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.
Mr David Burrowes (Enfield, Southgate) (Con)
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.
Jane Ellison
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 Lily 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.
Steve Baker (Wycombe) (Con)
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.
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.
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.
Richard Fuller (Bedford) (Con)
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?
Jane Ellison
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 distinguish 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.
Jane Ellison
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 it 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.
Sir William Cash (Stone) (Con)
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?
Jane Ellison
The clinical trials directive applies only to medicines. It does not apply to embryology, so it is not relevant in this case.
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.
Steve Baker
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—
Steve Baker
She nods, and I am grateful. If the germ line is to be modified, to me this is genetic modification. I heard the hon. Member for Cambridge (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 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.
Jane Ellison
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 the hon. Member for Heywood and Middleton (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.
Jane Ellison
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 the Member for Sutton and Cheam (Paul Burstow), I have today spoken to 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 of 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 the Member for Chesham and Amersham (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 to 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.