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Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 — Motion to Approve

– in the House of Lords at 4:15 pm on 24th February 2015.

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Votes in this debate

Moved by Earl Howe

That the draft regulations laid before the House on 17 December 2014 be approved.

Relevant documents: 23rd Report from the Secondary Legislation Scrutiny Committee and 17th Report from the Joint Committee on Statutory Instruments

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health 4:23 pm, 24th February 2015

My Lords, the purpose of the regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.

Mitochondria are present in almost every cell in the body and produce the energy that we need to function. This is why they are often referred to as the “powerhouse” of the cell. Unhealthy mitochondria can cause severe medical disorders known as mitochondrial disease, for which there is no cure. There are 37 genes in the mitochondrial DNA, compared with more than 20,000 in the nuclear DNA. This represents less than 0.1% of the total genetic make-up. The techniques provided for by these regulations offer the only hope for some women who carry the disease to have healthy, genetically related children who will not suffer from the devastating and often fatal consequences of serious mitochondrial disease.

Provision to make these regulations was introduced by Parliament into the Human Fertilisation and Embryology Act 2008. It followed an amendment that recognised the progress being made in research. In 2010, researchers at Newcastle asked the Department of Health to take forward steps to develop regulations. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014. There have been three separate reports into the safety and efficacy of these mitochondrial donation techniques by an expert panel convened by the HFEA, published in 2011, 2013 and 2014. The expert panel members were selected for their broad-ranging scientific and clinical expertise, and for having no direct or commercial interest in the outcome of the review.

This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence:

“the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law”.

Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these regulations. The two proposed techniques that would be allowed under these regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.

I know that many noble Lords will have their own tributes to pay, but I would like to make my own acknowledgment of the ground-breaking work that the scientists at Newcastle University have led, which is world-leading in the development of these new techniques. It is also very important to praise the Lily Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, which has reminded us about the human story that inspired this scientific advance.

I turn now to the detail of the regulations made under powers in the 1990 Act which, as I said, were added in 2008, with Parliament’s express agreement, in anticipation of the advancement of science to this point. These powers would permit mitochondrial donation in order to prevent the transmission of serious mitochondrial disease.

Regulations 3 to 5 set out the circumstances for mitochondrial donation techniques using eggs. Regulations 6 to 8 set out the circumstances for mitochondrial donation using embryos. That would allow the two techniques that have been the subject of extensive UK-wide review and consultation: maternal spindle transfer and pronuclear transfer.

Regulations 11 to 15 and 19 set out the information that can be provided about a mitochondrial donor to any child born from the donation and information to that donor. Regulations 16 and 17 set out special provisions for consent, which were identified through the public consultation process. These regulations apply UK-wide, and the devolved Administrations have been kept informed of development and progress.

Concerns have been raised in advance of this debate by some noble Lords about both compliance of the regulations with European Union law and how the regulation-making powers were originally drawn in the 2008 Act. Those are complex issues, and I have taken care to write to noble Lords about them before the debate. In doing so, I set out the Government’s clear view that we are acting within EU law and that the legislation is sound and robust.

As I have set out in recent parliamentary replies to the noble Baroness, Lady Hollins, the clinical trials directive does not cover treatment services, which is what would be allowed under the terms of the regulations. Furthermore, to be clear, the clinical trials directive relates to medicines and therefore has no relevance in the context of mitochondrial donation.

There has also been much discussion of the safety of these mitochondrial donation techniques, and, as I have outlined, there have been three reports by the HFEA-convened expert panel during this Parliament. On each occasion, the expert panel has concluded that there is nothing at all to indicate that the two donation techniques are unsafe. Although the expert panel has recommended that further experiments should take place, the panel has said that it expects such research to support the conclusions that it has reached so far.

In public discussion, there has been some misunderstanding of the term “critical” when used by the expert panel. This point was helpfully clarified in the HFEA briefing note, which has been endorsed by the expert panel. It clarifies that these experiments could take place before or after the approval of regulations by Parliament.

We have said that it is our view that this Parliament should be given the opportunity to consider these regulations, as the key developments and reviews have taken place during the lifetime of this Parliament. We cannot be certain about what priorities the future Administration will have and whether, in the event that the regulations were deferred, there may be an extended delay in considering them further.

My position on this, shared by my ministerial colleagues, is very simple. Families can see that the technology is there to help them and are keen to take it up. They have noted the conclusions of the expert panel. It would be cruel and perverse, in my judgment, to deny them that opportunity for any longer than absolutely necessary.

Let me explain further the safeguards that would apply here. If these regulations are passed by Parliament, the HFEA would put in place a robust regulatory process, as it has in other areas of fertility treatment. The regulations would also bring into being important safeguards through the HFEA’s own licensing procedures. For a licence to be issued to a provider of mitochondrial donation, it would first have to demonstrate that it could carry out the procedure safely and effectively. Each provider would need to be authorised, and treatment for each patient would be approved on a case-by-case basis.

Every such decision would be based on the scientific evidence, including: information on the safety and efficacy of the techniques at the time of the application; advice submitted to the licensing committee by the clinic; and an assessment of each individual patient. The HFEA is highly respected across the globe as a model for the regulation of fertility and embryology treatments and research. Many other countries do not have this framework in place.

In setting out the purpose and effect of these regulations I hope I have been able to offer reassurance to noble Lords that the long process of consideration of mitochondrial donation has been rigorous, sensible and inclusive. The UK is admired across for the world for the approach that it takes on matters such as this. I recognise that some noble Lords will be opposed in principle to mitochondrial donation. While I respect their point of view, I cannot agree with it. The Government’s view is that it is right that we bring this matter to this Parliament to ask parliamentarians to make an informed decision about what happens next.

I end by emphasising what, to me, is the ethical heart of this issue. This House now has the opportunity to give real hope to families and the chance for doctors to offer more to those families carrying serious mitochondrial disease than yet another generation of avoidable suffering and shortened lives. The UK can offer this world-leading science within a robust regulatory regime and, in so doing, the chance to make a real difference to families. I commend these regulations to the House and beg to move.

Amendment to the Motion

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”

Photo of Lord Deben Lord Deben Conservative 4:30 pm, 24th February 2015

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.

Photo of Lord Willis of Knaresborough Lord Willis of Knaresborough Liberal Democrat

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?

Photo of Lord Deben Lord Deben Conservative

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.

I do not think anyone can complain that I am somehow in the thrall of some exterior power. I do not think anybody should suggest that I was other than willing to rebel on those things that I thought right. If there is any doubt about that, the Chief Whip will say that that is rather a wider rebellion on many other issues. So I hope no one will say that I am putting this case for any reason other than the one that I put forward. I put it forward because I believe that this House has a parliamentary duty to ensure that the legislation stands up. I do not accept the argument of some that this is a matter for only the experts and the scientists.

Many will remember that, as Minister for Agriculture, I dealt for four years with the BSE crisis. I spent a great deal of time listening to the scientists, standing up for the scientists and getting it in the neck almost every day by refusing to do the unscientific, which I was asked to do. It gave me a great respect for scientists, but it was my responsibility as a Minister to ensure that Parliament made the fundamental decisions. It is not up to anybody—even an organisation as distinguished as the one that will have this responsibility—to make the final decision about safety. That is, as Dr Harris, an old opponent in the other House, made quite clear, for Parliament to decide.

I come to this problem by saying that Parliament very nearly did not get much of a decision here anyway, because we were going to do it around the corner. So there would have been no contribution. That is why I am sorry we called it a killing Motion. It is not that at all: it is intended to give us this debate.

Parliament, however, must recognise that there are real doubts about safety. At the very last moment, we heard some information today. There has been, of course, an attempt to use one of these two mechanisms. It took place in China. The result was an abortion, a stillbirth and a child who died immediately: three—all dead. As a result, China banned the procedure. I discovered today, in answer to a Question, that the Human Fertilisation and Embryology Authority has not even asked for the evidence from China about how that happened, why it happened, why that decision was taken and whether what those who do not wish this matter to be raised say is true: that it was nothing to do with the technique but was to do with other exterior matters. It is not acceptable to tell the country that this is safe when we have not even asked for the evidence from the one occasion on which it has been used, and upon which three babies died.

Secondly, there has been a lot of usage of words. I try not to get myself into any of those difficulties, but it is quite clear that most people expected that there would be a complete test on at least one set of animals that were rather closer to human beings than mice. Of the two techniques, the one that gives me some problems has been performed only on mice. However, there is a test under way at this moment on more advanced animals, if we are allowed to use such a phrase. Macaques have been given the technique and it appears to have worked and produced healthy babies. However, we do not yet know whether those babies themselves can reproduce. We will not have a long period to wait but we do not know the answer yet.

We have a huge responsibility to these mothers who cannot bear a well baby, but we also have a responsibility to the baby that they bear. What a terrible comment it would be if those who longed to have a baby and were therefore able to have it gave birth to a child who could not have a baby. That would be unacceptable. Yet when we had discussions with those who wanted to convince me—this is the thing that appals me—the scientist concerned said, and I quote, “Well, what’s wrong with sterility anyway? I’m sterile”. The public out there do not realise it is being seriously suggested that it does not matter whether these children are sterile. I am sorry, but that is not what the public think. They think we will ensure that the children and the mothers are properly protected.

I am very concerned about this. In the end, if it all goes wrong, it will be no use for us to say, “I took the opposite view”. I was one of the 16 Conservative Members of Parliament who voted against the Iraq war. I want to tell the House that there is no satisfaction in being able to say, “I was right”, or, “I proved you wrong”. The same is true here. I do not want to say at the end, “I was right to ask for a bit more care”.

What I am asking for is very simple. The Minister says, perfect reasonably, that we must not hold this up as some future Government may not be as enthusiastic about it as we are. I must say to him that I can think of no Government who, if a Joint Committee of the two Houses recommended that we should go ahead, would do anything other than put it before the House. Already, he has had a chance to get much more support by allowing the House what it ought to have: some ability to choose between these two techniques. I have asked why we cannot choose the technique that is ethically acceptable to so many but must have them bundled up in this way. The answer, I am afraid, is about money. Because some people have been investing in one technique and others in another, we want to ensure that both will be able to be used. I do not find that acceptable as an answer but it is the only one that I have had so far. It is tied up in a very careful phrase: that it will enable the authority to decide which of the techniques is “most appropriate in the circumstances of the woman concerned”. There is no appropriateness in the circumstances of the woman concerned; the appropriateness is about whether this or that laboratory is available to do it and has invested the resources to make it possible.

We ought to have been able to make a choice in this House. We were denied that, even though we asked for it. The Government seem determined to ensure that these things are not decided by this House but are packaged in a way that means we are not able to choose.

There are many people in this House who do not have a worry about the use of embryos. I recognise that. However, I also recognise that we have a duty to take with us the majority of people if that is humanly possible. To do that, certain simple things are required.

Clearly, the public are worried. I know that it is fashionable to be rude about public opinion polls. Indeed, so rude were some officials that they ran rather close to the libel laws. However, the truth is that in the ComRes test of public opinion, which was a direct test asking questions that the public would understand about things that they have read in the newspapers, the majority of people were unhappy about this; up to 90% said that it should not go ahead unless the tests had been completed. So far, the Government have not convinced the public of the sense of this.

Nor have the Government given us the opportunity to make a proper choice. The Government are presenting this today only because they were forced to do so after a 90-minute discussion in the House of Commons; otherwise this would have been gone through in the Moses Room, in a technique that is very convenient for the Executive.

So why should we ask for this to be fought over again? Your Lordships will know that I am an enthusiastic supporter of genetic modification of food. I am very unpopular among many environmentalists on this matter. Many of the modifications that we want involve very, very small amounts of genetic change, yet out there, there are marchers and campaigns. I think they are wrong because the testing and the science are clear. If the testing and the science in this case were as clear, complete and total, I believe that I would be able to vote for one of these two proposals. However, it is not.

Therefore I say to the Government that it is unacceptable to use a series of words that make it sound as though all is okay. I am fascinated by the refusal to use the phrase “genetic modification”. When it was asked whether one of these two techniques would be genetic modification if it were used on weasels, the Government accepted that it would. So it is genetic modification when it concerns weasels but not when it concerns human beings. All the way through, the arguments that could have won us over and got many more of this House on side have been refused. I say this with great pain because, in my view, this is the best Minister in this House and the man whom we most respect. I am sorry that we have not been able to join him in accepting this.

The proposal that I put forward is that we should have a committee that would be responsible for ensuring that this is legal and safe. I hope that it would also ensure that this House would have a proper choice about the ethical question. I am not raising that on this occasion, but there is a difference between the two proposals that are put forward. I hope that this House will take seriously this issue as we must protect three sets of people: the families—mothers and fathers—the children and the wider society. We would be the first country in the world to allow this. We have to be very careful that we do so with full and wholehearted support, and that we have fulfilled the safety needs.

No one is more aware that there is no such thing as absolute safety. I refer to the arguments over BSE. All you can do is make it as safe as possible by doing all the things that are necessary to see that you have covered every eventuality, and then you have to step out. My own family motto is “Duc in altum”: “launch out into the deep”. However, you do not launch out into the deep unless you have made absolutely sure that you have taken all the possible different issues into account.

The reason I ask this House to reject the Government’s proposition, and to insist that safety and law be looked at again and that the terms also be reconsidered, is not because I do not want to help these men and women who are so affected or because I have an ethical objection to one of the two proposals before us, but because I want this to work. I want it to work in a way that will enable other countries to follow us and to provide this for women who need it so much.

Is it too much to ask that we complete the tests, that we learn from the Chinese why the only time one of these two techniques has been used, they were so appalled by the results that they banned them—they had very clear evidence, which we can have—and that we have absolute assurance on the matter of the European law? We can then all do what is best, and if it goes wrong, we can say, honestly, that we took the best steps and did what was right at the time. That is the only thing human beings can ever do. If we are wrong then, that is due to the wrongness of human nature, and not the wrongness of avoiding what it is necessary to do to make us as safe as is humanly possible. I therefore hope that this House will accept that what could be the shortest of delays is a necessary part of making sure that none of us comes back and says, “We allowed something to happen that should never have happened”.

