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National Insurance cOntributions Bill (Money)

Queen’s recommendation signified.


That, for the purposes of any Act resulting from the National Insurance Contributions Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.—(Mark Lancaster)

National Insurance Contributions bill (programme) (No.2)


That the following provisions shall apply to the National Insurance Contributions Bill for the purpose of supplementing the Order of 8 September 2014 (National Insurance Contributions Bill (Programme)):

Consideration of Lords Amendments

(1) Proceedings on consideration of Lords Amendments shall (so far as not previously concluded) be brought to a conclusion two hours after their commencement at today’s sitting.

Subsequent stages

(2) Any further Message from the Lords may be considered forthwith without any Question being put.

(3) The proceedings on any further Message from the Lords shall (so far as not previously concluded) be brought to a conclusion one hour after their commencement.—(Mark Lancaster).

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National Insurance Contributions Bill

Consideration of Lords amendments

Madam Deputy Speaker (Mrs Eleanor Laing): I must draw the House’s attention to the fact that financial privilege is involved in Lords Amendment 1. If the House agrees to it, I shall ensure that the appropriate entry is made in the Journal.

Before Clause 1

Secondary Class 1 contributions: apprentices under 25

1.26 pm

The Financial Secretary to the Treasury (Mr David Gauke): I beg to move, That this House agrees with Lords amendment 1.

Some right hon. and hon. Members may recall the important initiative on apprentices announced by my right hon. Friend the Chancellor of the Exchequer in his autumn statement on 3 December. The Chancellor announced that the Government will abolish employer class 1 national insurance contributions for apprentices under the age of 25 from April 2016, building on the removal of employer class 1 national insurance contributions for all under 21-year-olds from April 2015.

Amendments to section 9 and new section 9B of the Social Security Contributions and Benefits Act 1992 and the Social Security Contributions and Benefits (Northern Ireland) Act 1992 give effect to the Government’s intention to abolish employer class 1 NICs for apprentices under the age of 25. From April 2016, employers of apprentices under the age of 25 will pay a zero rate of secondary class 1 NICs on the earnings of those employees, and that zero rate will apply to earnings below the upper earnings limit.

As my right hon. Friend the Chancellor made clear, apprenticeships are at the heart of the Government’s drive to equip people of all ages with the skills valued by employers. This measure is intended to support employers who provide apprenticeships to young people by removing the requirement that they pay secondary class 1 NICs on earnings up to the upper earnings limit for those employees. The measure is also intended to support youth employment. Under this Government, employment is at its highest ever level while unemployment is now lower than when the Government came to power. However, there is more to do to tackle youth unemployment and ensure that no one is left behind.

The amendment provides a zero rate of employer class 1 national insurance contributions on the earnings of apprentices under the age of 25 from 6 April 2016. The measure will apply to both new and existing apprentices aged under 25 and is not time limited.

The main features of the clause are, first, that there is a regulation-making power to define “apprentice”. There are existing statutory definitions relating to apprenticeships. For example, in England and Wales, the Apprenticeships, Skills, Children and Learning Act 2009 introduced the concept of an apprenticeship agreement, which is defined in part with reference to “an apprentice”. Because education and training is a devolved matter, and because not all apprentices are employed under apprenticeship agreements, we will need to look at the approaches taken towards

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apprenticeships in the different devolved Administrations. The power will allow time to discuss the definition with interested parties such as the Skills Funding Agency and their devolved equivalents. The power will also enable us to respond simply to changing statutory definitions and requirements in future.

Secondly, there are regulation-making powers to vary the age group to which the zero rate of secondary class 1 NICs for apprentices applies. For example, the Government could in future allow for an increase in the age bracket of apprentices falling into the zero rate earnings band of secondary class 1 NICs.

Thirdly, there is a regulation-making power to ensure that the benefit of the zero rate of secondary class 1 NICs for apprentices can be enjoyed only in respect of earnings below a certain level. In other words, the power will provide a means to introduce an upper secondary threshold for apprentices in the same way as we are doing for under 21s. That threshold will be set at the level of the upper earnings limit in the 2016-17 tax year.

The Government’s objective is to make all apprenticeships world class. Around £1.5 billion is spent annually to support apprenticeship training, and the Government are committed to driving up the quality of apprenticeships. We are currently taking forward a number of reforms that will have a positive impact. The Government believe that the measure will, alongside other initiatives on apprenticeships and the abolition of employer’s NICs for under 21s from April 2015, help to address the problem of youth unemployment in the UK.

I hope that, with that explanation, the House will accept the amendment made in the other place.

Shabana Mahmood (Birmingham, Ladywood) (Lab): I am grateful to the Minister for introducing Lords amendment 1, which was the main amendment made in the other place. As he said, it enacts the announcement made in the autumn statement that employer national insurance contributions for apprentices aged under 25 will be abolished from April 2016. The Opposition support the measure. There is agreement on both sides of the House and across party political boundaries that we need more apprenticeships; and that youth unemployment, and long-term youth unemployment, remain a problem not only for the individuals involved, but for the economy as a whole. We hope the measure helps to alleviate that somewhat.

The Minister said that there is a regulation-making power within the measure for the definition of “apprentice” and referenced the 2009 Act definition, which relates to an apprenticeship contract. That concern was raised in the other place when the measure was debated. Will he give the House more information about progress in discussions with the devolved legislatures about the definition to be applied? How confident is he that the provision will not be manipulated in a way that enables a reduction by companies of their tax liabilities? The lack of a definition of “apprentice” causes concern that that might arise.

The current quality of apprenticeships has come under scrutiny in this Parliament. A recent report from the Department for Business, Innovation and Skills showed that 15% of apprentices are paid below the national minimum wage, and that 28% of level 2 and

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level 3 apprentices who do not have a written contract are paid below the national minimum wage. We also know that one in five apprentices receive no formal training. Will the Minister consider a stipulation on quality when he looks at the definition of apprentice? That would go some way to alleviating some of the concerns raised about potential gaps in the measure that could lead to abuse, or to a proliferation of apprenticeships that are not of a high quality and that do not add too much to the future prospects of the young people engaged in them. It would be helpful to hear the Minister’s further comments on those points.

Mr Gauke: I welcome the hon. Lady’s support for the measures. It is worth noting the considerable progress made on apprenticeships under this Government. We have created 2 million apprenticeships during this Parliament; they are giving young people the skills they need to succeed in the global race and get on in life. That is significant progress—progress on the number of apprenticeships has been considerably faster than was previously expected. For example, the previous Prime Minister, the right hon. Member for Kirkcaldy and Cowdenbeath (Mr Brown), said in 2008 that he intended to have 90,000 more young people taking part in apprenticeships by 2013. He said that, together with opportunities for those in their 20s and older, that would mean 220,000 people starting an apprenticeship each year overall. In 2011-12, 520,000 people started an apprenticeship, so we can see that there has been dramatic progress. The measure helps us to pursue that policy yet further.

Jim McGovern (Dundee West) (Lab): I am intrigued as to how the Minister will define an apprenticeship these days. I was an apprentice in the construction industry. I served a four-year apprenticeship from the age of 16 to the age of 20. My father had to sign my indentures to say that I was indentured to that company, and possibly sold into slavery in a way. What is an apprenticeship these days? The Minister talks about half a million new apprenticeships, but are they apprenticeships as I understand them?

Mr Gauke: The hon. Gentleman goes to the heart of the question asked by the hon. Member for Birmingham, Ladywood (Shabana Mahmood) about who will qualify for the relief. As I have remarked, we are taking a power to define apprenticeships. Given that this is a devolved matter, it is important that we discuss it with the devolved Administrations. We want to support apprenticeships and will seek to achieve a broad definition for the purposes of the relief. However, the apprenticeship system across the UK is complex and evolving. Education and training is a devolved matter. Apprenticeships operate slightly differently in England, Scotland, Wales and Northern Ireland, and there are differences between Government-funded apprenticeships and independent employer schemes. The Government will discuss the definition of “an apprentice” with the Skills Funding Agency and its devolved equivalents before committing ourselves to a final definition. It is important that the definition is robust, satisfying minimum compliance standards while achieving the objective of supporting the provision of apprenticeships to the under-25s.

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In terms of overall support for apprenticeships, the Government have done a great deal. We spend about £1.5 billion annually to support apprenticeship training. In Budget 2014, £170 million of additional funding was made available for apprenticeship grants for employers in 2014-16, providing a grant of up to £1,500 per apprentice for small businesses. The new budget will fund more than 100,000 additional incentive payments for employers to take on young apprentices.

