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Human Fertilisation and Embryology

Living Wage (Reporting) – in the House of Commons at 2:01 pm on 3rd February 2015.

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Votes in this debate

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health 2:01 pm, 3rd February 2015

I beg to move,

That the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, which were laid before this House on 17 December 2014, be approved.

Mitochondria are present in almost every cell in the body and produce the energy we need to function. This is why they are often referred to as “the battery pack” of the cell. Unhealthy mitochondria can cause severe medical disorders, known as mitochondrial disease, for which there is no cure. The techniques provided for by these regulations offer the only hope for some women who carry the disease to have healthy, genetically related children who will not suffer from the devastating and often fatal consequences of serious mitochondrial disease.

First, I would like to bring the House up to date with the process followed since the principle of mitochondrial donation was first debated by Parliament during the passage of the Human Fertilisation and Embryology Act 2008 in 2007-08. There has been much consideration of this issue in this Parliament. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including an ethical assessment by the Nuffield Council on Bioethics in 2012; a public dialogue and consultation exercise carried out by the Human Fertilisation and Embryology Authority in 2012-13; and a public consultation on draft regulations carried out by the Department of Health in 2014.

There have been three reports into the safety and efficacy of mitochondrial donation techniques by an expert panel convened by the HFEA which were published in 2011, 2013 and 2014. The expert panel members were selected for their broad-ranging scientific and clinical expertise, and for having no direct or commercial interest in the outcome of the review. Indeed, Professor Frances Flinter, a genetics consultant who works with affected families, has said:

“There has been more scientific review of this proposed process than any other medical technology.”

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

The Minister says that there is no point in further review, but the safety tests recommended by the HFEA in its three reports have not yet been completed, written up or peer reviewed. Does that sound like a completed analysis?

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I will come to that point in my remarks.

There has been much parliamentary scrutiny of the proposals, including three parliamentary debates and over 200 parliamentary questions in both Houses. As part of this parliamentary scrutiny, the Science and Technology Committee held an evidence session into mitochondrial donation in October last year. Following the hearing, the Chair, Andrew Miller who I see in his place, wrote to me on behalf of the Committee, expressing the opinion that there was sufficient information for Parliament to make an informed decision, and urging the Government to bring forward regulations. Given the extensive scrutiny in this Parliament, I believe it is right to allow this

Parliament to decide whether to take the next step for mitochondrial donation, which can progress only with these regulations.

The two proposed techniques, maternal spindle transfer and pro-nuclear transfer, are covered by the regulations. They are about replacing the battery pack that contains a small number of unhealthy genes with a healthy battery pack. Mitochondrial DNA is just 0.054% of our overall DNA and none of our nuclear DNA, which determines our personal characteristics and traits and is not altered by mitochondrial donation.

I would like to take this opportunity to pay tribute to the scientists at Newcastle university, who have led the world in the development of the new techniques—an area where Britain is at the forefront of life sciences.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

The Minister is extremely generous with her time. She says that these scientists are leading the way, but is she not aware of the work done in China over a decade ago in exactly this area? It was clearly pioneering, and it led to the Chinese Government outlawing the use of these techniques because of the appalling, tragic outcomes.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I am aware of that work, which has been the subject of extensive parliamentary questions. The expert panel considered all of those issues, including that piece of work, during the course of their deliberations.

Photo of David Burrowes David Burrowes Conservative, Enfield, Southgate

Does the Minister acknowledge that scientists broadly accept that the procedures are nuclear cell transfer? That is what regulations 4 and 7 make clear. That means that nuclear DNA in the egg is explicitly altered. Therefore one has to agree that an honest, clear definition of what we are dealing with is genetic modification.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

No, I cannot accept that description. I recognise that my hon. Friend has objections to the procedure, but I do not recognise his description. Nuclear DNA is not affected; mitochondrial DNA is different.

As well as paying tribute to the scientists at Newcastle university, I want to pay tribute to the Lilly Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, and who have shown us the human suffering behind this scientific advance. Many right hon. and hon. Members, like me, have constituents who are affected, and I am sure that some Members will talk about such families in their own speeches.

Photo of Steven Baker Steven Baker Conservative, Wycombe

Does the Minister accept that a person born as a result of a mitochondrial replacement would not pass on mitochondrial disease to their successors? In other words, the germ line would have been modified so that the mitochondrial disease had stopped with their parents. It seems to me that if she accepts that the germ line has been modified, what she said a few moments ago cannot possibly be right.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

We have made it clear that the removal of the faulty mitochondria will be passed on to the next generation. That is exactly what we have been describing, but I do not accept my hon. Friend’s description of it as genetic modification. It has to be said that there is no universally agreed definition of genetic modification, but for the purposes of these regulations, we have used a working definition and it involves not altering the nuclear DNA.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I know my hon. Friend is going to make her own contribution. If she will forgive me, I want to outline for the benefit of Members less familiar with the regulations their detailed content.

Turning to that detail, the regulations are made under the powers in the Human Fertilisation and Embryology Act 1990. They were added to in 2008 to permit mitochondrial donation to prevent the transmission of serious mitochondrial disease, anticipating the advancement of science to this point. Regulations 3 to 5 set out the circumstances for mitochondrial donation techniques using eggs; regulations 6 to 8 set out the circumstances for mitochondrial donation using embryos. They would allow the use of the two techniques that have been subjected to extensive UK-wide review and consultation: maternal spindle transfer and pro-nuclear transfer.

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

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

Does the Minister consider that the Government’s own regulator, the HFEA, was wrong to state, in a consultation document that “PNT involves genetically modifying a human embryo”?

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I shall deal shortly with the regulatory regime that the HFEA would introduce. However, that and many other points have already been examined in great detail and responded to in great detail in parliamentary answers, to which I refer my hon. Friend.

Photo of Richard Fuller Richard Fuller Conservative, Bedford

It is clear to many of us who have spoken to our constituents that this procedure will make a huge difference to individual families. There is, in a sense, an ethical gateway to the framework that will allow the scientists and medical experts to move forward. Can my hon. Friend tell us why there appear to be a number of people who, for ethical and religious reasons, are quite close to agreeing with the Government but have not quite agreed yet, and have asked for more time?

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I think that those Members may speak for themselves during the debate. No one would deny that this is ground-breaking science—it is—but there have been three expert panel reviews. What I am trying to demonstrate in my speech is that we have taken all the necessary rigorous steps towards the point at which Parliament can make an informed decision. I think it important to differentiate things that are knowable and on which Parliament can make that informed decision, and things that can only be known when we take the next step, which involves making the regulations. I hope that that is helpful.

Several hon. Members:

rose—

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I want to make a little progress, but I may take another intervention later. I am conscious that many Members wish to speak.

There has been much discussion of the safety of mitochondrial donation techniques. As I have said, three reports have been produced by the HFEA-convened expert panel during the current Parliament. On each occasion, the panel has concluded that there is nothing to indicate that the two donation techniques are unsafe. Although the panel has recommended that further experiments should be conducted, it expects such research to support the conclusions that it has reached so far.

In public discussion, there has been some misunderstanding of the term “critical”, which was used by the expert panel. That is helpfully clarified in the HFEA’s introductory briefing note, which has been endorsed by the panel and which makes clear that the experiments could take place before or after the approval of regulations by Parliament. The chief medical officer sent a copy of the briefing note to all Members yesterday.

Photo of Bill Cash Bill Cash Chair, European Scrutiny Committee

Is my hon. Friend aware that there are profound legal reasons for believing that the regulations are ultra vires in respect of the primary Act—the Human Fertilisation and Embryology Act 2008—and are also in breach of the clinical trials arrangements that are set out in the European Union clinical trials directive? Does she understand that that allegation has been made, and what is her response?

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

The clinical trials directive applies only to medicines. It does not apply to embryology, so it is not relevant in this case.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I am sorry. I know that many Members wish to intervene, but I am trying to leave time for Back-Bench contributions.

If the regulations are passed by Parliament, the HFEA will introduce a robust regulatory process, as it has in other areas of fertility treatment. The regulations would also establish important safeguards through the HFEA’s own licensing procedures. Before licences could be issued to providers of mitochondrial donation, they would have to demonstrate that they could carry out the procedure safely and effectively. Each provider would need to be licensed, and treatment for each patient would be approved on a case-by-case basis. Decisions would be based on the scientific evidence and advice that were submitted to the licensing committee. The HFEA is highly respected across the globe as a model for the regulation of fertility and embryology treatments and research. Many other countries do not have such a framework.

