My Lords, the purpose of the regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.
Mitochondria are present in almost every cell in the body and produce the energy that we need to function. This is why they are often referred to as the “powerhouse” of the cell. Unhealthy mitochondria can cause severe medical disorders known as mitochondrial disease, for which there is no cure. There are 37 genes in the mitochondrial DNA, compared with more than 20,000 in the nuclear DNA. This represents less than 0.1% of the total genetic make-up. 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.
Provision to make these regulations was introduced by Parliament into the Human Fertilisation and Embryology Act 2008. It followed an amendment that recognised the progress being made in research. In 2010, researchers at Newcastle asked the Department of Health to take forward steps to develop regulations. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014. There have been three separate reports into the safety and efficacy of these mitochondrial donation techniques by an expert panel convened by the HFEA, 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.
This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence:
“the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law”.
Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these regulations. The two proposed techniques that would be allowed under these regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.
I know that many noble Lords will have their own tributes to pay, but I would like to make my own acknowledgment of the ground-breaking work that the scientists at Newcastle University have led, which is world-leading in the development of these new techniques. It is also very important to praise the Lily Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, which has reminded us about the human story that inspired this scientific advance.
I turn now to the detail of the regulations made under powers in the 1990 Act which, as I said, were added in 2008, with Parliament’s express agreement, in anticipation of the advancement of science to this point. These powers would permit mitochondrial donation in order to prevent the transmission of serious mitochondrial disease.
4.30 pm
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. That would allow the two techniques that have been the subject of extensive UK-wide review and consultation: maternal spindle transfer and pronuclear 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 for consent, which were identified through the public consultation process. These regulations apply UK-wide, and the devolved Administrations have been kept informed of development and progress.
Concerns have been raised in advance of this debate by some noble Lords about both compliance of the regulations with European Union law and how the regulation-making powers were originally drawn in the 2008 Act. Those are complex issues, and I have taken care to write to noble Lords about them before the debate. In doing so, I set out the Government’s clear view that we are acting within EU law and that the legislation is sound and robust.
As I have set out in recent parliamentary replies to the noble Baroness, Lady Hollins, the clinical trials directive does not cover treatment services, which is what would be allowed under the terms of the regulations. Furthermore, to be clear, the clinical trials directive relates to medicines and therefore has no relevance in the context of mitochondrial donation.
There has also been much discussion of the safety of these mitochondrial donation techniques, and, as I have outlined, there have been three reports by the HFEA-convened expert panel during this Parliament. On each occasion, the expert panel has concluded that there is nothing at all to indicate that the two donation techniques are unsafe. Although the expert panel has recommended that further experiments should take place, the panel has said that 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” when used by the expert panel. This point was helpfully clarified in the HFEA briefing note, which has been endorsed by the expert panel. It clarifies that these experiments could take place before or after the approval of regulations by Parliament.
We have said that it is our view that this Parliament should be given the opportunity to consider these regulations, as the key developments and reviews have taken place during the lifetime of this Parliament. We cannot be certain about what priorities the future Administration will have and whether, in the event that the regulations were deferred, there may be an extended delay in considering them further.
My position on this, shared by my ministerial colleagues, is very simple. Families can see that the technology is there to help them and are keen to take it up. They have noted the conclusions of the expert panel. It would be cruel and perverse, in my judgment, to deny them that opportunity for any longer than absolutely necessary.
Let me explain further the safeguards that would apply here. If these regulations are passed by Parliament, the HFEA would put in place a robust regulatory process, as it has in other areas of fertility treatment. The regulations would also bring into being important safeguards through the HFEA’s own licensing procedures. For a licence to be issued to a provider of mitochondrial donation, it would first have to demonstrate that it could carry out the procedure safely and effectively. Each provider would need to be authorised, and treatment for each patient would be approved on a case-by-case basis.
Every such decision would be based on the scientific evidence, including: information on the safety and efficacy of the techniques at the time of the application; advice submitted to the licensing committee by the clinic; and an assessment of each individual patient. 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 this framework in place.
In setting out the purpose and effect of these regulations I hope I have been able to offer reassurance to noble Lords that the long process of consideration of mitochondrial donation has been rigorous, sensible and inclusive. The UK is admired across for the world for the approach that it takes on matters such as this. I recognise that some noble Lords will be opposed in principle to mitochondrial donation. While I respect their point of view, I cannot agree with it. The Government’s view is that it is right that we bring this matter to this Parliament to ask parliamentarians to make an informed decision about what happens next.
I end by emphasising what, to me, is the ethical heart of this issue. This House now has the opportunity to give real hope to families and the chance for doctors to offer more to those families carrying serious mitochondrial disease than yet another generation of avoidable suffering and shortened lives. The UK can offer this world-leading science within a robust regulatory regime and, in so doing, the chance to make a real difference to families. I commend these regulations to the House and beg to move.
Amendment to the Motion