It is also worth pointing out that in 2012 the National Audit Office recognised the strengths of the Government’s apprenticeship programme, highlighting how it continued to be valued by learners and businesses. It concluded that public spending on apprenticeships offered a good return, estimated at £18 for each £1 of Government investment. Evidence from the Department for Business, Innovation and Skills suggests that returns may be higher, at £28 for every £1 of Government investment. I hope Members will resist the temptation to criticise the substantial progress that has been made on apprenticeships over the course of this Parliament. It has been significant.

On the definition of apprentices, which I touched on earlier, there will need to be discussion with the devolved Administrations and the Skills Funding Agency. We want a robust definition, but we have to bear in mind the complexities in this area.

On eligibility, for a business to be eligible to work with training providers to create an apprenticeship programme, the employer offering an apprenticeship needs to employ an apprentice for a minimum of 30 hours per week, pay at least the national minimum wage for apprentices, support on-the-job learning and be involved in reviewing their progress. On the question raised by the hon. Member for Birmingham, Ladywood regarding manipulation, I would make the point that those safeguards are in the system.

One further point I believe is important is that, as the Government are doing with employment allowance and under-21s from April this year and as we did when we came to office and increased the threshold before employer national insurance contributions is paid, we have done a great deal to reduce the burden on businesses of employer national insurance contributions. That has helped in creating the substantial progress in employment we have seen in recent years. Had we pursued the policy we inherited—an increase in the jobs tax—we would not have seen that progress.

Steve Baker (Wycombe) (Con): On reducing the burden on business, the Government have previously considered the notion of merging national insurance. Has the Minister made any progress down that line? I am acutely aware that national insurance still creates the impression that people have contributed to a fund out of which benefits are paid, when of course they are mostly pay-as-you-go. Can we reduce the burden on business, simplifying national insurance by simplifying the overall tax system?

Mr Gauke: My hon. Friend raises an interesting point in this context. He is absolutely right that the Office of Tax Simplification recommended we looked at that. There is quite a lot going on in relation to payroll: devolution of income tax in Scotland, the auto-enrolment of pensions and the introduction of real-time information to the payroll system. They have caused considerable

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challenges—all for good reason; all are doing much to improve the tax system—and we have held off pursuing further integration of income tax and the national insurance contributions system.

My hon. Friend was right to raise a point about people’s understanding of the tax system and greater transparency. The Government have introduced tax summaries so that people can see how much they are paying in income tax and national insurance. That brings greater transparency to our tax system, so we have made progress on that front. On the integration of national insurance and income tax more widely, it remains a position we continue to review. Some evidence from internal reviews was that the benefits to business of bringing the two systems together were perhaps not as great as some outside commentators had anticipated. In those circumstances, we did not want to rush into this matter, but I assure my hon. Friend that we continue to keep it under review.

Steve Baker: Will the Minister remind me whether tax summaries include employers’ national insurance? I am always conscious that when we are employees we must generate an amount of value for our employer somewhat greater than even our gross pay, so is employers’ national insurance contribution also reflected in the summary? If not, could it be?

1.45 pm

Mr Gauke: There is a reference to employers’ national insurance contribution. The tax summaries state how much is paid in income tax and in employees’ national insurance contributions. There is also a line in the summaries saying, “Your employer has paid this much employers’ national insurance contribution.” Returning to the issue directly before us in relation to apprenticeships, there is an argument—I think a lot of economists would make this point—that ultimately the burden of employers’ national insurance contributions is taken up by the employee, as they receive less in salary as a consequence. There is also a case that it may be a disincentive for employers to take on employees.

We believe this sensible and well-targeted measure will encourage businesses to take on apprentices. We have not focused particularly on the limit, but there is provision to prevent manipulation such as the classifying of premier league footballers as apprentices, which might result in a 24-year-old footballer paying no NICs on a salary of £1 million. We have sought to address such abuses.

George Hollingbery (Meon Valley) (Con): Will the Minister develop that point a little by saying exactly how many apprentices he thinks the change will encourage?

Mr Gauke: We anticipate that there will be about 3 million apprenticeships over the course of the next Parliament. The provision will come into effect in 2016-17. Not every apprentice is under 25, so not every apprentice will benefit from the provisions, but a large number of apprentices in the next Parliament will benefit.

Overall, we estimate that about 180,000 employers offering apprenticeships in the UK are likely to benefit from the measure. Apprenticeship data from the Department for Business, Innovation and Skills for England for the 2013-14 academic year show that about

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500,000 apprentices under the age of 25 are employed throughout the country, and we estimate that about 130,000 apprentices in England are aged 21 to 24. That group will be directly affected by the measure, with those under 21 already benefiting from the zero rate for under-21s from April this year. I hope that information is helpful to the House.

Many Members were delighted by the Chancellor’s announcement on apprenticeships in the autumn statement, which demonstrated, yet again, the Government’s commitment to apprenticeships. If we wish to succeed in the global race, we need a well-educated and well-trained work force and to support employers who provide the training and experience that young people need if they are to be more productive and effective and more likely to make a substantial contribution to the economy.

Quite rightly, we often debate how to improve living standards, but ultimately it is down to improvements in productivity. As the economist Paul Krugman said—I do not often quote him:

“Productivity isn’t everything, but…it is almost everything”.

As part of our long-term economic plan, one measure we are taking to improve productivity is ensuring a well-trained work force, and encouraging apprenticeships is key to that. It is yet another aspect of our long-term economic plan. It will help us improve our productivity, and as productivity increases, so too will wages, salaries and living standards.

George Hollingbery: Will the Minister elaborate on the Government’s own productivity and on whether our investment in apprenticeships has been compared with other possible investments in productivity?

Mr Gauke: My hon. Friend makes a good point. As I said, the Government invest about £1.5 billion a year in apprenticeships. In its 2012 report, the NAO suggested that for every £1 spent in this area, we got a return of £18, and studies by the Department for Business, Innovation and Skills suggest that the return might be even greater: £28 for every £1 invested. Therefore this offers good value for money. Our policy on apprenticeships is an additional step, and I am delighted that the tax system can be used in this way. Once again, it demonstrates that the Government are on the side of those who wish to work hard, improve their skills and get on in life.

With those remarks, I hope that the House will agree with the Lords amendment.

Lords amendment 1 agreed to, with Commons financial privilege waived.

Mr David Burrowes (Enfield, Southgate) (Con): On a point of order, Mr Speaker.

Mr Speaker: I think we shall treat of the hon. Gentleman’s point of order afterwards.

Mr Burrowes rose—

Mr Speaker: Does it relate to current business?

Mr Burrowes: No, it concerns the next business.

Mr Speaker: In that case, we shall come later to the hon. Gentleman. I am saving him up. It would be a shame to squander him too early.

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Clause 2

Consequential etc power

Mr Gauke: I beg to move, That this House agrees with Lords amendment 2.

Mr Speaker: With this it will be convenient to consider Lords amendments 3 to 5.

Mr Gauke: This group comprises four minor technical amendments to clause 2 and schedule 1, which deal with simplifying the collection of class 2 national insurance contributions payable by the self-employed.

It might help the House if I briefly outline the four amendments. Amendments 2 and 3 are the Government’s response to the report, published on 27 November, by the Delegated Powers and Regulatory Reform Committee on the delegated powers contained in the Bill. The report drew to the House’s attention the power in clause 2 to amend primary and secondary legislation as a consequence of the reform of class 2 NICs. This power is currently subject to the negative procedure. The Committee said that the justification in HMRC’s “Delegated Powers Memorandum” was not sufficient for the negative procedure to apply where the power allows for the amendment or repeal of primary legislation, and the Committee recommended that in this instance the power be subject to the affirmative procedure. The Government have considered and acted on the Committee’s report. Lords amendment 2 provides that regulations made under clause 2 that amend or repeal primary legislation be subject to the affirmative procedure. Lords amendment 3 provides that the negative procedure will continue to apply to any use of the power set out in clause 2 where a statutory instrument does not contain any regulations amending or repealing primary legislation.

Lords amendments 4 and 5 are minor technical amendments dealing with the simplification of the collection of class 2 NICs payable by the self-employed. This is a matter that I have previously debated, if not at great length, with the hon. Member for Birmingham, Ladywood (Shabana Mahmood). Amendment 4 amends schedule 1, which inserts new section 11A into the Social Security Contributions and Benefits Act 1992. It will ensure that the relevant self-assessment penalties apply to class 2 contributions collected through SA by adding a missing reference to the SA under-declaration penalty contained in schedule 24 to the Finance Act 2007. It was always the Government’s intention to align penalties for class 2 contributions more closely with those for SA as part of the reform of class 2 so that the self-employed are not subject to two different regimes, but this penalty was unintentionally omitted. Lords amendment 5 makes a corresponding amendment to the Social Security Contributions and Benefits (Northern Ireland) Act 1992.

