Clause 11 — Activities that may be licensed

Orders of the Day – in the House of Commons at 6:30 pm on 19th May 2008.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 6:30 pm, 19th May 2008

I beg to move amendment No. 31, page 8, line 21, leave out subsection (1) and insert—

'(1) Section 11 of the 1990 Act (licences for treatment, storage and research) is amended as follows—

(a) in the title, for "and research" substitute ", research and therapy".

(b) in subsection (1)(b), for "and embryos" substitute ", embryos or human admixed embryos"; and

(c) after subsection (1)(c) add—

"(d) licences under paragraph 3B of that Schedule authorising activities for the purposes of therapy".'.

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Photo of Jimmy Hood Jimmy Hood Labour, Lanark and Hamilton East

With this it will be convenient to discuss the following amendments:

No. 14, in schedule 2, page 54, line 22, at end insert—

'Licences for therapy

1ZA (1) A licence under this paragraph may authorise any of the following—

(a) bringing about the creation of embryos in vitro, and

(b) keeping or using embryos, for the purposes of therapy specified in the licence

(2) No licence under this paragraph is to be granted unless the Authority is satisfied that any proposed use of embryos is necessary for the purposes of the therapy.

(3) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence.

(4) A licence under this paragraph may authorise the performance of any of the activities referred to in sub-paragraph (1), in such manner as may be so specified.

(5) A licence under this paragraph may be granted for a period not exceeding three years as may be specified in the licence.

(6) This paragraph has effect subject to paragraph 1ZB.

Purposes for which activities may be licensed under paragraph 1ZA

1ZB (1) A licence under paragraph 1ZA cannot authorise any activity unless the activity appears to the Authority—

(a) to be necessary or desirable for any of the purposes specified in sub-paragraph (2) ("the principal purposes"),

(b) to be necessary or desirable for the purpose of providing knowledge that, in the view of the Authority, may be capable of being applied for the purposes specified in sub-paragraph (2)(a) or (b), or

(c) to be necessary or desirable for such other purposes as may be specified in regulations.

(2) The principal purposes are—

(a) treatment of serious disease, or

(b) treatment of a serious medical condition.'.

No. 24, page 55, line 14, leave out from 'a' to 'that' in line 15 and insert

'harmful gene, combination of genes, chromosome or mitochondrion'.

No. 25, page 55, line 18, leave out from 'any' to 'establishing' in line 19 and insert

'harmful gene, combination of genes, chromosome or mitochondrion'.

No. 26, page 55, line 19, leave out second 'abnormality' and insert 'genotype'.

No. 27, page 55, line 20, leave out from 'other' to end of line 21 and insert

'harmful gene, combination of genes, chromosome or mitochondrion'.

No. 15, page 55, leave out lines 24 to 28 and insert—

'(i) a gender-related physical or mental disability which is life-threatening or severely impairs their quality of life,

(ii) a gender-related serious illness which is life-threatening or severely impairs their quality of life, or

(iii) any other gender-related serious medical condition which is life-threatening or severely impairs their quality of life

No. 4, page 55, leave out lines 30 to 37.

No. 17, page 55, line 33, leave out 'serious'.

No. 16, page 55, line 33, after 'medical condition', add

'which is life-threatening or severely impairs their quality of life'.

No. 18, page 55, line 35, after 'other', insert 'regenerative'.

No. 28, page 55, line 45, leave out 'abnormality' and insert 'harmful genotype'.

No. 29, page 56, line 1, leave out 'abnormality' and insert

'harmful gene, combination of genes, chromosomes or mitochondrion'.

No. 30, page 56, line 3, leave out 'abnormality' and insert 'harmful genotype'.

No. 5, page 56, line 11, leave out subsection (4) and insert—

'(4) In a case where a person ("the sibling") who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from any medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, a licence under paragraph 1 cannot authorise embryo testing for the purposes of establishing whether the tissue of any resulting child would be compatible with that of the sibling or for embryo testing for any purposes for the subsequent medical treatment of that sibling's medical condition.'.

No. 19, page 56, leave out lines 34 to 40.

No. 6, page 56, line 35, at end insert

', with the exception of sub-paragraph (4) of that paragraph.'.

No. 20, page 57, leave out lines 2 to 4.

No. 32, page 59, line 6, at end add—

'Licences for therapy

3B (1) A licence under this paragraph may authorise any of the following—

(a) bringing about the creation of embryos in vitro, and

(b) keeping or using embryos, for the purposes of therapy specified in the licence.

(2) Subject to the provisions of this Act, a licence under this paragraph may be granted subject to such conditions as may be specified in the licence.

(3) A licence under this paragraph may authorise the performance of any of the activities referred to in sub-paragraph (1) in such a manner as may be so specified.

(4) A licence under this paragraph may be granted for such period not exceeding three years as may be specified in the licence.

(5) This paragraph has effect subject to paragraph 3C.

Purposes for which activities may be licensed under paragraph 3B

3C (1) A licence under paragraph 3B cannot authorise any activity unless the activity appears to the Authority—

(a) to be necessary or desirable for any of the purposes of developing or deriving treatments for serious disease or other serious medical conditions, or

(b) to be necessary or desirable for such other purposes as may be specified in regulations.'.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

On a point of order, Mr. Hood. I am concerned as to whether amendment No. 31 is within the remit of the Bill, given Lord Darzi's letter of 31 January in response to a similar amendment in the other place. He made it clear that regulatory oversight by the Human Fertilisation and Embryology Authority finishes once a stem-cell line is derived and deposited in the UK stem-cell bank. Any stem-cell lines intended for human use will need to comply with the requirements of the Human Tissue Authority and are, therefore, subject to its regulations and to the Human Tissue Act 2004. As that is not the subject of the Bill and as other amendments, not least mine dealing with the collection of umbilical cord blood, were within the remit of the Human Tissue Act and the Human Tissue Authority, I ask the judgment of the Chair as to whether the amendment is in any way relevant, given that it is not within the remit of the Bill.

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Photo of Jimmy Hood Jimmy Hood Labour, Lanark and Hamilton East

I cannot accept the hon. Gentleman's point of order, as the amendment would not have been on the amendment paper had it not been in order. It was selected by the Chairman of Ways and Means.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 7:15 pm, 19th May 2008

Amendment No. 31 is important, but I take this opportunity to speak to the other group of amendments in my name, and to deal with the issue of saviour siblings, which is clearly one that will dominate the debate.

Embryo selection can be negative or positive. Negative embryo selection, which has been lawful under the Human Fertilisation and Embryology Act 1990, means that if a family suffers from an inheritable disease, they are able—even if otherwise fertile—to have in vitro fertilisation. If it is successful, embryos can be gathered and tested at an early stage, while outside the woman, by the removal of one cell. That has not been found to damage the embryo and the testing of the cell enables clinicians to identify whether each embryo is affected by the condition. If an embryo is affected, the couple undergoing treatment can avoid selecting that embryo for implantation and use one of the unaffected embryos.

Since 1990, the HFEA has licensed such negative selection on a number of occasions and families have benefited by avoiding inheritable disease, particularly when they already have a child significantly affected by the disease. That is a reasonable thing to do and I absolutely reject the suggestion that helping a family to avoid having a child with a serious disease is in any way discriminatory against the disabled. There is a complete difference between seeking to alleviate or avoid suffering by such techniques and discriminating against disabled or sick human beings after they are born. Indeed, many of the doctors who work so hard to provide pre-implantation genetic diagnosis also work hard both to provide in utero surgery to avoid or ameliorate congenital defects and to look after children born with serious diseases. Although I realise that views on the issue run strongly, I hope that the allegation of discrimination is not levelled against clinicians, parents and those of us who think that PGD is legitimate to help people to avoid having a child with a forecast serious genetic disorder. Such an allegation borders on the offensive.

My second point is that when taking a cell to check whether a child is affected by a disease it is also possible to carry out other tests on the cell—for example, tissue typing. I shall briefly describe two cases. The first involves the Hashmi family whose child was very sick with thallassemia and needed a transplant, but none was available from the bone marrow or cord banks, as is often the case for families with certain genotypes—particularly, but not exclusively, those from ethnic minorities. The Hashmis needed to check whether their next child would have the same disease, and whether they could select an embryo who did not have it. They also wanted to see whether they could get a tissue match. The HFEA said, after serious consideration, that that was a legitimate thing to do, and the courts upheld that decision as lawful under the 1990 Act. I understand that the Hashmis were unfortunately not successful in conceiving.

The next case that came along was that of the Whitakers, a family from Oxfordshire. They had a child who was seriously ill with Diamond Blackfan anaemia, who was kept alive by weekly transfusions and nightly treatments of an infusion of a drug. It was not an inherited disease but a sporadic mutation, so when they had another child—they wanted to have another child anyway—they did not need to test the embryo for the genetic disease, but they did wish to use a tissue-typing technique. They were fertile but they wanted to have IVF so that they could select an embryo that was a tissue match, in order that a wanted, loved child could provide a cord blood transplant for the afflicted older sibling.

The family were denied that opportunity by the HFEA, which disagreed with its own ethics committee. It later changed its mind, but in the interim the Whitakers went to Chicago for the treatment. It was successful, and they had another child, who was healthy. That child's cord blood was used in a transplant for the older sibling. The procedure was successful, and the sibling was cured. As a result of the intervention, instead of neither of the two children being alive and healthy, they were both alive and healthy. That makes the case more eloquently than any speech or policy document could.

What are the problems? Well, I do not think that there are any. I do not accept the allegation that there will be a burden on the saviour sibling. There is no evidence of that. There is evidence that if the intervention does not take place the sibling will suffer bereavement, because the young child will be born into a family who have a seriously diseased child who may die. It would be a benefit if that could be avoided. As I said on Second Reading, even if we could forecast circumstances in which there would be a burden, those potential circumstances have to be balanced against the certainty of harm if the family is not allowed to have a second child in the way that I have described.

We do not know whether the removal of a cell creates long-term harm to the embryo; it is fair to say that the technology is relatively new. However we do know that so far—thousands of children have been born following pre-implantation genetic diagnosis—there does not appear to be any harm, although it is important to keep observing. We do know that the birth of many sick children has been avoided, and healthy ones have been born instead, and that a handful of saviour siblings have been permitted. The HFEA has made it clear that it will not allow the procedure if there is an alternative that does not involve the destruction of embryos, so if there is a bone marrow match or a cord blood match, it is likely that that will be pursued first, because such a transplant is clearly less onerous for the parents than IVF, which is burdensome, and pregnancy.

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Photo of Ian Gibson Ian Gibson Labour, Norwich North

Is it true, though, that many ailments and afflictions are multi-factorial, and that in those cases one could not easily find a single-gene disorder by carrying out PGD? In many cases, 50 or 60 genes are involved. What is the hon. Gentleman's view about those situations and the children with those afflictions?