I recognise that some Members disagree in principle with mitochondrial donation, and I respect their point of view, although I do not share it. To those who do not disagree in principle I have sought to demonstrate—as we have sought to demonstrate over the years of expert panel reviews and further consideration—that all reasonable and rigorous steps have been followed to reach the point at which Parliament can be asked to make an informed decision about whether to allow these techniques to be licensed on a case-by-case basis. It is a bold step for Parliament to take, but it is a considered and informed step.

This is world-leading science within a highly respected regulatory regime, and for the families affected it is a light at the end of a very dark tunnel. I commend the regulations to the House.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health) 2:15 pm, 3rd February 2015

The impassioned and thoughtful contributions to the public debate that we have heard in recent weeks and months are testimony to what a sensitive and complex matter this is. Only last night, an event held in Committee Room 10 was attended by hundreds of people who are interested in the debate, and we heard representations from both sides.

On one hand, we have celebrated the triumph of science that these new techniques represent. It is thanks to years of pioneering research by the university of Newcastle on how we can prevent the transmission of genetic mutations that we are finally reaching the point at which we can consider using these transformative techniques in humans. We have within our reach the possibility of eradicating mitochondrial disease from families who have been blighted by it for generations: families who have endured a disease for which there is no cure, who have suffered daily battles with painfully debilitating symptoms, and who have sadly lost their children prematurely. Those families have had to face up to the risk, and perhaps the certainty, that to be a parent must come at the expense of a difficult and, in too many cases, painful life for their children. Not only would children born through such techniques be free of such conditions, but so would their children and grandchildren. This treatment would break a chain of misery that would otherwise have ruined generations of lives.

On the other hand, we are grappling with the serious ethical and moral questions that are raised by the proposed introduction of such techniques. Members have previously shared their anxiety about the uncharted territory in which we now find ourselves. The proposed regulations would make Britain the first country to legalise mitochondrial transfer, and scientists have acknowledged that there would always be a “leap of faith” the first time the technique was used.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

I think we need to dispel the myth that there will be a “first time”. This was done more than a decade ago. In its recent analysis, the HFEA ignored the Zhang study. The Minister is shaking her head. She has clearly not read the study, which showed that when the technique was first tried, triplets were conceived. One was terminated almost immediately—within 30 days—and, of the other two, one was stillborn and the other died as a result of miscarriage. That is the reality. This is not groundbreaking; it has been done before.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I shall be dealing with the expert panel reviews that have been conducted since the date to which my hon. Friend has referred.

It is right that we have had a chance to hear all the arguments and to give them full and proper consideration, but it is critical to the integrity of the decision that is eventually reached for the debate to be based on the facts. When debating matters such as this, we will naturally hear a number of contradictory assertions. I am sure that the Minister will reassure the House about any further issues that are raised during the debate.

Photo of Brian H Donohoe Brian H Donohoe Labour, Central Ayrshire

May I ask the shadow Minister a simple question? Is this a case of DNA being genetically modified?

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I do not believe that that is what is being proposed, but I shall deal with my hon. Friend’s very specific point later in my speech.

Photo of Richard Drax Richard Drax Conservative, South Dorset

I know from a meeting that I attended before the debate that the HFEA has said, “PNT involves genetically modifying a human embryo”.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

That point was raised in an earlier intervention. I think it is clear from reports following reviews by the expert panel that it has already been specifically addressed, but I shall deal with it in more detail later.

Photo of Julian Huppert Julian Huppert Liberal Democrat, Cambridge

There seems to be a lot of confusion between nuclear DNA and mitochondrial DNA. It might help the hon. Lady and the House if I point out that they have completely different origins. They have a different genetic code; they are not related. The origin of mitochondria is bacteria that were engulfed by cells. They are very different. The House should be aware of that.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I thank the hon. Gentleman for that clarification.

Many concerns have been raised, the first of which is that this process is being rushed through. Anyone who has been involved in the development of these techniques would disagree that this has moved quickly. Professor Doug Turnbull and his team at the university of Newcastle have been researching this for 15 years. It was over six years ago, back in 2008, that the Human Fertilisation and Embryology Act 1990 was amended to introduce the powers to allow regulations that would enable mitochondria replacement to take place to be brought forward. It was back in 2010 that researchers at the university of Newcastle developed the techniques to avoid diseased mitochondria being passed from a mother to her children. After another three years of consultation and review processes, the Government announced in July this year that they would be bringing forward the regulations to enable mitochondrial donation techniques to be used, and that is what we are voting on today.

Photo of Guy Opperman Guy Opperman Conservative, Hexham

The hon. Lady and I both attended the meeting last night, which was very productive and helpful. Does she agree that this is about choice for the families? I have constituents who have this particular disease and constituents who work at Newcastle university, and what we are trying to do is provide a scientific way forward, under a highly structured and licensed regime, to alleviate these particular families’ suffering.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I thank the hon. Gentleman for that intervention. It was clear last night when we heard from the affected families that they wanted that choice, and these regulations very specifically only apply to those families that are affected by mitochondrial disease.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I am going to finish my point, if I may.

In the intervening years the science and ethics of these techniques have been extensively debated. The Nuffield Council on Bioethics and the HFEA held extensive public consultations in 2012 and identified broad public support for the use of these techniques. There have been three expert scientific review panels—in April 2011, March 2013 and June 2014—all of which found no evidence to suggest that the techniques are unsafe for clinical use, and only last week a group of eminent scientists and experts in medical ethics, including Professor Sir John Sulston, Baroness Warnock and Sir Paul Nurse, wrote to The Times urging Parliament to approve the new regulations. They argued that the question parliamentarians must consider is not whether we would want to use this technique ourselves, but whether there are grounds to prevent affected families from doing so. I again reiterate what we have heard in the representations from families, and particularly women of child-bearing age: they want the opportunity to use these techniques.

Photo of Peter Bone Peter Bone Conservative, Wellingborough

The hon. Lady is making a very good speech and is trying to make it balanced. She talked about last night’s meeting, which I understand went on for quite some time, and there has been a lot of debate outside this Chamber, but is she satisfied that we come here to the Chamber this afternoon with only 90 minutes to discuss this? Would it not be better if we were to withdraw this motion today and come back with more time to debate it next week?

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

Unfortunately, it is not in the Opposition’s gift to determine the time allocated for these debates. I would have welcomed further debate, and we had an opportunity in a previous Backbench Business Committee-initiated debate to discuss these matters.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I am going to make some progress, because I am conscious—referring back to the intervention of Mr Bone—that we have limited time and many Back Benchers wish to contribute.

It is important to note that the use of these techniques will not be rushed into lightly if Parliament does pass them today, and specialist clinicians will then have to obtain a licence from the HFEA to use the techniques. We heard last night that this will only be in centres of excellence, and the HFEA will consider applications on a case-by-case basis.

We have heard concerns in previous debates that allowing mitochondrial donation is a dangerous road to start down, and that it could potentially lead to designer babies and parents being able to select the physical characteristics of their children. But we have also heard in the public debate that these fears do not take into account that these regulations are very specific and cover only mitochondrial DNA, not the nuclear DNA that determine our physical characteristics. The legislation only permits the use of these techniques in the clearly defined situation of incurable mitochondrial disorders.

The fact that these techniques apply only to the mitochondrial DNA and not to nuclear DNA should provide further reassurance to those Members concerned that this process would result in “three-parent babies.” As we have heard, mitochondrial DNA only controls mitochondrial function and energy production. Importantly, nuclear DNA, which makes us who we are and determines appearance and personality, will not be altered by the techniques that we are discussing today.

The regulations clarify that a mitochondrial donor is not to be treated as a parent, in contrast to the legal position for sperm and egg donors, who are treated as people who would, or might, be the legal parent of a child born from their donation.

There are questions around the safety of these techniques. As we have heard, this technique has received unprecedented scrutiny by the HFEA’s specially convened expert scientific review panel. However, it is possible that side effects could emerge over time and scientists have acknowledged that there would always have to be a “leap of faith” the first time the technique is used in humans.

Photo of Edward Leigh Edward Leigh Chair, Public Accounts Commission

On the question of safety, does the hon. Lady not consider it significant that the Food and Drug Administration in the United States said that it was not clear that the scientific procedures were effective and safe? The FDA, of course, refused to allow the use of Thalidomide while we did, and the rest, as they say, is history.