With that explanation, which I know the House was keen to hear, I hope it will agree with the Lords amendments.

Lords amendment 2 agreed to.

Mr Speaker: I call the Minister to move the remaining Lords amendments.

Mr Gauke: Formally.

Mr Speaker: It is always a joy to hear the Minister develop the argument, but he is exercising a self-denying ordinance. I must say that the way he has addressed

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matters thus far—comprehensively and courteously, in his usual manner—has been accompanied by a slight increase in the number of Members present for the next business. It is not for me to suggest that those two phenomena are causally related, but some people might think they are. I suppose if one is in a tight corner and hoping that the Minister will develop the arguments fully, one can always best depend (a) on a Treasury Minister and (b) on a lawyer, and he is both.

Lords amendments 3 to 5.

Mr David Burrowes (Enfield, Southgate) (Con): On a point of order, Mr Speaker. Has any consideration been given to disapplying Standing Order No. 16(1), which allocates 90 minutes to consideration of the mitochondrial donation regulations? When similar regulations, concerning embryo research, came before the House in 2000, some 3 hours and 19 minutes were taken. Through the usual channels, the House has previously disapplied Standing Orders when dealing with issues of great significance, not least in this area. Obviously, many are concerned about the significant impact of these regulations, not least in respect of mothers at risk of passing on serious diseases to their children. This matter is of great significance to the country, because, for the first time in the world, we would be permitting human germ-line genetic modification. Given the significance of these matters, not just for those in the House but for the public, and in the interest of considering them in detail, I would have thought these matters deserved fuller debate and scrutiny, although I respect the fact that we will be turning to a general debate on rural phone and broadband connectivity afterwards. Given all that and the significant safety and legal issues, as well as ethical issues, surely we need longer than 90 minutes. Has any consideration been given to disapplying Standing Orders?

Mr Speaker: I am grateful to the hon. Gentleman both for his point of order and for his usual courtesy in notifying me in advance of its intended content. I am very sympathetic to the hon. Gentleman, but I fear—I say this in all sincerity—that I am unable to help him. The hon. Gentleman is right that it is within the power of Ministers to propose an extension of time available for a debate to which the 90-minute limit under Standing Order No. 16 applies. Notice is required, and there is no such motion on today’s Order Paper. I am clear that that is extremely regrettable, so far as the hon. Gentleman is concerned and many other Members may feel likewise. But we are where we are. In practical terms, the possibility of proposing such an extension is in the hands of the Government business managers, and is not available to Back Benchers.

The hon. Gentleman knows my views about the importance of empowering Back Benchers, and I have never been much fussed about empowering Ministers in any Administration, as the hon. Gentleman knows. Obviously, however, the Speaker has to operate within the established procedures of the House. As far as I can see—I have taken advice on the matter—today’s business must therefore conclude after an hour and a half.

The Minister is always a most courteous Minister, and she will have taken note of what has been said. Knowing the Minister as I do, I know she is planning to

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be pithy in her remarks to facilitate the majority of Back Benchers. About 18 Members wish to speak in the debate. If Members help each other, it will maximise the number of contributors. I fear we will have to leave it there for now.

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Human Fertilisation and Embryology

2.1 pm

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

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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

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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.

Fiona Bruce (Congleton) (Con) rose—

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.

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Several hon. Members rose

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.

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

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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.

2.15 pm

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

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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.

Mr Donohoe: May I ask the shadow Minister a simple question? Is this a case of DNA being genetically modified?

Luciana Berger: I do not believe that that is what is being proposed, but I shall deal with my hon. Friend’s very specific point later in my speech.

Richard Drax (South Dorset) (Con): I know from a meeting that I attended before the debate that the HFEA has said, “PNT involves genetically modifying a human embryo”.

Luciana Berger: That point was raised in an earlier intervention. I think it is clear from reports following reviews by the expert panel that it has already been specifically addressed, but I shall deal with it in more detail later.

Dr Julian Huppert (Cambridge) (LD): There seems to be a lot of confusion between nuclear DNA and mitochondrial DNA. It might help the hon. Lady and the House if I point out that they have completely different origins. They have a different genetic code; they are not related. The origin of mitochondria is bacteria that were engulfed by cells. They are very different. The House should be aware of that.

Luciana Berger: I thank the hon. Gentleman for that clarification.

Many concerns have been raised, the first of which is that this process is being rushed through. Anyone who has been involved in the development of these techniques would disagree that this has moved quickly. Professor Doug Turnbull and his team at the university of Newcastle have been researching this for 15 years. It was over six years ago, back in 2008, that the Human Fertilisation and Embryology Act 1990 was amended to introduce the powers to allow regulations that would enable mitochondria replacement to take place to be brought forward. It was back in 2010 that researchers at the university of Newcastle developed the techniques to avoid diseased mitochondria being passed from a mother to her children. After another three years of consultation and review processes, the Government announced in July this year that they would be bringing forward the regulations to enable mitochondrial donation techniques to be used, and that is what we are voting on today.

Guy Opperman (Hexham) (Con): The hon. Lady and I both attended the meeting last night, which was very productive and helpful. Does she agree that this is about choice for the families? I have constituents who have this particular disease and constituents who work at Newcastle university, and what we are trying to do is provide a scientific way forward, under a highly structured and licensed regime, to alleviate these particular families’ suffering.

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Luciana Berger: I thank the hon. Gentleman for that intervention. It was clear last night when we heard from the affected families that they wanted that choice, and these regulations very specifically only apply to those families that are affected by mitochondrial disease.

Mr Peter Bone (Wellingborough) (Con): Will the hon. Lady give way?

Luciana Berger: I am going to finish my point, if I may.

In the intervening years the science and ethics of these techniques have been extensively debated. The Nuffield Council on Bioethics and the HFEA held extensive public consultations in 2012 and identified broad public support for the use of these techniques. There have been three expert scientific review panels—in April 2011, March 2013 and June 2014—all of which found no evidence to suggest that the techniques are unsafe for clinical use, and only last week a group of eminent scientists and experts in medical ethics, including Professor Sir John Sulston, Baroness Warnock and Sir Paul Nurse, wrote to The Times urging Parliament to approve the new regulations. They argued that the question parliamentarians must consider is not whether we would want to use this technique ourselves, but whether there are grounds to prevent affected families from doing so. I again reiterate what we have heard in the representations from families, and particularly women of child-bearing age: they want the opportunity to use these techniques.

Mr Bone: The hon. Lady is making a very good speech and is trying to make it balanced. She talked about last night’s meeting, which I understand went on for quite some time, and there has been a lot of debate outside this Chamber, but is she satisfied that we come here to the Chamber this afternoon with only 90 minutes to discuss this? Would it not be better if we were to withdraw this motion today and come back with more time to debate it next week?

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

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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.

Sir Edward Leigh (Gainsborough) (Con): On the question of safety, does the hon. Lady not consider it significant that the Food and Drug Administration in the United States said that it was not clear that the scientific procedures were effective and safe? The FDA, of course, refused to allow the use of Thalidomide while we did, and the rest, as they say, is history.

Luciana Berger: I understand that the FDA has written to the British press in the course of the last week to contradict that position. There is a very different political situation in the US, and there is a very different set-up there in terms of the FDA compared with here and what we are discussing today.

Angela Smith (Penistone and Stocksbridge) (Lab): Does my hon. Friend agree that the fact is that any scientist would say that no technique is entirely safe but the risk in this case is very low indeed, and completely justifies the leap of faith she describes, which is in effect a further advance in the use of IVF technology—which itself was pioneered as a leap of faith in 1978?

Luciana Berger: My hon. Friend makes some very important points, particularly about the assessment of risk, which has been done extensively throughout this process.

The question is whether the benefits of preventing the transmission of mitochondrial disease, and the likelihood that children will continue to be born who will die in infancy, outweighs the risks of the techniques. The scientific community and the families experiencing mitochondrial disease say that they do; and according to research, almost 2,500 women in Britain of child-bearing age are at risk of passing the condition on to their children. It is now up to Members to decide whether they agree.

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Mrs Cheryl Gillan (Chesham and Amersham) (Con): I am most grateful to the hon. Lady for setting out a balanced case. Can she clear something up for me? I understand that there are two sources of mitochondrial disease: the DNA in the nucleus as well as the mitochondrial DNA. Can she confirm that mitochondrial disease from the nuclear DNA will remain in our population even after this treatment is licensed?

Luciana Berger: I hope the Minister might be able to address that in her response to the debate, with the support of her officials. It is not something I have been made aware of, and it certainly has not come up in any of the discussions or debates that I have attended.