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

It is most likely that the procedure will be possible only in a handful of cases, so we are not talking about widespread tissue typing of a lot of embryos. Of course, many parents will choose not to have IVF and will instead take their chances, which are one in four.

Clear evidence has been presented to me that a tissue-matched transplant from a relative is more likely to be successful—at least in the case of Diamond Blackfan anaemia, from which the Whitaker child suffered—than a tissue-matched transplant from someone who is unrelated. We all support the idea of a bone marrow bank and umbilical cord blood banks, but they will never be a complete replacement. However, if those banks expand, there will be less need for procedures of the kind that we are discussing. I do not think that we need to have the discussion that I fear we will have about the merits of umbilical cord blood banking and bone marrow banking, such as that provided by the estimable Anthony Nolan Trust. The measure is self-limiting; if cord blood and bone marrow transplants work, the procedure will not be done. The measure relates to the few circumstances in which the procedure will still be required.

As far as my party is concerned, there is to be a free vote on the issue. I know that some of my hon. Friends do not share my view, but I think that the procedure should take place. We are not talking about eugenics. Eugenics is a state-sponsored scheme of building in genetic advantages, or excluding certain genetic conditions. The procedure is not state-sponsored at all. It is for doctors and patients to agree to the procedure together, under informed consent, and then apply to the regulator for permission. It is not eugenics, and it is offensive to suggest that it is.

I should like to move on to the other significant amendments in the group. First, I want to talk about the amendments in my name concerning the use of the term "abnormality" in the Bill. That wording causes a problem. It allows genetic testing for a genetic abnormality. There are some characteristics that, together, might cause serious diseases or life-threatening disease—or whatever the threshold happens to be—but that cannot properly be called abnormalities. I have had a briefing from leading geneticists, including Marcus Pembury, that says that if the Government do not make this minor amendment, they may find themselves fighting a High Court case in which opponents of PGD will say, "This particular combination of normal genes, which causes a serious disease in this individual, is not an abnormality, so how can you say that you're testing for an abnormality, according to the terms of the Bill, when the problem is caused simply by a combination of normal components?"

The best comparison is with rhesus disease. Carrying certain rhesus factors—positive or negative—can cause serious disease in a second child, but the rhesus factor is not an abnormality; it just so happens that in that case, it is bad news for a child. I therefore urge the Government to consider the alternative form of words that I have suggested, which includes reference to a "harmful gene" or "combination of genes", because that is what we are talking about. In the other House, it was suggested that the phrase "genetic characteristic" be used—that is, a genetic characteristic that caused serious disease, not a genetic characteristic that was being screened for; we have to be clear about that. Either of those wordings would solve the problem, and I should be interested to know whether the Minister of State, Department of Health, Dawn Primarolo, can be certain that her form of words will not be challenged.

Finally, I turn to amendment No. 31. It is linked with amendment No. 32, which would amend schedule 2. Amendment No. 32 is the key one; it is very important, but I do not have time to give it its due. It would insert a new provision that would enable the HFEA to give a licence for therapy as well as for research. The problem with the current Bill is that if, one day, the research works, and it is possible to derive from embryos stem cells that could be used to treat, say, diabetics by providing new, insulin-producing cells, or Parkinson's disease, it is not clear whether it would be possible to create embryos and use or store them for the purpose of therapy. Clearly, clinical trials are covered by the term "research", so it will be possible to create, store and use an embryo to provide stem cells for use in clinical trials. One cannot keep doing clinical trials once a treatment is known to work; it is unethical to randomise someone to placebo and someone else to a treatment that is known to be effective. At that point, one has to stop trialling, and instead deliver treatment. At that point, it is not clear whether the original embryo, from which the new stem cells are derived, will be covered, under the HFEA, by a licence, because one can get a licence only for treating infertility or for research.

The Government are right to say that the stem-cell therapies will be controlled by the Medicines and Healthcare products Regulatory Agency and, before that, by the Human Tissue Authority. That is not in doubt, and I am sure that the joint statement from those bodies and the HFEA will lead to a seamless transfer. The problem is that if, once research trials work, a company called, say, Stem Cells R Us comes along and says, "We can produce embryonic stem cells for treatment and sell them to the NHS as therapy", it will not get a licence under the Bill, because it cannot show what the research ends are. It is not good enough for the Government to say that there will always be quality assurance testing on any stem cells derived and that that counts as research. Quality assurance is not research. Research must pass muster on clinical research ethics, and a clear programme of research with inclusion criteria and exclusion criteria is therefore required.

The Government gave two different answers when the issue was raised in the Lords—I can send the Minister the exact quotes. That makes their position difficult—if their position is that there is no problem—because if there were a challenge in court, it would be found that Ministers in the Lords said diametrically opposed things in Committee and on Report. In Committee, the Minister said that such a provision would be a step too far, because it would raise a series of issues about, for example, how many embryos per stem cell line are needed for therapy. On Report, the Government changed their mind, when the Minister said that such a provision would be unnecessary, because the practice is already permitted under the 1990 Act. The Government stuck to that line in the letter that was referred to in the point of order raised by Mr. Burrowes and on Third Reading.

That will not do. It is necessary to clarify the situation, which would not be a step too far. Indeed, Baroness Warnock expressed concern in Committee that despite everything we went through on cloning regulations, which related to conducting stem-cell research and providing therapies, the Government say that they would permit research but would not permit the fruits of that research—the therapies themselves—to be used.

Lord Patel and I worked on the amendment that has since been tabled by Mark Simmonds, but my amendment No. 32 is better than that, which is why I have re-submitted it—the two amendments do the same thing. I do not intend to divide the Committee, but whatever the Minister says in reply, will she meet me, scientists and stem-cell research funders, who are concerned, along with her officials to explain precisely why—I fear that she will not have time today—my amendment is unnecessary?

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health) 7:30 pm, 19th May 2008

The Wellcome Trust, the Medical Research Council and a large number of scientists support the Government's interpretation of the 1990 Act. While I am always happy to exchange discussion points with the hon. Gentleman over a cup of tea, I regret that I will not give him such a commitment this evening.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I am astonished. The views of the MRC do not matter, because this is a legal question. I have received legal advice stating that the Government's position will not do and that it is challengeable, and potential investors in stem-cell research have said the same thing. I think that the Minister accepts that the first answer given by the Minister in the other place was incorrect, and she is now sticking by the answer given at a later stage.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

The hon. Gentleman is persistent. [ Interruption. ] His colleagues have confirmed that, although they do not agree with him. If he wants to draw things to my attention, then he can send them to me. However, the advice that I have received and the consultation that has been undertaken indicate that the interpretation that the Government put on allowing research to be conducted into therapies, which is the purpose of the Bill, is clear, as explained in the other place.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I am very worried now, because that is not the question. The question relates not to research but to after research has finished. Let us say that in five to 10 years' time the research has worked and that the researchers want to create embryos to derive the therapies without the research stage. How would they do that, when only a research licence is available for that purpose? That is the problem. The Minister might say, "Well, we will have another Bill in five to 10 years' time." However, I do not think that she will want to go through this again. Furthermore, the history of legislation on the issue indicates that it does not come up very often.

I urge the Minister to recognise that she has not addressed my question. If someone wanted to produce embryos for therapy after trials had been conducted either elsewhere in the world or in this country, how would they apply, because they would not have a research project? The Minister should take this issue more seriously.

I know that many hon. Members want to speak. In expressing disappointment in the Government's response—

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

It is utterly outrageous for the hon. Gentleman to suggest that I am not taking the Bill seriously, simply because I am not prepared to undertake to meet him. I hope that he will withdraw that remark.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

The record will show that I said that the Minister is not taking this issue seriously; so she is being unreasonable in suggesting that I have suggested that she is not taking the Bill seriously.

I have received legal advice that suggests that there is a problem, but the Minister has been unable to address it. The Government gave contradictory opinions in the House of Lords, but she will not even meet people who disagree with her. [ Interruption. ] I think that she is saying from a sedentary position that she would be happy to meet me.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

Apparently not, which I find amazing. The Minister will find that the issue comes back on Report, when she will be seen to be unreasonable on that issue.

I have set out why I believe it right to permit saviour siblings and why the drawbacks that have been ascribed to that approach do not apply. For a handful of families, allowing tissue typing as a form of PGD will give them the opportunity to help one child, while at the same time producing another healthy child who is also wanted.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

Anybody listening to the debate on saviour siblings, both in Committee today and in the wider media—I exempt Dr. Harris from this, but there are other speeches still to come—might be forgiven for falling under the misapprehension that the moral argument lies entirely in one direction and that the legislation has been drafted by a latter-day Mary Shelley who wants to allow scientists to create monsters. I am not exaggerating in making that remark—when we debated the amendments to clause 4, Mr. Leigh prayed in aid Mary Shelley.

When one hears comparisons between this Bill and, for example, the Third Reich, it is easy to forget that we are discussing treatments that, if successful, could save lives and prevent needless suffering. We should make decisions based on the best available evidence and put highly charged language to one side. As with most contentious issues, no one side has a monopoly on the moral argument, and it is important that we avoid such pretensions and focus on real people's lives and the effects on real people's lives, as supported by evidence.

I respect the views of those who have reservations about the Bill, but the three main arguments against saviour siblings are flawed. I will discuss those arguments and touch on some of the moral arguments that support our moving in that direction. The first argument that is often put is that saviour siblings would be treated as commodities. In other words, parents who choose to have a further child in the knowledge that that might save the life of its sibling are somehow driven by unacceptable motives. At the heart of that argument lies the alarming notion that the state has the right to question the motives of prospective parents. It does not take a great deal of thought to realise the odd directions in which that could take us. I strongly believe that it is up to parents to decide their own justifications for having children. In practice, to be perfectly honest, it is unclear how it would be possible accurately to judge intentions in every specific case. I do not want to stray too far from the point, Mr. Hood, but it does not take a great deal of imagination to envisage a number of different cases where any of us would disapprove of the circumstances in which a child was conceived. However, would we have the right to condemn their birth? That example has a direct parallel with the argument that I have mentioned.

The second argument expressed by opponents of saviour siblings suggests that saviour siblings would be the first step on a slippery slope to designer babies. Frankly, that argument could be put only in a completely different context, because the rules in the Bill explicitly prevent such a development. If we went through life rejecting Bills on the basis of what subsequent legislation might propose, we would probably never pass any laws whatever.