Photo of Lord Patel Lord Patel Crossbench

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.

Some scientists who support the idea that the science currently is not safe cite examples of that kind, involving experiments done on fruit flies and inbred mice. But let me pose a question. Suggestions that more animal experiments are required to test the consequences of disrupting co-evolved mito-nuclear interactions are reasonable if we want to understand the importance of these interactions in the animals used. I agree with that. However, they are unlikely to be relevant to humans, precisely because the specific interactions will have evolved to be different in humans compared with other animals.

In humans, it is possible that the future work to which the noble Lord, Lord Deben, referred, on embryonic stem cells derived from human embryos created by either maternal spindle cell or pronuclear transfer, where very different mitochondrial haplotypes—characteristics within the mitochondrion—are exchanged, might reveal issues. But any effect is likely to be subtle. If people are asking for these experiments to be done, if the view of some scientists now is that it is not necessary to take the next step of offering this treatment to mothers and fathers, it would require—

Photo of Lord Gordon of Strathblane Lord Gordon of Strathblane Labour 5:15 pm, 24th February 2015

Would the noble Lord comment on the HFEA’s recommendation that, as available data are limited, an extensive range of pre-clinical research should be carried out before proceeding?

Photo of Lord Patel Lord Patel Crossbench

The data that the report suggested were not available were actually presented to the committee. They have not been published because, as any scientist would know, if you publish—

Photo of Lord Winston Lord Winston Labour

I wonder whether I can help my noble friend Lord Patel. Does he agree with me that there were very few available data for the first in vitro fertilisation babies, and that that was a step in the dark, as were pre-implantation diagnosis and sperm microinjection? Before he concludes his speech, would my noble friend be kind enough to answer an important question asked by the noble Lord, Lord Deben, about the possibility that we might be making infertile children? Was that not the accusation made when infertility was treated by in vitro fertilisation, and was there not a widespread fear at that time, too, that we would be making infertile children?

Photo of Lord Patel Lord Patel Crossbench

I thank my noble friend for that interruption. It was worse than that: it was suggested not only that those children might be infertile, but that they might be half monsters of some kind. To answer the question raised earlier about the HFEA’s evidence—yes, it did ask, and the evidence was verbally produced. The reason why it is not published is that anything that is published, even in the form of an extract, cannot then be published in a reputable journal. I know that that evidence has now been sent for publication.

To go back to the subject of the evidence requested, if we were to go down that road and do those experiments, what would be required in the human population is the deliberate creation and destruction of many hundreds, if not thousands, of embryos—to prove a point that does not require proving. Hundreds and thousands of human embryos have already been tested and found to go to a blastocyst state, and I hope my noble friend Lord Winston will agree that if we see them in that state, the embryo will be satisfactory. He nods slightly.

The alternative would be human population genetic studies to fulfil that requirement for evidence. What that shows is that exchange of mitochondrial DNA haplotypes by normal reproduction should reveal combinations that are deleterious. Human population genetic studies will do that. Such studies include genome-wide association studies and whole genome sequencing projects looking at many specific diseases and syndromes. Those kinds of studies will be required. They do not require embryos to be created, nor is it necessary to do these studies before this treatment is available.

I know I am going on a bit, but other points were made. If there are points about epigenetics et cetera, those are also spurious and have no basis in science.

Let me go now to something that the noble Lord, Lord Deben, mentioned twice: the Chinese example. The technique that was used in the United States and in this Chinese example is called cytoplasmic injection. No doubt the noble Lord, Lord Winston, is more familiar with it from his work than I am. It is a technique that is not allowed in the United Kingdom. That is the first point. It is completely different in design and intent from what we are talking about in mitochondrial replacement; it is nothing to do with it.

What was done in China was a cytoplasmic injection not for replacing mitochondria, but for infertility treatment in older women. That was also the case in the United States; it was an extra cytoplasm with possible mitochondria in older women, where both are at risk of producing chromosomal abnormality. In China it was used in only one study, which was conducted by an American, Professor Grifo. They inserted five embryos. We do not allow that in the United Kingdom because of the risk of multiple pregnancy. It resulted in a multiple pregnancy. They then tried to reduce the number of foetuses by injecting one of them to reduce the number of foetuses from three to two. I do not know what kind of technique they used—

Photo of Lord Patel Lord Patel Crossbench

“Dangerous”, my noble friend says. It killed the other two and resulted in a premature birth. They never published this, despite being asked if there was a publication. It is wrong to say that the HFE did not ask them; the review panel did. Professor Grifo sent a letter saying that, in his view, all the foetuses were normal but they died of prematurity. What they died of was an obstetric botch-up. It had nothing to do with what we are talking about today. It was a completely different technique. We should dismiss it completely. It would be wrong to put any credence on it and say that it is a good reason why we should not do this.

I could go on about other safety aspects that were brought up, but let me close by saying that hitherto the science has gone as far as it can in thousands of animal experiments that have resulted in normal pups. In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on. None of us stops researching: the noble Lord, Lord Winston, still carries on researching; the noble Lord, Lord Kakkar, still carries on researching. If a chance was given, the noble Lord, Lord Walton, would still carry on researching. We do not stop researching; that is the nature of medicine and of academic medical science. I hope that we will pass these regulations.

Photo of Lord Turnberg Lord Turnberg Labour

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.

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.

Photo of The Bishop of Carlisle The Bishop of Carlisle Bishop 5:30 pm, 24th February 2015

My Lords, for those among us—and I include myself—who are not scientists, this is a demanding topic. In fact, I guess that even those who are scientists do not always find it exactly straight- forward. A significant part of that complexity derives not from the difficulty of the science itself but from the different—sometimes diametrically opposite—things that we are told by people who have been studying and researching mitochondrial transfer for many years.

Like many others in your Lordships’ House, I have recently attended a number of presentations, drop-ins and seminars on this subject. I have also read through the many written representations that have been referred to and which most of us will have received. They mirror the speeches being made in this debate.

On the one hand, we are assured, as we have been today, that scientists are clear about both the safety and the efficacy of mitochondrial transfer. It is no different from giving a blood transfusion or changing the batteries, so there is no problem there. On the other hand, we are warned by scientists—not just the correspondents to whom my noble friend Lord Turnberg referred—that mitochondrial transfer is a form of genetic modification which does affect the germ line, albeit not the nucleus, and could have a potential impact on the traits of any children, and their children, born as a result of this procedure. Some suggest that this would involve crossing a key bioethical threshold that we could later regret, and we are all aware of the pressure that is being brought to bear on us from elsewhere in the world.

In addition to all that, from a purely ethical point of view, as my noble friend Lord Deben mentioned, one form of treatment, maternal spindle transfer, is for many people clearly preferable to the other type—pronuclear transfer. Unfortunately, as my noble friend Lord Patel pointed out, the spindle method is currently less stable, although that may change.

The so-called “genius” of the Church of England has always been its via media—the middle way—and that is where I find myself today. Over the last few years, we have consistently taken a fairly nuanced position on this subject. Despite some misleading press reports, we are not in principle opposed to mitochondrial transfer, and it makes a pleasant change for the church not to be against something. Indeed, I explained this to the Minister, Jane Ellison, before the debate in the other place and she referred to our conversation in her comments there. But, at the same time, we have always counselled a degree of caution, given the potential implications of this development. In particular, we have always argued that the research tests into safety—set out quite clearly as essential before any further move is made by no less than the HFEA expert panel in 2011— should be completed and reported before these regulations are approved. That has not yet happened. We are therefore disappointed by the element of rush now, which I guess could be occasioned by the forthcoming election. I was talking this morning with a GP friend, who said that she could not imagine any drug or treatment being authorised before all the necessary tests had been undertaken and reported. In this case, that clearly, according to the HFEA’s own recommendations, has not been achieved, even though, as we have been reminded, the research has of course been taking place for several years.

Like every other Member of your Lordships’ House, I am very keen to see help offered to couples who face the terrible prospect of a child born with mitochondrial disease. I also know which of the conflicting scientific viewpoints I would rather believe. To reiterate, both personally and as a representative of the Church of England I am basically very much in favour of this development. However, I cannot ignore the compelling arguments against pushing this through in haste, and for that reason I am minded to vote for the amendment proposed by the noble Lord, Lord Deben. I know that it is regarded by some as a wrecking amendment. I do not see, read or hear it in that way. I would hope that any Joint Committee’s work could be completed without undue delay. For the same reason, if we reach a Division on the initial Motion before us, I will feel compelled to abstain.

Photo of Viscount Ridley Viscount Ridley Conservative

My Lords, I must declare an interest in that much of the groundbreaking science of mitochondrial donation has happened at Newcastle University, where my wife also works, although in a different field. Also, some of the relevant work has taken place on the premises of the International Centre for Life in Newcastle, of which I am honorary president. I am also a fellow of the Academy of Medical Sciences.

I shall be as brief as I can. We have a duty to consider five simple questions. Is it legal? Is it safe? Is it necessary? Is it ethical? Is it rushed? It seems to me that, as the noble Lord, Lord Turnberg, said, we have clear evidence that it is legal for Parliament to enact these regulations. They are explicitly foreshadowed in the Human Fertilisation and Embryology Act 2008. They are not covered by the clinical trials directive. They are not eugenic, and therefore not in conflict with the EU Charter of Fundamental Rights.

Is it safe? We have heard that the safety and efficacy of both techniques have been established as far as is possible by exhaustive study, independent scrutiny and public consultation. The case of the Chinese example, as the noble Lord, Lord Patel, has said, is simply not relevant to this case. This was an obstetric disaster that happened to one woman and was a technique that was intended to cure infertility and had nothing to do with mitochondria anyway. As far as we can tell, the mitochondrial transplant element of that technique worked.

As for the infertility question, I have to say that I think my noble friend Lord Deben has misquoted a very distinguished scientist, Professor Robin Lovell-Badge. I was in the same meeting and I did not hear him say the words that the noble Lord said. He made the point that some techniques that are already legal and used probably perpetuate some forms of infertility. We therefore already accept that some techniques that are used may produce children who lead very happy lives but will themselves require assisted reproduction.

Incidentally, I completely agree with my noble friend Lord Deben that we should not argue from authority, that the consensus of scientists may sometimes be wrong and that we should make up our own minds. As always in science, however, it is the evidence, not the existence of a consensus, that convinces me that this is efficacious and safe.

Is mitochondrial donation necessary? If there is one thing that we have learnt from 30 years of in vitro fertilisation, it is that adoption is not a full alternative to conception. Were we right to give women assisted reproduction so that they could have their own children? Yes. Millions of happy mothers bear witness to that.

Is pre-implantation genetic diagnosis an alternative in this case? Often it is not, because it is more likely, as we have heard from the noble Lord, Lord Patel, because of heteroplasmy, to produce an afflicted child. I was also surprised to hear the noble Lord, Lord Deben, say that the reason we are going ahead with the techniques of maternal spindle transfer and pronuclear transfer is “about money”. I just do not think that is the case. It is very clear, as we have heard from the noble Lord, Lord Patel, and others, that there are very good reasons to go ahead with both these techniques.

Is it ethical? We do not, in the 21st century, have the luxury of deciding these things in a theological way. If we block an advance of this kind and it turns out that it could have eliminated suffering safely, then it is on our consciences in a way that it would not have been 30 years ago, when we could do nothing. In losing our impotence, we also lose our innocence. In other countries, this decision would be up to the regulator already. Here, uniquely, we have explicitly said that Parliament should first decide whether the regulator can take such cases, which is what we are deciding today.

Once Parliament has decided that mitochondrial donation is not likely to be unsafe, and the HFEA has judged that it is safe, it should be up to families to decide whether they wish to use it. It would be unethical for the state to deny them that choice.

We may become the first country to do mitochondrial donation, but there is nothing wrong with that. Britain has been the first with most biological breakthroughs, from natural selection to the double helix, from monoclonal antibodies to in vitro fertilisation. In every case, we look back and see that we did more good than bad as a result.

In this House, we have been deluged with off-the-shelf emails from people overseas demanding that we support my noble friend Lord Deben’s amendment to stop so-called GM babies. However, I am afraid the senders have been misinformed, as the noble Lord, Lord Turnberg, said. Describing mitochondrial donation as producing GM babies or, indeed, three-parent babies is using phrases that are wildly misleading. You cannot call someone with 0.1% of their genes and 0.054% of their DNA donated from somebody else the child of three parents. That is a misuse of the English language.

The reason it is not genetic modification, as the term is understood by most people, is simple: this is therapeutic, not eugenic. It is germline only for female babies. As the noble Lord, Lord Patel, said, this is a dead end in males. I do not, however, hear the opponents arguing that we should license this technology for male babies, even though that would be perfectly logical if that is their real concern.

Finally, is it rushed? Far from being hurried, it has been under development for more than 30 years, under debate for 15 and under scrutiny for five. There is nothing slippery about this slope. There has been no rush. Now, however, that we have reached this stage there jolly well should be some reasonable haste on behalf of the women whose reproductive life is running out and who desperately want their own child, people such as Claire Wright, who is now 40 and who had to watch her son Jacob lose his smile on the way to a cruel death. Yes, there is understandable urgency. We would have to have very good reasons to argue that the ethical thing to do is to prolong her suffering and that of others like her. I cannot see those reasons.

Photo of Baroness O'Loan Baroness O'Loan Crossbench 5:45 pm, 24th February 2015

My Lords, I very much support the Motion that has been tabled by the noble Lord, Lord Deben, for the reasons he very articulately expressed. The Minister has reassured us significantly about these regulations, but he did express many of the uncertainties that remain. In moving his Motion, the noble Lord, Lord Deben, talked about uncertainty. The noble Lord, Lord Patel, gave us graphic details of the uncertainties of the two processes that are proposed, which may result in increased risk of chromosomal defects. In the light of all that uncertainty, how can it be right that your Lordships’ House be asked to make a decision of this magnitude before the conclusion of all the necessary research?

