chromosomal abnormality. Maternal spindle transfers are very sensitive to manipulation. The embryo is less sensitive in its early stage to such manipulation.

Furthermore, both techniques have been found to be variable for avoiding mitochondrial disease. Which technique will be used for each individual patient will be a decision for the patient, based on their informed consent, their clinicians, the evidence from research and the safety aspects. In my view, it would be inappropriate for Parliament to make a scientific judgment as to which technique should be able to be used. One thing is certain: the scientists and the clinicians will go with whichever method is the safest and most efficacious. If it turns out, through research that is currently going on, that we can make maternal spindle transfer safer and less likely to lead to chromosomal abnormalities, that is the method that the scientists and the clinicians will choose. Research is going on to make that process safer. There are many ways of doing this. I am not being flippant when I say that one of the methods that has been tried is to use a small amount of caffeine to make the maternal spindle transfer more stable. Eventually, we will get that research right and whatever method is safest will be used. However, it would be wrong to opt now for one method which is not as successful as others.

Issues have been raised about the health and safety risks of some of the techniques. I agree with the noble Lord, Lord Deben, that it is never possible to be certain that new medical procedures will be 100% safe or effective. That applies to the whole of medicine—drugs, devices or surgery. Risks have been assessed in detail. As the Minister said, there have been three separate reviews of the scientific evidence on the technique’s safety by a specially convened independent panel of experts. It would be wrong to suggest that these experts might be biased when none of them has any financial interest in mitochondrial research or treatment, or that they might not have understood the issues and that we in this Parliament are more likely to understand the science which underpins this research, which has led to the point where it is now possible to use this technique to help women to have normal babies.

Decisions on safety and efficacy should be taken by the statutory regulatory authority created to do this—the HFEA. Risks must be balanced. Evidence suggests that any risks of mitochondrial donation are proportionately less than the significant risk that children will continue to be born who will develop severe mitochondrial disease if these techniques are not used. Ultimately, it will be up to affected families to judge the balance of these risks. They are the ones who will take the risks.

I would like to explore some of the health risks that the noble Lord, Lord Deben, mentioned, although he did not mention that of the potential effects of the donated mitochondrial DNA on the rest of the cell. I turn first to traits attributed to mitochondrial DNA. On variations in the 37 well studied genes, a whole mitochondrial genome has been sequenced for all these genes and they have all been found to have one function in expressing the protein that produces energy. No other trait has been identified from the sequencing of the whole mitochondrial genome. Therefore, the variations have been well studied. Although this is still contentious among mitochondrial experts, theoretically—I admit—it is possible that a child born after mitochondrial donation might have a slightly different energy metabolism compared with his or her female ancestors. However, none of this has resulted in devastating mitochondrial disease.

Evidence has also been cited that a mismatch between the DNA in the donor’s mitochondria and the mother’s nuclear DNA might have a negative impact, namely sterility and impaired growth—the noble Lord mentioned sterility—in the resulting child, as well as slow metabolism. This issue was considered in great detail by the HFEA scientific panel. In normal human populations the mixing of nuclear DNA during sexual reproduction means that there can be a complete exchange of nuclear and mitochondrial DNA type over a few generations—I calculate it to be about six generations. Given that I married an English lady, the mitochondria of my children have changed dramatically. My ancestors’ mitochondria are no longer in my children—they have English mitochondria. However, I am glad to say that they have produced terrific children. Evidence of mismatch between nucleus and mitochondrial genomes has come mostly from research where new combinations have been made experimentally across animal species that have been separated for many hundreds of thousands of years or longer—for example, rats and mice. Within species, such as in some experiments involving mice or fruit flies, evidence of mismatch is seen only when particular sub-strains of a species have been reproductively isolated from each other and each inbred. The one species, the human race, is the most outbred species there is. Some of us are examples of that.

--- Later in debate ---

I will now conclude. In introducing the regulations I outlined the rolling programme of work that has gone into assessing the safety and efficacy of these techniques, as well as their ethical and public acceptability. That process has, I believe, been admired and commended across the world. So much progress has been made in the lifetime of this Parliament that in the Government’s view it is right that Parliament should now have the opportunity to vote on whether to allow the families who wish to use these techniques to have children free of the devastating consequences, which we have heard about from noble Lords, within a robust regulatory framework. The request to the Department of Health to develop these regulations was made at the start of this Parliament in 2010. The subsequent in-depth consultation and assessment has taken place through the lifetime of this Parliament. It seems highly appropriate that we complete the task by approving the regulations today.

[Lord Deben]

My Lords, if ever anyone questions the value of this House, this evening proves it. It has been a really valuable debate and I hope that all noble Lords who have taken part in it and those who have listened will recognise that we have all learnt and valued what we have heard, even from those who have spoken from a different point of view.

There was a phrase used during the debate that particularly annoyed me—an attack on playing God. I do not believe that that is a proper way to discuss these issues, not least because it is of the nature of the Christian understanding of creation that we share with God in His creative power. It is the great gift of the Almighty to us. Therefore, the idea that we should not do any of these things because for some reason or other they are reserved to God seems to me to be fundamentally theologically unsound as well as philosophic nonsense. I hope no one has suggested that those who take the view that I take do so from some arcane understanding of the Almighty.