The third argument suggests that saviour siblings may be physically and/or psychologically harmed. It is flawed for several reasons. First, the Bill includes an amendment that limits other tissue, so it does not include whole organs and will have the effect of preventing an embryo from being tested if the intention is to remove an organ from a child. Although it is true that, according to all reports, making a bone marrow donation is not a pleasant experience, there is little, if any, evidence that donors suffer any lasting adverse effects. In fact, the contrary is true: as the hon. Member for Oxford, West and Abingdon suggested, many people who can offer the gift of life report an overwhelming psychological benefit.

Arguments against saviour siblings are weak. What are the arguments in favour of them? More importantly, what principles should guide us on the issue?

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Photo of Gary Streeter Gary Streeter Conservative, South West Devon

I am grateful to the right hon. Gentleman, who is making a thoughtful speech.

Does he not give any weight to the possible psychological harm to a second child—a saviour sibling—who had given, say, bone marrow on a number of occasions and came to discover, be told or believe that he had been created, selected or put together primarily for a particular purpose? Would such a child not wonder about what kind of child he would have been had that selection not taken place, and would that not add to the teenage angst and turbulence that we see in too many youngsters already?

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

I understand the hon. Gentleman's point, which is important. However, I do not know where the balance of the evidence takes us. I do not wish to be in any way disagreeable, but 30 or 40 years ago it could have been argued that somebody born out of wedlock would be disadvantaged for the rest of their lives. Some people might have made a value judgment, but all I can say is that I know a lot of people who were born to unmarried parents and do not seem to have suffered any psychological disadvantage at all. I return to my previous point: the one thing that we do know is that most people who have benefited a sibling through this sort of procedure report that it makes them feel good about themselves and creates a greater bond.

The issue is complicated and it is difficult to say that in every case the use of saviour siblings would be damaging or that in every case it would be wonderful; there will be a wide spectrum of reactions to the experience. However, I do not think that the argument put by Mr. Streeter seriously militates against their use.

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Photo of Steve Pound Steve Pound PPS (Rt Hon Stephen Timms, Minister of State), Department for Work and Pensions

I agree that my right hon. Friend is making a sober and considered case. However, I ask him to consider the circumstances of a saviour sibling whose creation fails to resolve the problem for which he or she was created. What psychological damage would that do the child, and how would the parents view that child—created to save, yet unable to do so?

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

I understand my hon. Friend's point. I said that there would be a wide spectrum of circumstances and that cases would be different. One could equally argue that a child who had an elder sibling with a congenital disease that would lead to certain death, and who was not used for such a treatment, would suffer a bereavement that would result in an even greater psychological disadvantage. There is no easy answer to any of these problems and I do not pretend to have all the answers. However, I return to my previous point: I can foresee circumstances in which a young person would feel good about having played a part in the survival of an elder sibling.

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Photo of Mark Todd Mark Todd Labour, South Derbyshire

My right hon. Friend referred to the positive feelings cited by siblings who have donated. Surely those siblings had given consent to the process—in other words, they were knowingly engaged in assisting another sibling. In the instance that we are discussing, no such consent would be obtained. The decision would be made by the parents.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East 7:45 pm, 19th May 2008

My hon. Friend is correct. However, parents make all sorts of decisions about their babies and children without there being any possible consultation. I cannot see how somebody could be consulted about what could happen in their infancy before they were even born. My hon. Friend's point is not strong.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

I shall give way to John Bercow and then to my hon. Friend Tom Levitt. After that, I really should make progress.

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Photo of John Bercow John Bercow Conservative, Buckingham

I am extremely grateful to the right hon. Gentleman for giving way. The fact that the savour sibling would not be in a position to give his or her consent at the time for something that proved to be thoroughly beneficial does not mean that he or she could not feel a great sense of retrospective satisfaction at having done something very good. The two concepts are by no means mutually exclusive.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

I am very grateful to the hon. Gentleman, who answered my hon. Friend Mr. Todd more eloquently than I did.

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Photo of Tom Levitt Tom Levitt Labour, High Peak

I agree with everything that my right hon. Friend has said. The answer to my hon. Friend Mr. Todd is that when Siamese, conjoined twins have to be separated clinically and the chances are that one will die, I do not recall that the twin least likely to survive is consulted. The situation is difficult and parents have to make the decision. The situation is no different from that involving savour siblings.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

I am grateful to my hon. Friend. Perhaps I should just take interventions; the more I take, the stronger my argument becomes.

It is important to remember that, as the hon. Member for Oxford, West and Abingdon pointed out, the only real difference between conventional IVF treatment and the process of creating a saviour sibling is in the reduction of chance at the point when eggs are selected for implantation. In my view, claiming that that is a manipulation of DNA cells or a creation of designer babies is a misrepresentation of the facts. The reality is that it simply enables an informed selection of embryos so that there is a greater likelihood of a healthy baby who also has the potential to save their sibling's life. If, as I do, we accept that the principle of IVF is a good thing and if we have the technology to make this important decision in a more informedway, we should use that technology, as long as all therapeutic alternatives have been exhausted.

It is a question of using the best available knowledge to maximise the chances of saving lives and reducing suffering. As was noted in the previous debate, there are other sources of therapeutic cells—bone marrow transplants and cord blood from non-related donors provide such possibilities. However, only 20 to 35 per cent. of patients have a matching sibling by chance and the odds of obtaining matching stem cells from an unrelated donor vary according to the ethnic origin of the patient. As matching is significantly improved when the donor and recipient have the same ethnic and racial background, this Bill will have even greater benefits for people from minority ethnic groups struggling to find a suitable donor. Indeed, one of the cases that the hon. Member for Oxford, West and Abingdon referred to made that point equally well.

When we think about the principles involved, it is all too easy to forget that we are dealing with uncertainties. The best available scientific evidence can only predict the most likely future therapies. Indeed, the history of medicine shows, repeatedly, that life-transforming treatments in one area often arise from work with a very different original rationale. The obvious example is that of Alexander Fleming's discovery of penicillin—a chance discovery from an already discarded contaminated Petri dish. The drug sildenafil was originally used to treat angina before a notable side effect was deemed to have a significant therapeutic use in its own right. For those in the Committee who are not immediately familiar with this drug, its more popular brand name is Viagra.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

Mr. Hood, I shall refrain from responding to my hon. Friend's sedentary interventions.

We should ensure that we provide sufficient flexibility in the Bill to allow new therapies to be developed that at the moment are nothing more than theoretical possibilities. For example, the only conditions that can currently be treated by saviour siblings are those that can be cured through bone marrow or umbilical cord blood cells. In future, scientific techniques may have advanced so that other cells, perhaps from the umbilical cord itself, may be of use. It is, therefore, important to include such possibilities to maximise the potential to develop new cures and therapies.

Finally, there is a powerful moral argument in support of the measures in the Bill. Subject to the safeguards it contains, we should allow medicine to intervene to save lives and to reduce suffering wherever possible.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

Before moving on to saviour siblings, I would like to deal with the amendments in the name of Dr. Harris, including amendments Nos. 24 to 28, which would significantly widen the embryo testing provisions from a situation where there is a risk of a gene chromosome of mitochondrian abnormality to cases where there is a risk from a harmful genotype or any other harmful gene. One has to raise the question of what a harmful gene or chromosome is. How is "harmful" defined? To whom is it harmful—a society that cannot tolerate disease? My concern about the amendments, and the Bill itself, is the value we put on life, and whether we seek to focus on the quality of life and make the judgment that some lives are more valued than others. I am particularly concerned about that lack of definition in the amendments.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I would like to draw the hon. Gentleman's attention to proposed new paragraph 1ZA(2) in schedule 2(2), which states that not only does there have to be an abnormality or a harmful combination of genes, but also

"a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition."

Whatever that threshold is—the hon. Gentleman may think that it should be life-threatening, if anything—those conditions still have to be satisfied. There is no way one could widen the number of people to whom the provisions apply. It is just the way we define what it is that creates the risk that is at stake in the amendments.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

I am grateful for that intervention because it is the issue of definition that concerns me. Amendment No. 25 sets out an extension to harmful genotypes. I have looked up the meaning of genotype, and it includes a range of definitions of the genetic make-up of an individual. Genotype can also be defined as the physical or psychological genetic potential of a person when born—for example, someone born with a genetic predisposition to depression. However, whether that person develops depression depends on their upbringing and environment. I looked further at the definition of genotype, and it is defined as one's genetic potential when born, physically and psychologically. Someone may be born with the physical genotype to play football for his or her country. One would have to judge whether it would be a harmful genotype that led someone to play football for England, Scotland or Wales. One certainly would not want to include a definition of genotype in relation to this area of the law.

I wish to press amendment No. 4 to a Division because it raises important issues of principle that I do not believe are met by the safeguards, which we shall debate later. The safeguards are helpful to the debate, and they have been discussed in detail in the other place. Nevertheless, it is important for this House to decide for the first time on the principle of saviour siblings. Indeed, that is one of the reasons we are discussing the matter in a Committee of the whole House. It is an important issue of principle.

I listened carefully to Mr. Howarth, for whom I have great respect. It is certainly important that we do not simply consider the matter in some vacuum of principle away from the application of the real issues of anguish that have been mentioned—the cases we have heard that, for the avoidance of repetition, I will not go over in detail. The whole House shares considerable concern for those parents caring for a seriously ill child, and understands their desperate search for a cure. After they have been through all avenues to seek a match—from bone marrow or any available cord blood—and are told of an opportunity to create a sibling to provide a match, one can understand why they would want to consider that option. It is important that we take account of those concerns and recognise that they are rare concerns. I heard clearly the Government's response on Second Reading that the measure is one of last resort, but it is important that the House deals carefully with the ethical principles involved.

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Photo of Brian Iddon Brian Iddon Labour, Bolton South East

Would the hon. Gentleman agree with many other Members that it is better to regulate saviour sibling technology tightly in this country instead of forcing people such as the Whitakers to travel long distances at a traumatic period in their lives? They went to Chicago, as we have already been told.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

It is important for Parliament to have legislation that deals with the citizens of this country and to ensure that it is based on sound ethical principles. We need to do that and be vigorous, rather than simply devolving and delegating matters to a regulatory authority. Indeed, good practice might suggest that we devolve the matter to a court. I want to go through those issues and the safeguards in detail shortly.

First of all, however, it is important to consider the issue of principle. The important principle that we need to vote on today is whether it is legitimate and right deliberately to create a baby who has the same tissue type as a sick sibling with the intention of harvesting the cord blood, bone marrow or other tissue. Do we wish to do that, having taken into account the concerns of parents who are desperate for a match for an existing child? We need to ensure that we take account of those concerns. We have a duty as a caring society to offer all the services we can through modern medicine, and to ensure that there is a cure available, or an alleviation of those parents' concerns. I want to deal with those matters, too.

