Human Fertilisation and Embryology

Fiona Bruce Excerpts

Tuesday 3rd February 2015 Commons Chamber

[Jane Ellison]

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.

[Fiona Bruce (Congleton) (Con)]

rose—

[Jane Ellison]

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.

[Fiona Bruce]

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”?

[Jane Ellison]

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.

--- Later in debate ---

[Fiona Bruce (Congleton) (Con)]

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 votable.

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?

[Sir Paul Beresford (Mole Valley) (Con)]

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

[Fiona Bruce]

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 the hon. Member for Liverpool, Wavertree (Luciana Berger), the shadow Minister. This technique will not cure that disease.

[David T. C. Davies (Monmouth) (Con)]

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?

[Fiona Bruce]

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.

[Dr McCrea]

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 the right hon. Member for Chesham and Amersham (Mrs Gillan), and that all she could say was that she hoped the Minister would clear the matter up?

[Fiona Bruce]

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 preclinical 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 preclinical 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?

[Robert Flello]

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.

[Fiona Bruce]

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:

“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—

[Fiona Bruce]

The answer has to be that we—

[Mr Speaker]

Order. I think Members thought that the hon. Lady had concluded her speech, but she has not. Let us have a courteous hearing for everybody. I call Fiona Bruce.

[Fiona Bruce]

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.

--- Later in debate ---

[Frank Dobson]

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—

[Fiona Bruce]

Will the right hon. Gentleman give way?

[Frank Dobson]

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.

--- Later in debate ---

[Fiona Bruce]

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?

[Liz McInnes]

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.

[Liz McInnes]

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 the Member for Stoke-on-Trent South (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 of using this technique to select certain characteristics. It will simply allow mitochondria to function normally and for the child to be free of mitochondrial disease.

[Fiona Bruce]

Will the hon. Lady give way?

[Liz McInnes]

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.