Nor do I think anyone will now suggest that we were trying to push this whole debate into the long grass—and in case anyone should be worried, I do not intend to take up the time of the House for very much longer. The long grass was certainly not my intention. As the Minister knows, I have unbounded admiration for him and he again showed why we should return to the position of Ministers in this House being Cabinet Ministers as well. However, in describing his side he still left me with three very fundamental reasons for saying that we need to have certain things in place before we vote.

First, on the two issues, he is perfectly right to say that it is reasonable to bring them before the House. The objection is that they are brought before the House without it being able to make a decision on each of them separately because they each present separate issues. I do not think he has answered that. I know why he said that. It is because the Government know perfectly well that if you divide the two it would become clear that there is an ethical distinction between them. We did not discuss that today because we knew we could not discuss that ethical distinction because only one of them held it and the other did not. So my objection to the Government’s position—not of course to my noble friend’s position—is that they could have given us that choice and they decided not to.

It is the choice that I object to, not the fact that one might use the two techniques if both were approved. I suspect that both would have been approved, but we would have been able to explain why we hoped that the work done on the maternal spindle transfer and the third mechanism, which is coming along, would be prioritised and done in an ethically acceptable way. That is the first reason why I believe it would be better to allow a committee to look at this very rapidly and to insist that it be a decision in which we have a choice.

The second reason is that there is clearly a legal disagreement. I bow to nobody in my support for my noble and learned friend Lord Mackay of Clashfern. I know that it is normal in this House to accept that what he says is infallible. If it were not for his denomination, I would use that word, but I think that it would probably embarrass him considerably if I were to use it in conjunction with his name. However, I point out that the noble and learned Baroness, Lady Scotland, spoke for a number of people, including the Attorney-General, whose statement made it clear that he felt that this was unsound for legal reasons. Incidentally, I want to say that it is perhaps surprising that the Lord Chancellor is not a lawyer. I think that the Lord Chancellor should always be a lawyer. I also think that he should not be a career politician but ought to sit in this House. I make that point while I have the chance to say it, as until now I have not had a chance to make that provocative comment. However, the fact is that there are very clear legal disagreements.

I perfectly agree with the noble and learned Lord, Lord Hope, with whom I am normally ad idem: we have marched together on most of the subjects when I have rebelled against the Government and I have taken much pleasure in our arguments. However, I say to him that there is a distinction here. It is very dangerous for this House to leave it to someone else to decide whether something is legal. I think that this House should make that decision itself, and then, if it makes the wrong decision or a questionable decision, the matter will come before the courts. I understand that distinction but I agree with the noble and learned Baroness, Lady Scotland, on that front. However, I am worried about entering into legal issues because I have always prided myself on being the only member of the Cambridge mafia who did not read law.

That leads me to the third point, which is safety. It is no good—we cannot kid ourselves about this. The terms under which we were originally told that we were going to have this debate have not been met. The experiments which we were told would be done have not been completed. The most important of those is the primate experiment to make sure that such procedures do not result in sterility. People have said that even suggesting that is an attempt to frighten people. I am not doing that at all. It is simply the case that that was what we wanted to do but there has not been enough time to do it, although it would not take very long. Therefore, I again come to the question of why this measure is being pressed at this moment when we could very rapidly have the answers to all the questions that we have raised. I want to end on that but I shall say why I think that that is important—much more important even than the issue itself.

I believe that we are moving into a society in which the search for consensus and agreement is becoming increasingly much less urgent and much less important to people. I believe that we could have gained very considerable support for this measure. The noble Earl caused a certain amount of laughter when he referred to the ComRes poll. It was intended to ask people, in the words that they had read in the newspapers, what their reaction was. That is why the poll was held. Therefore, passing the matter to the Wellcome Trust and others to look at it as though it were a scientific statement was entirely contrary. I was pleased to find out that we had so failed to communicate with the public that 90% did not want us to go ahead with these regulations, and that was the case when using words which had meaning for the public. The Government’s consultation was in fact very limited. That is not the burden of this whole debate, but I just want to say to the House that we are beginning not to try to take everyone on board. There was a real opportunity to do so here and I would still like to recapture that. That is why I would like to test the opinion of the House.

[Lord Winston]

Before the noble Lord does that, I wonder whether he would consider this point very seriously for a moment. If we delay this measure, we will, as I am sure he understands very well, be committing a number of people to terminating pregnancies. Not only will we be terminating their pregnancies but those women will experience a number of lost pregnancies—a loss of life. Is that what the noble Lord really wants in pressing this amendment?

[Lord Deben]

I do not want to prolong this but the fact is that the human embryology committee and the terms under which it can give the permissions will take longer than it would take to have the committee that I am calling for in my amendment. It would not hold matters up for one moment. However, I think that the House wants to go to a vote.