It is important that we do not make decisions in a moral vacuum—I do not believe that any hon. Member wants to do that. While taking account of parents' concerns, we must keep hold of the important principle that a child should not be deliberately used or created for the benefit of another, no matter how pressing the need.

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Photo of Desmond Turner Desmond Turner Labour, Brighton, Kemptown 8:00 pm, 19th May 2008

The hon. Gentleman is rightly concerned about moral principle. If amendment No. 4 is passed, a few—fortunately not many—children will die because they cannot be treated. There is a moral imperative, if therapeutic measures exist—they do in the case we are considering, through scientific advances, pre-implantation genetic diagnosis and the tissue typing of embryos—to use them to save life. What is his reaction to that?

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

My reaction to that moral imperative, which has existed for several years, is to challenge the Government about the extent to which they are properly focused on and investing in umbilical cord blood to ensure that the necessary resources are available. We can then join Peter Braude of the Royal College of Obstetricians and Gynaecologists, who chaired the committee on cord blood. When asked about saviour siblings, he said that the need for donor siblings would be temporary and that, in future, he hoped that stem-cell supply, especially the use of cord blood from national cord blood banking, would virtually remove the need for donor siblings.

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Photo of David Howarth David Howarth Shadow Solicitor General, Ministry of Justice

The hon. Gentleman mentioned the moral principle that people should not be merely means rather than ends. I agree. It is also important that harm is not done to the resulting children. However, I do not understand how those principles apply to the cord blood in a saviour sibling because no person is being used merely as a means and no harm is being done to a person.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

Many hon. Members would be satisfied if the saviour sibling provided the cord blood. Indeed, the Joint Committee considered the matter and tried to follow that route. However, as I shall explain in more detail shortly, there is no guarantee that a match to cord blood will work. The next stage would be bone marrow and, after that, "other tissue".

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Photo of Patrick Hall Patrick Hall Labour, Bedford

Surely the hon. Gentleman acknowledges that bone marrow biopsy, with one child donating to another, already takes place.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

Yes, but there is the important issue of consent. The Anthony Nolan Trust properly recognises informed consent. That happens in the case of bone marrow matches and is important. We are considering the most vulnerable children in terms of rights and providing proper protection for them. The House needs to ensure that we provide that protection.

The child has autonomous rights and it is important that we recognise them and ensure that they cannot be subjugated, however pressing the need, to the concerns and needs of the parents. We should apply that principle fully and vigorously.

Let us consider the practice in relation to saviour siblings and, more broadly, to pre-implantation genetic diagnosis and IVF treatment. One must acknowledge the difficulty of the process. I understand that it can take four cycles of IVF treatment to find the necessary match. As hon. Members know, in any one cycle of IVF treatment, around 12 eggs will be extracted. Of those, 10 will become embryos, eight will be biopsiable and it is possible to diagnose only seven. Two would be normal, with only one potentially described as good quality. Once that embryo has been implanted in the womb, the chance of it being carried to term is estimated at 15 or 20 per cent. That may not be of paramount concern for all hon. Members, but it is for some. Cycles of IVF treatment lead to many discarded embryos, both diseased and healthy. That causes some hon. Members concern, especially those who support amendment No. 4, which would prohibit saviour siblings. However, I appreciate that other Members have other concerns.

Some of those other concerns relate to the woman. As has been said in previous debates, there is a significant risk of ovarian hyperstimulation syndrome to the woman who undergoes the procedure. As the ovaries are stimulated to extract eggs, the ovulated ovaries release increased amounts of hormones into the abdominal cavity, causing it to become permeable. That raises concerns about the woman undergoing the procedure.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

Surely it is up to the woman. There is informed consent in those procedures. She may say that she wants a chance to save the affected sibling's life and wants a child who can give that chance. She is prepared, as are all those who undergo IVF, to take the risks, which are not trivial, to have that child. The hon. Gentleman's comments apply to all IVF treatment and assume that people cannot give informed consent, which they do, in their thousands.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

I made a point about the practical implications for women. I do not want to deny them a choice, but to draw attention to the practical risks involved in the procedure and emphasise that it is not easy to reach the point of finding a matched embryo to provide a saviour sibling.

Let me consider the safeguards that the Government want to establish to ascertain whether they satisfy many Members' concerns about the principle of saviour siblings. In Committee in the other place on 3 December, umbilical cord blood stem cells, bone marrow or other tissue were discussed. When questioned about "other tissue" in November, Lord Darzi stated:

"The Bill does not limit which tissue can be used in the treatment of a sibling... and the Human Tissue Authority must approve any transplants involving organs from living donors and children who are too young to give consent."—[ Hansard, House of Lords, 21 November 2007; Vol. 696, c. 869.]

That raises questions about not only a matched saviour sibling for cord blood or even bone marrow, but how "other tissue" can be properly defined and limited. The subsequent concern was that, if the embryo were found to be immune, it would be implanted deliberately to become a source of what those in the other place described as spare parts for an existing child—its sibling—even when too young to give consent.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

If I may continue, perhaps I can give way shortly.

Since that time, the Government have amended the Bill to clarify that the reference to "other tissue" does not include any whole organ of the child. The Government have sought to provide that safeguard and make it clear that a decision to allow embryo testing on the basis of providing a future organ transplant for a sibling would not be allowed. I can see the Government's good faith in that. They want to extend that safeguard in respect of the saviour sibling becoming a whole organ donor.

Nevertheless, the Bill still contains a definition of "other tissue". The matter has been debated and challenged in the other place. I understand from correspondence and debate that when reference was made to extending the safeguard and to defining "other tissue" as regenerative tissue—my hon. Friend Mark Simmonds will probably want to expand on that—the Government's position was that "other tissue" certainly does not include whole organs.

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Photo of Brian Iddon Brian Iddon Labour, Bolton South East

The regulator has so far allowed such treatment for only aplastic anaemia, Diamond Blackfan anaemia and beta thalassaemia. The regulator decides which conditions can be treated by the saviour sibling technology, which in turn determines which tissues can be taken. Would the hon. Gentleman agree with that?

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

That raises the question of whether we should extend the use of saviour siblings not only to life-threatening conditions, but to the wider threshold of serious illnesses. In time, their use may be extended to illnesses beyond those that the hon. Gentleman mentioned. That is why we must consider the safeguards carefully. However, I will deal with the process of regulation shortly.

Rather than removing the phrase "other tissue", the Government wanted to encompass the whole matrix of umbilical cord blood, in respect of research suggesting that cells of the umbilical cord, rather than the cord blood, may offer potential for treatment. That is the Government's primary focus when using the phrase "other tissue". However, one cannot be wholly satisfied with that response. In the debate in the other place, in response to Lord Alton of Liverpool, who was particularly concerned about the possibility of "other tissue" being extended to other regenerative tissue, such as part of a liver or a lung lobe, Baroness Royall of Blaisdon said:

"With regard to parts of an organ, the Bill has been drafted in this way to allow the use of cells of the umbilical cord or, for example, if it were possible in the future to treat conditions with cells cultured from a small biopsy from the liver or any other organ."—[ Hansard, House of Lords, 21 January 2008; Vol. 698, c. 23.]

Reference was made in the debate in the other place to muscle as regenerative tissue and to ensuring that the Bill was inclusive enough to allow for biopsies from muscle for future treatments.

The Government's position on defining "other tissue", as well as including umbilical cord blood and bone marrow, is inclusive. It seeks to deal not only with the current circumstances, but future treatments that may follow. That raises profound questions. Those questions have been raised in correspondence between Lord Alton of Liverpool and Lord Darzi, in a letter dated 25 January, which not only questions the Government's position on "other tissue" in detail, but questions why, if the Government are focusing primarily on umbilical cords as the donation source, they are not minded to omit the word "blood" from between "umbilical cord" and "stem cells", so that the Bill would read "umbilical cord stem cells". Would that not be sufficient to capture stem cells from both the cord and cord blood? If not, would adding "and cord" to the existing wording, so that it read "umbilical cord and cord blood stem cells", be sufficient?

I invite the Minister to respond to that. However, if she feels that that approach would not wholly incorporate both the cord matrix cells and a small biopsy of regenerative tissue, why are the Government not explicit in the definition of "other tissue"? The concern remains that "other tissue" as currently defined still raises the spectre of part organs being available for donation, whether regenerative or not. I say, "not", because then we come to the regulatory role of the Human Tissue Authority after the child is born and the possibility that the courts could be involved too, in decisions relating to transplants of whole or part organs from children.

That spectre is raised because, as I intimated in my point of order, it is currently not within the remit of the Bill to deal with those details as they affect the Human Tissue Authority and its regulation. We are only one side of the coin, but the House does not have the opportunity to put into primary legislation its concerns about how far a saviour sibling could go in terms of donation. We all need to be aware that once the embryo is tissue typed, it has implanted an immune matched sibling for life and is known to have organs compatible with the older sibling, whether the initial reason related to tissue typing or not. That raises the danger that a saviour sibling could become a lifelong donor.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 8:15 pm, 19th May 2008

There is a flaw in the hon. Gentleman's argument. What if there was a fortuitously matched sibling who was not tissue typed or selected? They would not be allowed to donate organs or parts of organs, because of criminal law—the law of assault—and the rule that the best interests of the child must be maintained, and because the General Medical Council would take a strong view. What the hon. Gentleman describes is not going to happen in the vast majority of cases, so why does he think that special statutory protection is needed in this case?

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

That is a helpful intervention, because the distinction must be borne in mind. With saviour siblings, we are dealing not just with a fortuitous match, but a child who has been deliberately created and tissue typed for the purpose of matching the sick sibling. That is the deliberate reason for their creation. When one comes before the Human Tissue Authority, one cannot be wholly sure about the dangers that I have set out—that the child will be a lifelong donor—because it has not been possible to provide the cord blood or bone marrow match as a resource, but the sick sibling in that family still needs the cure for their debilitating illness, but has an immune, matched sibling, who has a genetic footprint that potentially provides the answer.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

I want to extend my argument.

The pressure is there. It is not beyond the realms of reason that the Human Tissue Authority would, in time to come, question the signal that the House had given it on saviour siblings.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

As it is a new hon. Member intervening, I will.

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Photo of Kevin Barron Kevin Barron Chair, Health Committee

I do not know whether the hon. Gentleman has ever read the Hansard report of the debate on the legislation that introduced the Human Fertilisation and Embryology Authority, but I was involved in those debates on the Opposition Benches, many years ago. Many of the arguments that he is rehearsing were made then, too, albeit in a different light, but most people in our society—and, I suspect, most people in the House—have had great confidence in that authority over the past 17 or 18 years, and are confident that in future it will do nothing more or less than what society would allow it to do.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

It is perhaps regrettable that we in this House cannot consider the Human Tissue Act 2004 in the context of saviour siblings, and debate it more fully so that the House can be clear about its intentions. The Human Tissue Authority—or, indeed, lawyers—might be seeking to make the case that Parliament would effectively be sanctioning the creation of a sibling for the specific purpose of tissue matching. If the alleviation or cure does not come through the use of cord blood or bone marrow, the next considerations will be about other tissues and whether there should be other donations.