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I understand that the FDA has written to the British press in the course of the last week to contradict that position. There is a very different political situation in the US, and there is a very different set-up there in terms of the FDA compared with here and what we are discussing today.

Photo of Angela Smith Angela Smith Shadow Minister (Environment, Food and Rural Affairs)

Does my hon. Friend agree that the fact is that any scientist would say that no technique is entirely safe but the risk in this case is very low indeed, and completely justifies the leap of faith she describes, which is in effect a further advance in the use of IVF technology—which itself was pioneered as a leap of faith in 1978?

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

My hon. Friend makes some very important points, particularly about the assessment of risk, which has been done extensively throughout this process.

The question is whether the benefits of preventing the transmission of mitochondrial disease, and the likelihood that children will continue to be born who will die in infancy, outweighs the risks of the techniques. The scientific community and the families experiencing mitochondrial disease say that they do; and according to research, almost 2,500 women in Britain of child-bearing age are at risk of passing the condition on to their children. It is now up to Members to decide whether they agree.

Photo of Dame Cheryl Gillan Dame Cheryl Gillan Conservative, Chesham and Amersham

I am most grateful to the hon. Lady for setting out a balanced case. Can she clear something up for me? I understand that there are two sources of mitochondrial disease: the DNA in the nucleus as well as the mitochondrial DNA. Can she confirm that mitochondrial disease from the nuclear DNA will remain in our population even after this treatment is licensed?

Photo of Luciana Berger Luciana Berger Shadow Minister (Public Health)

I hope the Minister might be able to address that in her response to the debate, with the support of her officials. It is not something I have been made aware of, and it certainly has not come up in any of the discussions or debates that I have attended.

I will now conclude, as I know that many Members wish to contribute. The research has been done, the reviews carried out and the experts and the public have been consulted. Time is precious for those parents at risk of passing on mitochondrial inherited disease to their children, and I believe that we must not delay any further.

Several hon. Members:

rose—

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

Order. On account of the number of Members wishing to contribute to this debate, I must impose with immediate effect a six-minute limit on Back-Bench speeches. That limit will almost certainly have to be revised downwards, and I appeal to colleagues to help me to help them.

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton 2:29 pm, 3rd February 2015

I want to speak against the Government motion, and I draw the House’s attention to my alternative motion in part 2 of the Order Paper—page 54—although it is not voteable.

Human mitochondrial disease is a dreadful condition and, as a caring society, we must do all we can to address it, and do so as sensitively as we can for those families affected by it. As a caring society, however, we must also do so in an ethical manner and with proper regard for safety. I believe that the regulations we are considering today fail on both counts—ethics and safety—and that they are inextricably interlinked.

Let me be straightforward: I do oppose these proposals in principle. However, that should not prevent my concerns regarding their safety from being given a fair hearing. One of the two procedures that we are being asked to sanction today—pro-nuclear transfer—involves the deliberate creation and destruction of at least two human embryos, and in practice probably more, to create a third embryo, which it is hoped will be free of human mitochondrial disease. Are we happy to sacrifice two early human lives to make a third life?

Photo of Paul Beresford Paul Beresford Conservative, Mole Valley

I question my hon. Friend’s definition of “embryo”. We are talking about two ova being used to create one embryo.

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

Let me put it this way. Some may take the view that at such an early stage of human life, it is acceptable deliberately to create human embryos to then destroy them. However, the truth is that once upon a time I was an embryo and so was every other Member in this Chamber.

This debate is about the principle of genetically altering—indeed, genetically creating—a human being, and no matter how well meaning the motives, and my heart goes out to the families with mitochondrial disease, this technique will not cure that disease. That answers the question asked in the intervention on Luciana Berger, the shadow Minister. This technique will not cure that disease.

Photo of David Davies David Davies Chair, Welsh Affairs Committee

I am completely undecided on this issue. Can my hon. Friend tell me whether it is the case that any woman taking the pill could arguably be destroying an embryo? If it is the case, what is the difference morally between using this technology and using the pill?

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

What we are talking about is a particular process, which we know—with certainty—will destroy embryos. That is what I am addressing. As I say, this technique will involve the permanent alteration of the human genetic code. The Nuffield Council on Bioethics, which was cited by the shadow Minister in support of her arguments, says that these techniques are

“a form of germline gene therapy.”

This alteration will be passed down generations. The implications of this simply cannot be predicted. However, one thing is for sure: as someone has said, once this alteration has taken place and once the genie is out of the bottle, and once these procedures that we are being asked to authorise today go ahead, there will be no going back for society, and certainly not for the individuals concerned.

Photo of William McCrea William McCrea DUP, South Antrim

Does the hon. Lady find it strange that while the shadow Minister was telling the House that we should support these regulations, she had no answer to the direct question she was asked by Mrs Gillan, and that all she could say was that she hoped the Minister would clear the matter up?

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

I was indeed surprised, but in a sense that is why those who have made the case for much more parliamentary time and debate on this issue are quite right.

There will be no going back for society and certainly not for the individuals and children involved. My hon. Friend the Minister said that we have taken all rigorous steps before bringing this matter to the House, but it is profoundly concerning that the outstanding pre-clinical trials, as recommended by the HFEA panel, have still not been undertaken, written up and peer-reviewed. Will my hon. Friend confirm that, setting aside the completion of pre-clinical trials, there have been no clinical trials of these procedures, that there will be no clinical trials of them and that, in effect, if we pass the regulations the techniques will be applied to the creation of children without clinical trials? In other words, we will be approving uncontrolled experimentation—because there will be no controls—on children. In the absence of clinical trials, would that not effectively contravene EU regulations?

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

There is a lot of muttering around the Chamber that there will be clinical trials, but there cannot be clinical trials because they would breach the EU directive.

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

That is exactly the point I was about to make. As has been highlighted in a letter from 44 MEPs who have written from the European Parliament this week to the Secretary of State for Health, the EU directives—the European clinical trials directive 2001, which was confirmed by the 2014 directive in the same area—state that

“No gene therapy trials may be carried out which result in modifications to the subject’s germ line genetic identity.”

My hon. Friend the Minister indicated that in some way these particular procedures were excluded from these trials. That cannot be correct. The European clinical trials directive 2001 applies to clinical trials involving germ-line engineering. It applies to all clinical trials using medicine, and to these procedures. For the Department of Health to argue that it can move straight to using these procedures on children without clinical trials gives us, apart from anything else, one reason to vote against these regulations.

If anyone doubts that, Lord Brennan QC has given a legal opinion on these regulations, which is of central importance. He says:

“It is a well-established principle that EU law is to be interpreted…in light of the purpose, values, social and economic goals the provisions aim to achieve. Given that…both the Directive and the 2014 Regulation…ban any gene therapy trials that involve modification of the subject’s germ line identity, then it would clearly fall within their purposes and values to prevent their use in clinical practice of any procedure with that effect without investigation or trials first having taken place.”

I believe that this Government are at risk of infringement proceedings being brought against them if these proposals go ahead.

Several hon. Members:

rose—

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

The answer has to be that we—

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

Thank you, Mr Speaker.

Once we approve this procedure, where will it lead? The answer has to be that we stop here and say, “This is a red line in our country, as in every other country in the world, that we will not cross.” This is the place for that to be said. As MPs, we are accountable to the people of this country.

The Government’s own consultation in July 2014 received 1,857 responses, of which 1,152 were opposed to the introduction of these techniques. That has been confirmed by ComRes polling last weekend, which showed that more than twice as many people are against these proposals as are in favour—41% of respondents, compared with 21%. A third public survey, being conducted today on The Daily Telegraph website, shows that as of this morning 68% of the public oppose these techniques in principle. Do their concerns not deserve respect from those of us present here?

The truth is that the Government have not waited for the conclusion of trials, as they should have done, so that this House could make a fully informed decision, and that is wrong. Whether one ultimately approves or disapproves of these proposals, the right procedure on such a profound issue is for the elected representatives of the people of this country to have full information before being rushed into a decision, as we would be today if we voted for these proposals.

Photo of Andrew Miller Andrew Miller Chair, Science and Technology Committee (Commons) 2:38 pm, 3rd February 2015

Fiona Bruce set out her case clearly and I respect her beliefs, but I do not agree with her conclusions. If we took them to the logical point, we would ban any intervention that introduces some part of one person to another. It would mean boycotting blood and organ transfers, simply because—[Interruption.] I listened with courtesy to the hon. Lady and I hope that my hon. Friend Robert Flello will listen to me with courtesy. When these pioneering techniques started, nobody knew the answers for certain. People made judgments—scientific judgments—on the best available evidence, and it turned out that people’s fears were ill-founded.