I will now conclude, as I know that many Members wish to contribute. The research has been done, the reviews carried out and the experts and the public have been consulted. Time is precious for those parents at risk of passing on mitochondrial inherited disease to their children, and I believe that we must not delay any further.

Several hon. Members rose

Mr Speaker: Order. On account of the number of Members wishing to contribute to this debate, I must impose with immediate effect a six-minute limit on Back-Bench speeches. That limit will almost certainly have to be revised downwards, and I appeal to colleagues to help me to help them.

2.29 pm

Fiona Bruce (Congleton) (Con): I want to speak against the Government motion, and I draw the House’s attention to my alternative motion in part 2 of the Order Paper—page 54—although it is not votable.

Human mitochondrial disease is a dreadful condition and, as a caring society, we must do all we can to address it, and do so as sensitively as we can for those families affected by it. As a caring society, however, we must also do so in an ethical manner and with proper regard for safety. I believe that the regulations we are considering today fail on both counts—ethics and safety—and that they are inextricably interlinked.

Let me be straightforward: I do oppose these proposals in principle. However, that should not prevent my concerns regarding their safety from being given a fair hearing. One of the two procedures that we are being asked to sanction today—pro-nuclear transfer—involves the deliberate creation and destruction of at least two human embryos, and in practice probably more, to create a third embryo, which it is hoped will be free of human mitochondrial disease. Are we happy to sacrifice two early human lives to make a third life?

Sir Paul Beresford (Mole Valley) (Con): I question my hon. Friend’s definition of “embryo”. We are talking about two ova being used to create one embryo.

Fiona Bruce: Let me put it this way. Some may take the view that at such an early stage of human life, it is acceptable deliberately to create human embryos to then destroy them. However, the truth is that once upon a time I was an embryo and so was every other Member in this Chamber.

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This debate is about the principle of genetically altering—indeed, genetically creating—a human being, and no matter how well meaning the motives, and my heart goes out to the families with mitochondrial disease, this technique will not cure that disease. That answers the question asked in the intervention on the hon. Member for Liverpool, Wavertree (Luciana Berger), the shadow Minister. This technique will not cure that disease.

David T. C. Davies (Monmouth) (Con): I am completely undecided on this issue. Can my hon. Friend tell me whether it is the case that any woman taking the pill could arguably be destroying an embryo? If it is the case, what is the difference morally between using this technology and using the pill?

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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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.

Several hon. Members rose

Fiona Bruce: The answer has to be that we—

Mr Speaker: Order. I think Members thought that the hon. Lady had concluded her speech, but she has not. Let us have a courteous hearing for everybody. I call Fiona Bruce.

Fiona Bruce: Thank you, Mr Speaker.

Once we approve this procedure, where will it lead? The answer has to be that we stop here and say, “This is a red line in our country, as in every other country in the world, that we will not cross.” This is the place for that to be said. As MPs, we are accountable to the people of this country.

The Government’s own consultation in July 2014 received 1,857 responses, of which 1,152 were opposed to the introduction of these techniques. That has been confirmed by ComRes polling last weekend, which showed that more than twice as many people are against these proposals as are in favour—41% of respondents, compared with 21%. A third public survey, being conducted today on The Daily Telegraph website, shows that as of this morning 68% of the public oppose these techniques in principle. Do their concerns not deserve respect from those of us present here?

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The truth is that the Government have not waited for the conclusion of trials, as they should have done, so that this House could make a fully informed decision, and that is wrong. Whether one ultimately approves or disapproves of these proposals, the right procedure on such a profound issue is for the elected representatives of the people of this country to have full information before being rushed into a decision, as we would be today if we voted for these proposals.

2.38 pm

Andrew Miller (Ellesmere Port and Neston) (Lab): The hon. Member for Congleton (Fiona Bruce) set out her case clearly and I respect her beliefs, but I do not agree with her conclusions. If we took them to the logical point, we would ban any intervention that introduces some part of one person to another. It would mean boycotting blood and organ transfers, simply because—[Interruption.] I listened with courtesy to the hon. Lady and I hope that my hon. Friend the Member for Stoke-on-Trent South (Robert Flello) will listen to me with courtesy. When these pioneering techniques started, nobody knew the answers for certain. People made judgments—scientific judgments—on the best available evidence, and it turned out that people’s fears were ill-founded.

The trials that have been undertaken on this work have led the scientific community—a powerful group of scientists with an extraordinary degree of knowledge in this area—to conclude that the risks are small but worth taking because the benefits on the other side of the equation are enormous. In all cases where there are risks, we need to consider the risks as against the benefits. I put it to the House that there are potential benefits for the about 2,500 families affected by mitochondrial disease up and down this nation, and they deserve our support. Of course we have to assess the risks, as we do with all risks, but that has to be done in a rational and balanced way.

Richard Drax: I am listening carefully to the hon. Gentleman. Everyone in this House wants the best for these families—there is no doubt about that—but it is the speed of the introduction of the regulations that concerns us. As for experimentation, I heard today that no trials are being carried out on primates, which are as close to us as can be. This process has proved successful on mice, but on primates—a standard part of this procedure, apparently—it has not been carried out, and that is interesting.

Andrew Miller: The hon. Gentleman makes an interesting point, but there are plenty of occasions when such tests are not carried out. In central Africa we have been testing Ebola vaccines without first testing them on primates, because the benefits outweigh the risks. We are in that position already. My hon. Friend the Member for Stoke-on-Trent South referred to research undertaken in China 10 years ago. He rightly said that that work took place, but I put it to Members of this House that the ethical and scientific rigour applied to experimentation in the UK far exceeds anything in China 10 years ago. Indeed, the technologies have also moved on to a very high degree since then.

Dr Huppert: Some critics of this approach have pointed out that this country would be the first to go ahead with it. Does the hon. Gentleman agree that we should be

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proud to be leading the world in medical treatments and that, as he says, we can provide some of the best ethical safeguards in the world?

Andrew Miller: The ethical basis on which science is conducted in this country is world leading. The hon. Gentleman is right to say that we should be immensely proud of the successes—again—of our scientific community in a range of life science disciplines. This one affects a very small group of the population but does so in such a profound way. Although there are issues that need properly regulating, the regulatory structure that we have created does that properly. The Minister was asked about, and indeed mentioned, the issues associated with designer babies. Of course this House would want to impose limits, but we are considering a specific set of regulations about dealing with mitochondrial disease—they do nothing else. I, for one, would not stand here to defend the concept of designer babies and people choosing eye colour and so on. Today, we are dealing purely with those terrible illnesses.

Steve Baker: Will the hon. Gentleman give way?

Andrew Miller: No, as it would not be fair on other people. In case colleagues have not seen them, let me commend the e-mails sent to all Members by the Muscular Dystrophy Campaign; Jonathan Kingsley wrote to us all, and the Lily Foundation has written to us all in very powerful language. Those people who have sat and listened to some of the families will understand, and colleagues who have constituents affected by mitochondrial disease will understand the message.

We are in a society where people are entitled to have their beliefs, and I respect those beliefs; everyone should be entitled to express their opinion. But this is about focusing on the needs of that small part of the population that I mentioned. I urge the House, in coming to a conclusion this afternoon, to think about those families, to focus on their needs and to set aside general beliefs in the overwhelming interest of that small part of the population who have suffered immensely and who have an opportunity at their disposal because of the extraordinary science that has been advanced.

2.45 pm

Steve Baker (Wycombe) (Con): I approach this subject with a considerable degree of humility, for two reasons. First, I will never forget meeting a family in my constituency whose child suffers from mitochondrial disease; there was both a haunting sorrow in that family and the hope that if these regulations are passed they will be able to have a child without this problem. Secondly, I am very aware of my own shortcomings in relation to biological science. As a chartered engineer, I am perhaps more competent in the physical sciences, and I do not mind admitting that I had to look up at least a few of the words in the regulations in order to understand them.

As I have listened to this debate, not only today but previously, I have wondered whether we have really reflected on how science proceeds, because scientific truth is not established by authority or by democratic vote; it is established, as Karl Popper put it, through “conjecture and refutation”—trial and error. Someone who reads Thomas Kuhn’s “The Structure of Scientific Revolutions” will discover that it is possible for quite large bodies of knowledge to be developed with errors

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in them. When those errors are corrected, the paradigm shifts—that is a term we have all heard. That is how science proceeds, through trial and error. The reality is that there will always be uncertainty in any scientific procedure.

When the Commons Library summarised the Nuffield Council on Bioethics’ review, the second point mentioned was this:

“The knowledge about these techniques is uncertain and could remain so for several generations—their use could potentially harm future persons.”