The burden on the sibling and the parents to find the cure, which they see before them in the saviour sibling, would be immense and might be of concern psychologically. The argument has been made that such a situation might, alternatively, help the family to bond. What would happen if a person who has been created to cure or help their sibling cannot do so? The pressure would continue. What would be the psychological impact on a saviour sibling of knowing that they were created for a purpose that they cannot achieve? There is no evidence on that, but the burden is on the Government to establish whether there has been any assessment or study of the psychological impacts.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

What is the difference between a saviour sibling being unable to fulfil such hopes, despite tissue typing, and a sibling who was not tissue matched also being disappointed because they cannot provide tissue? That is simply a sad situation, and the hon. Gentleman has produced no evidence that the sense of disappointment would be greater simply because the parents had tried harder in that situation. At least they would have tried their best.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

My response to that is similar to my response to the hon. Gentleman's previous intervention: those cases are entirely different. We are dealing with a sibling who has been created specifically because of their tissue match and genetic footprint to find a cure for their sibling. The case of another sibling would be wholly different.

I should like to move to the Human Tissue Act test and consider the best interests of the child in relation to donation. The best interests test includes not only medical considerations, but a person's social, psychological and emotional best interests. That is why the psychological impact is relevant. Those interests would have to be examined if there were an application for donation. That could leave a child in a vulnerable situation and under unique internal and family pressures, having been created specifically to be a donor for the elder sibling. They could be put in a situation in which their older sibling might die if they do not provide the required organ. Those are considerations that could well arise in a chain of events, and it is therefore important that we do not simply rely on the safeguards in the Bill or even those suggested in amendments.

We must consider carefully, rely upon and uphold the important principle that we should not deliberately create a child for the benefit of another. The way to respond to this issue is not simply through prohibition but by promoting an area of resource—umbilical cord blood stem cell research. What is happening is a crying shame; there is a moral imperative on the Government to have more than four hospitals collecting cord blood. It imperative that we do not lag at 13th position in a league table of 17 countries for our collection of cord blood units per inhabitant. We are way behind other countries. It is imperative that we inform parents of the value of cord blood and of the opportunities to collect it, and that we encourage collection so that we have that ready resource that can provide the match and cure for parents who desperately want a cure for their children. On those points of principle, I invite hon. Members to support my amendment. We should not countenance a break in the principle, effectively, that a means justifies the end.

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Photo of Mark Todd Mark Todd Labour, South Derbyshire

I have a brief speech to make on a narrow point of concern. What we are sanctioning in this debate is the use of an invasive procedure on a child without their consent and without their gaining any direct benefit from that intervention. There has been speculation that such a child might benefit from feelings of good will towards the sibling that they might or might not have helped, but there is no certainty of that. I shall dwell on those elements, starting with consent.

There are many procedures for which children are not required to give consent. My son has had to undertake certain procedures on the basis that I have consented to them, and that is an entirely familiar principle in law. However, such procedures are usually associated with the principle that that child—the focus of this speech is that the child is an autonomous being in this matter—should derive some benefit from the procedure that they are undergoing. If the parents' consent is not directly associated with that child enjoying a benefit, but is so that another child will enjoy a benefit, we should reflect on that with some care.

The Bill sanctions invasive procedures. In the preceding speech, Mr. Burrowes made the point that that can occur in a variety of different ways that are sanctioned in the Bill. The commonest method will be concerned with bone marrow extraction, which my right hon. Friend Mr. Howarth described as an unpleasant procedure. Like any invasive procedure, it is not without risk. It carries a low risk, but it could go wrong. If the Bill excluded such steps and instead relied entirely on non-invasive procedures, I would probably accept the wording, but it sanctions a procedure that could, as has been said, involve the extraction of a part of a child's body, and could certainly involve the extraction of bone marrow.

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Photo of Patrick Hall Patrick Hall Labour, Bedford

Does not bone marrow biopsy already take place? The point has been made that that is not with the informed consent of the child, but it could not be, because a child is not of legal majority. None the less, such procedures already take place to try to help a sibling, so what is the difference in principle? If a child were created partly for that purpose—it would also be because they were wanted—that bone marrow could not be removed for at least a year after they were born, so what is the difference from existing procedure?

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Photo of Mark Todd Mark Todd Labour, South Derbyshire

I must say that I have some anxiety about existing practice sanctioning a potential injury to a child from which they will not derive any direct benefit, but in this instance I rely on the argument that was made in the preceding speech: the child will have been engineered specifically for that purpose rather than being created naturally. I do not regard the circumstances as being precisely comparable, but I take the point that there is a part answer to the ethical issue that I have raised.

Lastly, the potential psychological impact on the child has been discussed. I think that all our remarks on this point are speculative. As has been made clear from the start, the sample involved is likely to be tiny and is tiny now. There is no basis on which anyone can do anything other than guess what the impact on a child might be. The positive constructions that have been suggested are perfectly possible, and a child might well feel greatly loved and that it had contributed greatly in love to its sibling. However, it is also possible that much more negative feelings might arise. I personally feel that I cannot second-guess that in law, but that is what we are implicitly doing in the Bill, as it is currently worded.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

It is a pleasure to follow Mr. Todd, who made a thoughtful and thought-provoking speech, as did Mr. Howarth, whose logical and engaging speech carefully deconstructed the arguments that have been put forward against saviour siblings. My hon. Friend Mr. Burrowes made a very principled speech, and he was right to highlight the fact that we must not consider this important issue in an ethical vacuum. I have enormous respect for him, and he was right to highlight the concerns that exist about the HFEA. He was also right to emphasise the importance of cord blood. I do not agree with his amendments, however, which would effectively prohibit saviour siblings. As a father of three young children, who are thankfully very healthy—sometimes too healthy—I have great sympathy with those who are not fortunate enough to have such healthy children. I therefore understand why such people would do anything that they can within the structure of the law to enable their sick child to survive.

I want to speak specifically to the amendments to clause 11 and schedule 2. I also want to make some generic comments about this part of the Bill, because I understand that there are certain matters that we will not be allowed to discuss in the Public Bill Committee, and we might not have time to discuss them on Report, which will last for only one day.

The Bill is absolutely right to outlaw sex selection for non-medical reasons. However, pre-implantation genetic diagnosis—PGD—will be permitted if there is a significant risk of a child developing

"a gender-related serious physical or mental disability, a gender-related serious illness, or any other gender-related serious medical condition".

I want to return to the use of the word "serious" in a moment.

I support this general proposal, which will allow families who know that they are at risk of passing on a serious genetic condition to their offspring to test the embryos and to implant only an embryo that is free of the disease. Dr. Harris pointed out that it was not compulsory for parents with genetic illnesses to use PGD. It is not discriminatory, but it is right that it may not be used to select any positive characteristics.

The Bill also permits the selection of embryos to provide compatible

"cord blood stem cells, bone marrow or other tissue" to a sibling with a serious medical condition. One of the amendments tabled in my name refers to "other tissue". I will expand on that a little later. Cells are normally taken from the umbilical cord of the saviour sibling or, if that is not successful, from their bone marrow.

Of course this is controversial, but the creation of saviour siblings is currently occurring. It is very rare; I understand that, to date, the HFEA has licensed tissue typing for only six families. This is available only when all the other options are exhausted, and when there is no match on the bone marrow register, the NHS cord blood bank or other blood banks or within the family. We all hope that the number of cord blood banks in this country will be increased, and that the amount of cord blood that is thrown away will be significantly reduced. However, any decision to use that tissue must be a matter for the Human Tissue Authority to determine, rather than the HFEA.

As we have heard in the debate, there are serious concerns about the use of saviour siblings, and the HFEA and the HTA must consider closely each application to ensure that it is justified and necessary, and that there is absolutely no alternative. We have also heard discussions about the worth of the saviour child. I do not agree that the provisions would undermine that child's worth, particularly if the child were born into a loving, caring family, as it inevitably would be. In fact, the opposite impact would be achieved if a child knew that it had saved one of its siblings.

The amendments tabled in my name and that of my hon. Friend Mr. Lansley include amendment No. 15. Its effect would be to tighten the circumstances in which embryo testing can be carried out, so that it could take place only when an illness was life-threatening or severely impaired a person's quality of life. These provisions would replace the word "serious" that is in the Bill at the moment. Amendments Nos. 17 and 16 would do similar things in different parts of the schedule.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills 8:30 pm, 19th May 2008

Is the hon. Gentleman convinced that substituting the words

"severely impairs their quality of life" would tighten the provision that currently refers only to "seriously"? In other circumstances—I am not suggesting that this would apply in circumstances such as these—we know of conditions that seriously impair the quality of life. Myalgic encephalopathy is an example. However, other serious conditions that perhaps carry a risk of sudden death are otherwise asymptomatic and do not impair the quality of life. Is the hon. Gentleman really tightening up the provision, or simply creating more flexibility?

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I understand the hon. Gentleman's point. The legal advice that I have received on this is contradictory; I must be honest about that. However, everyone says that the use of the word "serious" does not create a very tight provision, and that any effort to tighten the clause would therefore be welcome. I shall say more about that later.

Amendment No. 18 would insert the word "regenerative". This goes back to the point made by my hon. Friend the Member for Enfield, Southgate about the words "other tissue". It would be helpful if the Minister could stipulate exactly what other tissue this means. I have no wish to duplicate the debate that took place in another place, in which it was made clear that this was not intended to include the removal of whole organs. I understand, however, that it could mean not only bone marrow and biopsies but partial organ removal, and that those organs—for example, a significant chunk of a liver—might not grow back. It would be helpful if the Minister could tell us whether that is being considered in this regard.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

Actually, I would like to use the liver as an example of something that might be caught by the hon. Gentleman's amendment, because it does regenerate, particularly in young people. Including it might make the liver an organ that the courts might deem the House to have considered. The liver is not the best example to use of an organ that does not regenerate.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I take the hon. Gentleman's point, but that is not my understanding of the situation. I am told that it depends on how much of the liver is taken. A significant percentage can be taken, even from a young person, and the person will still survive with the remnants of their liver. Not all of their liver will grow back, however. The Minister needs to tell the House whether that would be the impact of the amendment that I have tabled. A kidney is perhaps another example. People have two kidneys, and if one were taken, a person would survive. I understand, however, that that would not be allowed under these provisions because it would involve a whole organ being removed.