The trials that have been undertaken on this work have led the scientific community—a powerful group of scientists with an extraordinary degree of knowledge in this area—to conclude that the risks are small but worth taking because the benefits on the other side of the equation are enormous. In all cases where there are risks, we need to consider the risks as against the benefits. I put it to the House that there are potential benefits for the about 2,500 families affected by mitochondrial disease up and down this nation, and they deserve our support. Of course we have to assess the risks, as we do with all risks, but that has to be done in a rational and balanced way.

Photo of Richard Drax Richard Drax Conservative, South Dorset

I am listening carefully to the hon. Gentleman. Everyone in this House wants the best for these families—there is no doubt about that—but it is the speed of the introduction of the regulations that concerns us. As for experimentation, I heard today that no trials are being carried out on primates, which are as close to us as can be. This process has proved successful on mice, but on primates—a standard part of this procedure, apparently—it has not been carried out, and that is interesting.

Photo of Andrew Miller Andrew Miller Chair, Science and Technology Committee (Commons)

The hon. Gentleman makes an interesting point, but there are plenty of occasions when such tests are not carried out. In central Africa we have been testing Ebola vaccines without first testing them on primates, because the benefits outweigh the risks. We are in that position already. My hon. Friend the Member for Stoke-on-Trent South referred to research undertaken in China 10 years ago. He rightly said that that work took place, but I put it to Members of this House that the ethical and scientific rigour applied to experimentation in the UK far exceeds anything in China 10 years ago. Indeed, the technologies have also moved on to a very high degree since then.

Photo of Julian Huppert Julian Huppert Liberal Democrat, Cambridge

Some critics of this approach have pointed out that this country would be the first to go ahead with it. Does the hon. Gentleman agree that we should be proud to be leading the world in medical treatments and that, as he says, we can provide some of the best ethical safeguards in the world?

Photo of Andrew Miller Andrew Miller Chair, Science and Technology Committee (Commons)

The ethical basis on which science is conducted in this country is world leading. The hon. Gentleman is right to say that we should be immensely proud of the successes—again—of our scientific community in a range of life science disciplines. This one affects a very small group of the population but does so in such a profound way. Although there are issues that need properly regulating, the regulatory structure that we have created does that properly. The Minister was asked about, and indeed mentioned, the issues associated with designer babies. Of course this House would want to impose limits, but we are considering a specific set of regulations about dealing with mitochondrial disease—they do nothing else. I, for one, would not stand here to defend the concept of designer babies and people choosing eye colour and so on. Today, we are dealing purely with those terrible illnesses.

Photo of Andrew Miller Andrew Miller Chair, Science and Technology Committee (Commons)

No, as it would not be fair on other people. In case colleagues have not seen them, let me commend the e-mails sent to all Members by the Muscular Dystrophy Campaign; Jonathan Kingsley wrote to us all, and the Lily Foundation has written to us all in very powerful language. Those people who have sat and listened to some of the families will understand, and colleagues who have constituents affected by mitochondrial disease will understand the message.

We are in a society where people are entitled to have their beliefs, and I respect those beliefs; everyone should be entitled to express their opinion. But this is about focusing on the needs of that small part of the population that I mentioned. I urge the House, in coming to a conclusion this afternoon, to think about those families, to focus on their needs and to set aside general beliefs in the overwhelming interest of that small part of the population who have suffered immensely and who have an opportunity at their disposal because of the extraordinary science that has been advanced.

Photo of Steven Baker Steven Baker Conservative, Wycombe 2:45 pm, 3rd February 2015

I approach this subject with a considerable degree of humility, for two reasons. First, I will never forget meeting a family in my constituency whose child suffers from mitochondrial disease; there was both a haunting sorrow in that family and also the hope that if these regulations are passed they will be able to have a child without this problem. Secondly, I am very aware of my own shortcomings in relation to biological science. As a chartered engineer, I am perhaps more competent in the physical sciences, and I do not mind admitting that I had to look up at least a few of the words in the regulations in order to understand them.

As I have listened to this debate, not only today, but previously, I have wondered whether we have really reflected on how science proceeds, because scientific truth is not established by authority or by democratic vote; it is established, as Karl Popper put it, through “conjecture and refutation”—trial and error. Someone who reads Thomas Kuhn’s “The Structure of Scientific Revolutions” will discover that it is possible for quite large bodies of knowledge to be developed with errors in them. When those errors are corrected, the paradigm shifts—that is a term we have all heard. That is how science proceeds, through trial and error. The reality is that there will always be uncertainty in any scientific procedure.

When the Commons Library summarised the Nuffield Council on Bioethics’ review, the second point mentioned was this:

“The knowledge about these techniques is uncertain and could remain so for several generations—their use could potentially harm future persons.”

Luciana Berger, speaking from the Front Bench, made the point that, broadly, the question before us was whether there was a reason to withhold these techniques from people. If there is a reason, it is that they may do harm to future persons. I will not support the measure because this is inherently uncertain. That uncertainty is an inherent part of science, and it is no good appealing to authority to try to resolve the question, because different authorities will disagree and there is no way to resolve those disagreements apart from through empirical evidence, which we can obtain only by experimenting on humans.

Photo of Graham Stringer Graham Stringer Labour, Blackley and Broughton

The hon. Gentleman is making a typically thoughtful contribution to this important debate. Does he not have to balance that uncertainty, which he points out fairly, with the 100% certainty that the children of mothers with mitochondrial disease will suffer?

Photo of Steven Baker Steven Baker Conservative, Wycombe

The hon. Gentleman is absolutely right, which is why I began by expressing the humility I feel on this subject as a result of meeting and having had a lengthy conversation with a family who face just that issue. I remind myself, however, that we are dealing here not with a cure for those who have already been born, but with ensuring that those who are subsequently born do not suffer from that disease. If we were discussing a cure for those already living, perhaps the circumstances might be different.

Photo of Steven Baker Steven Baker Conservative, Wycombe

Prevention certainly is better than cure, but the question is: at what risk? I simply accept that on the earliest stages of human life there is a space for conscience; we will have different beliefs, some of which will be religious, and it is a matter of conscience. There are noble reasons for disagreeing about that stage and about what is and is not legitimate risk taking with human beings.

The second point I wish to make is that in the course of this conversation there seems to have been what, at best, I could describe as “semantic sophistry” as to whether or not this process is genetic modification. As always, there is space for debate about the definition of terms, but the germ line is to be modified if these techniques go ahead. The Minister has stated that plainly—

Photo of Steven Baker Steven Baker Conservative, Wycombe

She nods, and I am grateful. If the germ line is to be modified, to me this is genetic modification. I heard Dr Huppert give a clear explanation of the separate origins, and he understands the science better than I do. But for me the key thing is not so much where these parts of the DNA identity of a person came from, but where they are now. Each one of us has our own particular DNA identity. This procedure changes only a tiny part of it, but, having changed it, we cannot know what the future consequences will be. I know that families will be affected by the decision, but I have to say, with great sorrow, that, when it comes to human beings, this degree of uncertainty cannot be borne by my conscience and I shall be voting against the regulations.

Photo of Frank Dobson Frank Dobson Labour, Holborn and St Pancras 2:49 pm, 3rd February 2015

I have a sense of déjà vu, or perhaps déjà entendu. The objections that have been brought out today, and in previous discussions, about mitochondrial disease are identical to those that arose when Louise Brown was brought into this world at Oldham general hospital as a result of the risky work undertaken by Steptoe and Edwards and Jean Purdy. That was a risk that the scientists were willing to take and that Mr and Mrs Brown were willing to take.

Not long after I became a Member, Enoch Powell proposed a total ban on embryo research. I understand people’s ethical objections to embryo research, but if they object to something on principle, they do not need to add any other references to safety or effectiveness. If someone is opposed to it on principle, they are opposed to it, and I can respect that. When the Warnock report was published, this House had a creditable debate—to those who say that the House of Lords has a better quality of debate, I say that they should read its first debate on the Warnock report, and they might modify their views. All the things that are being said today were being said then, and all the things that were said in the debates about the establishment and development of the Human Fertilisation and Embryology Authority were the same.