I want to talk briefly about one issue that relates to the protection of women’s health. We are told that these proposals are all about advancing women’s rights, and yet it seems to me that we are at risk of overlooking one very important matter in relation to which these procedures plainly do not advance women’s rights. That is the repercussions of the increased demand for donor eggs for the women who donate the eggs. The requirement for more eggs is a consequence of scientific development, and that is widely accepted. A Nuffield Council on Bioethics report looked into the ethical issues around mitochondrial donation and stated:

“One of the major barriers mentioned by scientists when assessing the potential for cell reconstruction techniques to become treatments is the fact that many more egg donors will need to be found to undertake the research required in order for the safety and efficacy of PNT and MST to be established, and if therapies are to be provided in future. A shortage of egg donors is an acknowledged problem in respect of donations for reproduction, and it is not yet clear whether egg donors would be more likely to come forward”.

Photo of Lord Winston Lord Winston Labour

I am grateful to the noble Baroness for giving way, but I do not think that she speaks from experience. Sadly, I have to say that I do speak from experience. I have run a very large infertility practice for a very long time, and we found donors very easily when it was concerned with these sorts of serious conditions. There was never a problem about finding donor eggs for this kind of problem.

Photo of Baroness O'Loan Baroness O'Loan Crossbench

I thank the noble Lord for that intervention. However, the research shows that there is a shortage of women donors.

Eggs used have to be extracted from women’s ovaries by a process known as controlled ovarian hyperstimulation, which can lead to complications for women. According to the Royal College of Obstetricians and Gynaecologists, it affects up to one in three women to some degree. It says that between 3% and 8% of IVF cycles are complicated by either moderate or severe OHSS, which can cause a variety of painful and upsetting symptoms such as abdominal pain, nausea, diarrhoea, haemoconcentration, thrombosis, pleural effusion and respiratory distress. It can be further complicated by ovarian rupture and renal insufficiency. In some cases, it can be life-threatening.

The Newcastle Centre for Life conducted research on the prevalence of OHSS and published the results. It found that the risk of hospitalisation increased massively if more than 20 eggs were collected. We do not know whether the pattern that it established is repeated at other research centres because the data have not been compiled. There is a gap in the evidence base. The really important point is that, as I understand it, the collection of 20 or more eggs is very common in the UK. Tens of thousands of women have been through the process, so there is a substantially increased risk of a serious medical condition.

Mitochondrial donation is impossible without a supply of donor eggs. The procedures rely on the willingness of women to undergo a process which may bear serious health risks and about whose safety there are not extensive data. Two Answers were given in Parliament last summer which suggested that the monitoring of the incidence of ovarian hyperstimulation syndrome is inadequate. On 9 July, the Health Minister in another place said:

“The HFEA does not, therefore, hold definitive data on the number of women admitted to hospital with OHSS, including non-patient egg donors and egg-share donors”.—[Hansard, Commons, 9/7/14; col. 313W.]

On another occasion, it was said that,

“licensed fertility clinics are only required to report instances of OHSS to the authority that require a hospital admission with a severe grading”.—[ Official Report , Commons, 24/6/14; col. 157W.]

It was stated that other cases that other cases were reported as well. I do not think that the Government have given enough consideration to the effects of the legalisation of mitochondrial donation on the donor’s health. There is a possibility that it will lead to further problems.

This concern is underlined very effectively by the fact that the Newcastle scientists pressed Parliament very hard to sanction legislation to permit the creation of animal hybrid embryos. Parliamentarians who recall that debate will remember that the principal justification for changing the law was to allow the creation of admixed human embryos in order for research to be conducted without it being dependent on human eggs because of their limited availability. The legislation was passed; the research is dead.

Photo of Lord Patel Lord Patel Crossbench

I thank the noble Baroness for giving way. It is important to clarify that point, particularly as it was crucial in the debate on that amendment.

Admixed embryos were required for the research to be carried out then in order to study the diseases in embryonic stem cell lines without using human eggs. She is correct in saying that. On why that research has been abandoned, as the noble Lord, Lord Alton, may well remember, I made the comment in closing that the utopian dream of the scientist would be that, one day, we might reach a point where we were able to take a skin fibroblast and down-regulate it so that it behaved like a pluripotent cell. That dream came true two weeks after that legislation was passed, when Yamanaka in Japan published an article saying how it could be done. That is why the research stopped; it was not because it could not be done.

Photo of Baroness O'Loan Baroness O'Loan Crossbench

I thank the noble Lord for his intervention. It remains the case that there is a shortage of donated eggs. My concern is for the women who are asked to donate eggs.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

I am sorry to interrupt my noble friend, but, given that my noble friend Lord Patel mentioned this case, perhaps I might reinforce what she is saying, because Newcastle is not offering to provide donation opportunities for women but is asking them whether they will sell their eggs, at £500 per cycle. We all know that that can lead to hyperovulation syndrome, an issue which I raised in your Lordships’ House last week and which I know concerns many of us from all sides of this argument. So there is another dimension involved in this. My noble friend Lord Patel was also right to say to my noble friend Lady O’Loan that when we debated these issues in 2009 many of us pointed to things like adult stem cells and the work being done by Professor Shinya Yamanaka. We said then that arguing for animal/human hybrids was a diversion when much more important work, like that which the noble Lord, Lord Patel, has just mentioned, could have been undertaken.

Photo of Baroness O'Loan Baroness O'Loan Crossbench

I thank the noble Lord for that intervention. I am not arguing against this process; I am arguing against the introduction of these regulations at this time in the absence of sufficient knowledge and protection. We have to look at the factors, as the noble Lord, Lord Alton, said. Being paid to donate one’s eggs constitutes a very serious issue for women who are in poverty and who will do it as a way of raising money, possibly even to look after their own children. We need to provide protection for such women.

In conclusion, we should not hasten ahead without putting in place clear and comprehensive systems for monitoring the outcomes of all controlled ovarian hyperstimulation treatments, including those treatments that would result in the generation of eggs to facilitate PNT and MST. In this context, I simply ask that we proceed more carefully and that we back the Motion moved today by the noble Lord, Lord Deben.

Photo of Lord Winston Lord Winston Labour

My Lords, I declare an interest in that it was my scientific group which started pre-implantation diagnosis—the first attempts to diagnose genetic diseases in embryos in families who have these fatal, sad genetic flaws in them. I congratulate the Minister on his absolutely balanced and fair speech. From time to time, we have not agreed, but I think that his care, compassion and courtesy are deeply appreciated by the whole House. I also congratulate the noble Lord, Lord Deben, on his very clever speech. I do not agree with what he said and I hope that, at other times, we can see why we disagree. I accept that he is talking with deep conviction, but I think that we have already sorted out most of his objections, both the legal and the difficulties of side-effects.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

My Lords, before my noble friend goes any further, I say to him that there are real differences in legal opinion. I do not think that we have quite sorted them out yet.

Photo of Lord Winston Lord Winston Labour

I am very grateful to my noble and learned friend for that.

I want to do something which I have done previously in debates of this kind, which is to talk from personal experience. I may be one of the few people in the House who have sat with an endless number of parents who have a genetic disease in the family, have listened to their problems and have seen the kind of dilemma that they face. I am reminded of the child Jeremy “Martinez”—forgive me if I change the surname, but I do not have approval to give the surname of that patient from some time ago. We were doing in vitro fertilisation and pre-implantation genetic diagnosis in the 1980s, and the first babies, who are now 25, were born in 1990. At that time, we were looking at the very common genetic disorders. It is interesting to consider that there is a vast number—too many, some of us think—of Members of this House. At least 40 of you, on mathematical probability, will carry the fatal genetic mutation for cystic fibrosis. That is very common indeed and much more common than the problem with mitochondrial disease, even though we are beginning to see that it is becoming rather more common as we get better molecular techniques.

What is very clear, and it is very important because it has not been stated, is that the number of families who will be of child-bearing age when a mitochondrial disease is diagnosed will be very few. That is important because we are not talking about a large number of people; we are talking about a small number, but they have a definite problem for which they need some desperate solution. They are prepared to do whatever they think is best for their families, with informed consent.

In the case of Jeremy, he was a bit slow to grow, but by nine months he could not lift his head. He started to vomit; he had diarrhoea; he then progressively developed muscular weakness and started to get epileptic fits. These fits would often go on all night; this child screamed with pain and was uncontrollable; eventually, having gone both blind and deaf, with severe mental problems with his brain, he died at the age of two. There was no treatment. His mother came to see me to ask if there was any possibility that she might have some screening of her embryos in the future. This was in 1989. Certainly, Alan Handyside and I had discussed the possibility of looking at mitochondrial disease, but we did not have the molecular techniques at that time to have any chance of being able to screen an embryo. It is true that that screening has now happened and can be done; indeed, there is a very interesting report from Newcastle University showing how that can be done in some cases. However, it is not always satisfactory, for the reasons that the noble Lord, Lord Patel, stated.

We could not do pre-implantation genetic diagnosis; the lady had another problem. Interestingly, I will say this to the noble Lord, Lord Deben: this lady had had two stillbirths. She had also had a couple of miscarriages. It is quite probable that those losses of life from within her were a result of undiagnosed mitochondrial disease. Of course, we will never know, but these people have reproductive failure rather more often. She therefore had only one choice: her choice was to have antenatal testing, which has become increasingly possible, and now can be rather more reliable than it was then, with either chorionic villus sampling or sampling the fluid from around the baby. Amniocentesis is now done. Of course, if the diagnosis is made, this woman would then be left with the decision whether or not to have an abortion.

I must tell the noble Lord, Lord Deben—because I understand that he is very much against abortion, and I respect that deeply and appreciate that stance that he has made repeatedly—that the reason why women go for pre-implantation genetic diagnosis is mostly because they want to avoid the chance of having an abortion of their pregnancy. That has been the consistent reason with all the cases that we tackled in the early stages of this technology. The other interesting thing is that, although cystic fibrosis is so very common, in fact in the first 10 years of our treatment of this disease, we had only about 12 births, because very few people want to go through with this technology in any case because it is so complicated. We were not charging; it is not an expensive treatment but it was a question of whether they really wanted to go through it.

I remember the first patient, Mrs Edwards, whom I can talk about. She was adamant that she was not prepared to consider another termination of pregnancy because it was so damaging, and she felt that it was morally wrong. I say that facing the right reverend Prelates opposite, because they will understand how clearly that ethical issue is something that these patients consider. I want to make that absolutely clear from the start.

Ultimately, in a pluralistic, democratic society, we have certain ethical principles. We have the principle to try to do good, not to do harm; to arrive at a just solution wherever possible, as doctors; and to respect the autonomy of the individual in front of us. That respect for autonomy means making sure that you discuss the difficulties of the treatment, the possible side-effects, and the risks that you might get the diagnosis wrong. By the way, we made a pre-implantation misdiagnosis. I remember one family that ended up with an affected child in spite of our diagnosis; mistakes can happen medically. That child, remarkably, is still alive, which is very surprising. The family came to terms with that mistake and fully understood that we had taken all possible due care, so there was never a massive issue about that. That was a very remarkable family.

None the less, we have to accept that there is nothing worse than losing your child except one thing: I do not know of a worse injury than losing your child after watching a gradual deterioration and devastating death in pain and discomfort, with the disruption that that means for the rest of that family. That is something that these families do not get over easily; they have to try to find some way out of this. Therefore, I beg your Lordships to understand that we need to consider the autonomy of individual patients who might not share precisely the same values that we have, who may not have the same religious views that we have. I speak very clearly about this, because I understand absolutely that our ethical principles are based on respect for human life. That is something that I absolutely share: we understand from the chapters in Genesisthat we are created in the image of God. We understand also that sometimes we are accused of playing God. I say to the right reverend Prelates opposite—and this is perhaps very presumptuous of me—that playing God is something that we do very properly; it is something that we do by imitatio Dei. We do not try to supplant God, but to augment His works because we feel that that is one way of improving and supporting life and nurturing it. Let us be clear: it is not so much about we do; it is about having the wisdom and the judgment to make certain that we are doing the best we can in these individual cases. We have come to the point now with this particular diagnosis that it is absolutely right to go ahead with the technology that the noble Earl, Lord Howe, talked about in his speech.

Finally, I do not believe—in spite of what we have heard this evening—that this technology threatens the fabric of our society in the slightest bit. It does not threaten the fabric of our society; on the contrary, in a way it protects it because what we are doing is recognising our limits by accepting regulation. We have not said that we are going to go ahead with this; we will have to see what the regulatory authority wants. The noble Earl knows perfectly well that I have some misgivings about regulation in certain areas, but none at all about this. I think that will be shared universally by my colleagues, some of whom are listening to this debate.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench 6:00 pm, 24th February 2015

My Lords, the noble Lord and I agree on much of what he has been saying today. However, in 2013—just two years ago—when he spoke at the Intelligence Squared debate, he said:

“And it’s worth bearing in mind that abnormal children have been born as a result of mitochondrial transfer. This has been completely unpredictable”.

I wonder what, if anything, has happened to change his mind about that. I suspect that he and I are agreed that there obviously are dangers involved in this and safety questions that he will want to address. May I also ask him—and I will not intervene again—whether he agrees with what my noble friend Lord Patel said earlier about the situation in China? I have with me the document Fertility and Sterility 2003, vol. 80, published on 3 September 2003, which was written by Zhang and others, who looked at the procedure that was used in China. Although we were told that this was not cytoplasmic transfer, does he agree with my noble friend Lord Patel, or does he agree with what is here in the statement that this was a pregnancy derived from human nuclear transfer?

Photo of Lord Patel Lord Patel Crossbench

May I comment on that, since the noble Lord refers to me?

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

I did actually ask the noble Lord, Lord Winston.

