Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Ribeiro Excerpts

Tuesday 24th February 2015 Lords Chamber

[Baroness Hollins]

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.

[Lord Ribeiro (Con)]

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.

[Lord Ribeiro]

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.

[Lord McAvoy (Lab)]

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.

[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.