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Photo of Greg Clark Greg Clark Shadow Minister (Cabinet Office)

Does the key distinction relate not to the difference between regenerative and other tissue, but to the invasive techniques that are required? These were referred to by Mr. Todd. Many of us would be content for stem cells from cord blood to be used, because that does not involve invasive techniques, but we have concerns about the necessity literally to invade the body of a child in order to provide some of the other kinds of tissue.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I understand my hon. Friend's point, but I would raise with him in response the issue of what would happen if a saviour sibling were born and the umbilical cord were wrapped around the baby's neck and had to be discarded. Is my hon. Friend suggesting that the parents would have to take a decision to have another saviour sibling that would generate the particular cord blood or other tissue required to save the elder child? I do not think that that would be acceptable, which is why I believe that invasive procedures such as removal of bone marrow should, as a last resort, be allowed for saviour sibling purposes.

Amendment No. 19 would remove the regulation-making power from the Secretary of State. It is a probing amendment. It would be helpful if the Minister put on record the circumstances in which embryo testing could be licensed and if she clarified which particular circumstances the Government envisaged might be changed in the process of licensing. Would it include circumstances in which seriousness is diluted even further than I believe it is at the moment? Will she also confirm that any changes to the powers for regulating saviour siblings would be put before the House in the form of regulations, requiring the affirmative resolution procedure?

The issue of seriousness is relevant to amendments Nos. 15, 16 and 17 on the circumstances in which a saviour sibling can be created. They are too open to interpretation. Reservations relate to how an illness will be defined as "serious" and by whom. What will be serious to one party may not be so serious to others. In my view, using the words

"life-threatening or severely impairs their quality of life" makes it more specific to an individual, which the term "serious" is not. I understand why the Government do not want only the term "life-threatening" in the Bill, which is why I have insisted that "quality of life" should also be in the provisions. Some serious illnesses may seriously impact on the quality of life of an individual without actually killing that individual. Clearly, a saviour sibling may resolve that particular problem.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

Let me make a little progress; I will give way to the hon. Gentleman in a few moments.

Will the Minister also clarify what would be allowed under the term "serious" that would not be allowed under "life-threatening" or seriously impairing the "quality of life"? If there are any serious differences, the Committee should know what they are. I understand from lawyers—I say this in response to an earlier intervention—that neither "serious" nor "quality of life" provides the utopian phraseology that would be needed to ensure that this provision is drafted as tightly as it should be.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I am trying to be helpful, so I am grateful to the hon. Gentleman for taking my intervention. He said that "serious" was not tight enough, as it was open to interpretation and was essentially subjective. However, the fact that it is open to interpretation is important in clinical practice, because doctors and patients together take decisions that are specific to their circumstances. That is what medical care is. Secondly, if "serious" is subjective—not a bad thing when dealing with patients—so is seriously impairing the "quality of life". They are both subjective; one is no better than the other in that respect.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

That is where we disagree. I think that my amendments are better because they are, in my view, tighter. I accept that there has to be some flexibility—there was a debate in the other place about this issue—in that we cannot have a list of specific diseases or illnesses that will be treated. I understand the decision taken not to accept that: it would be very difficult to agree the list in the first place; and as new techniques came along, the list might have to be amended, which would be complex.

Let me move on to deal with amendment No. 18, which relates to the types of tissue used to create saviour siblings. As I have said before, whole organs are prohibited, but I am still concerned about allowing the removal of parts of organs that might not grow back—hence the issue of regeneration. As the hon. Member for South Derbyshire said, the issue of consent is also relevant. Indeed, consent is rightly viewed as the cornerstone of this legislation. Given that the child cannot possibly give consent, it would be interesting to know whether the consent of the parents overrides any particular ownership of tissue that the child may have. Adults can, of course, consent to kidney donation, but children and certainly saviour siblings cannot.

Let me deal finally with licences for therapy in amendment No. 14. It is similar to amendments Nos. 31 and 32, which were tabled by the hon. Member for Oxford, West and Abingdon. The general thrust of the Bill must be that it should last as long as the 1990 Act. It is a testament to the robustness of debate on that Act that it has lasted for so long. I am sure that the Minister and all other Members of the House who are interested in these issues do not want to have to return regularly to this legislative structure, although I fear that this is one of those areas that may need looking at as technologies and sciences develop.

Clearly, people believe that scientists may still be a long way off developing cures, but the motivation behind all that research is finding therapies and, ultimately, cures. I understand that no provisions in the 1990 Act provide for treating conditions other than those related to reproduction. The HFEA licenses for treatment non-medical fertility services, storage and research, including—correctly—clinical trials. The amendment would enable the HFEA to license the creation and use of embryos for therapy. Again, it would be helpful if the Minister clarified whether my comments are correct.

I understand that if a cell line that could cure an illness was deregulated under current regulations, researchers would have to go back to square one and create another cell line to comply with EU regulations. Clearly, that may well delay the application of the cures and treatments.

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Photo of John Bercow John Bercow Conservative, Buckingham 8:45 pm, 19th May 2008

I hope that my hon. Friend will forgive me if I press the rewind button and ask him briefly to revert to the issue of consent, on which he touched a few moments ago. I am genuinely slightly puzzled by what he said and I am interested to know his position.

It seems to me to be unavoidably the case that consent cannot be given. I do not see how it can be given retrospectively. My hon. Friend then began to talk about the issue of ownership of tissues. What conclusion has he reached on the point about consent and does it differ from my own and that of Mr. Howarth?

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I am grateful for that intervention. I am pressing the Minister on the apparent confusion between the HFEA and the Human Tissue Authority over who is responsible for giving licences.

Of course the cornerstone of this legislation has to be consent, and clearly it must be the consent of the parents that enables a saviour sibling to be created in the first place, but there is confusion and I suspect that the Government are resisting adding "Licences for therapy" to the Bill because of the complex regulatory package that would be required, including the HFEA for embryo research, the HTA for tissues and the Medicines and Healthcare products Regulatory Agency for human applications, although those bodies already act in sequence and it would be possible for them to work together to regulate stem cells derived from human embryos for therapies.

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

I am grateful to my hon. Friend for drawing out the complications in dealing with the licensing authorities—within the remit of the Bill, we have only part of the picture. Returning to the principle and the comments on consent made by my hon. Friend John Bercow, does my hon. Friend Mark Simmonds agree that the lack of consent is obviated by retrospective satisfaction? Would he care to comment on whether consent could be given in such a manner?

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health)

I do not think that that is right, because we would get into the difficult issue, which was raised earlier, of what would happen if a saviour sibling did not provide a satisfactory conclusion to the illness or the problem. Ultimately, the parents have to make the decision, along with the licensing from the HFEA within the legislative structure that we are discussing, but consent has to be the cornerstone—where possible—of the legislation. Of course, if there are to be exceptions, all sorts of other issues will be created, which we shall explore in the Public Bill Committee. We will discuss such things as mitochondria and the potential solutions for those with mitochondrial inherited diseases.

Parliament needs to consider the issue now and not allow it to be slipped through by the HFEA as technology runs ahead of legislation. Indeed, one reason why there has been anxiety and angst is that the HFEA has moved forward as technology has run ahead of the legislation. The Minister will gather from the exchanges and my responses that there is clearly confusion about that issue. Clarity would be helpful.

In response to the hon. Member for Oxford, West and Abingdon, the Minister mentioned that she has received legal advice that there is no necessity to put a licence for therapies into the Bill. While I can quite understand why she does not want another meeting, it would be helpful if she perhaps placed in the Library for those who are participating in the Committee the detailed legal advice that she referred to, which, as I understand it, states that there is no problem with the HFEA licensing stem-cell therapies.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

Let me try to explain the Government's thinking on clause 11 and schedule 2, and on the issues that have been raised.

The Bill sets out five purposes for which embryos can be tested, and a regulation-making power to amend them. One of the purposes is the creation of so-called saviour siblings. As we have observed this evening, that is an issue that provokes very strong feelings in people on both sides of the discussion. Some feel that the creation of a tissue-matched sibling is entirely appropriate to treat an affected child when it is the only treatment option, and that not to allow it would essentially impose a life sentence on the child. Others feel that, despite that, saviour siblings should not be permitted.

Some parents with an affected child whose only treatment option—perhaps because the child has an unusual tissue type—relies on the creation of a tissue-matched sibling would feel very strongly that the Bill's proposals offer a practical solution. Having a child to satisfy a particular need, in this case the treatment of a sick sibling, is not uncommon. As Mrs. Lait pointed out so eloquently on Second Reading, no one has a child solely for the child's own purposes. It is often done to satisfy the needs of parents to be parents, or the need for a brother or sister for an existing child.

Let us consider a family who are in that position. The parents love the existing child so much, and are so motivated to do whatever they can to protect that child, that they are willing to undertake embryo testing. Embryo testing is an invasive and expensive procedure, and such motivated parents are highly unlikely to be anything other than loving and supportive to any child born into their family.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General

I have been listening carefully to the Minister's arguments. I also listened carefully to the arguments of Mr. Howarth. The right hon. Gentleman said that one thing we are not discussing is the creation of designer children, but that is exactly what is being discussed. It would be useful if that could be accepted. We cannot really have a sensible debate without such acceptance, because it absolutely underpins the debate.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

I entirely disagree with that proposition. Regardless of whether the principle of saviour siblings is accepted in the House, there is no suggestion whatever that they would be designer children.

Arguments for banning tissue typing on grounds of psychological harm to the children who are born are difficult to justify, as my right hon. Friend Mr. Howarth said in his eloquent speech. In practice, so few families have used the technologies that any children born are so young that it is not possible to draw reliable conclusions about the impact of being a saviour sibling. I absolutely acknowledge that fact, and Members must have that clearly in their minds.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

As many points have been raised, I would like to make a little progress before taking an intervention from the hon. Gentleman.

The amendments tabled by Mr. Burrowes would ban tissue-typing completely. That would be a backward step, and it would prevent people from accessing treatment to which they currently have access. In practice, tissue-typing is only very occasionally carried out. As has been said, the HFEA has licensed tissue-typing only in a handful of cases, and always for life-threatening conditions. It considers applications for the process on a case-by-case basis, and we would expect it to continue to proceed on that basis. Where it has agreed to proceed—for rare blood disorders—tissue typing already takes place, but that is not specifically set out in the 1990 Act, and this Bill rectifies that. Tissue typing is a treatment of last resort, and while I acknowledge the concerns of many Members, in my opinion and that of the Government there is not sufficient justification to remove the last-chance treatment option for the sick children who would be affected by such a ban.

