Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Baroness Scotland of Asthal Excerpts

Tuesday 24th February 2015 Lords Chamber

[Lord Winston]

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.

[Baroness Scotland of Asthal (Lab)]

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.

[Lord Winston]

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.

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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.

[Baroness Scotland of Asthal (Lab)]

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—

[Lord Hope of Craighead (CB)]

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.

[Baroness Scotland of Asthal]

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.

[Lord Hope of Craighead]

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? The 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.

[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.

[Lord Mackay of Clashfern (Con)]

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—

[Baroness Scotland of Asthal]

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.

[Lord Mackay of Clashfern]

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.

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[Earl Howe]

My Lords—

[Baroness Scotland of Asthal]

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.

[Lord Mackay of Clashfern]

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

[Baroness Scotland of Asthal]

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.

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[Baroness Scotland of Asthal]

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.

[Earl Howe]

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 to 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.