Human Fertilisation and Embryology

Robert Flello Excerpts

Tuesday 3rd February 2015 Commons Chamber

[The Parliamentary Under-Secretary of State for Health (Jane Ellison)]

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 on 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.”

[Robert Flello (Stoke-on-Trent South) (Lab)]

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?

[Jane Ellison]

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 on mitochondrial donation in October last year. Following the hearing, the Chair, the hon. Member for Ellesmere Port and Neston (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.

[Robert Flello]

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.

[Jane Ellison]

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.

--- Later in debate ---

[Luciana Berger (Liverpool, Wavertree) (Lab/Co-op)]

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 the 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.

[Robert Flello]

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.

[Luciana Berger]

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.

--- Later in debate ---

[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.

--- Later in debate ---

[Robert Flello (Stoke-on-Trent South) (Lab)]

The hon. Member for Birmingham, Yardley (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 the Member for Holborn and St Pancras (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.

[Dr Huppert]

rose—

[Robert Flello]

I will take an intervention shortly. Reference has been made to 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.

[Dr Huppert]

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.

[Robert Flello]

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.

[Mr Bone]

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

[Robert Flello]

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.

I have only a minute left but my speech would cover more than that time. It is 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.

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[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—

[Robert Flello]

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

[Jim Shannon]

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 contradict 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.

--- Later in debate ---

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

[Robert Flello]

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?

[Mr Speaker]

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 the hon. Member for Enfield, Southgate (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.

The hon. Member for Stoke-on-Trent South (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.