The hon. Member for Liverpool, Wavertree (Luciana Berger), speaking from the Front Bench, made the point that, broadly, the question before us was whether there was a reason to withhold these techniques from people. If there is a reason, it is that they may do harm to future persons. I will not support the measure because this is inherently uncertain. That uncertainty is an inherent part of science, and it is no good appealing to authority to try to resolve the question, because different authorities will disagree and there is no way to resolve those disagreements apart from through empirical evidence, which we can obtain only by experimenting on humans.

Graham Stringer (Blackley and Broughton) (Lab): The hon. Gentleman is making a typically thoughtful contribution to this important debate. Does he not have to balance that uncertainty, which he points out fairly, with the 100% certainty that the children of mothers with mitochondrial disease will suffer?

Steve Baker: The hon. Gentleman is absolutely right, which is why I began by expressing the humility I feel on this subject as a result of meeting and having had a lengthy conversation with a family who face just that issue. I remind myself, however, that we are dealing here not with a cure for those who have already been born, but with ensuring that those who are subsequently born do not suffer from that disease. If we were discussing a cure for those already living, perhaps the circumstances might be different.

Angela Smith: Is prevention not better than cure?

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—

Jane Ellison indicated assent.

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

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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.

2.49 pm

Frank Dobson (Holborn and St Pancras) (Lab): I have a sense of déjà vu, or perhaps déjà entendu. The objections that have been brought out today, and in previous discussions, about mitochondrial disease are identical to those that arose when Louise Brown was brought into this world at Oldham general hospital as a result of the risky work undertaken by Steptoe and Edwards and Jean Purdy. That was a risk that the scientists were willing to take and that Mr and Mrs Brown were willing to take.

Not long after I became a Member, Enoch Powell proposed a total ban on embryo research. I understand people’s ethical objections to embryo research, but if they object to something on principle, they do not need to add any other references to safety or effectiveness. If someone is opposed to it on principle, they are opposed to it, and I can respect that. When the Warnock report was published, this House had a creditable debate—to those who say that the House of Lords has a better quality of debate, I say that they should read its first debate on the Warnock report, and they might modify their views. All the things that are being said today were being said then, and all the things that were said in the debates about the establishment and development of the Human Fertilisation and Embryology Authority were the same.

In a previous speech, there were two novelties. One was that Robert Winston was being misquoted as opposing the proposal, which he cannot do any more as he actually wrote a full article in favour of it yesterday. The second was that US experts, some of the most distinguished experts who have written papers on the matter, were against it.

Sir William Cash rose—

Mr Laurence Robertson (Tewkesbury) (Con) rose—

Frank Dobson: No, I will not give way, because I do not want to take up more than my allocated six minutes.

The question arises: will it be safe and will it work? The answer is that no one can make any guarantees, but that is the nature of scientific development. The thing to remember is that mitochondrial disease is horrible and that there is no treatment for it. I remind people that the team at Newcastle university did not start off with this riskier novel approach. It has been studying and trying to come up with treatments for mitochondrial disease for the best part of 20 years, and is still doing so now. Some 90% of its work is trying to come up with a treatment. The best that it has managed to come up with after all these years is helping parents cope with the horrible symptoms before their children fade away

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and die. As has already been said, the team has decided that if it cannot come up with a treatment—and it is still trying—it would be better to prevent the disease arising in the first place because prevention is better than cure. That is why I hope the regulations will be passed and handed over to the HFEA. Members should realise that it is a credit to this country and to this House that the HFEA was established. We must find a middle way between the free-for-all, which a few nutters want, and the total ban, which some others want because they are opposed to embryo research on principle.

The system that has been established is well regulated through the HFEA. Despite all the predictions to the contrary, there has not been a single scandal in all the time that the HFEA has been in existence. There has been no sign of a slippery slope. These people with great reputations at Newcastle think the time is right to take risks and to risk their reputations—

Fiona Bruce: Will the right hon. Gentleman give way?

Frank Dobson: No, I shall not. Those people are taking risks, because if the treatment does not work, there will be those who will gloat—even, I am sad to say, Members in this Chamber. The parents are also willing to take the risks. Parents with children do not want this to happen again, and we have the opportunity to do something about it. The results are uncertain, but that is in the nature of both medicine and science. We cannot guarantee that it will work, but the people most involved in the matter and all the scientific advisory bodies in this country think that it will work, and we should take note of what they say.

Several hon. Members rose

Mr Speaker: Order. The time limit on Back-Bench speeches is now reduced with immediate effect to four minutes.

2.56 pm

John Hemming (Birmingham, Yardley) (LD): This is a difficult issue for everybody. I have a real difficulty with this, which is that I cannot see the difference between modifying mitochondrial DNA and nuclear DNA. Both are inherited, and both can prevent inherited diseases. If we agree to this as a process, we are, in essence, potentially agreeing to swapping a pair of chromosomes—[Interruption.] I know that we are not agreeing to it in law, but in practice the same arguments can be used to justify—

Andrew Bridgen (North West Leicestershire) (Con): Will the hon. Gentleman bear in mind the fact that mitochondrial DNA only codes the mitochondria, which were undoubtedly alien DNA to the human cells, and actually were probably bacteria that are now symbiotically living within us?

John Hemming: They remain—

Several hon. Members rose

John Hemming: I will not take lots of interventions because it would damage the debate. They remain inherited, and, in essence, we face the same difficulty. My concern is a legalistic one, which is that we are moving away from a society in which we value people as people to

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one where we start looking at people in terms of what categories they fall into and things such as that. To that extent, I cannot back the motion today, particularly as it is being pushed through in such a rush.

Mr Speaker: If the hon. Gentleman is finished, I call Mr Robert Flello.

2.57 pm

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.

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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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Several hon. Members rose

Mr Speaker: Order. I understand the widespread unhappiness about the time constraints, but we are where we are. I simply point out that Members are not obliged to take their full four minutes if they do not wish to do so.

3.4 pm

Mr David Willetts (Havant) (Con): I apologise to you, Mr Speaker, and to the House for missing the opening speech in the debate. Nevertheless, I was keen to speak because I think that the proposals before us today would tackle a real human need. There are parents who are currently bringing into the world children with a horrible disease and the suffering is made more acute by the fact that now, for the first time, prospective parents know that they could be doing this procedure and they therefore face the dilemma of whether or not to have children.

I realise that there are important objections. My hon. Friend the Member for Congleton (Fiona Bruce) put forward the ethical objection. I fully understand the fact that our benefit from this treatment does not of itself overcome the ethical issues, which are crucial. The red line to which she referred is, I think, a red line over which we have designer babies and change the DNA that makes the character of a person. I am persuaded by the scientific evidence that the mitochondria is not part of the core DNA that does that. In the previous debates and the previous legislation, it was absolutely clear that the red line that the House was trying to set was one that stopped the changing of human nature, and we do not cross it today.

Sir Edward Leigh: But it can be inherited.

Mr Willetts: It is absolutely true that mitochondria can be inherited through the mother, but it does not change the character of the baby.

Secondly, let me consider the health and safety objection. Sometimes that objection is being used as a cover for what is really an underlying objection in principle. The scientists say, with typical caution and care, that there is no evidence that this is unsafe. It is true that nobody can have 100% certainty about that, but there have been 15 years of research and seven years of scrutiny, including by various scientific bodies and ones promoted under this Government, and so far no one has been able to come up with a concrete and powerful objection that suggests that the process is unsafe. It is right for us today to be considering moving on to the next step.

Mrs Gillan: Will my right hon. Friend give way?

Mr Willetts: Let me make some progress, as others want to speak.

Thirdly, I hear a rejection on the grounds that we are somehow rushing because we are going to be first. People ask, why us? Why now? Why in Britain? I must say, having had the privilege of serving as the Minister responsible for science, that we are first because we have world-leading research in this area. We should be proud of the fact that it is in British labs and British universities that this fundamental research is happening. It was in our country that the structure of DNA was discovered

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and I had the privilege of going to the Nobel prize ceremony for Robert Edwards, who won the Nobel prize for his work on IVF, which would properly not have passed through the levels of scrutiny we require of research today.

That brings me to my fourth and final point. What is our role in this Chamber today, faced with this very difficult question? We must make a judgment on whether any ethical issues stand in the way of tackling a clear human need. We are not agreeing that any specific programme of treatment should be licensed or should go ahead. We are very fortunate in this country to have a regulatory structure that is different from that in the US. In the US, if Congress voted for such legislation to go ahead, that would be the end of the matter. If we vote for the regulations today, as I hope that we will, we are saying that the HFEA can decide whether or not to license specific uses of mitochondrial DNA donation after it has assessed all the risks. There is that further safeguard. All we are doing is saying we require it to make that assessment and we are not objecting in principle. My sense of the mood of this House is that there are not many people who object in principle.