In a previous speech, there were two novelties. One was that Robert Winston was being misquoted as opposing the proposal, which he cannot do any more as he actually wrote a full article in favour of it yesterday. The second was that US experts, some of the most distinguished experts who have written papers on the matter, were against it.

Photo of Frank Dobson Frank Dobson Labour, Holborn and St Pancras

No, I will not give way, because I do not want to take up more than my allocated six minutes.

The question arises: will it be safe and will it work? The answer is that no one can make any guarantees, but that is the nature of scientific development. The thing to remember is that mitochondrial disease is horrible and that there is no treatment for it. I remind people that the team at Newcastle university did not start off with this riskier novel approach. It has been studying and trying to come up with treatments for mitochondrial disease for the best part of 20 years, and is still doing so now. Some 90% of its work is trying to come up with a treatment. The best that it has managed to come up with after all these years is helping parents cope with the horrible symptoms before their children fade away and die. As has already been said, the team has decided that if it cannot come up with a treatment—and it is still trying—it would be better to prevent the disease arising in the first place because prevention is better than cure. That is why I hope the regulations will be passed and handed over to the HFEA. Members should realise that it is a credit to this country and to this House that the HFEA was established. We must find a middle way between the free-for-all, which a few nutters want, and the total ban, which some others want because they are opposed to embryo research on principle.

The system that has been established is well regulated through the HFEA. Despite all the predictions to the contrary, there has not been a single scandal in all the time that the HFEA has been in existence. There has been no sign of a slippery slope. These people with great reputations at Newcastle think the time is right to take risks and to risk their reputations—

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

Will the right hon. Gentleman give way?

Photo of Frank Dobson Frank Dobson Labour, Holborn and St Pancras

No, I shall not. Those people are taking risks, because if the treatment does not work, there will be those who will gloat—even, I am sad to say, Members in this Chamber. The parents are also willing to take the risks. Parents with children do not want this to happen again, and we have the opportunity to do something about it. The results are uncertain, but that is in the nature of both medicine and science. We cannot guarantee that it will work, but the people most involved in the matter and all the scientific advisory bodies in this country think that it will work, and we should take note of what they say.

Several hon. Members:

rose—

Photo of John Hemming John Hemming Liberal Democrat, Birmingham, Yardley 2:56 pm, 3rd February 2015

This is a difficult issue for everybody. I have a real difficulty with this, which is that I cannot see the difference between modifying mitochondrial DNA and nuclear DNA. Both are inherited, and both can prevent inherited diseases. If we agree to this as a process, we are, in essence, potentially agreeing to swapping a pair of chromosomes—[Interruption.] I know that we are not agreeing to it in law, but in practice the same arguments can be used to justify—

Photo of Andrew Bridgen Andrew Bridgen Conservative, North West Leicestershire

Will the hon. Gentleman bear in mind that mitochondrial DNA only codes the mitochondria, which were undoubtedly alien DNA to the human cells, and actually were probably bacteria that are now symbiotically living within us.

Several hon. Members:

rose—

Photo of John Hemming John Hemming Liberal Democrat, Birmingham, Yardley

I will not take lots of interventions because it would damage the debate. They remain inherited, and, in essence, we face the same difficulty. My concern is a legalistic one, which is that we are moving away from a society in which we value people as people to one where we start looking at people in terms of what categories they fall into and things such as that. To that extent, I cannot back the motion today, particularly as it is being pushed through in such a rush.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South 2:57 pm, 3rd February 2015

John Hemming almost caught me napping.

It would be ridiculous to suggest that anybody in this House does not want a cure for mitochondrial disease; it is a horrible disease. But if we understood properly how mitochondrial DNA worked, we might find ourselves closer to finding a cure for that disease. My right hon. Friend Frank Dobson said that we had heard all these arguments before. Well, yes, we did hear an argument before. It was back in 2007 when Members were marched through the Lobby to support the human-animal hybrid legislation. That legislation was going to solve numerous problems, and some Members said, “How could anybody dare to object to such legislation?” But what has happened to that legislation, that panacea? Well, nobody can get a grant for that work now because it has been proved that it does not work. All the concerns, hopes and heartache of the time got us nowhere. I really fear for the families today. If this motion passes today and it does become law, those families, who are, understandably, pinning everything on it, will be tragically let down.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

I will take an intervention shortly. My hon. Friend Liz McInnes mentioned the Zhang study. That study was not considered by the HFEA. Even if we said that Chinese medicine is terrible and that 10 years ago it was irrelevant and not ethical, the HFEA should still have considered it, but it did not. A number of Members have claimed that mitochondrial donation is like blood transfusion—nothing more than that. Well, no it is not like that. It is modifying the human germ line. As the HFEA has said, maternal spindle transfer is genetic modification of the egg and pronuclear transfer is genetic modification of the embryo. Think about it, colleagues. Why are we in the Chamber today to discuss this procedure if it is not genetic modification? If changing the germ line is not genetic modification, we do not need the statutory instrument. The HFEA could get on with it. It has therefore answered itself.

Photo of Julian Huppert Julian Huppert Liberal Democrat, Cambridge

I listened to what the hon. Gentleman said about hope, and he is right that we do not know how this will play out. There might be people who have hope who will not succeed. What I cannot understand is why he is saying that to avoid people having their hopes dashed later, we should dash them today.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

It is simply that this legislation will open up research that is illegal, as I shall describe in a moment. I also think there are greater concerns about generations down the line.

The EU clinical trials directive, which applies to all clinical work, states:

“No gene therapy trials may be carried out that result in modification to the subject’s germline genetic identity.”

The HFEA itself has said that this procedure does. In the legal opinion on the regulations, Lord Brennan QC has said that they are caught by the directive and that they are

“likely to be in breach of EU law” on clinical trials.

The Department of Health examined the legal opinion but rejected it, saying that the licence will not be granted for clinical trial but for treatment and therefore will not be caught by that law. Apparently, this is not about clinical trials and furthering the science but about going straight for treatment.

Lord Brennan’s opinion anticipated that. He set out the relevant paragraphs from the 2011 report on safety from the review panel set up by the Secretary of State to monitor the procedures to the HFEA, which said:

“Once assessed as safe to use in clinical practice, the panel strongly recommends that permission is sought from the parents of the children born from MST and PNT to be followed up for an extensive period” and that such permission should be sought from the children themselves once they are old enough. In the case of females, that should ideally be to the next generation. Those recommendations should also apply to pre-implantation genetic diagnosis for mitochondrial DNA genetic disease.

Photo of Peter Bone Peter Bone Conservative, Wellingborough

Why, in the hon. Gentleman’s opinion, are the Government trying to rush this through?

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

I think they are doing that because the legislation on the EU clinical trials directive will be tightened up even more next year.

Until knowledge has built up that says otherwise, the panel recommends that any female born following MST or PNT should be advised, when old enough, that she herself might be at risk of having a child with a significant level of mutant mitochondrial DNA. The HFEA is putting that child and, if they are female, subsequent generations at risk.

Mr Speaker, I have only a minute left but my speech would cover more than that time. It is a ridiculous nonsense to try to ram through this statutory instrument in no time at all. This is not about whether we should be helping families afflicted by this appalling disease but about saying we should get things right. We should ensure that this is done properly, with proper parliamentary scrutiny. The ultimate role of Government is to protect the safety of the citizens of this country and the regulations do not do that. They open the gates to a procedure that is completely untested, with no pre-clinical trials or clinical trials. The regulations talk about going straight to treatment and that has all been done so that the Department of Health can wangle its way around the legislation, or so it thinks. This is terrible. It is not good for the families with this chronic, horrible disease. We need proper and considered research. If these regulations were on genetically modified crops, we would all be up in arms. That is what is happening here.

Several hon. Members:

rose—

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

Order. I understand the widespread unhappiness about the time constraints, but we are where we are. I simply point out that Members are not obliged to take their full four minutes if they do not wish to do so.

Photo of David Willetts David Willetts Conservative, Havant 3:04 pm, 3rd February 2015

I apologise to you, Mr Speaker, and to the House for missing the opening speech in the debate. Nevertheless, I was keen to speak because I think that the proposals before us today would tackle a real human need. There are parents who are currently bringing into the world children with a horrible disease and the suffering is made more acute by the fact that now, for the first time, those prospective parents know that they could be doing this procedure and they therefore face the dilemma of whether or not to have children.