Photo of Lord Patel Lord Patel Crossbench

I think that the noble Lord was asking him to reply to my comment. He is quite right that China has used pronuclear transfer techniques, but the disaster was upsetting to me.

Photo of Lord Winston Lord Winston Labour

I am very concerned that the noble Lord, Lord Patel, might get into trouble with the Whip sitting on the Front Bench. I am always in her bad books, and I would not want to allow him to be in her bad books as well.

Let me answer the noble Lord, Lord Alton. It is true that, two years ago, I said that it was unpredictable; of course, these things are unpredictable. In the context in which I was speaking, that was correct. To be fair, however, the noble Lord, Lord Alton, knows that, with the case of Jacques Cohen in New Jersey, 17 babies were born after mitochondrial transfer. Therefore, there has been some other evidence—other than that evidence from China—that suggests that this is not quite as daft as proposed. Added to which, of course, in two years, a huge amount of research has been done by our colleagues in Newcastle. They have been working flat out on a whole range of tests which, I think, have made a very big difference. Since the statement that I made in the House, three different committees have looked at the safety.

Science does not have the truth; we have a version of the truth. We have to interpret what we can as best we can.

I deeply respect the noble Lord, Lord Alton, as he knows very well. We both come from a very strong view about what is the right thing to try to do wherever possible. However, I feel here that, apart from the issue of preserving healthy life, if we decide not to vote for the amendment of the noble Lord, Lord Deben, we are doing something really important. We are expressing our concern—our compassion—as a House for people who are faced with an invidious and horrendous choice.

Under those circumstances, given that this will be a limited procedure affecting very few people, it would be utterly wrong for this House to turn down the democratically elected Chamber and not to support what the Government propose.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, at the outset, I have to declare two interests. First, I am the honorary life president of Muscular Dystrophy UK, which, along with the Wellcome Trust and other organisations, has been sponsoring and funding some of this research. Secondly, I have to say that I have an avuncular interest in the department in Newcastle upon Tyne, because Professor Douglas Turnbull, who now holds the chair of neurology in that university, holds the chair which I held 32 years ago.

I say just in passing to the noble Lord, Lord Deben, to whom I listened with the greatest possible interest, that he may not remember that I was the neurologist on the Southwood working party, which advised his department on BSE and produced a report which ultimately led to the disappearance of BSE and its human form, Creutzfeldt-Jakob disease, so he does not need to lecture me about the precautionary principle.

There is one sensitive matter which I feel that I must raise at this stage. I am a lifelong member of the Methodist Church, although I at present attend an Anglican church. I know full well that from the very first day that the whole issue of human fertilisation and embryology came before this House, it was bitterly opposed by the Roman Catholic Church. I do not suggest to either the noble Lord, Lord Deben, or my noble friend Lord Alton that their adherence to and strong faith in the Roman Catholic principles has in any way influenced their attitude to the regulations; but at every stage from the first regulations to allow human fertilisation and embryology to take place, they have been bitterly opposed.

I must confess that I did discuss the whole issue of the status of the human embryo with an old friend, the late Cardinal Hume, whose father was a professor of medicine in Newcastle, Sir William Hume, who taught me briefly when I was a medical student in the early 1940s. Cardinal Hume and I discussed the whole issue, and I told him that I simply could not accept what the Roman Catholic Church has now decreed. Many, many years ago, St Thomas Aquinas said that life did not begin until the foetus was capable of independent existence outside the womb. It was a Pope in the 19th century who decreed that life began at the moment that the sperm entered the egg.

I said to Cardinal Hume that I really could not believe that a small bundle of cells carry the same status in society as a mature adult, and that that was something with which I profoundly disagreed. We discussed it and regularly went on to have a powerful exchange of views and then to decide that we could not agree, but then moved on to discuss a matter of much more mutual concern: the fortunes of Newcastle United Football Club. When, in 1980, the city of Newcastle decided to create a number of new honorary freemen to celebrate its 900th anniversary, among them were me as dean of medicine, Cardinal Hume and Jackie Milburn, the former England and Newcastle centre forward. Cardinal Hume said that it was the greatest day of his life: all his life he had been waiting to meet Jackie Milburn.

I move on from that to say that the whole issue of human fertilisation and embryology and each of the amendments to the Act and new Acts all came under attack from the Roman Catholic Church and its adherents throughout the process. They opposed the whole question of preimplantation diagnosis of serious diseases, such as Duchenne muscular dystrophy, in which I had a particular research interest. They opposed the development of stem cells based on human embryos—bearing in mind, of course, that many of the eggs that were later to be produced from those human embryos were donated voluntarily by the women from whom they were obtained, just as the eggs that are used in mitochondrial transfer have been voluntarily and willingly donated by the women when they were surplus in in vitro fertilisation programmes.

I need to remind the House that in 2008, when we discussed the new regulations and what became the Human Fertilisation and Embryology Act 2008, one of the plain purposes of the Act was to permit regulation-making powers to amend the definition of a permitted egg and a permitted embryo for the purposes of preventing the transmission of serious mitochondrial disease. That was a decision by this House in 2008, and I was heavily involved in the debates at the time and discussed the whole process by which mitochondrial transfer, as carried out by pronuclear transfer in Newcastle, could be used to prevent the birth of children with those devastating diseases.

They are devastating diseases. I diagnosed many such patients in my time as a neurologist in Newcastle and elsewhere. Epilepsy, muscular paralysis, dementia, blindness and deafness can result from mitochondrial mutations. The problem always was that women carrying those mutations would pass them on to all their children of either sex. Of course, the results were variable, and still are. Some of those diseases are devastating and produce death in infancy. Some are much less serious, but none of them is treatable, except by supportive treatment. None of them can be cured by any form of treatment.

In 2008, I tabled an amendment stating that “a licence may provide”, with the intention at the time of seeing whether we could accept that the HFEA could at that stage issue a licence to legalise the process. It was made clear to me that it was premature, and that much more research was necessary. That research has been done over the succeeding seven years in Newcastle and elsewhere. The researchers have worked tirelessly and produced a substantial number of embryos by pronuclear transfer, embryos which gave every evidence of being totally normal—the only problem being that, until regulations such as these are passed, it is illegal to implant them into a uterus to allow children without mitochondrial disease to be born.

I believe that the time has come. I talked to so many of the women who carried the mutations. I talked to so many of their families. The agony and distress that they experienced, knowing that any children that they had would carry those devastating diseases, was pitiful and caused me very great concern. I have to say that I now firmly believe that the work has been done: all the research has been done, the consultations have been widespread. The Nuffield Council on Bioethics, along with the expert committees, has issued a series of completely positive reports. All the organisations in the medical profession, starting with the BMA, the royal colleges, the Medical Research Council and the Association of Medical Research Charities, are universally in favour of accepting the regulations at this stage, because they believe that the consultation, along with the research, has probably been the widest, most comprehensive and most detailed that has happened in the case of any medical procedure in history. I believe that very strongly, and I cannot stand the thought of now extinguishing the hope of these women and families, who believe that this procedure will allow them and their offspring to have normal children without mitochondrial disease. For that reason it is crucial that these regulations should now be passed. It is not the end of the story, because once the regulations are passed in this House no procedure to implant these embryos can be carried out except under a licence from the HFEA. Every individual case will be considered. That process will be there to provide the protection that many doctors and Members of this House appear to need. However, the time has come when we must move forward.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour 6:15 pm, 24th February 2015

My Lords, this has been an extraordinary debate. We have had a feast from the best in the medical profession on all sides. It is clear that there is real agreement and empathy about the need to make a difference for those women who suffer so perniciously in relation to mitochondrial difficulties. There is also consensus on the need to do something to relieve that suffering and pain. There is no dissonance between any of those who spoke, although they differed on what we should do about it. Perhaps the calm voice of reason, if I may respectfully say so, came from the very balanced intervention of the right reverend Prelate, who, with great modesty, rejoiced in the fact that for once the Church of England could agree with the noble Earl, Lord Howe, about something of real importance. Therefore, there is no disagreement about the need to do something.

I congratulate the noble Lord, Lord Deben, on giving us the opportunity for this debate. He is right to say that had he not tabled the amendment, which has exercised so much of our attention, we would not have been able to take advantage of the House’s wisdom. The real question raised by the amendment of the noble Lord, Lord Deben, is one of timing. I listened with great care to the very fair, very balanced and exemplary introduction of the noble Earl, Lord Howe. It came to this. We have now all worked extremely hard, the election is upon us and we have no idea of the complexion of the next Government. Therefore, carpe diem—do this now. The right reverend Prelate the Bishop of Carlisle fairly raised this question. But for that election, would we now be in such haste? The concluded results of the research would normally be waited for. An opportunity for real debate would be seized.

I, like all Members of the House, have been bombarded by emails and letters of all complexions on this issue. What surprised me as a former law officer was to see who agreed and who disagreed. There is a view that if you have three law officers in a room you might get five different results. Therefore, it was with real surprise, and a little concern, that I noted that both of my successors in title, the right honourable Dominic Grieve and Her Majesty’s current Attorney-General, did not agree that this regulation should go through now. That gave me—I do not know about any other noble Lord—real pause. Why would my two successors in title disagree on the timing? I therefore looked first at the explanation that the current Attorney-General gave to his constituents. It is probably fair that this House should have the benefit of it. He said:

“This week the House of Commons debated and decided to approve regulations allowing mitochondrial donation, a process of replacing a small amount of DNA in cells in an egg or embryo to avoid the child which will later be born suffering from genetically inherited mitochondrial disease”.

He went on to say:

“First let me set out where I think there has been general agreement. This is a difficult decision to take. Everyone will have huge sympathy for parents who know their children will inherit this severe disease and are desperate to pursue treatments which can help them to have a healthy baby. They have every right to make their case for this change. Similarly, we all admire the hard work and ingenuity of scientists who have developed these techniques with intention of combating genetic disease”.

I warmly agree with that statement. We have scientists in our country who are second to none. He continued:

“However, legislators have to consider not just individual interests but the interests of our society more broadly and should consider too what precedents are set and what lines are crossed by the laws and regulations we make. Different legislators will of course reach different conclusions on these questions and views may change, but I am not persuaded this would be the right thing to do now”.

That view was clearly shared by Dominic Grieve, because both voted against the Motion in another place. That is why I was worried. Why did my two colleagues disagree? Why were they not comfortable with this position? I looked at the science and had the most wonderful explanation—I will not call it a lecture because it was a delight—from my noble friend Lord Patel when we were in Doha of the differences that made this such a safe and necessary option. Here, on our Benches—they now sit together—are two of the best members, I respectfully suggest, of the medical profession. They, too, are urging us to go on. Why, therefore, were my two legal colleagues so concerned? I looked for myself. Did they have a point? Was there a legal problem that was not being faced? I regret to say that there is.

This issue is complex and difficult because it is an issue that is not just centred on ourselves. The European dimension is also important. One of the reasons why I understand this issue so painfully well is that I had the advantage of being the UK’s advocate when we were arguing about the charter between 2001 and 2003. I therefore looked again at the regulations. I wanted to understand them better. I must ask the noble Earl, Lord Howe, why he is so certain that these rules comply with the European legislation and why the Government are confident that the concerns expressed by both the current—

Photo of Lord Hope of Craighead Lord Hope of Craighead Judge 6:30 pm, 24th February 2015

I am very grateful to the noble and learned Baroness for giving way. Can she explain to the House what advantage there would be in referring the matter to which she is now addressing her remarks to a Joint Committee? Take, for example, compliance with the statute that already exists where the regulations are ultra vires. Surely that is a matter for determination by a judge and nothing that your Lordships can say in the House today, or indeed that a Joint Committee could say in its report, would resolve that issue in a way that would tie the hands of a court. I rather suspect, although her knowledge is greater than mine, that the position is exactly the same in Europe. Therefore, I cannot see that referring the matter to a Joint Committee, as the noble Lord, Lord Deben, asks us to do, would advance it except simply to delay the decision on the issue, which would ultimately have to be taken by a court.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

My Lords, the issues in relation to how the charter impacts upon the legislation that we are discussing have not been sought out, have not been argued and have not been developed. One of the essential issues, if we are to do something which everyone agrees is novel, different and important internationally, is that we have to be confident that we are on solid ground because if we are not, we give a disservice. There are two things. One is that the research that is still awaited and, as was mentioned by the right reverend Prelate, is to be forthcoming should be available. The second is that these issues in relation to the charter could be properly articulated. I looked quite carefully to see whether this has already been done. Had that already been looked at, and was there an answer in the letter of the 17th that the noble Lord issued? Were all the worries that I have—I am afraid that there are about 20 pages of them—dealt with? However, they have not been. So the question comes back: why the haste?

Everybody agrees that we have to get this right and having worked so hard and so long, and knowing of the pain that many have already spoken about, what a cruel thing it would be to do this and then say that the legal basis upon which it was founded was flawed. The noble and learned Lord, Lord Hope, is right that if in the final analysis the arguments we articulate and which go through the Select Committee are not sufficiently sound, the only way in which the sagacity and value of these legal principles can be tested would be in a court. That is what would happen.

Photo of Lord Hope of Craighead Lord Hope of Craighead Judge

Does the noble and learned Baroness also agree that until the regulations are made, the matter cannot be tested because courts do not deal with hypothetical arguments? They regulations have to be made, so if this issue is to be properly tested in a court the first step is to make the regulations.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

My Lords, there are two steps. I would argue that the first step is that if a Select Committee is able to deal with all these matters the proposal currently before us in draft, and which would today go into regulations, would be the basis of the Select Committee’s examination. If that basis is found to need some minor alteration or amendment, it would be that amended version which would then come before this House and form part of the regulations. That would be the issue that would likely be tested if there was still disagreement.