Andrew Bridgen: We yearn for Back-Bench debates and free votes and we have one today. However, I detect that those who perhaps have not studied the issue are going for the status quo, saying that there has not been enough time. Does my right hon. Friend agree that it would be disappointing if the regulations were not passed today because people had not done their research? It is rather like the case for a student who has not done his revision—the exam is always too soon.

Mr Willetts: We all know the feeling.

One thing we are proud of in this country and, I hope, on both sides of the House is our innovation, research and enterprise, provided that the risks are clearly understood and regulation is in place. I hope that we will support innovation, particularly innovation that tackles a clear human need.

We are not saying that this must go ahead today. We are saying that we trust a body to consider licensing it with very strict requirements, and on that basis I hope that the House will support this admirable measure.

3.9 pm

Liz McInnes (Heywood and Middleton) (Lab): As we have heard, mitochondrial DNA makes up a tiny proportion of our total DNA. Unlike nuclear DNA, it does not pass on any personal attributes; it is purely involved in the chemistry of energy production. That is why, when there is a defect in mitochondrial DNA, it tends to affect organs that require a high amount of energy, such as the heart, muscles, brain and liver. All of our mitochondria are inherited from the egg and, as we have heard, researchers have worked on techniques to replace faulty mitochondria using those from a healthy donor. To refer to that donor as a third parent, as some have, is something of a misnomer. There are 37 genes in mitochondrial DNA, which is less than 0.01% of our total DNA. Altering the mitochondria will not alter a child’s characteristics inherited from its biological parents, but it may provide a way to prevent a debilitating and sometimes fatal disease.

3 Feb 2015 : Column 180

Fiona Bruce: I want to pick up on the point the hon. Lady makes about mitochondria not affecting characteristics. The Government’s own consultation document acknowledged that diverse characteristics are associated with mitochondria, including learning disabilities, neurological problems and dementia, and that every person’s symptoms are different. Is there not an insurmountable contradiction in saying that this is just like changing a battery if on the one hand one is saying that the aim is to prevent damage to those characteristics, but on the other hand one is saying that the techniques will not affect them at all?

Liz McInnes: I did not say it was just like changing a battery. In fact, I try to avoid using that terminology. The hon. Lady mentions learning disabilities, but as I just said, the organs affected the most by mitochondrial disorders are organs that require a large amount of energy, such as the brain, so that comes as no surprise to me.

Allegations have been made that the techniques are not safe.

Jacob Rees-Mogg (North East Somerset) (Con): Will the hon. Lady give way?

Liz McInnes: No, I will not, because I need to make progress and let other people speak.

Last night, it was my privilege to attend the debate on the safety and ethics of this technique and to hear Professor Doug Turnbull, who leads the research team at Newcastle university, talk about the 15 years of work done by his team and the extensive safety checks that have taken place during those years. In the Chinese case to which my hon. Friend the Member for Stoke-on-Trent South (Robert Flello) referred, the treatment was carried out by an American clinician on a single patient in China. The patient became pregnant with triplets, one of whom was aborted and the other two were born prematurely and died. Importantly, the clinician attributed the outcome entirely to multiple pregnancy and obstetric complications, not to the method of conception. I do not accept that that one case represents a proper clinical trial.

What we have to remember is that mitochondrial disease is a life-limiting debilitating disease, causing severe distress to parents and their affected children. We have here a technique with the ability to alleviate their suffering and to allow affected parents the chance to have a healthy child who is genetically related to them in all aspects apart from a tiny proportion of mitochondrial DNA. The spectre of designer babies can be dismissed. There is no possibility of using this technique to select certain characteristics. It will simply allow mitochondria to function normally and for the child to be free of mitochondrial disease.

Fiona Bruce: Will the hon. Lady give way?

Liz McInnes: I will not, no.

In safety, the UK has a robust regulatory framework. A vote in favour of the motion will not in itself open the way for mitochondrial donation to be used in clinics. It will simply enable the HFEA to consider each individual family’s request for treatment on a case-by-case basis,

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taking expert scientific and medical advice and licensing the procedure only if the evidence shows that that is appropriate.

I am lucky enough to have worked at the Royal Oldham hospital, where the first IVF baby, Louise Brown, was born. When IVF was first introduced, there was no certainty that it was completely safe. Only after the first babies were born using the technique could scientists be completely reassured that their detailed research had led to the birth of healthy babies, but to this day research continues on IVF, just as more research must be done on mitochondrial transfer. That is the nature of science: it is a continuous process; it does not stand still.

For families affected by mitochondrial disease, this research has given them new hope that they may at last have the chance to bear a healthy child of their own. Last night I heard from a woman who suffered from mitochondrial disease, which had also affected her mother. That young woman had taken a considered decision not to have her own children, for fear of passing on the condition. The opportunity to have this treatment presents her and many other women in that situation with new hope. The science is there to alleviate the suffering of affected families, and in my opinion it would be unethical to withhold this treatment. I urge the House to approve the regulations.

3.15 pm

Sir Edward Leigh (Gainsborough) (Con): Everybody who is following this debate will of course have the most profound sympathy for families who are affected by these appalling diseases, and I quite understand why so many colleagues want to vote for the regulations to lessen human suffering, but I am afraid that I will oppose the regulations. I do so on three grounds: ethics, safety and the importance of parliamentary procedure.

On the first, ethics, I think what we are considering is a new step. It will affect the germ line. Mitochondria is inherited; it is not just another organ of the body. What is proposed is a fatal and important step. As my hon. Friend the Member for Congleton (Fiona Bruce) asked, where do we stop? Given the nature of the human condition, these appalling diseases, sadly, will occur, but where do we stop? What further modifications will we make?

My second ground for opposing the regulations is safety. Under European conventions and regulations and so on, we should have full clinical trials and the scientific community should be united on aspects of safety, which it is not. Unfortunately, we will be the first state in the world to authorise the technique, and in that sense, in bioethical terms, we will be in a unique position. We should ask ourselves why no other state—not in the EU, not the US, not yet anybody—thinks that this is proved to be absolutely safe.

As for the third reason for my opposition, it has been said that this is not a final decision, and that we are just handing it over to the HFEA, but this is the final decision; it is a monumental decision. For the first time, Parliament is saying that we authorise people to affect mitochondrial DNA. That is a monumental decision. This will now happen and colleagues who vote for the regulations must appreciate that.

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For those three reasons—on ethical grounds, on safety grounds and on procedural grounds—I will vote against the regulations.

3.17 pm

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

3 Feb 2015 : Column 183

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—

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.

3.22 pm

Paul Burstow (Sutton and Cheam) (LD): Mitochondrial disease shortens lives, causes serious disability and leaves heartache in its wake. Now, thanks to the world-class research led from the university of Newcastle, we have the potential of innovation in IVF that could make a real difference for thousands of families in this country.

We have not arrived at this moment of decision in a rush. This House made provision in the Human Fertilisation and Embryology Act 2008 for regulations to be brought to this House

“to prevent the transmission of serious mitochondrial disease”.

Since those debates there has been a lengthy process to consider the benefits, the risks, the ethical issues and public consent. All these matters should be carefully considered. What all this work has revealed is broad public, ethical and scientific support for approving mitochondrial donation.

3 Feb 2015 : Column 184

Clearly, safety is paramount. That is why the procedure has been scrutinised on three separate occasions by independent panels of experts. No evidence has been found to suggest that these techniques are unsafe. Are they ethical? Mitochondrial donation does not alter the essential personal characteristics or traits. It gives the gift of freedom from mitochondrial disease. It does not confer on a third person the parenthood that has been claimed in this debate. It is not about a third parent.

I have received many e-mails and letters from constituents on both sides of the argument, and I understand and respect those who have principled objections to the approach. I was struck by what the Right Rev. Dr Lee Rayfield and the Rev. Dr McCarthy said in a recent letter to The Guardian:

“The HFEA has made clear that even if parliament were to permit these two techniques, no licences would be issued until there was sufficient assurance from expert reviewers that mitochondrial donation is ‘not unsafe’”.

For me, that assurance—

David T. C. Davies: Will the right hon. Gentleman give way?

Paul Burstow: No, I must not. We must make progress.

That assurance from the HFEA is important. It means that although today is an important milestone in addressing mitochondrial disease, it is not the end. I was struck by what the Church of England said in its response to the HFEA’s consultation. The Church of England is not opposed in principle to these proposals. Its opposition is not absolute. It makes it clear that it is supportive in principle. As a Christian, I take heart from that.