I realise that there are important objections. My hon. Friend Fiona Bruce put forward the ethical objection. I fully understand the fact that our benefit from this treatment does not of itself overcome the ethical issues, which are crucial. The red line to which she referred is, I think, a red line over which we have designer babies and change the DNA that makes the character of a person. I am persuaded by the scientific evidence that the mitochondria is not part of the core DNA that does that. In the previous debates and the previous legislation, it was absolutely clear that the red line that the House was trying to set was one that stopped the changing of human nature, and we do not cross it today.

Photo of David Willetts David Willetts Conservative, Havant

It is absolutely true that mitochondria can be inherited through the mother, but it does not change the character of the baby.

Secondly, let me consider the health and safety objection. Sometimes that objection is being used as a cover for what is really an underlying objection in principle. The scientists say, with typical caution and care, that there is no evidence that this is unsafe. It is true that nobody can have 100% certainty about that, but there have been 15 years of research and seven years of scrutiny, including by various scientific bodies and ones promoted under this Government, and so far no one has been able to come up with a concrete and powerful objection that suggests that the process is unsafe. It is right for us today to be considering moving on to the next step.

Photo of David Willetts David Willetts Conservative, Havant

Let me make some progress, as others want to speak.

Thirdly, I hear a rejection on the grounds that we are somehow rushing because we are going to be first. People ask, why us? Why now? Why in Britain? I must say, having had the privilege of serving as the Minister responsible for science, that we are first because we have world-leading research in this area. We should be proud of the fact that it is in British labs and British universities that this fundamental research is happening. It was in our country that the structure of DNA was discovered and I had the privilege of going to the Nobel prize ceremony for Robert Edwards, who won the Nobel prize for his work on IVF, which would properly not have passed through the levels of scrutiny we require of research today.

That brings me to my fourth and final point. What is our role in this Chamber today, faced with this very difficult question? We must make a judgment on whether any ethical issues stand in the way of tackling a clear human need. We are not agreeing that any specific programme of treatment should be licensed or should go ahead. We are very fortunate in this country to have a regulatory structure that is different from that in the US. In the US, if Congress voted for such legislation to go ahead, that would be the end of the matter. If we vote for the regulations today, as I hope that we will, we are saying that the HFEA can decide whether or not to license specific uses of mitochondrial DNA donation after it has assessed all the risks. There is that further safeguard. All we are doing is saying we require it to make that assessment and we are not objecting in principle. My sense of the mood of this House is that there are not many people who object in principle.

Photo of Andrew Bridgen Andrew Bridgen Conservative, North West Leicestershire

We yearn for Back-Bench debates and free votes and we have one today. However, I detect that those who perhaps have not studied the issue are going for the status quo, saying that there has not been enough time. Does my right hon. Friend agree that it would be disappointing if the regulations were not passed today because people had not done their research? It is rather like the case for a student who has not done his revision—the exam is always too soon.

Photo of David Willetts David Willetts Conservative, Havant

We all know the feeling.

One thing we are proud of in this country and, I hope, on both sides of the House is our innovation, research and enterprise, provided that the risks are clearly understood and regulation is in place. I hope that we will support innovation, particularly innovation that tackles a clear human need.

We are not saying that this must go ahead today. We are saying that we trust a body to consider licensing it with very strict requirements, and on that basis I hope that the House will support this admirable measure.

Photo of Liz McInnes Liz McInnes Labour, Heywood and Middleton 3:09 pm, 3rd February 2015

As we have heard, mitochondrial DNA makes up a tiny proportion of our total DNA. Unlike nuclear DNA, it does not pass on any personal attributes; it is purely involved in the chemistry of energy production. That is why, when there is a defect in mitochondrial DNA, it tends to affect organs that require a high amount of energy, such as the heart, muscles, brain and liver. All of our mitochondria are inherited from the egg and, as we have heard, researchers have worked on techniques to replace faulty mitochondria using those from a healthy donor. To refer to that donor as a third parent, as some have, is something of a misnomer. There are 37 genes in mitochondrial DNA, which is less than 0.01% of our total DNA. Altering the mitochondria will not alter a child’s characteristics inherited from its biological parents, but it may provide a way to prevent a debilitating and sometimes fatal disease.

Photo of Fiona Bruce Fiona Bruce Conservative, Congleton

I want to pick up on the point the hon. Lady makes about mitochondria not affecting characteristics. The Government’s own consultation document acknowledged that diverse characteristics are associated with mitochondria, including learning disabilities, neurological problems and dementia, and that every person’s symptoms are different. Is there not an insurmountable contradiction in saying that this is just like changing a battery if on the one hand one is saying that the aim is to prevent damage to those characteristics, but on the other hand one is saying that the techniques will not affect them at all?

Photo of Liz McInnes Liz McInnes Labour, Heywood and Middleton

I did not say it was just like changing a battery. In fact, I try to avoid using that terminology. The hon. Lady mentions learning disabilities, but as I just said, the organs affected the most by mitochondrial disorders are organs that require a large amount of energy, such as the brain, so that comes as no surprise to me.

Allegations have been made that the techniques are not safe.

Photo of Liz McInnes Liz McInnes Labour, Heywood and Middleton

No, I will not, because I need to make progress and let other people speak.

Last night, it was my privilege to attend the debate on the safety and ethics of this technique and to hear Professor Doug Turnbull, who leads the research team at Newcastle university, talk about the 15 years of work done by his team and the extensive safety checks that have taken place during those years. In the Chinese case to which my hon. Friend Robert Flello referred, the treatment was carried out by an American clinician on a single patient in China. The patient became pregnant with triplets, one of whom was aborted and the other two were born prematurely and died. Importantly, the clinician attributed the outcome entirely to multiple pregnancy and obstetric complications, not to the method of conception. I do not accept that that one case represents a proper clinical trial.

What we have to remember is that mitochondrial disease is a life-limiting debilitating disease, causing severe distress to parents and their affected children. We have here a technique with the ability to alleviate their suffering and to allow affected parents the chance to have a healthy child who is genetically related to them in all aspects apart from a tiny proportion of mitochondrial DNA. The spectre of designer babies can be dismissed. There is no possibility in using this technique of being able to select certain characteristics. It will simply allow mitochondria to function normally and for the child to be free of mitochondrial disease.

Photo of Liz McInnes Liz McInnes Labour, Heywood and Middleton

I will not, no.

In safety, the UK has a robust regulatory framework. A vote in favour of the motion will not in itself open the way for mitochondrial donation to be used in clinics. It will simply enable the HFEA to consider each individual family’s request for treatment on a case-by-case basis, taking expert scientific and medical advice and licensing the procedure only if the evidence shows that that is appropriate.

I am lucky enough to have worked at the Royal Oldham hospital, where the first IVF baby, Louise Brown, was born. When IVF was first introduced, there was no certainty that it was completely safe. Only after the first babies were born using the technique could scientists be completely reassured that their detailed research had led to the birth of healthy babies, but to this day research continues on IVF, just as more research must be done on mitochondrial transfer. That is the nature of science: it is a continuous process; it does not stand still.

For families affected by mitochondrial disease, this research has given them new hope that they may at last have the chance to bear a healthy child of their own. Last night I heard from a woman who suffered from mitochondrial disease, which had also affected her mother. That young woman had taken a considered decision not to have her own children, for fear of passing on the condition. The opportunity to have this treatment presents her and many other women in that situation with new hope. The science is there to alleviate the suffering of affected families, and in my opinion it would be unethical to withhold this treatment. I urge the House to approve the regulations.

Photo of Edward Leigh Edward Leigh Chair, Public Accounts Commission 3:15 pm, 3rd February 2015

Everybody who is following this debate will of course have the most profound sympathy for families who are affected by these appalling diseases, and I quite understand why so many colleagues want to vote for the regulations to lessen human suffering, but I am afraid that I will oppose the regulations. I do so on three grounds: ethics, safety and the importance of parliamentary procedure.

On the first, ethics, I think what we are considering is a new step. It will affect the germ line. Mitochondria is inherited; it is not just another organ of the body. What is proposed is a fatal and important step. As my hon. Friend Fiona Bruce asked, where do we stop? Given the nature of the human condition, these appalling diseases, sadly, will occur, but where do we stop? What further modifications will we make?

