Human Fertilisation and Embryology

Debate between Jane Ellison and William Cash

Tuesday 3rd February 2015 Commons Chamber

[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.

--- Later in debate ---

[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.

[Sir William Cash]

Will my hon. Friend give way?

[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.