My hope would be that the concerns that have properly been raised could be dealt with by the Select Committee, particularly if we were to persuade some of the noble and learned Lords who had perhaps served in the Supreme Court in the past to lend us some of their expertise on that Select Committee. One of the advantages that we have in this House is of having that level of expertise. That is why we could do this in rather a short compass. First, I do not agree with those who think that this issue should be kicked into the long grass. It should not. Secondly, I do not believe that a Government of any complexion, as has been said in this debate, who had a very well reasoned and consensual Select Committee report would hesitate from implementing it.

Photo of Lord Willis of Knaresborough Lord Willis of Knaresborough Liberal Democrat

Does the noble and learned Baroness agree that if the regulations were agreed today, and therefore passed, the HFEA itself would have the opportunity to test the legal opinion? It certainly did that with the cytoplasmic hybrid embryos, if we go back to 2007. The HFEA then took a series of legal opinions to inform it in its opinion against the Government at that time. Why cannot that process go on at the same time?

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

The real issue is whether we are going to abrogate our own responsibility. Is this something which we should ask an outside agency to do? Should we make a decision where we cannot come to a fully informed and articulated decision ourselves? If we are left in the position of saying, “I am not entirely sure about the research or the sagacity of the legal principles being advanced that enable me to pass this”, surely we should wait until that is clarified. If the House believes that it wishes to abrogate that responsibility because the nature of the issues we are dealing with are such that we feel comfortable about doing that, then of course that is always a matter for us. But I simply argue that what is being asked for is what I hope to be a relatively short period for these matters to be fully considered and fully put to rest.

I am very conscious of time but there are a number of arguments that we could put forward on the law, which would help to further exemplify that this matter is not easy. It is complex. The reason I emphasise that the law officers are disagreeing is the following. All law officers are in the same position. We are not here to tell people what they want to hear; we are here to tell them what they need to know. That should be valued by the House and I am sure that the House would want to be confident that doing this, which everyone hopes would be a good thing, should be lawfully done, too.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, one of the bases of my noble friend Lord Deben’s amendment to the Motion is this question of whether these regulations are lawful. I have studied quite carefully the opinion of the noble Lord, Lord Brennan, with a junior. I have seen other opinion as well but I am thinking now only of my own analysis of what the noble Lord and his junior said.

The first point is: is this lawful under the domestic law of the United Kingdom? My answer is that it is clearly lawful because, in 2008, this Parliament passed an amendment for the purpose of allowing such regulations to be made. That is as clear as it can be, and you do not need to be a lawyer to think that it is possibly quite a good point. The result of the opinion that the noble Lord, Lord Brennan, has given on this point is that that amendment would be held to be pointless. The courts are not very keen on reaching a conclusion that a deliberate action of Parliament is without point, so I feel very strongly that these regulations in draft are lawful, within the domestic law of the United Kingdom.

Now we come on to the complexities of the European law. Like the noble and learned Baroness, I have had some experience, now long past, of appearing before the Court of Justice in Luxembourg. Masters of complexity are very difficult to find at a greater level than it has. The essential point about this, however, is very clear. If the noble Lord, Lord Brennan, is right, it is not a question of these regulations being wrong; it is that the whole procedure that they are aiming to do is unlawful according to European law. That is fundamental.

I do not believe that it is correct, because I do not think that the European Union has a treaty basis if we are dealing with medical procedures in the member states. The regulations that are referred to in great detail—huge definitions and all the rest of it—are intended to deal with the furtherance of the common market. Therefore, if you get a tablet in Germany that is supposed to be suitable for you, then it would be equally suitable in this country—

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

Can I just help the noble and learned Lord by saying that the thing that concerns me is Article 6.3 of the treaty and the way in which the charter has been incorporated to consolidate all the other European laws that were there before the making of the charter? It was the charter itself, and the way in which it has changed things, which makes the difference. I am not focusing primarily on the issues that have been referred to by my noble friend Lord Brennan in his opinion. I am really looking at those issues that arise as a result of the charter. I do not believe that their proper interpretation has been dealt with. I know that the House will not like me very much if I go through the whole charter, but I am very happy to share the issues which really concern me with the noble Earl, Lord Howe.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

So far as I have understood the European treaties, they do not confer an authority as yet to interfere in the medical procedures within the member states. That is basic, and means that they cannot interfere or render unlawful a medical procedure such as the one proposed in these regulations. I could go into the detail of it—I am sure that would not be very acceptable—but I have two principal reasons for thinking that that is right. The first is that no challenge, so far as I know, has been offered by the European Commission to the provisions in the 2008 Act—which of course would be the right place to challenge this, if it were unlawful. This provision was definitely intended to make these regulations possible. The second reason that I advance is that in the opinion of the noble Lord, Lord Brennan, a reference is cited to a treaty dealing with these matters which is outside the European Union. It has a number of members of the European Union as signatories, but it has not been signed by the United Kingdom, nor ratified of course by the United Kingdom, so it is not part of our law. That is the kind of law that deals with embryology in a way that might have been difficult for us if it had been part of the European Union.

These are simple reasons why I think this situation is reasonably clear. Of course, I accept that the law officers have taken a different view. We have not had a chance of discussing it in detail with them. The other point I have to make is that no amount of discussion in a Joint Committee can settle this matter. The only place it can be settled is in a court of law, either the domestic courts of the United Kingdom or, if necessary, the Court of Justice of the European Union in Luxembourg. In a sense, if that is a real point, the sooner the regulations are passed the better so that they can be tested.

So far as the point made by the right reverend Prelate is concerned, I understood that the research that the HFEA was asking for has been done and is in the process of publication. It just does not happen to have completed publication. As he was speaking I was reminded that when I had the responsibility of taking the 1990 Act—the original Act in this area—through this House, the then Bishop of London took quite a prominent part in the discussions. His watchword was caution—and he thought that that amount of caution had been built into the procedure by having the HFEA examine individual cases and be in charge of the licensing.

Photo of Baroness Hollins Baroness Hollins Crossbench 6:45 pm, 24th February 2015

My Lords, I take a rather different view from some of my eminent medical colleagues. I have worked for over 30 years with families of severely disabled children. As a psychiatrist—and as the mother myself of a child born with a severe developmental disability—my heart goes out to those parents facing the prospect of inherited mitochondrial disorders. As a mother, I understand what is called the moral imperative to try to help. However, our first responsibility must be to the children who may be created through these proposed interventions: the most important moral imperative must be to do no harm.

A new technology of such potential importance must take as long as is needed to be as sure as possible of its safety. Being first is not always best. I have carefully read the HFEA 2014 review of scientific methods. It has been implied that the scientific reviews have not raised any concerns, but in paragraph 3.7.25 the review states,

“although the results with the two techniques continue to be promising, further experiments need to be carried out before introducing either into clinical practice to provide further reassurance about efficiency and safety”.

I asked a Written Question in December asking whether clinical trials were being planned and I am grateful for the helpful reply from the Minister and the mention he made of it in his opening remarks—although I disagree with his interpretation of medicine, which is defined much more broadly in the European directive. The Minister also explained that,

“for any new IVF technique there will need to be careful monitoring of the procedure and, subsequently, any pregnancies”.

But we are not talking about pregnancies primarily; this is me as the psychiatrist talking now. As the noble Lord, Lord Deben, pointed out, we are talking about children—children who will, we hope, grow up to be healthy human beings, and who will themselves be able to have healthy children. But what if they do not?

In paragraph 3.7.29 the HFEA expert panel said:

“Until knowledge has built up that suggests otherwise, the panel recommends that any female born following MST or PNT”— maternal spindle transfer or pronuclear transfer—

“should be advised, when old enough, that she may herself be at risk of having a child with a significant level of mutant mtDNA, putting her child, and if female, subsequent generations at risk of mitochondrial disease”.

The science is complicated, but there is apparently a real possibility that resulting embryos from a woman born after MST or PNT could be heteroplasmic—

Photo of Lord Patel Lord Patel Crossbench

May I ask the noble Baroness what experiments she would propose to determine that the children born through this procedure will be healthy in every way, including reproduction-wise?

Photo of Baroness Hollins Baroness Hollins Crossbench

My Lords, I do not think that intervention is very helpful as it is not relevant to the point I am making. The issue of heteroplasmy was spoken about earlier, and it simply means two or more different mitochondrial DNA types coexisting in a single cell. The review panel concluded:

“These levels may still not be sufficient to cause her children to have a problem, but subsequent generations could be affected”.

In paragraph 4.3 the panel stresses that,

“it should be accepted that there will always be some risk and unknowns associated with the use of MST or PMT in humans until it is tried in practice”.

I understand that and agree with it.

One argument for agreeing the recommendations now is to enable the HFEA to license these techniques as soon as it is convinced that there is sufficient evidence of safety without then having to seek parliamentary approval, thus possibly delaying implementation. In 2008, Dr Evan Harris, the former Member for Oxford West and Abingdon, a champion of the 2008 Act, said:

“Safety is clearly a concern… If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations”.—[Official Report, Commons, Human Fertilisation and Embryology Bill Committee, 3/6/08; col. 35.]

Agreeing the recommendations now seems to be putting the chicken before the egg. Supporters of the techniques—

Photo of Viscount Ridley Viscount Ridley Conservative

The noble Baroness made the point that heteroplasmy, and therefore the carryover of the diseased mitochondria, is possible under this technique. Does she agree that experiments show that the likelihood is less than 5%, whereas pre-implantation genetic diagnosis has it at up to 40%? That is a legal procedure, so we are talking about trying to legalise a safer procedure than something that is currently legal.

Photo of Baroness Hollins Baroness Hollins Crossbench

Again, I do not think that is the point that I am trying to make. Maybe I am not being quite clear enough.

Photo of Lord Tebbit Lord Tebbit Conservative

Would the noble Baroness not agree that there is only one absolutely safe way to ensure that this disease is not handed down from generation to generation, and that is for those women who are carriers of the genetic fault not to have children? That may be an appalling thing for me to have said, many people would think, but there are many people who for various reasons cannot have children.

Photo of Baroness Hollins Baroness Hollins Crossbench

That is a good point.

Supporters of the techniques simplify the impact of these proposed procedures by saying that mitochondrial donation is like changing a battery. Their argument runs that mitochondrial DNA relates only to power production in the cell but does not affect the DNA, which encodes our characteristics, and therefore that exchanging mitochondria should not be seen as ethically significant. In a debate last September, the honourable Member for Havant in another place summed up this position well when he said that the techniques represented,

“a change in the membrane of the cell so that the battery function continues, but it does not affect human identity even by 0.1%. That is why I do not believe that there is an issue of dignity or integrity of the individual”.—[ Official Report , Commons, 1/7/14; col. 98.]

The Government underlined how important this point was to their policy in their consultation response when they said:

“Most importantly, mitochondrial donation techniques do not alter personal characteristics and traits”, of the person, the implication being that if this technology were to affect personal characteristics then the Government would withdraw their support.

So the ethics and the safety of the science are inextricably linked. Unfortunately, it seems that we are still at the beginning of understanding the complex interactions between mitochondrial and nuclear DNA. Some recent empirical studies on animals have suggested that mitochondria indeed affect characteristics, and that there is a relationship between mitochondria and memory, temperament and behaviour. As a psychiatrist, I see temperament as a personal characteristic, and I think it was for that reason that the New Scientist withdrew its support for the techniques. In an editorial last year it said that,

“we may have seriously underestimated the influence that mitochondria have. Recent research suggests that they play a key role in some of the most important features of human life”.

I note that the Government’s own consultation document acknowledged the diversity of problems associated with mitochondrial disease, including learning disabilities, neurological problems, autonomic dysfunction and dementia, and that every person’s symptoms are different. The Government’s response to the consultation concluded that they do not alter personal characteristics. One problem that I have with the current proposals is the idea that mitochondria are mere batteries, which is what has been quoted in so many of the papers that have been circulated to Peers. The New Scientist leader comment in September last year said that most debate around the issue had worked on the assumption that mitochondria were simply cellular powerhouses. However, given their newfound influence over our bodies, the implications of this technology may be far more radical than we have assumed. The leader made the point that it seems that mitochondria, far from being passive power plants, influence some of the most important aspects of human life, from memory and ageing to combating stress and disease. They even have influence over the DNA in your cell nuclei and change and evolve during your lifetime.

I have been inundated by emails, as I am sure we all have, from people who are concerned. I had an email from a cell biologist working in California, Professor Paul Knoepfler, who contributed to the HFEA’s call for evidence. He said that,

“mitochondrial transfer might be proven safe, but then again it might not. From my perspective as an impartial (scientific) observer … putting myself at some risk by publicly opposing this technology … its approval at this time would be a … risky gamble with children’s health and lives”.

He says that many scientists have told him that privately they share his concern.

I have one question for the Minister: would he withdraw his support for the regulations if he thought that the role of mitochondria was more than mere power production? Would he then support the amendment of the noble Lord, Lord Deben, for further consideration of this matter?

Until recently, the Wellcome Trust had on its website a statement suggesting that the procedure would be able to go ahead in late 2014, when the science was ready. But is the science ready? I am not quite convinced yet. As noble Lords may be aware, I chair the BMA board of science, which has not yet discussed this matter. I have discussed my support for the noble Lord’s amendments with senior officers of the BMA, and perhaps I may clarify the BMA’s position. Its support for the principle of such reproductive technologies has been expressed as an ethical principle to allow the cautious exploration and development of such technologies. I have concerns about the timing of these regulations, and for that reason I welcome the opportunity to debate them presented by the noble Lord, Lord Deben.

Photo of Lord Ribeiro Lord Ribeiro Conservative

My Lords, we have heard from legal and medical experts. I am happy to say that I am not an academic and I know very little about the subject. However, it strikes me that if we look at the practicalities from the point of view of the parents who are afflicted by this condition, and we turn back to 1978 when baby Louise Brown was born as a result of the in vitro fertilisation undertaken by Steptoe and Edwards—

A noble Lord:

In Oldham.

Photo of Lord Ribeiro Lord Ribeiro Conservative

In Oldham—quite right. From that one invention, nearly 5 million children have been born who otherwise would not have been because their parents were infertile. There was a strong religious lobby against it at the time; indeed, a lot of people were against it because it was interfering with the genesis of life. This fatal Motion seems to carry some of that feeling with it.