My second ground for opposing the regulations is safety. Under European conventions and regulations and so on, we should have full clinical trials and the scientific community should be united on aspects of safety, which it is not. Unfortunately, we will be the first state in the world to authorise the technique, and in that sense, in bioethical terms, we will be in a unique position. We should ask ourselves why no other state—not in the EU, not the US, not yet anybody—thinks that this is proved to be absolutely safe.

As for the third reason for my opposition, it has been said that this is not a final decision, and that we are just handing it over to the HFEA, but this is the final decision; it is a monumental decision. For the first time, Parliament is saying that we authorise people to affect mitochondrial DNA. That is a monumental decision. This will now happen and colleagues who vote for the regulations must appreciate that.

For those three reasons—on ethical grounds, on safety grounds and on procedural grounds, I will vote against the regulations.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Human Rights) 3:17 pm, 3rd February 2015

I hold the Minister in the utmost respect, but I feel greatly aggrieved that we are discussing this matter today in the House and that the Government are pushing forward with legislation on a process that I believe is unethical and unproven.

When assessing the reports published by the Human Fertilisation and Embryology Authority, we must take into account the point that the expert panel comprises a small group of scientists convened by the HFEA. Hearing the tone of today’s debate, one could be forgiven for thinking that they represent world scientific opinion. I do not want the House to be hoodwinked into thinking that there is a consensus on this issue, because there certainly is not. In fact, numerous world-leading scientists have been at pains to express their concerns about the proposals.

They include Professor David Keefe of New York university medical centre, himself a pioneer of spindle transfer techniques, who said:

“the application of the…techniques…represent intriguing advances of earlier work, but displays of technical virtuosity should not blind us to potential hazards.”

He explains that his research group moved away from these procedures because

“vexing concerns linger about the safety of mitochondrial replacement”.

He is far from alone. Stem-cell scientist Professor Paul Knoepfler is so concerned that he wrote an open letter to Parliament urging caution on the ground that rushing ahead would damage the reputation of science as a whole. He concluded:

“Overall, the UK would most likely be making an historic mistake by allowing 3-parent technology to proceed in the near future. Please wait on this critical decision for the additional information needed to make a wise choice in the long run.”

Clearly, we need time. Australian expert Professor Justin St John calls for more tests in non-human primates, so that we better understand the possible effects of the techniques. He says:

“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”.

None of those figures objects to the ethics of the techniques. Their objections are based purely on the science. Lest we think that they are lone voices, it must be remembered that the United States Food and Drug Administration considered the techniques last year and decided that there was not enough preclinical evidence to justify proceeding. I understand that the same body has reopened the debate and has insisted that it will be at least two yeas before it is ready to make a judgment.

In that context, I find it extraordinary that the Government have not waited for the conclusion of the preclinical safety experiments that the HFEA said should be conducted before proceeding.

Photo of William McCrea William McCrea DUP, South Antrim

In her opening speech the Minister mentioned that the devolved Administrations had been kept abreast of these proposals. I wanted to intervene to ask her whether the regulations will apply in Northern Ireland if they are passed in this House. That is an important question to which an answer is needed.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Human Rights)

I am glad my hon. Friend raised that point.

We cannot have a real debate today without the evidence. New Scientist, typically a champion of progress in all areas of research, warned of lack of understanding of the links between mitochondria and nuclear DNA. The fact is that the procedures for creating children are so controversial that no other country makes legal provision for them. The Council of Europe convention on biomedicine expressly prohibited them. The fact that experiments recommended by the Human Fertilisation and Embryology Authority itself have not been concluded, written up and peer reviewed raises extensive safety concerns. Yet we as parliamentarians are asked to make a decision today without having all the clinical evidence before us.

In the pre-clinical tests that have been carried out, one of the techniques was tried in humans and resulted in three foetal deaths. The obligations in international law, specifically the European directive on clinical trials—

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

On that point, will the hon. Gentleman give way?

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Human Rights)

I am sorry, I cannot give way. I do not have enough time.

The legal opinion of the Labour QC, Lord Brennan, seemed to suggest that the Government will not bother with clinical trials. That seems extraordinary and will come as a shock to many who spoke in favour in the debate on 1 September. My colleague, Lord Morrow, spoke to the Northern Ireland Attorney-General about the attempt of the Department of Health to argue in the response to Brennan that these regulations are not caught by the clinical trials directive, on the basis that the intention is to skip clinical trials. The Attorney-General told Lord Morrow that in his opinion the Department of Health is wrong and the regulations do indeed contradict the clinical trials directive. If the regulations go through today, they will be contradictory to international law as well. The same point was made by 44 Members of the European Parliament. I urge the House to vote against the regulations.

Photo of Paul Burstow Paul Burstow Liberal Democrat, Sutton and Cheam 3:22 pm, 3rd February 2015

Mitochondrial disease shortens lives, causes serious disability and leaves heartache in its wake. Now, thanks to the world-class research led from the university of Newcastle, we have the potential of innovation in IVF that could make a real difference for thousands of families in this country.

We have not arrived at this moment of decision in a rush. This House made provision in the Human Fertilisation and Embryology Act 2008 for regulations to be brought to this House

“to prevent the transmission of serious mitochondrial disease”.

Since those debates there has been a lengthy process to consider the benefits, the risks, the ethical issues and public consent. All these matters should be carefully considered. What all this work has revealed is broad public, ethical and scientific support for approving mitochondrial donation.

Clearly, safety is paramount. That is why the procedure has been scrutinised on three separate occasions by independent panels of experts. No evidence has been found to suggest that these techniques are unsafe. Are they ethical? Mitochondrial donation does not alter the essential personal characteristics or traits. It gives the gift of freedom from mitochondrial disease. It does not confer on a third person the parenthood that has been claimed in this debate. It is not about a third parent.

I have received many e-mails and letters from constituents on both sides of the argument, and I understand and respect those who have principled objections to the approach. I was struck by what the Right Rev. Dr Lee Rayfield and the Rev. Dr McCarthy said in a recent letter to The Guardian:

“The HFEA has made clear that even if parliament were to permit these two techniques, no licences would be issued until there was sufficient assurance from expert reviewers that mitochondrial donation is ‘not unsafe’”.

For me, that assurance—

Photo of Paul Burstow Paul Burstow Liberal Democrat, Sutton and Cheam

No, I must not. We must make progress.

That assurance from the HFEA is important. It means that although today is an important milestone in addressing mitochondrial disease, it is not the end. I was struck by what the Church of England said in its response to the HFEA’s consultation. The Church of England is not opposed in principle to these proposals. Its opposition is not absolute. It makes it clear that it is supportive in principle. As a Christian, I take heart from that.

For myself, I am persuaded that we make our decision today with the benefit of a thorough process, including thorough parliamentary scrutiny, and we have a robust regulatory framework. Today’s vote does not open the doors to mitochondrial donation as a matter of routine in clinics. Rather, we grant the HFEA the responsibility to consider on a case-by-case basis and weigh the expert scientific and medical advice. On every occasion safety and efficacy will be considered as a consequence of the regulations—the very concern that many hon. Members have cited as their reason for objecting to these proposals. I hope hon. Members will support them.

The Minister was right. This is about light at the end of the tunnel for thousands of families in this country. It is about the prospect of life lived, life realised, and about the potential opportunity to live.

Several hon. Members:

rose—

Photo of David Burrowes David Burrowes Conservative, Enfield, Southgate 3:25 pm, 3rd February 2015

We are here today to consider the regulations. The explanatory note says that the debate gives Parliament the opportunity to consider whether the new techniques are safe enough for use in a treatment setting. I said in a point of order at the start of the debate that I did not believe that we had had sufficient opportunity to make that decision today—sufficient opportunity, yes, to consider the passionate views of those mothers about whom we have heard today, who are at risk of passing a serious disease to their children, and also to consider on behalf of the country the prospect of our being world leaders in permitting human germ-line genetic modification. I say “genetic modification” because that is what it is. We need a clear and honest debate.

A number of scientists have accused the Government of dishonesty for trying to redefine what we are here for today, which is to debate whether to permit genetic modification. Only last week, the United States Institute of Medicine said that what we are discussing today are

“assisted reproductive methods involving genetic modification of eggs and zygotes for the prevention of mitochondrial disease.”

The HFEA, too, accepted honestly on its website that whether we go for PNT or MST, they are both genetic modification.

