Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Alton of Liverpool Excerpts

Tuesday 24th February 2015 Lords Chamber

[Baroness O'Loan]

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.

[Lord Alton of Liverpool (CB)]

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.

[Baroness O'Loan]

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.

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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.

[Lord Alton of Liverpool (CB)]

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?

[Lord Patel]

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

[Lord Alton of Liverpool]

I did actually ask the noble Lord, Lord Winston.

[Lord Patel]

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.

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[Lord Ribeiro]

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—

[Lord Alton of Liverpool]

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?

[Lord Ribeiro]

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.

[Baroness Warwick of Undercliffe (Lab)]

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.

[Lord Alton of Liverpool]

My Lords—

[Lord Maginnis of Drumglass (Ind UU)]

My Lords—

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[Lord Alton of Liverpool]

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.

[Lord Alton of Liverpool]

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—

[Baroness Farrington of Ribbleton (Lab)]

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.

[Lord Alton of Liverpool]

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.

[Lord Willis of Knaresborough]

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.

[Lord Alton of Liverpool]

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.

[Baroness Barker (LD)]

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.