I am a mere surgeon. I had the opportunity to visit the Lister Fertility Clinic with a parliamentary group to learn a bit more about IVF and how it was carried out. I watched the technicians—not the doctors—who had gained expertise in intracytoplasmic sperm injection. That is the technique whereby you isolate the egg, find a lively sperm and then inject it straight into the cytoplasm. The technique that has been suggested for mitochondrial donation is not dissimilar from that. A lot of expertise has been gained over the years when that has been done. I heard the noble Baroness, Lady O’Loan, and, I think, my noble friend Lord Elton refer to the situation of donors.

Photo of Lord McAvoy Lord McAvoy Opposition Whip (Lords), Shadow Spokesperson (Northern Ireland), Shadow Spokesperson (Scotland)

The noble Lord seems to be saying that there is no difference between IVF and the mitochondrial process. However, IVF does not require the genetic modification of human eggs and embryos, or tampering with the contents of the egg or embryo itself. This technology requires both.

Photo of Lord Ribeiro Lord Ribeiro Conservative 7:00 pm, 24th February 2015

I take the noble Lord’s point. If I wanted to, I could explain why this is not an issue. One point that arises is that it is illegal to tamper with the nucleus. The technique that we are discussing relates specifically to mitochondria.

I will move on. Having seen this technique at work in the clinic, I am absolutely reassured that the expertise is there and, therefore, that the technique of mitochondrial donation, if allowed, could be carried out successfully.

I will speak briefly about the families who are currently facing the prospect of having children with severe mitochondrial disease. We are told that the numbers of those who will have severe disease is in the order of 10 or 20 per year. This technique can be fully utilised only after the regulations have passed, the HFEA has ensured that it is safe and each unit has demonstrated that it can do it safely. Only then will these families be able to have this done.

Informed consent is a prerequisite in any medical procedure. Informed consent is important because patients have to be sure that what they are having done is in their best interest. They have a choice of whether to accept what the doctor is offering or to reject it. My noble friend Lord Ridley referred to Claire Wright, a mother who lost a baby at 18 months. I was fortunate to meet her yesterday and to hear her story. What she said to me was very moving and touching. If she had the opportunity to have mitochondrial donation done, her concern was that the clock was ticking and that she may have reached the point where she would no longer be able to undergo the procedure. Yes, she could remain childless. Yes, she could adopt. But she would like to have a child that bears some of her genetic characteristics. I think that this technology will allow that to happen.

Nothing that we have in medicine at the moment can provide 100% safety—

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

I am grateful to the noble Lord. Before he moves on, I want to speak to his point about adoption. Your Lordships will have seen the recent parliamentary reply on this. In the past five years, around 5,000 newborn babies have been available for adoption. That is all, compared with more than 1 million babies that have been aborted during that period. Does he not think that we should be much more interested in seeing if we can put right that imbalance?

Does he also recognise that there is a difference between the two techniques that are being offered to the House today, maternal spindle transfer and pronuclear transfer, in that one requires the destruction of human embryos, 2 million of which have been destroyed since the original legislation was enacted in 1990, and the other does not? On the basis of what I think he believes and says, is it therefore not only more prudent but more ethical to use the technique that does not result in the destruction of human embryos?

Photo of Lord Ribeiro Lord Ribeiro Conservative

It was made very clear by the noble Lord, Lord Patel, and others that the need for the two techniques is to allow the HFEA to make a decision on which is the preferable technique. We have a situation at the moment where many of the embryos that are produced are discarded after the 14 days or so that are allowed. I will not go into the question of adoption. It is a matter of choice. If the family would prefer to have a child without this affliction, that is their choice, and they may not choose to go down the adoption route.

Returning to the subject of safety, as has been stated, no procedure can guarantee 100% safety. Even the natural birth that we all go through will produce children with defective genes and abnormalities; even nature cannot get it 100% right. To expect a situation where we have to demonstrate to all and sundry that this procedure is 100% safe is impossible.

Finally, it is important to recognise that passing this regulation is not opening Pandora’s box. We are not going down the route of eugenics and we will not create monsters. We must trust the scientists. We must recognise that we have regulation in this country—one of the most regulated countries in the world in the health field—and I believe that we must leave it to them to make the case. As was said by my noble and learned friend Lord Mackay of Clashfern, the decision was already made in 1990, when he was responsible for taking the Bill through Parliament. In 2008, it was modified with the full understanding that this type of technique might well be brought into use.

The day has come, the time has come and, frankly, we must just get on with it.

Photo of Baroness Warwick of Undercliffe Baroness Warwick of Undercliffe Labour

My Lords, I come to this debate without any expert legal or medical experience or perspective. As a former chair of the Human Tissue Authority, I worked closely with the Human Fertilisation and Embryology Authority, the well established regulator in this area. I came to know the way in which it regulated and certainly had confidence in it, as indeed Parliament has. As a former chief executive of Universities UK, I am also familiar with the research trials that are rigorously and vigorously undertaken in health research before any change or new technique is introduced into clinical practice. I have come to know the bodies which speak for science and for medical research, such as the MRC and the Royal Society, and the Association of Medical Research Charities, of which my noble friend Lord Turnberg has been a scientific adviser, as well as the Nuffield Council and the Wellcome Trust. I realise how fortunate we are in this country to have pre-eminent organisations, respected around the world, the main aim of which is to ensure that research is rigorous, honest, thorough and ethical. I say all this because I take great comfort in the fact that, where there are complex areas of science or new techniques, particularly where they might be controversial—as with fertility and genetics—we have the knowledgeable, forensic and wise guidance of these bodies to help us in Parliament to arrive at secure solutions.

Mitochondrial DNA disease is severe. In most cases, we are told, it causes early infant death, and the few children who survive suffer multiple health problems. Mitochondrial donation, a new reproductive technology developed by our world-leading scientists in Newcastle, is important because it enables families affected to have a healthy child. Our decision today will be immensely important to those families.

A key question has been raised about the safety of the procedure. As others have said, while no medical procedure can be guaranteed to be 100% safe, a huge amount of testing has been done to establish the relative safety of this particular procedure.

I have no professional expertise in this or in any other area of disease. So, like most other women and men in the street, I rely on the rigour and competence of our regulators, ethicists and clinical testing systems to provide the best possible guidance on new techniques and procedures, to enable me to make up my mind—even if some of the evidence is contradictory. All the bodies that I referred to earlier, and others which represent the families of those tragically affected by the disease, favour this regulation to permit mitochondrial donation. They have provided excellent briefings, and there was a hugely helpful seminar yesterday where experts on different aspects of this issue addressed a range of concerns. They have pointed to seven years of intensive scrutiny, three separate reviews of the scientific evidence on the technique’s safety, independent ethical reviews and an extensive public consultation. Currently, the law allows for these techniques to be used only in research. It is up to us in Parliament to decide whether these techniques are ethical and whether they may, with safeguards, be used in patients.

The Nuffield Council on Bioethics found that, given the benefits to individuals if shown to be sufficiently safe, the techniques are ethical for families to use. The public, during consultation, concurred. The Wellcome Trust has helpfully set out the scientific evidence and detailed reasons why the procedure cannot be seen as genetic modification. What is very clear is that scientists throughout the lengthy period of research have been open and transparent. Nothing has been hidden, including their disagreements. There has been no conspiracy, as some of the critics seem to have suggested.

I found that I had a lot of sympathy with my noble friend Lord Turnberg and the noble Viscount, Lord Ridley. All the evidence I have seen and the arguments I have heard reassure me that this is not a slippery slope or an open door, or any other cliché. Nuclear DNA is not altered, so donation will not affect the child’s appearance or personality, or its uniqueness. It will simply allow parents to choose to have children who are genetically related to them but who are free from potentially devastating disease. I trust that the House will support these regulations.

Photo of Lord Taylor of Holbeach Lord Taylor of Holbeach Captain of the Honourable Corps of Gentlemen-at-Arms (HM Household) (Chief Whip, House of Lords), Deputy Chairman of Committees

My Lords, it is a rule of this House that only one person speaks at one time. I ask noble Lords to be seated, please. We are in some difficulty. A number of noble Lords still want to speak. I understand that; this is a serious matter. Perhaps I might suggest to them that they will attract the approval of the House if they keep their remarks brief. Most noble Lords have come here with contributions to make, and they are speaking from extensive notes. It would help us all if we could move this debate to a conclusion; many noble Lords have indicated that to me. Therefore, while I do not for a moment suggest that we move to that stage now, I ask noble Lords to be orderly in allowing others to speak and to be brief.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I am grateful to the House. Although of course I have ethical objections to the regulations, which are well founded and have been pretty well rehearsed on previous occasions, the Motion in the name of the noble Lord, Lord Deben, does not invite us to vote on the ethics. Therefore, accepting what the noble Lord, Lord Taylor, has just said to the House, I will not explore those ethical issues today but will stick to the points that the noble Lord, Lord Deben, raised earlier on, which concentrate on safety, legality and definitions. In supporting the Motion I want to address three points: procedure, pertinent questions and the specific issues posed by pronuclear transfer—one of the techniques made legal by these inappropriately combined regulations. It is worth saying in parenthesis that there is a third technique, polar body transfer, which was referred to during the discussions that the noble Earl was good enough to arrange for a group of us to have. That is being explored at this time, and will require yet more regulations to come before your Lordships’ House.

A noble Baroness:

So it should.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

Yes, and so it should, as the noble Baroness says. However, why are they not being taken together, why is there a hurry, and why are we not considering them all at the same time? Some raise particular issues, and others raise different issues, so many of us find that being asked to take it or leave it today is very difficult.

Some 41 Members from all sides of the House of Commons have written to your Lordships asking us to provide the opportunity for further consideration to be given to these regulations. For 18 years I served in another place. I would have been appalled if only 90 minutes had been provided during my time there, when we discussed in 1990 the original legislation or subsequent changes to it—90 minutes on unamendable regulations. Half the House of Commons—300 compared with 350—either voted against or abstained: 128 voted against, 172 abstained, and 300 voted for. As the noble and learned Baroness, Lady Scotland, said to us earlier on, the Lord Chancellor—and we have heard from an eminent and very learned noble Lord today, a former Lord Chancellor—and the Attorney-General both voted against the regulations. Subsequently, we have received representations from 50 Members of the European Parliament—I say to my noble friend Lord Walton that they were not all Roman Catholics—including Socialists, Christian Democrats, Communists, Greens and others, and internationally respected scientists, challenging the safety and the legality of what we are being asked to approve. Last week Professor Christopher Exley, a British scientist, described these procedures as,

“a genetic experiment which could have disastrous consequences for generations”.

That is not a religious view. This requires us to take the moderated view that the right reverend Prelate the Bishop of Carlisle commended to us earlier on. Yet, procedures permitted only a 90-minute debate in the Commons on an unamendable order, and if it were not for the noble Lord, Lord Deben, today, we would not have the opportunity to be discussing these complex questions—

Photo of Baroness Farrington of Ribbleton Baroness Farrington of Ribbleton Labour 7:15 pm, 24th February 2015

As a point of fact—and I hope that the government Chief Whip will agree with me—we would have debated this order in this Chamber under the normal procedures of this House with or without the amendment that was put down, because that is the practice of this House. I can see the government Chief Whip nodding and the noble Baroness who chairs the Delegated Powers Committee agreeing.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

I am glad to hear what the noble Baroness, Lady Farrington, has said to us today. It is important that it should be on the Floor of this House, therefore we are all agreed. I contrast the 90 minutes given to the House of Commons to discuss this with the 90 hours that Parliament spent discussing fox hunting. I ask noble Lords to contrast those things. We are required to show due diligence and scrutiny, especially over controversial legislation.

It is not just the absence of the preclinical tests recommended by the HFEA that suggests that the cart has been placed before the horse, but the disingenuous decision by the clinic promoting these regulations—even before your Lordships have debated, let alone approved, these regulations—to offer women money, as we heard from my noble friend Lady O’Loan earlier on, to sell their eggs for these procedures, a practice which itself can be injurious to their health, while telling us:

“It was never about politicians voting on whether it was safe or not”.

That seems almost a contempt of Parliament, and is certainly an extraordinary dismissal of health and safety considerations, which everyone has admitted this afternoon are a consequence of what we are being asked to agree. We have a duty to satisfy ourselves about questions of public safety.

I have experienced this afternoon something of a sense of déjà vu on the arguments, which are so reminiscent of those which persuaded your Lordships to vote for animal/human hybrid embryos in 2007. Although my noble friend Lord Patel, who I think is about to intervene on me again, said earlier on that there was a significant breakthrough by Professor Shinya Yamanaka just two weeks after the Bill passed, that is not entirely accurate. The Yamanaka breakthrough came in 2006 in the journal Cell, not after the Bill passed but before it was even published. If you look back at the Hansard, as I hope Members will, I argued repeatedly that the proposal was redundant because of the Yamanaka breakthrough and that we should not have voted for it. However, despite the Yamanaka breakthrough, many argued that animal/human hybrid embryos were necessary.

Before we rush pell-mell into authorising something which the rest of the world—from the federal agency in the United States to the People’s Republic of China—has prohibited, may I ask the Minister to answer some pertinent questions? First, what regard has he had to the increasing demand for women to give up their eggs for these techniques, the failure of the HFEA to monitor the drugs and dosages used for ovarian stimulation, and published data by Newcastle indicating an incidence of hospitalisation due to such stimulation due to the frequent collection of more than 20 eggs per cycle? Does he regard it as ethical to ask women to sell their eggs for £500?

Secondly, what is the cost of these regulations, both human and financial, when pronuclear transfer—the second of the procedures that have been referred to— requires the destruction of at least two and in some cases 10 healthy embryos for every procedure? Contrast the financial cost, too, of an issue I have raised regularly on the Floor of your Lordships’ House; namely, the failure to provide vital and much needed public funding into finding a cure for diseases such as mesothelioma, which will take the lives of 60,000 British people in the next 30 years.