I do not know how many Members have read the regulations. This is not a wide debate about mitochondrial donation or about the principle. It is specifically about the regulations. They make it clear that the procedures entail a cell nuclear transfer, which alters the nuclear DNA in the egg that the DNA is transferred into. It is clear that mitochondrial DNA makes up part of the human genetic code. This technology that we are debating modifies that code by separating nuclear mitochondrial DNA. Regulations 4 and 7 make it clear that this is a complete transfer of nuclear DNA into the donor’s egg or embryo. The Government should admit that the interaction between mitochondria and nuclear material is not clear. We cannot say with certainty that these techniques will not affect the characteristics of children.

In conclusion, the Government said in their consultation response that this is about providing greater understanding of the ways in which mitochondrial DNA mutations are passed down from mother to child. In many ways it is an experiment, or a wider trial, and it is a trial that I do not think we should go ahead with. It is unprecedented in the world. Some might say that it is leading the pack, and others might say that it is leaving us out on a limb. Ethically, it breaks international norms. Legally, we have heard about the directive. With regard to safety, the tests are not yet complete. Members might think “Not yet” or “No”. Either way, please vote against the motion.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health 3:28 pm, 3rd February 2015

I will try to touch on some of the points raised in this high-quality debate, in which views have been expressed on all sides of the argument. I will deal first with the technical questions. I really cannot add to the excellent explanation that Liz McInnes gave of the Zhang et al study from China. She was precisely right and explained it very well.

In answer to an earlier question, we are satisfied that regulations are necessary and that they are not ultra vires. The clinical trials directive is not relevant in this context. It is part of a suite of EU measures that set out common rules across Europe to ensure the free movement of safe medicines in the EU. Mitochondrial donation is not a medicine, so those provisions do not apply. The follow-up assessment of the treatment’s efficacy is part of good clinical practice.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

I am afraid that I cannot, because my role now is to respond to the points that have already been made.

On international support, Britain does not stand alone, as some Members have suggested. The Department of Health has recently received a lot of correspondence from researchers and scientists in Germany, France, the Netherlands, Sweden, Japan, Hong Kong and two states in Australia, all indicating support for UK advances on mitochondrial donation. It is also important to note that nobody is saying that scientists are of one voice or one mind on the issue, but the House should note that the overall weight of international scientific opinion is very much in favour of these techniques, and they have been looked at exhaustively.

Following the point made by my right hon. Friend Paul Burstow, I have today spoken with the right reverend Prelate the Bishop of Carlisle, who speaks for the Church of England on ethical matters in the other place, and with the Rev. Dr Brendan McCarthy, the Church’s national adviser on medical ethics, and they have told me that I can confirm that the Church is not opposed in principle to mitochondrial donation.

We have discussed germ-line therapy, with Members disputing definitions on genetic modification. The HFEA agrees that these techniques are germ-line therapy, but it has also agreed with the Government’s working definition that mitochondrial donation is not genetic modification; but I accept that others will have a different view, because there is no international or universally accepted definition.

With regard to the techniques being successfully performed in non-human primates, I can confirm that maternal spindle transfer is a technique developed in the US that has been performed successfully in non-human primates. Lord Brennan’s comments on the regulations were made to the Joint Committee on Statutory Instruments, which did not draw any special attention to his remarks. In answer to my right hon. Friend Mrs Gillan, the regulations will not prevent mitochondrial disease caused by faults in nuclear DNA; the techniques make no alteration to nuclear DNA.

It is really important, in the seconds remaining, to point out for those Members who have said that we are rushing, and that it is open season on all these things, that that is not true. It is defined in primary legislation that the regulations can apply only to serious mitochondrial disease. There is no slippery slope. I looked back at the debates in the House on IVF all those years ago, when some were worried about a slippery slope, and all the safeguards are still in place more than two decades later. I think we can give the House confidence that we have considered this very carefully and that there is enough information. As I have said before, this is a bold step for Parliament to make, but it is a considered and informed one. We have world-leading science set in a well respected regulatory regime. For many families affected, this is indeed the light at the end of a dark tunnel. I commend the regulations to the House.

Question put.

The House divided:

Ayes 382, Noes 128.

Division number 147 Living Wage (Reporting) — Human Fertilisation and Embryology

Aye: 382 MPs

No: 128 MPs

Ayes: A-Z by last name

Tellers

Nos: A-Z by last name

Tellers

Question accordingly agreed to.

Resolved,

That the draft Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, which were laid before this House on 17 December 2014, be approved.

Photo of Rob Flello Rob Flello Labour, Stoke-on-Trent South

On a point of order, Mr Speaker. We have just had a 90-minute debate during which a number of right hon. and hon. Members from across the Chamber and with different views had to rush through their speeches. We had people putting on the record views—sometimes genuinely held views although not necessarily correct—that nobody was able to challenge. Some hon. Members did not even have the chance to contribute to the debate.

Could you confirm, Mr Speaker, that there were indeed hon. Members who indicated that they would have liked to speak? Secondly, do you think it right that we have had a 90-minute rush and will now have three hours on a Backbench Business Committee motion?

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

I thank the hon. Gentleman for his point of order, and I confirm that two hon. Members who wished to speak were unable to do so. I expressed sympathy at the start of the debate for Mr Burrowes who would have preferred a longer allocation of time, but I must operate within the rules and procedures of the House. It is also fair to emphasise that 12 Back-Bench Members representing different viewpoints were called. That is the factual answer.

Robert Flello invites my view as to the propriety or otherwise of this matter, and I can say only that we have operated entirely in accordance with procedure. There has been no impropriety and nothing disorderly. I understand that some people are discontented, but I hope people will not take offence if I say that to a degree, I think there will always be people who are discontented. It is difficult to get unanimity on these matters, either on the merits of the issue or on the procedure. However, I think we have done our best, and people have done their best today to help each other, which is worthy of note.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Human Rights)

Further to that point of order, Mr Speaker. It is obviously of great concern to many Members of the House that only 90 minutes was allocated for that debate, and you outlined at the beginning of the debate that the Minister could control that. What advice would you give to Back Benchers who want to ensure that in future, if there are debates about such enormous change for the whole United Kingdom, we can ensure a three-hour debate rather than a 90-minute debate?

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

I am always happy to offer my advice to the hon. Gentleman, but whether he takes it or not is entirely up to him. The short answer is twofold. The hon. Gentleman is an assiduous attender of debates—indeed, I have often wondered if he sleeps here overnight because he is invariably present in the Chamber at all times and for every Adjournment debate. First, he should always turn up at business questions when he can raise such matters with the Leader of the House. Secondly, if he feels that Back Benchers should have a greater say in the allocation of time on matters of this kind, he might want to join forces with other hon. Members who are championing the creation of a House business committee. That was to be introduced by the third year of this Parliament, but I think it momentarily slipped the Government’s memory and therefore has not happened. It might happen in the next Parliament, however, and I have a feeling that the hon. Gentleman might be a cheerleader for it. We will leave it there.

Photo of Paul Beresford Paul Beresford Conservative, Mole Valley

Further to that point of order, Mr Speaker. The hon. Gentleman that introduced the point of order has conveniently forgotten that he spoke in the Back-Bench debate on just this cause, as it is in his case. He was one of the leading Members at that debate.

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

Well, that was—dare I say it?—a meaty point of order, or even a toothy one, but it was certainly a useful point of order and I am grateful to the hon. Gentleman. We must not delay indefinitely, but we must take Dr McCrea.

Photo of William McCrea William McCrea DUP, South Antrim

Further to that point of order, Mr Speaker. There is general dismay among many Members, and I am sure among our constituents, that we could get only 90 minutes in this House to debate a decision of such magnitude, and hand it over to others to take the decision forward, without parliamentarians having the final say, and yet we have three hours on the next motion, a general debate on rural phone and broadband connectivity. Only one Northern Ireland Member was able to speak, and he had to rush through his speech, and yet we find out that the legislation applies equally to Northern Ireland, where a devolved Government cannot stop it, as in other regions of the United Kingdom.

Photo of John Bercow John Bercow Chair, Speaker's Committee for the Independent Parliamentary Standards Authority, Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons, Speaker of the House of Commons

I always listen to the hon. Gentleman, and I hope to every Member, with courtesy. I hope he will not take offence when I say that that point was made in the course of the debate. If the Leader of the House wants to respond, he can, but we must operate in accordance with our rules. Members would rightly complain if we did not or if I did not.

We will have to leave it there for today. I thank all hon. Members both for their contributions to the debate, and of course for their points of order. I thank the Minister for her courtesy and consideration of other Members in terms of her own taking up of time.