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Photo of Stewart Hosie Stewart Hosie Shadow Chief Whip (Commons), Shadow Spokesperson (Treasury)

I have been listening carefully, and I have a genuinely open mind on this bit of the Bill, but many of my constituents are deeply concerned about the concept of saviour siblings. Will the Minister at least acknowledge their fear that a saviour sibling who is born and then fails in their cord blood, marrow or part of an organ to fulfil one of the purposes for which they were born—to save another child—might be left utterly bereft and despondent? That is a concern that many of my constituents have for such children in the future.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

I touched on that point. I absolutely acknowledge that in these extremely difficult cases very hard choices have to be made by loving, caring parents about their families, but those same choices are made by parents who already have younger or older children and who, for example, give their consent now for a bone marrow transplant where an existing child might save another child in the family. So these hard choices sometimes have to be made whether or not such a child has been created through the process under discussion. The hon. Gentleman is right to say that there are difficult issues that need to be considered, but they are not unique to the provisions in this Bill.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

May I just finish the point before giving way?

I know that I would want to move heaven and earth if my child were involved. Under this clause and schedule, we are asking the House to agree to leave it to the parents who are in this dreadful situation to make an application for the special treatment that is provided—testing within saviour siblings—and to to the HFEA to consider that on a case-by-case basis in order to come to a decision about such families. I say frankly and in all sincerity that unless we are to deny those parents the opportunity ever to access the testing, that is the best that we can currently do in the House with the constraints as they are.

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Several hon. Members:

rose —

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Photo of Tom Levitt Tom Levitt Labour, High Peak 9:00 pm, 19th May 2008

My right hon. Friend rightly identifies the motivation of the parents involved. I hope to catch the eye of whoever is in the Chair in order to tell the story of a constituent who is in one of the six families who have been licensed for this procedure so far. May I assure her that in their case it is not a question of a traditional treatment or even of the cord blood bank, which is not suitable in this case, because the alternative is to watch a young child have a slow, lingering, dreadful and early death?

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

I know, and I am sure that every Member in the House this evening and those listening to our proceedings elsewhere in the House will dread the prospect that, as a parent, they might ever be in that position. These are difficult issues, but we must assure ourselves that we do not deny the parents, who ultimately are the people who must decide to have access to this testing. We must satisfy ourselves in the House that such a process is properly regulated to deal with the unique circumstances that might arise. I promised to give way to the hon. and learned Member for Torridge and West Devon, so I shall do so.

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Photo of Geoffrey Cox Geoffrey Cox Conservative, Torridge and West Devon

Is not the difference between the normal situation—one calls it normal because we are dealing inherently with the abnormal in these circumstances—where a parent is faced with the choice of whether to give approval for an invasive procedure on an existing child whose tissue matches that of another, and a situation where a child has been deliberately conceived and bred for the purpose, that faced with the latter situation a parent would be under enormous pressure and would not, in law, be regarded necessarily as an independent and impartial person capable of taking a decision on consent in the best interests of that child? So we have a problem of consent. Is not the difference that in one case the child is bred for the purpose whereas in the other it is not and the parent is simply weighing impartially between the two children the interests of each?

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

The hon. and learned Gentleman picks unfortunate phrases in articulating his point this evening. The proposition is that somehow parents would approach this matter lightly and that, in the occasions that we can examine, they have had other children in the hope that there would be a tissue match. It is incredibly unfortunate that they could possibly be accused of being disrespectful or of entering into breeding a child—as he puts it—in a cavalier or unreasonable way. I would also say to him that before the HFEA issues the licence, it has to satisfy itself, within the terms and conditions of the legislation, that such a licence should be provided. Consideration would be given to all the details, to the motivations and to the appropriateness of such a licence being given in order to deal with these difficult choices. Before I move on to deal with the amendments, I shall give way once more, to my right hon. Friend the Member for Knowsley, North and Sefton, East.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

A few moments ago, Mr. Grieve made the allegation that schedule 2 and the relevant clause were really about authorising designer babies. May I draw his attention to proposed new paragraph 1ZB(1), in schedule 2? It states:

"A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other."

If the sex of the child cannot be determined, it is hardly possible that it can be a designer child.

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

My right hon. Friend makes a fair point. What is at issue is whether hon. Members agree in principle with saviour siblings, as my right hon. Friend pointed out in his speech. It would help the debate enormously if Members concentrated on what is actually in the Bill and what it would and would not permit, as my right hon. Friend did, rather than on their fears or their hopes in an attempt to undermine the principle.

The hon. Member for Enfield, Southgate persisted in suggesting that the Bill did not explicitly rule out the donation of organs. He did try to correct himself, but he continued to make that assertion, although it is not the case. The Bill sets out that the siblings must be suffering from a serious medical condition that could be treated by umbilical cord blood stem cells, bone marrow or other tissue, except whole organs, resulting from the child—

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Photo of Dawn Primarolo Dawn Primarolo Minister of State (Department of Health) (Public Health)

The hon. Gentleman has intervened a lot and he has also spoken. If I could make some progress in answering the points that he has already made, I would be happy to give way later. He owes the Committee an explanation of whether his motivation is just that he is completely against this Bill and its provisions. That would be a legitimate position, but it would be helpful if he could make that clear.

Amendment No. 18 would limit to regenerative tissue the cases in which embryo testing can be used where the intention is to use tissue other than bone marrow or cord blood. It is our view that that might prevent the use of some potentially desirable types of tissue in the future, such as cells of the umbilical cord itself.

Amendments Nos. 15, 16 and 17 address the issue of whether a disease is life-threatening. Embryo testing allows families with inherited genetic conditions to avoid passing on the particular condition that affects them. The HFEA has licensed more than 80 conditions for pre-implantation genetic diagnosis, including Huntington's disease, muscular dystrophy and cystic fibrosis. Three of the purposes for which an embryo can be tested relate specifically to medical conditions, and the Bill specifies that embryo testing for those three purposes can be done only when the condition is serious.

I accept the points made in the debate that the Bill does not contain a definition of "serious". The HFEA will have to determine how that term should be used in practice when considering the appropriateness of embryo testing for any particular condition. We expect its ethics committee, using its full experience as an authority, to make appropriate interpretations.

Amendments Nos. 15 and 16 would change the test required to license a condition for some of the embryo-testing purposes from "serious" to "life-threatening" or

"severely impairs...quality of life".

The effect will be to tighten the criteria for which some types of embryo testing can be carried out. As I have said, embryo testing is not a trivial process. It involves invasive stages of IVF including the drug regime and egg collection, plus an additional stage of testing, which will ultimately reduce the numbers that are suitable to be placed in the woman. People would not and do not undertake the process lightly or for trivial conditions.

How much effect the amendments would have on practice would depend on how the criteria are applied. The HFEA would still need to consider what makes a condition life-threatening: whether such a condition is one that shortens the life of the affected person by a number of years, or one that causes death in childhood. How much of an impairment must the condition be to the person's quality of life? Those are difficult decisions. The use of the word "serious" in the Bill is to determine for which conditions embryo testing is appropriate. It gives a strong steer about what kinds of conditions can be tested, while allowing scope for the HFEA to apply definitions using its licensing experience.

Amendments Nos. 24 to 30, tabled by Dr. Harris, relate to the use of the word "abnormality" in embryo-testing provisions. He seeks both an alternative description and an extension of the provisions. Under the amendments, the embryo-testing provisions would be extended to allow the testing of combinations of genes, as well as genes that are not necessarily harmful on their own but could be in combination with another factor. That would involve testing for genes that in the majority of the population are normal variants and would not necessarily cause a medical condition.

The amendments go further than the provisions in the Bill, and the Government have concerns that as currently drafted the effect might not be as intended. The Bill reflects current HFEA policy, and we are not aware of anyone having used the technology for the wider uses envisaged by the amendments to date. For some people, that type of testing would be considered a step too far. However, we recognise the desire for future-proofing of the legislation. Accordingly, we have allowed for that via a secondary power enabling the provisions relating to embryo testing to be amended in the future. Such regulations would be subject to the affirmative procedure. The amendments are not appropriate as they would allow testing for conditions that to date the HFEA has not licensed. If necessary in future, the legislation could be amended using the regulation-making power.

Amendments Nos. 19 and 20 seek to remove the regulation-making power so that the provisions in the Bill when enacted could not be updated if necessary—a point to which Members keep referring. To ensure that the desirable purposes of testing can be permitted, and the undesirable ones prohibited, the regulation-making power is appropriate. The amendments would not allow the legislation to keep pace with science and would limit the longevity of the new Act.

Let me deal with amendments Nos. 14, 31 and 32, on licences for therapy. Under the 1990 Act, the HFEA is given the power to issue licences in respect of four types of activities: treatment, non-medical fertility services, storage and research. The Bill does not change that. The amendments tabled by the hon. Members for South Cambridgeshire (Mr. Lansley) and for Oxford, West and Abingdon would add the further specific category of the licensing of the creation and use of embryos for therapy—that is, the creation of embryos to generate embryonic stem cells for use in the treatment of disease that is not infertility related.

The Government have always supported the use of embryonic stem cells in the development of treatments for serious diseases and medical conditions. Following discussion in the House of Lords, we gave the need to license non-reproductive therapies serious consideration. The Government are of the view that the licensing framework that would be in place following the introduction of the Bill would allow for the derivation of embryonic stem cells if it took place as part of a research project. In the vast majority of cases, it is highly likely that clinical research would be involved. The Bill would then allow the development of those cells into a therapeutic product without the need for further amendment.

Any embryonic stem-cell line that is intended for therapeutic use will need to undergo considerable safety assessment and then a substantial research phase involving pre-clinical and clinical studies. Each and every cell produced with the intention of treating disease would be different, and therefore each and every cell line produced would require the same clinical research, including pre-clinical and clinical studies. It is therefore unlikely that stem cells will be taken directly from an embryo and inserted into the patient.

Even with the most advanced and effective protocols for stem cells and for the differentiation of those stem cells into the tissue required, the pre-clinical and clinical testing of those cells will invariably be required before wider use can be sanctioned. As we have explained in detail and in a letter circulated to the House of Lords, it is therefore difficult to envisage a situation, despite the propositions that we have heard, where stem cells will be used for patients without some element of research involving pre-clinical and clinical studies. That would be the appropriate time to consider what further regulatory framework we need.

Some hon. Members are concerned that if embryonic stem cells are derived under a research licence they cannot be used in treatment, because that goes beyond research. Let me address those concerns. Regulatory oversight by the HFEA finishes once a stem-cell line is derived. That means that once embryonic stem-cell lines have been developed, the HFEA regulatory framework under which the embryo was produced is not relevant to any further use of that cell line, whether for further research or for treatment.

The Medical Research Council has recently made available £3 million in order to allow the consideration of 25 embryonic stem-cell lines for therapeutic application, which is to be awarded to research projects in that area. That reflects recognition of the potential for the creation of embryonic stem cells for use in therapy. The House should consider what it does next when that potential is closer to realisation.