Thirdly, and more specifically, why have the Government not waited for the outcome of the HFEA’s recommended preclinical experiments before proceeding? Fourthly, like noble Lords today, Dame Sally Davies, the Chief Medical Officer, said at a meeting that I attended with the noble Earl:

“No one will guarantee that it is safe”.

That being so, and given the absence of safety trials, how much has the National Health Service set aside for compensation if safety fears are realised? One recent payment to the parents of a baby damaged at a hospital reached a staggering £10 million.

Finally, I turn to the specific issue of pronuclear transfer. These regulations have bundled together two different procedures. As I said, pronuclear transfer—PNT—unlike maternal spindle transfer, requires the destruction of human embryos. It is a technique that has been specifically advocated by researchers at Newcastle. To date, most applications of this technique have been in mice. However, the Weatherall report of 2006, sponsored by the Academy of Medical Sciences, the Royal Society, the Wellcome Trust and the Medical Research Council, on page 85 stated the following:

“Humans and non-human primates share many features of reproductive biology that are not present in other mammals … Hence, rodents and other non-human primates have only limited usefulness as models of human reproductive physiology”.

Consistent with this, the report of the HFEA’s expert panel in April 2011 said that before the technique could be considered safe to use clinically, it was critical to undertake,

“PNT in a non-human primate model, with the demonstration that the offspring derived are normal”.

Has this been done? Nearly four years later, the answer is still no—even though most postgraduate researchers would have already completed a doctorate within this timeframe.

Strikingly, a news article for the journal Nature stated on 19 January 2012:

“The Newcastle researchers do not have plans to determine whether primates conceived through pronuclear transfer come to term and are healthy”.

Remarkably, the HFEA’s expert panel then changed its mind about preclinical experimentation in primates being critical for pronuclear transfer, in its ensuing report in 2013. The only explanation provided was exceptionally brief and far from compelling. It said that:

“Current research using PNT in Macaques has yet to be shown to be successful. From unpublished data it appears that Macaque zygotes do not survive the PNT process well”.

The panel now believes that the macaque may not be a sufficiently good model for the human. If macaque embryos do not have a good record of surviving pronuclear transfer, and human eggs are even more sensitive, are not problems with human embryos more likely? Surely this suggests the need for proceeding even more cautiously, not less.

The Joint Committee proposed by the noble Lord, Lord Deben, should reflect on the HFEA expert panel’s minutes of 12 February 2013, in which Dr Dieter Egli, of the New York Stem Cell Foundation, explains that he was,

“sceptical about the clinical application of PNT”, because a structure known as the centrosome may be left behind, and that,

“the consequences of this need to be investigated”.

The proposed Joint Committee should also consider the minutes of the HFEA teleconference with Dr Shoukhrat Mitalipov on 30 January 2013, which reported:

“Dr Mitalipov expressed the view that development of MST or PNT embryos to blastocyst was not in itself enough to give confidence that the techniques are safe and effective”, and the recent remarks of Professor Justin St John, a geneticist at Monash University in Australia with considerable expertise on the behaviour of mitochondria in nuclear transfer, who said:

“As well as analysing foetal development in a non-human primate model, it is essential to analyse offspring to determine that no abnormalities appear at least during early life”.

Not only have the researchers at Newcastle refused to perform such preclinical research in non-human primates, I have been unable to find evidence of their own prior experience in obtaining healthy offspring of any species following pronuclear transfer, or even in taking any such embryos past the blastocyst stage.

Photo of Lord Willis of Knaresborough Lord Willis of Knaresborough Liberal Democrat

Clearly, I am not going to get to speak this evening, so I ask the noble Lord a very simple question. Does he have any faith at all in the HFEA to do what it actually says on this tin? If the regulations are passed today it will then have the job of deciding when it will be safe to go ahead and grant a licence. If he does not have that faith in the HFEA, will he please say that? Because I do.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

I serve on my own university’s ethics committee, which looks at the use of animals in experiments. Apparently, one of my roles on that committee is to be, as it were, the animals’ friend and to ask whether the experiment is repetitive, whether it is necessary to do such things and what it is going to lead to. There is no one on the HFEA who is the friend of the human embryo. That is a bizarre situation and one I would like to see rectified. But to take the noble Lord at his word, of course I think the HFEA often does a good job, and I admire many of its members.

I will simply say one other thing to the noble Lord. The HFEA is a regulator, not a legislator. That is our duty here today and that is why we are having this discussion. I am conscious that others wish to intervene and I am grateful for the patience of your Lordships’ House in allowing me to put these points. As we ponder on these serious issues revolving around public safety and questions of definition and legality, they deserve far better consideration and scrutiny than has been provided thus far. Surely we should remember the wise advice that those who legislate in haste repent at leisure. Therefore, the proposal of the noble Lord, Lord Deben, for a Joint Committee of both Houses to examine the safety and legality of these regulations deserves our support.

Photo of Baroness Barker Baroness Barker Liberal Democrat

My Lords, since 1990, this Parliament, and, in particular, this House, has shown the rest of the world how these matters should be dealt with. It is for that reason that I hope that we will pass these regulations today.

In 1990, the noble Baroness, Lady Warnock, set down the ethical framework within which we make decisions and within which scientists must do their work and regulators must regulate. In 2008, as the noble Lord, Lord Walton, the noble and learned Lord, Lord Mackay, and others will remember, we debated these and related issues at considerable length. At that time, the scientists came to us and said, “We believe that very shortly it will be possible for mitochondrial transfer to happen”. At that point, Parliament sat and listened to the scientists and said, “Not yet. Not yet”. That is why we passed the permissive legislation that we did, which has led to these regulations.

The noble Lord, Lord Deben, in putting forward his very cogent and persuasive argument, missed out one crucial fact that undermines his argument: research is not linear. Researchers do research and it takes them to places that they had not imagined or they hit obstacles that they did not anticipate. Things change radically, as they did in the case of animal hybrids. That is why we operate as we do, within a system whereby Parliament sets out the principles and the ethics. We require the scientists to come back to us again and again and we are dependent on the information that they give to us.

I went to the same meeting as the noble Lord, Lord Deben, and I formed a very different impression of the scientists. Our top scientists have been making themselves available to Members of Parliament for all of the past year to explain as clearly as they can this science as it is emerging. I do not think that we should abrogate our responsibility in this House. I think we should continue to listen to the scientists. I like the fact that I live in the United Kingdom where we debate these matters. We have the involvement of people from the church and from different faiths and walks of life. We also listen to contributions from people such as the noble Lord, Lord Alton, who are consistently and wholly opposed to this issue. However, it is important that his voice is heard. I do not want the ethical decisions to be sent off to the courts as they are in the United States.

Noble Lords have talked a lot about the emotional issue of meeting the needs of families but they have also discussed the safety of these issues. However, I simply put before the House the response of parents to the suggestion that they might have a child who proved to be infertile. When they were asked how they would feel about that, they gave the clear response, “We love our children as they are and we would not have not had them. However, if we could have had a child who did not have the illnesses that they have, we would have opted to have such a child, even if that child proved to be infertile”.

The scientists have been absolutely straight with us and have given us the relevant information. They have not said that this process is safe or guaranteed because they cannot do so. The noble Lord, Lord Alton, is right—they will have to come back to us if techniques developed in the future prove to be better and safer than those we are discussing. However, given the information that we have, I for one feel that this Parliament has been fully informed and that we can make a decision—and I hope that we do.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Shadow Spokesperson (Health), Shadow Deputy Leader of the House of Lords 7:30 pm, 24th February 2015

My Lords, I sense that the House wants to come to a decision.

Just over 14 years ago, I asked the House to agree that embryology research could be extended to cover diseases such as Parkinson’s disease, Alzheimer’s disease, cancer and diabetes. This provision had been anticipated and included as a regulation-making power in the Human Fertilisation and Embryology Act 1990, which had allowed embryology research but only for conditions such as infertility and congenital diseases.

The 2001 regulations were passed following a Motion moved by the noble Lord, Lord Alton, to whom I pay tribute for his integrity and perseverance. However, his Motion to establish a Select Committee prior to the regulations being approved was defeated by 212 votes to 92.

The 1990 Act followed the work of a committee led by the noble Baroness, Lady Warnock, which made recommendations on developments in science and medicine in relation to human fertilisation and embryology. I pay tribute to the noble Baroness for her outstanding work in helping us get the balance right between the respect owed to human embryos and the potential for the use of embryos in research and treatment for devastating illnesses.

The 1990 Act was a model in the regulation of certain infertility treatments and embryo research. It reflected the need to have a strict framework in which regulation could be conducted to take account of the advances in medicine anticipated by both the noble Baroness, Lady Warnock, and Parliament in 1990.

Since 1990, the science and research have developed, just as has the need for Parliament to keep up and anticipate further developments. Thus, in 2001, we passed emergency legislation to put it beyond doubt that human reproductive cloning could not take place in the UK. In 2004, we passed regulations in which the identity of the donor of eggs, sperm or embryos could be given to the adult donor-conceived person under certain circumstances.

We have heard about the 2008 Act, which amended the 1990 Act to include restrictions on the types of embryos that may be placed inside a woman. Importantly, the 2008 Act amended the 1990 Act to insert a regulation-making power to enable techniques which were under development at that time to be used in treatment to prevent a child being born with serious mitochondrial disease. Surely, the noble Viscount, Lord Ridley, and the noble Lord, Lord Walton, are right—at every significant stage of embryology research and potential treatment, Parliament has been asked to give its approval and thus ensure public confidence in our scrutiny of these most difficult decisions. My view is that Parliament has discharged that responsibility thoroughly and well. However, I am glad that the noble Lord, Lord Deben, has given us the opportunity to have this debate. Of course, we would have had a debate but the noble Lord has served a great purpose in encapsulating the core argument and I am grateful to him for so doing.

We find ourselves asked to make a crucially important decision, with powerful contributions having been made on both sides of the argument. On the one hand, we celebrate the triumph of science that these new techniques represent. We have within our reach the possibility of eradicating mitochondrial disease from families who have been blighted by it for generations. On the other hand, we are grappling with serious moral, legal and ethical questions that are raised by the proposed introduction of such techniques for treatment. We on this side of the House have a free vote. Speaking for myself, and myself alone, I will vote in favour of the regulations.

The noble Earl, Lord Howe, will respond to many important points that have been raised, but I ask him to focus on a number of very important considerations that have also been raised. On the question of continuing research and the comments of the expert panel, will he confirm that the panel said there was no evidence to suggest that the techniques proposed in the regulations are unsafe? Will he also confirm that the panel has agreed that further research and reviews could take place either before or after the regulations are approved?

As regards whether this matter is being rushed through Parliament and would benefit from further scrutiny by a Select Committee, the question here is: what would be gained by delay? Will the noble Earl confirm that the principles that we are discussing were approved by Parliament in 2008 after thorough debate? I do not need to go over the work of the Nuffield Council on Bioethics or that of the HFEA and its expert panel because noble Lords have mentioned that, but I should comment on the 90-minute debate that took place in the House of Commons. I agree with the noble Lord, Lord Alton, that 90 minutes is too short. However, I have read that debate and it seems to me that it was thorough and well informed and that the points on both sides were put forcefully and interventions were made. My honourable friend Luciana Berger was asked a number of very tough questions, as was the Minister. Could anyone say that at the end of those 90 minutes MPs were not in a position to come to a conclusion? Indeed, can anyone say that we are not in a position to come to a conclusion following a debate which has lasted at least three and a half hours?

We have heard from eminent lawyers on both sides of the argument on the legal questions. We have had written submissions from the Department of Health and the legal advice of the Wellcome Trust, and other legal propositions have been put to us. However, you reach a point when it is time to make a decision. I think that we are in a position to make such a judgment.

A number of noble Lords, including the noble Lord, Lord Alton, referred to the two techniques and how one should be considered in relation to the other.

I understand the point that the noble Lord, Lord Alton, made. However, will the noble Earl, Lord Howe, confirm that the panel believes that at present there is insufficient evidence to choose between the two techniques? Does he consider that that is still the Government’s position? The noble Lord, Lord Deben, said that this was a question of resources. I have not seen evidence to suggest that that is the case. The important question is: can the Minister refute that? Can he say that the sole issue is that at the moment we are not in a position to judge which technique is likely to be more effective, and that it is solely for that reason that we are permitting the two techniques to be in the regulations?

Finally, we come to the position of the HFEA. At every point of our debates—this goes back to 2001—we have relied on the robustness of that body. The robustness of the HFEA is absolutely essential. There have been discussions and debates about how effective it is; my noble friend Lord Winston is a well known critic of some of its activities. Fair enough—but I believe that the HFEA has proved itself a highly effective and robust regulator over 20 years. I ask the Minister to confirm that it is the Government’s intention to continue to support the robustness of that regulatory approach.

As for the Chinese experience, will the Minister confirm that, although there are issues in connection with the techniques used, one big difference between the UK and the Chinese position is the regulatory framework and the robustness of the HFEA? I suspect that that was not the case in China years ago when those developments took place.

The question is whether the benefits of trying to eradicate this dreadful disease by preventing the transmission of mitochondrial disease, in view of the likelihood that otherwise children will continue to be born who will die in infancy, outweighs the risks of the techniques, which some noble Lords have described tonight. The scientific community—on the basis not of some kind of cosy consensus but of hard evidence—and the families experiencing this disease are clear that we are right to support the regulations. It is now up to us individually to decide whether we agree them. I, for one, am convinced that it is the right thing to do.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

My Lords, before the noble Earl starts his speech, may I apologise to the House? The noble Lord, Lord Alton, has clarified the fact that it was the Lord Chancellor and the current Attorney-General who voted against this measure in the House of Commons. I was told that two Law Officers had voted against, and I assumed that the two Law Officers must have been the right honourable Dominic Grieve and the current Attorney-General. It was not: it was the Lord Chancellor and the current Attorney-General. I should apologise for that; it was a misunderstanding of the information that I was given.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

It would be right to say that the Lord Chancellor is not a Law Officer of the Crown.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

My Lords, that is why, having been told that it was the two Law Officers, I came to the conclusion that the Lord Chancellor was not among them.