For myself, I am persuaded that we make our decision today with the benefit of a thorough process, including thorough parliamentary scrutiny, and we have a robust regulatory framework. Today’s vote does not open the doors to mitochondrial donation as a matter of routine in clinics. Rather, we grant the HFEA the responsibility to consider on a case-by-case basis and weigh the expert scientific and medical advice. On every occasion safety and efficacy will be considered as a consequence of the regulations—the very concern that many hon. Members have cited as their reason for objecting to these proposals. I hope hon. Members will support them.

The Minister was right. This is about light at the end of the tunnel for thousands of families in this country. It is about the prospect of life lived, life realised, and about the potential opportunity to live.

Several hon. Members rose

Mr Speaker: With the leave of the House, it is proper that the Minister should have five minutes to respond. One last contribution, very pithily—Mr David Burrowes.

3.25 pm

Mr David Burrowes (Enfield, Southgate) (Con): We are here today to consider the regulations. The explanatory note says that the debate gives Parliament the opportunity to consider whether the new techniques are safe enough for use in a treatment setting. I said in a point of order at the start of the debate that I did not believe that we had had sufficient opportunity to make that decision

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today—sufficient opportunity, yes, to consider the passionate views of those mothers about whom we have heard today, who are at risk of passing a serious disease to their children, and also to consider on behalf of the country the prospect of our being world leaders in permitting human germ-line genetic modification. I say “genetic modification” because that is what it is. We need a clear and honest debate.

A number of scientists have accused the Government of dishonesty for trying to redefine what we are here for today, which is to debate whether to permit genetic modification. Only last week, the United States Institute of Medicine said that what we are discussing today are

“assisted reproductive methods involving genetic modification of eggs and zygotes for the prevention of mitochondrial disease.”

The HFEA, too, accepted honestly on its website that whether we go for PNT or MST, they are both genetic modification.

I do not know how many Members have read the regulations. This is not a wide debate about mitochondrial donation or about the principle. It is specifically about the regulations. They make it clear that the procedures entail a cell nuclear transfer, which alters the nuclear DNA in the egg that the DNA is transferred into. It is clear that mitochondrial DNA makes up part of the human genetic code. This technology that we are debating modifies that code by separating nuclear mitochondrial DNA. Regulations 4 and 7 make it clear that this is a complete transfer of nuclear DNA into the donor’s egg or embryo. The Government should admit that the interaction between mitochondria and nuclear material is not clear. We cannot say with certainty that these techniques will not affect the characteristics of children.

In conclusion, the Government said in their consultation response that this is about providing greater understanding of the ways in which mitochondrial DNA mutations are passed down from mother to child. In many ways it is an experiment, or a wider trial, and it is a trial that I do not think we should go ahead with. It is unprecedented in the world. Some might say that it is leading the pack, and others might say that it is leaving us out on a limb. Ethically, it breaks international norms. Legally, we have heard about the directive. With regard to safety, the tests are not yet complete. Members might think “Not yet” or “No”. Either way, please vote against the motion.

3.28 pm

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

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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

3 Feb 2015 : Column 187

indeed the light at the end of a dark tunnel. I commend the regulations to the House.

Question put.

The House divided:

Ayes 382, Noes 128.

Division No. 147]





