Human Fertilisation and Embryology

Lord McCrea of Magherafelt and Cookstown Excerpts

Tuesday 3rd February 2015 Commons Chamber

[Mr Brian H. Donohoe (Central Ayrshire) (Lab)]

rose—

[Dr William McCrea (South Antrim) (DUP)]

rose—

[Jane Ellison]

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.

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[Luciana Berger]

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.

[Dr William McCrea]

Will the hon. Lady give way?

[Luciana Berger]

I am going to make some progress, because I am conscious—referring back to the intervention of the hon. Member for Wellingborough (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 the fact 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, by contrast with 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.

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[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?

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[Jim Shannon (Strangford) (DUP)]

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.

[Dr McCrea]

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.

[Jim Shannon]

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 a 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 preclinical 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—

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[Mr Speaker]

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.

[Dr William McCrea]

rose—

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[Mr Speaker]

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.

[Dr McCrea]

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.

[Mr Speaker]

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.