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

My Lords, as I fully expected, this has been a debate of very high quality, with a range of views, both for and against the regulations, eloquently expressed. My principal job now is to respond to the Motion moved by my noble friend Lord Deben and to some of the additional points raised by other speakers.

My noble friend’s Motion covers three main points—safety, compliance with EU and UK law, and the key definitions in the draft regulations. My noble friend and the noble Lord, Lord Brennan, in his legal opinion, argued that there was some doubt about whether the regulations were compliant with EU law, in particular the EU directive on clinical trials. With respect to both noble Lords, the Government do not agree. The EU clinical trials directive does not apply here because it is concerned with medicinal products, and mitochondrial donation techniques simply do not fall under that definition.

My noble friend asked whether we had checked our position with the European Union. The simple answer is no. Within a framework of subsidiarity, it is entirely the responsibility of each member state to ensure that its own legislation is consistent with EU law. That is what we have done. The EU would be inundated with extensive queries from member states if a “legal advice” facility existed, and there is no such facility.

Photo of Lord Gordon of Strathblane Lord Gordon of Strathblane Labour 7:45 pm, 24th February 2015

Is the noble Earl equally confident that the regulations are compliant with the European directive that is due to come into force in 2016, and which might explain the timing?

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

My Lords, I think I can make an unequivocal statement that all the legal advice I have received is that the regulations we are considering are fully compliant with European law.

As has been said, any legislation agreed in Parliament could be subject to challenge, and it would be up to the Government at the time of challenge to defend their position. The noble and learned Lord, Lord Hope, made that point. Let me reassure noble Lords that we have considered these issues very carefully, and we are confident that the regulations are compliant. I am pleased that other noble Lords who have spoken agree with that.

The noble and learned Baroness, Lady Scotland, cited the European charter. The EU charter does not apply in this context, because Article 51 says that it applies to member states,

“only when they are implementing Union law”.

This means that a state must be either directly implementing an EU law obligation or acting within the scope of EU law. The regulations do not do either of those things.

We have considered the issues raised and, as I have said, we are very confident that these regulations do not contravene European law. The issue comes back to whether the clinical trials directive is engaged here. It is not. Our view, incidentally, was agreed with independent legal advice commissioned by the Wellcome Trust from Thomas de la Mare QC: mitochondrial donation simply does not come within the definition of medicinal products, to which the directive applies.

Photo of Baroness Scotland of Asthal Baroness Scotland of Asthal Labour

In the context of the horizontal articles of the charter, Articles 51 and 52, have the Government considered how Article 6.3 changes things, because it consolidates what the law was then? There is a difficulty, and I do not know whether the noble Earl has had specific advice on those matters. I know that this was not contained in the opinions that were promulgated earlier.

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

I can only say again that the legal advice I have had is that the charter cuts in only when there is an issue of European law. We do not consider that treatment services, which are what we are talking about here, are covered by EU law. The noble Baroness made a point of saying that my right honourable friend the Attorney-General did not vote in favour of the regulations, but it is difficult for me to comment on that. There was, rightly, a free vote in the other place, just as there is here. I cannot comment on the personal view of the Attorney-General—and I have to say that I do not think that anything said or quoted by the noble and learned Baroness threw much light on that issue.

I repeat that my department is confident that these regulations are necessary and have a sound legislative base in the Human Fertilisation and Embryology Act 1990, as amended. As my noble and learned friend Lord Mackay rightly pointed out, it was the clear intention of Parliament that this provision would enable mitochondrial donation to take place in a clinical setting.

On the issue of safety, my noble friend Lord Deben urges us to delay until further research is carried out. However, we could wait indefinitely for research and follow-up and still not have a 100% assurance about safety, because that is the nature of science and research. The standards of assurance that some are seeking are considerably higher than those for cancer treatment or heart disease. As far as the expert panel convened by the HFEA is concerned, there is no evidence to suggest that these techniques are unsafe. The critical experiments are progressing positively.

As I said, the mitochondrial donation regulations require the HFEA to assess each application for mitochondrial donation on a case-by-case basis. That will include consideration of the evidence on safety and effectiveness. As a statutory independent regulator, it is for the HFEA to determine its own procedures for assessing applications to carry out treatment regulated by the 1990 Act. Applications to provide mitochondrial donation treatment are no exception to this rule but, clearly, the HFEA will not authorise the treatment if it does not consider it safe to do so.

It is never possible to answer every safety question before new medical procedures are used in people for the first time. New techniques can be refined and reviewed. Even the most exhaustive research can establish only that a technique is sufficiently likely to be safe to justify “first in human” treatment. However, if medicine is to progress, clinicians should in my submission be permitted to use new techniques when evidence suggests these are sufficiently safe and effective. It is the Government’s view that medical knowledge in the field of mitochondrial disease and donation has now reached this stage and it is time to progress. The legislative framework of the HFE Act provides for Parliament to endorse the Government’s view before proceeding and, following the extensive process of consideration that I have already set out, we have properly brought this to Parliament for debate on affirmative regulations.

I listened with care to the noble Baroness, Lady Hollins. I absolutely concede that there is a balance of risks to be considered. As I have said, it is not possible to be certain that new medical procedures will be 100% safe or effective. These risks must be balanced with the risk of ongoing suffering for families with mitochondrial disease. For me, the simple point is this: scientific 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. As the noble Lord, Lord Patel, pointed out, ultimately it will be up to affected families to judge the balance of these risks with advice from their clinicians and then to decide whether they choose to proceed with treatment, subject to authorisation by the HFEA.

My noble friend Lord Deben mentioned the Chinese study. That study has not been published and we understand that it will not be. It concerns one pregnancy, using an earlier form of pronuclear transfer. One of the clinicians involved gave a full interview to the Independent recently and explained that the complications that occurred related to multiple pregnancies from multiple embryo transfer, rather than from the mitochondrial donation process. As I understand it, there were no genetic abnormalities in the foetuses.

Turning again to the speech by the noble Baroness, Lady Hollins, the HFEA-convened expert panel considered the issues that she raised: if the patient and the donor have different mitochondria, known as haplotypes, the donor’s mitochondria may not, as it were, “talk properly” to the patient’s nuclear DNA, causing health problems. The panel considered that as part of its third scientific review. However, it was of the view that the data submitted to it about this potential problem were not relevant enough to raise safety concerns. However, the panel has recommended, as a purely precautionary step, that consideration be given the mitochondria haplotype when matching donors to patients, even though the risks of not doing so are assessed to be very low.

The noble Baroness questioned whether successive generations, particularly girls, could have the same problems arise from unhealthy mitochondria. The principle behind the treatment is that the mitochondrial DNA that the child will inherit will be the disease-free mitochondrial DNA of the donor, not the faulty mitochondrial DNA of the mother, although there is a small risk that the low level of unhealthy mitochondria may be carried over when the patient’s nuclear DNA is moved from her egg or embryo to the donor’s. Evidence continues to be reassuring that carryover after mitochondrial replacement is very low and unlikely to be problematic. The risk of mitochondrial disease being present in these generations will, we believe, be low.

The noble Baroness also said that we still do not know enough about the relationship mitochondria have with the human body. This is true of many aspects of human physiology, not just mitochondrial DNA. The majority of the evidence indicates that mitochondria are primarily concerned with generating the power that every cell in the body needs to function. It is generally accepted that, as vital as the function of the mitochondria undoubtedly is to the human body, they do not play a role in developing a person’s physical appearance or personality traits, which are derived solely from nuclear DNA.

Photo of Lord Elton Lord Elton Conservative

Before my noble friend leaves the question of risk, may I ask him to close a little chink in the reassuring curtain that he is drawing before us? We are assured by the HFEA that there is no evidence of risk in what is proposed, but it also proposes quite a large phalanx of experiments that should be completed before proceeding. First, there appears to be a slight logical discontinuity there. Secondly, can we be reassured that, in the Minister’s view, the HFEA will not proceed to licensing anybody until they have completed that programme of experiments?

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

My Lords, I can confirm to my noble friend, and to the noble Lord, Lord Hunt, who asked a similar question, that the expert panel stated that the further experiments that it recommended could take place either before or after the passing of these regulations. However, they must be done before treatment can take place. I hope that that is sufficient reassurance.

The noble Lord, Lord Alton, and the noble Baroness, Lady O’Loan, spoke about the risk of ovarian hyperstimulation syndrome. OHSS is a well recognised side-effect of the drugs used to stimulate a patient’s or donor’s ovaries to collect multiple eggs for use in fertility treatments. The risks of OHSS are very well understood, with patients and egg donors carefully monitored. The HFEA’s code of practice requires women undergoing ovarian stimulation to be given information about the possible side effects and risks, including OHSS. Women are informed of the symptoms to look out for and are warned to contact their clinic if they feel unwell. Women donating eggs for use in mitochondrial donation will not be at any increased risk of developing OHSS.

The noble Lord and the noble Baroness both questioned the practice of paying for donated eggs. I submit that there is nothing sinister in that. Within the legal framework of the HFE Act, the HFEA sets the rates for compensation to donors of eggs or sperm; £500 for an egg donor is well within those limits. It certainly is not a sign that Newcastle University is anticipating the introduction of the regulations to allow mitochondrial donation. It is continuing its research and has an ongoing need for donated eggs for that purpose.

I turn now to the issue of definitions. In making the regulations, the Government have been clear about their approach, the definitions used and the source of their material. The Government’s consultation on the detail of the regulations set out very clearly: the definitions of scientific terms; the detail of the techniques that the draft regulations would cover; the terms that others might use, such as “genetic modification”; and the proposed approach to information for donors and those conceived through mitochondrial donation.

My noble friend questioned why we do not consider these techniques to amount to genetic modification. Mitochondrial donation does not alter the nuclear DNA which defines personal characteristics and therefore, in our view, does not constitute genetic modification. In the absence of a universally agreed definition of genetic modification in humans, the working definition was developed with the Chief Medical Officer in order to bring some clarity to the discussion about these processes. Opponents have not been able to offer a scientifically based alternative and the British Fertility Society, among others, has been happy to adopt the Chief Medical Officer’s working definition.

My noble friend also asked why we have not separated the two techniques in these regulations. I say to him and to the noble Lord, Lord Hunt, that the expert panel convened by the HFEA stated in its 2014 report that,

“based on 2014 considerations the panel still believes that there is at present insufficient evidence to choose between PNT and MST as a preferred technique”.

The Government are therefore satisfied that there is sufficient scientific evidence to justify Parliament being asked to consider regulations to enable the use of two mitochondrial donation techniques in clinical practice. As I have said, it will be for clinicians in consultation with families to decide which technique would be best in each case. It is worth noting that the HFEA’s public dialogue showed a considerable level of public acceptability for both techniques.

My noble friend also referred to the ComRes poll and suggested that we had somehow unfairly dismissed it. The ComRes poll was commissioned by the CARE organisation—Christian Action Research and Education—which I understand opposes the introduction of mitochondrial donation. An evaluation of the survey was conducted by Pier Logistics and Gene Rowe Evaluations. The evaluators considered the survey to be a deeply flawed piece of work. They criticised the intentional use of what they described as,

“sensationalist, inflammatory and misleading language to characterize the debate”.

There was also considered to be:

“An unreasonable degree of selectivity within respondents’ informational options and the intimation of an exercise focused on the generation of self-ordained results”.

The evaluation summary commented that the survey was,

“a good example of poor public consultation”.

As I have already set out, there has been extensive independent consideration of these issues during the lifetime of this Parliament. Noble Lords should not have the mistaken impression that the Government have in any way been acting in haste, as suggested by the right reverend Prelate the Bishop of Carlisle and the noble and learned Baroness, Lady Scotland. Mitochondrial donation has been subject to,

“more scientific review of its proposed process than any other medical technology”.

That is a description by independent commentators.

I can confirm to the noble Lord, Lord Hunt, that Parliament gave extensive consideration to the amendments to the 1990 Act in 2007-08—an occasion he and I remember well—including the regulation-making power that provides for these regulations. In addition to the scrutiny of the programme of assessment that I outlined earlier, the HFEA and I have offered briefing meetings for Peers to update them on the issues and more than 130 Parliamentary Questions have been answered on the subject in this House alone. Incidentally, there have been three debates in the House of Commons— not just the 90-minute debate on the regulations, where I should perhaps mention that the majority in favour was almost three to one.

The House allows for an affirmative debate to approve regulations and the Government have followed due process in establishing this, as soon as practical after the debate in the other place. I need to make it clear as well that it was never the intention to debate these regulations in the Moses Room. It was always quite rightly envisaged that we should consider them on the Floor of the House. As I have said, further delay would not be doing the right the thing for families who desperately want to have the choice to access these new techniques. Nor would it send the right signal to UK science, which has been researching in this area for very many years and reasonably wishes to see this work translate into help for patients.

My noble friend urges the House to send the matter to a Joint Committee. These issues have been considered by both the Commons Science and Technology Committee and the House of Lords Select Committee on Secondary Legislation. The Commons committee wrote to the Government stating that there was sufficient information for Parliament to make an informed decision and urged the Government to bring forward regulations.

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.

Photo of Lord Deben Lord Deben Conservative 8:00 pm, 24th February 2015

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.

Photo of Lord Winston Lord Winston Labour 8:15 pm, 24th February 2015

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?

Photo of Lord Deben Lord Deben Conservative

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.

Division on Lord Deben’s amendment

Contents 48; Not-Contents 280.

Amendment disagreed.

Division number 1 Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 — Motion to Approve

Aye: 46 Members of the House of Lords

No: 278 Members of the House of Lords

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Motion agreed.