Abrahams, Debbie

Adams, Nigel

Afriyie, Adam

Ainsworth, rh Mr Bob

Alexander, rh Danny

Alexander, rh Mr Douglas

Alexander, Heidi

Allen, Mr Graham

Andrew, Stuart

Arbuthnot, rh Mr James

Ashworth, Jonathan

Austin, Ian

Bailey, Mr Adrian

Baker, rh Norman

Baldwin, Harriett

Balls, rh Ed

Barclay, Stephen

Baron, Mr John

Barron, rh Kevin

Bayley, Sir Hugh

Beckett, rh Margaret

Begg, Dame Anne

Beith, rh Sir Alan

Benn, rh Hilary

Benyon, Richard

Beresford, Sir Paul

Berger, Luciana

Betts, Mr Clive

Bingham, Andrew

Blackman-Woods, Roberta

Blackwood, Nicola

Blenkinsop, Tom

Blomfield, Paul

Blunt, Crispin

Boles, Nick

Bottomley, Sir Peter

Bradley, Karen

Bradshaw, rh Mr Ben

Brady, Mr Graham

Brake, rh Tom

Brennan, Kevin

Bridgen, Andrew

Brine, Steve

Brooke, rh Annette

Brown, Lyn

Brown, rh Mr Nicholas

Brown, Mr Russell

Browne, Mr Jeremy

Bruce, rh Sir Malcolm

Bryant, Chris

Buck, Ms Karen

Buckland, Mr Robert

Burden, Richard

Burley, Mr Aidan

Burnham, rh Andy

Burstow, rh Paul

Burt, rh Alistair

Burt, Lorely

Byles, Dan

Byrne, rh Mr Liam

Cable, rh Vince

Cairns, Alun

Cameron, rh Mr David

Campbell, rh Mr Alan

Campbell, rh Sir Menzies

Campbell, Mr Ronnie

Carmichael, rh Mr Alistair

Carmichael, Neil

Carswell, Douglas

Caton, Martin

Chapman, Jenny

Clappison, Mr James

Clark, rh Greg

Clark, Katy

Clarke, rh Mr Kenneth

Clegg, rh Mr Nick

Clifton-Brown, Geoffrey

Clwyd, rh Ann

Coffey, Ann

Collins, Damian

Connarty, Michael

Cooper, rh Yvette

Corbyn, Jeremy

Crabb, rh Stephen

Creasy, Stella

Crockart, Mike

Crouch, Tracey

Cunningham, Alex

Cunningham, Mr Jim

Danczuk, Simon

Darling, rh Mr Alistair

Davey, rh Mr Edward

David, Wayne

Davidson, Mr Ian

Davis, rh Mr David

Davies, Geraint

De Piero, Gloria

Denham, rh Mr John

Dinenage, Caroline

Djanogly, Mr Jonathan

Dobson, rh Frank

Doran, Mr Frank

Dorries, Nadine

Doughty, Stephen

Duncan, rh Sir Alan

Dunne, Mr Philip

Eagle, Ms Angela

Efford, Clive

Ellis, Michael

Ellison, Jane

Ellman, Mrs Louise

Ellwood, Mr Tobias

Engel, Natascha

Evans, Chris

Evans, Graham

Fabricant, Michael

Fallon, rh Michael

Farrelly, Paul

Farron, Tim

Fitzpatrick, Jim

Flynn, Paul

Foster, rh Mr Don

Freeman, George

Freer, Mike

Gapes, Mike

Gardiner, Barry

Garnier, Sir Edward

Garnier, Mark

Gauke, Mr David

George, Andrew

Gibb, Mr Nick

Gilbert, Stephen

Gilmore, Sheila

Goodwill, Mr Robert

Gove, rh Michael

Graham, Richard

Grant, Mrs Helen

Green, rh Damian

Green, Kate

Greening, rh Justine

Greenwood, Lilian

Grieve, rh Mr Dominic

Griffith, Nia

Griffiths, Andrew

Gyimah, Mr Sam

Hague, rh Mr William

Hain, rh Mr Peter

Halfon, Robert

Hames, Duncan

Hamilton, Mr David

Hamilton, Fabian

Hammond, Stephen

Hancock, Mr Mike

Hands, rh Greg

Harman, rh Ms Harriet

Harper, Mr Mark

Harris, Rebecca

Harris, Mr Tom

Hart, Simon

Harvey, Sir Nick

Haselhurst, rh Sir Alan

Havard, Mr Dai

Healey, rh John

Heath, Mr David

Heaton-Harris, Chris

Henderson, Gordon

Hendry, Charles

Herbert, rh Nick

Heyes, David

Hilling, Julie

Hodge, rh Margaret

Hodgson, Mrs Sharon

Hollingbery, George

Hood, Mr Jim

Horwood, Martin

Hosie, Stewart

Howarth, rh Mr George

Howell, John

Hughes, rh Simon

Hunt, rh Mr Jeremy

Hunt, Tristram

Hunter, Mark

Huppert, Dr Julian

Hurd, Mr Nick

Irranca-Davies, Huw

Jackson, Glenda

James, Margot

Jamieson, Cathy

Javid, rh Sajid

Jenkin, Mr Bernard

Jenrick, Robert

Johnson, rh Alan

Johnson, Diana

Johnson, Gareth

Johnson, Joseph

Jones, Andrew

Jones, Graham

Jones, Mr Kevan

Jowell, rh Dame Tessa

Kendall, Liz

Kirby, Simon

Knight, rh Sir Greg

Kwarteng, Kwasi

Lamb, rh Norman

Lancaster, Mark

Lansley, rh Mr Andrew

Latham, Pauline

Lavery, Ian

Lee, Jessica

Lee, Dr Phillip

Leech, Mr John

Leslie, Charlotte

Leslie, Chris

Letwin, rh Mr Oliver

Lewell-Buck, Mrs Emma

Lewis, Brandon

Lewis, Dr Julian

Lilley, rh Mr Peter

Lloyd, Stephen

Llwyd, rh Mr Elfyn

Long, Naomi

Loughton, Tim

Love, Mr Andrew

Lucas, Caroline

Lucas, Ian

Luff, Sir Peter

Lumley, Karen

Mactaggart, Fiona

Mahmood, Mr Khalid

Malhotra, Seema

Mann, John

McCabe, Steve

McCarthy, Kerry

McCartney, Jason

McDonagh, Siobhain

McDonnell, John

McFadden, rh Mr Pat

McInnes, Liz

McKechin, Ann

McKenzie, Mr Iain

Mearns, Ian

Metcalfe, Stephen

Miliband, rh Edward

Miller, Andrew

Miller, rh Maria

Mills, Nigel

Milton, Anne

Mitchell, Austin

Moon, Mrs Madeleine

Moore, rh Michael

Mordaunt, Penny

Morgan, rh Nicky

Morrice, Graeme


Morris, Anne Marie

Morris, Grahame M.


Morris, James

Mosley, Stephen

Mowat, David

Munn, Meg

Munt, Tessa

Murray, Ian

Murray, Sheryll

Nandy, Lisa

Newmark, Mr Brooks

Newton, Sarah

Nokes, Caroline

Norman, Jesse

O'Donnell, Fiona

Offord, Dr Matthew

Onwurah, Chi

Opperman, Guy

Osborne, rh Mr George

Osborne, Sandra

Ottaway, rh Sir Richard

Paice, rh Sir James

Parish, Neil

Paterson, rh Mr Owen

Perkins, Toby

Perry, Claire

Phillips, Stephen

Phillipson, Bridget

Pickles, rh Mr Eric

Poulter, Dr Daniel

Powell, Lucy

Prisk, Mr Mark

Raab, Mr Dominic

Raynsford, rh Mr Nick

Redwood, rh Mr John

Reeves, Rachel

Reid, Mr Alan

Reynolds, Jonathan

Rifkind, rh Sir Malcolm

Riordan, Mrs Linda

Robathan, rh Mr Andrew

Robertson, Angus

Robertson, rh Sir Hugh

Robertson, John

Rotheram, Steve

Rudd, Amber

Russell, Sir Bob

Sanders, Mr Adrian

Sandys, Laura

Sawford, Andy

Seabeck, Alison

Shapps, rh Grant

Sheerman, Mr Barry

Shelbrooke, Alec

Simpson, Mr Keith

Skidmore, Chris

Skinner, Mr Dennis

Slaughter, Mr Andy

Smith, Angela

Smith, Chloe

Smith, Henry

Smith, Julian

Smith, Nick

Smith, Sir Robert

Soames, rh Sir Nicholas

Soubry, Anna

Spellar, rh Mr John

Spelman, rh Mrs Caroline

Spencer, Mr Mark

Stanley, rh Sir John

Stephenson, Andrew

Stewart, Bob

Stewart, Rory

Straw, rh Mr Jack

Stride, Mel

Stringer, Graham

Stuart, Ms Gisela

Stunell, rh Sir Andrew

Sturdy, Julian

Sutcliffe, Mr Gerry

Swales, Ian

Swinson, Jo

Swire, rh Mr Hugo

Tami, Mark

Thomas, Mr Gareth

Thornberry, Emily

Thornton, Mike

Thurso, rh John

Tomlinson, Justin

Tredinnick, David

Trickett, Jon

Truss, rh Elizabeth

Turner, Karl

Twigg, Derek

Twigg, Stephen

Tyrie, Mr Andrew

Umunna, Mr Chuka

Vaizey, Mr Edward

Villiers, rh Mrs Theresa

Walker, Mr Charles

Walker, Mr Robin

Ward, Mr David

Watkinson, Dame Angela

Watson, Mr Tom

Weatherley, Mike

Webb, rh Steve

Wheeler, Heather

White, Chris

Whiteford, Dr Eilidh

Whitehead, Dr Alan

Whittingdale, Mr John

Wiggin, Bill

Willetts, rh Mr David

Williams, Hywel

Williams, Roger

Williams, Stephen

Williamson, Gavin

Willott, rh Jenny

Wilson, Phil

Winnick, Mr David

Winterton, rh Ms Rosie

Wishart, Pete

Wollaston, Dr Sarah

Woodcock, John

Wright, Mr Iain

Wright, Simon

Yeo, Mr Tim

Young, rh Sir George

Zahawi, Nadhim

Tellers for the Ayes:

Gavin Barwell


John Penrose


Aldous, Peter

Amess, Sir David

Anderson, Mr David

Baker, Steve

Banks, Gordon

Bebb, Guto

Bellingham, Mr Henry

Berry, Jake

Binley, Mr Brian

Blackman, Bob

Brazier, Mr Julian

Bruce, Fiona

Burns, Conor

Burns, rh Mr Simon

Burrowes, Mr David

Campbell, Mr Gregory

Cash, Sir William

Chishti, Rehman

Chope, Mr Christopher

Clarke, rh Mr Tom

Coffey, Dr Thérèse

Colvile, Oliver

Crausby, Mr David

Cunningham, Sir Tony

Davies, Glyn

Davies, Philip

de Bois, Nick

Donaldson, rh Mr Jeffrey M.

Donohoe, Mr Brian H.

Doyle, Gemma

Doyle-Price, Jackie

Drax, Richard

Durkan, Mark

Elphicke, Charlie

Evans, Mr Nigel

Evennett, Mr David

Field, Mark

Flello, Robert

Francois, rh Mr Mark

Fuller, Richard

Gale, Sir Roger

Gillan, rh Mrs Cheryl

Glass, Pat

Glen, John

Goldsmith, Zac

Gray, Mr James

Grayling, rh Chris

Greatrex, Tom

Hanson, rh Mr David

Hayes, rh Mr John

Heald, Sir Oliver

Hemming, John

Hermon, Lady

Hillier, Meg

Hinds, Damian

Hoban, Mr Mark

Hoey, Kate

Holloway, Mr Adam

Howarth, Sir Gerald

Jackson, Mr Stewart

Jones, rh Mr David

Jones, Mr Marcus

Jones, Susan Elan

Kane, Mike

Kaufman, rh Sir Gerald

Kawczynski, Daniel

Leadsom, Andrea

Lefroy, Jeremy

Leigh, Sir Edward

Lopresti, Jack

MacNeil, Mr Angus Brendan

Mahmood, Shabana

Main, Mrs Anne

Marsden, Mr Gordon

McCann, Mr Michael

McCartney, Karl

McCrea, Dr William

McGovern, Jim

McGuire, rh Dame Anne

McIntosh, Miss Anne

McPartland, Stephen

Meale, Sir Alan

Menzies, Mark

Mudie, Mr George

Mulholland, Greg

Murphy, rh Paul

Neill, Robert

Nuttall, Mr David

Ollerenshaw, Eric

Owen, Albert

Pawsey, Mark

Penning, rh Mike

Percy, Andrew

Pincher, Christopher

Pound, Stephen

Randall, rh Sir John

Reckless, Mark

Rees-Mogg, Jacob

Ritchie, Ms Margaret

Robertson, Mr Laurence

Rogerson, Dan

Roy, Mr Frank

Ruffley, Mr David

Rutley, David

Scott, Mr Lee

Selous, Andrew

Shannon, Jim

Shepherd, Sir Richard

Sheridan, Jim

Shuker, Gavin

Stevenson, John

Stewart, Iain

Streeter, Mr Gary

Stuart, Mr Graham

Swayne, rh Mr Desmond

Syms, Mr Robert

Tapsell, rh Sir Peter

Teather, Sarah

Timms, rh Stephen

Turner, Mr Andrew

Vaz, rh Keith

Wallace, Mr Ben

Weir, Mr Mike

Wharton, James

Whittaker, Craig

Williams, Mr Mark

Wilson, Sammy

Wright, rh Jeremy

Tellers for the Noes:

Mr Peter Bone


Mr Philip Hollobone

Question accordingly agreed to.

3 Feb 2015 : Column 188

3 Feb 2015 : Column 189

3 Feb 2015 : Column 190