Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Willis of Knaresborough Excerpts

Tuesday 24th February 2015 Lords Chamber

[Lord Deben (Con)]

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

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

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

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

[Lord Willis of Knaresborough (LD)]

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

[Lord Deben]

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

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

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

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[Baroness Scotland of Asthal]

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 in 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.

[Lord Willis of Knaresborough]

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?

[Baroness Scotland of Asthal]

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.

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[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.