I hope that my comments have been helpful and have shown why the Government's view is that the clause and schedule, as drafted, should remain unamended.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General 9:15 pm, 19th May 2008

I had not intended to intervene in the debate, but the comments made by the Minister and Mr. Howarth cannot go unchallenged. I fully accept that the Committee has to consider some complex ethical issues. One of the underlying ethical issues, which the Minister touched on, is the extent to which one approves or disapproves of interfering in the process of procreation. That is one of the fundamental dividing lines between Members of the House; it has been illustrated in earlier Divisions and will doubtless crop up again.

On Second Reading, I took the view that I should not oppose the Bill, because whatever my ethical viewpoint on that fundamental matter, it could be argued that the pass was sold in that regard rather a long time ago—certainly some time before the Government took office. However, the problem that the Minister seemed quite unwilling to address this evening was that once the pass has been sold, and the House and the Government have taken over the task of making those ethical judgments, they cannot be ducked. The right hon. Member for Knowsley, North and Sefton, East said that the provision was not about designer children—an argument echoed by the Minister. I have to say that their argument has an intellectual incoherence that is truly breathtaking. It cannot be argued that the provision is not about designer children, because the intention behind it is to design children who will fulfil the particular purpose of being able to help their siblings. If the House is really to be soft-soaped into believing that is not the case, it really is to the discredit of the Government in their inability to engage in coherent argument.

There might be powerful reasons for the Minister to say that the provision represents an aspect of designing children that the Government conclude is justified. That argument would be intellectually valid, but it is to belittle any notion of common sense to argue to the contrary.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

The example I gave from schedule 2—I think, with some intellectual credibility—demonstrates that if we cannot design the gender of the child, it cannot possibly be in all respects a designer child. There is a world of difference between what the hon. and learned Gentleman is talking about and what is in the Bill and, if I may say so, the lack of intellectual credibility lies elsewhere than with my right hon. Friend the Minister and me.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General

I listened carefully to the right hon. Gentleman, but I have to disagree with him. I accept that he might be using the expression "designer child" in a sense that I am not, but if one decides to select the creation of a child on the basis that it has certain design characteristics, particularly in terms of its genes, which will be helpful to a sibling, to my mind that is a designer child. We really cannot escape that argument.

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Photo of Patrick Hall Patrick Hall Labour, Bedford

Is the hon. and learned Gentleman not treading into the area of saying that IVF is design? The tests made in that technique are normally to try to ensure that the child, or potential child, does not suffer from certain genetic conditions.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General

The hon. Gentleman makes a perfectly valid point—one could indeed advance that argument. On the whole, in vitro fertilisation to aid conception has been accepted by many as valid, particularly if it is carried out, in essence, randomly. However, if it was carried out selectively the hon. Gentleman would be right.

I want to move on. I was making a preliminary point, because as the debate moves away—as I hope I now will—from the fundamental potential ethical divide over interference in a natural process, what troubles me is that the House may be lulled by arguments that what we are doing is not very important or does not matter. It is important that we are not lulled into a situation where the Minister says, "All these things will add to freedom of choice", which was one of the arguments. That may be so, but the provisions will be subject to the HFEA, which was set up as the arbiter of that choice. That is not pure freedom of choice at all. We are not saying, "We leave it to everybody to make up their mind according to their conscience." Instead, we are setting up a whole series of processes. The Minister says that the processes will be limited, but what do some of those serving on the HFEA say? An external adviser, Dr. Simon Fishel, predicted that saviour siblings would soon be used to treat children with various forms of anaemia, and could eventually help those with other conditions. He said:

"You might start looking at organs...Suppose you have a family with a gene for polycystic kidney disease.

If they are going to have another child they could use these techniques not only to ensure that it does not suffer from the condition, but also use tissue typing just in case an older sibling does need a transplant later."

That is not what the Government intend, but it is worth the Committee bearing in mind the possible consequences of the decisions that we are making this evening.

There has been a lot of debate about the impact that the decision to bring a saviour sibling into the world will have on the saviour sibling, and whether it will depend on whether he fulfils the expectations of his parents. Those are valid points, but the question that we must ask, having balanced what we aim to achieve against the possible disbenefits, is whether it is necessary to proceed down that route. To argue that we are not engaging in design is a piece of casuistry that does not help us in our deliberations, because whether we are doing it for good or ill, that is what we are doing.

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Photo of Robert Key Robert Key Conservative, Salisbury

My hon. and learned Friend is making a characteristically erudite and clever speech, but he disappoints me, because he seems to be trying to argue that someone is literally designing a child. That is not the case. We are talking about discovering something that already exists, and simply choosing one kind of cellular structure rather than another, one of which will deliver genetic abnormality or disability, and one of which will not. That is not designing a child. That is taking what is on offer in nature, and it is helping to design only in the sense of choosing what is best.

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Photo of Robert Key Robert Key Conservative, Salisbury

It is not. It is not manipulating the genetics of the child in any shape or form.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General

I have to say that I disagree with my hon. Friend. It is a selection of a design for a purpose. Moreover, I do not know whether he was present at the time, but the Minister made it quite clear that we are using the expression "saviour sibling" because the design intention is to help the sibling. Indeed, that is the purpose of the Bill. The aim is not to remove the possibility of a child having genetic problems of their own, but specifically to help another child. I am trying to confine myself to the narrow issue, rather than stray on to the wider ethical question, but I find the proposition very dubious indeed.

The House has taken it upon itself to try to regulate these challenging ethical fields—through, I suppose, the mechanism of the HFEA; it is the arbiter. I find that impossible to justify, even if I try to approach it in the manner in which it has been presented by the Minister. For that reason, I shall certainly support the amendments of my hon. Friend Mr. Burrowes. I do not see the need for the process, to approach the issue from the narrow angle of the Minister, and I see many downsides to it. We are embarking on a new field of ethical activity—the creation of human beings specifically for the genetic benefit of others. I suggest to the House that it should try to think through logically the consequences of what it is doing before we embark on that course.

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Photo of George Howarth George Howarth Labour, Knowsley North and Sefton East

The hon. and learned Gentleman's argument is predicated on the assumption that a child born in such circumstances would be created for one purpose only, which is clearly not the case. I do not know whether he is aware of what was in his parents' minds when he was conceived; I certainly do not know what was in my parents' minds. I remain grateful for the fact that I was born—[Hon. Members: "So are we!"]—but I am unlikely to ask my mother, as she enters her 82nd year, what was in her mind at the time.

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General 9:30 pm, 19th May 2008

I have no idea what was in my parents' minds at the time, although I can speculate, but I am sure that it was not a tissue-type match for a sibling, which is the serious point that the Committee must consider. Underlying the regulation of those processes, which have been going on since 1990, is the notion that there are some underlying ethical matters, which have continued to trouble hon. Members and the Government. Moving to a situation in which people are created as tissue matches, which is the only reason the HFEA must regulate such activity, strikes me as an astonishing change for which I have not heard a single justification.

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Photo of Patrick Cormack Patrick Cormack Chair, Northern Ireland Affairs Committee

Is it not clear that my hon. and learned Friend was not chosen from a catalogue?

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Photo of Dominic Grieve Dominic Grieve Shadow Attorney General

If there was an attempt to choose me from a catalogue, it was unsuccessful, because the nature of human beings is our individuality and we are not capable of being so selected.

I want to bring my remarks to a close. If the Minister wants to justify the provision to the Committee, she will have to do better than arguing that it is not a design process for the purpose of helping somebody else, which means that it is of no relevance to the person being procreated. Even on that narrow basis, there are strong arguments not to go down this road.

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Photo of Tom Levitt Tom Levitt Labour, High Peak

I rise as a biologist, a rationalist and a supporter of the Bill. I am not attracted by any of the amendments that have been discussed tonight. However, I do not want to engage in intellectual argument or discuss high-falutin' matters of philosophy—we heard enough of that in the previous contribution.

I want to tell the Committee a story about one of my constituents. David is three years old and suffers from fanconi anaemia. There is no medical treatment or cure for that condition. He needs a bone marrow transplant before the age of 10 to avoid a slow and lingering death within the following 20 years, when he will die from bone marrow failure or from leukaemia. There is no existing tissue match for David. All 12 million people worldwide who are members of bone marrow databases have been checked, but a match has not been found. If David were to have a bone marrow transplant from a mismatched donor, there would be a 30 per cent. chance that he would survive in the short term. At that point, he would spend six months of his life in hospital, and he would have a life expectancy of perhaps another 15 years. He would not reach adulthood, if he were to have a mismatched donor.

Mr. Burrowes should note that the same point applies to cord blood banks. In an e-mail, David's father told me:

"A cord blood bank is potentially positive for any child having to undergo a bone marrow transplant but the specific nature of the disorder of Fanconi Anaemia, the commonest inherited bone marrow failure condition, is that a related sibling match will always have significantly less mortality and morbidity than an unrelated donor match irrespective" of whether it comes

"from an unrelated adult donor or unrelated cord blood."

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Photo of David Burrowes David Burrowes Shadow Minister (Justice)

I am grateful, particularly for the hon. Gentleman's reference to cord blood. It is the 20th anniversary of the first cord blood transplant specifically for fanconi anaemia; it was performed in France by Professor Elaine Gluckman, the major pioneer in the field. Should we not move heaven and earth, to cite the Minister's words, to ensure that we do not just throw away 98 per cent. of cord blood and so that we can use it as a resource to provide cures for fanconi anaemia without going down the ethically perilous route of saviour siblings?

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Photo of Tom Levitt Tom Levitt Labour, High Peak

I am sure that there is a role for cord blood banks. In this particular case, however, David's is one of the six families who have been licensed for the saviour sibling technique precisely on the grounds that there is no alternative treatment. Were David to have a sibling-saviour transplant, there would be a 95 per cent. chance of success in the short term. He would spend just three weeks in hospital and live the rest of his life as normal.

Conditions such as fanconi anaemia are very rare, and that may be why only six families are licensed for the treatment at present. David's father has explained why his family have embarked on the process:

"We would like to save his life. We would also like to have an unaffected child that will outlive us and that can give us hope in our lives...For most people who choose to have an opinion, this Bill will fortunately never affect them. This Bill is for families like us...Other families worry about what choice of secondary school they will send their child to, we worry about whether our child will be alive next year. Our son already asks about bone marrow, transplantation, and death...we are waiting with trepidation for the day he asks us to explain his condition."

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Photo of Patrick Hall Patrick Hall Labour, Bedford

My hon. Friend was present when Mr. Cox questioned the suitability of parents' engagement in decisions about the matters under discussion. Does my hon. Friend not agree that the process through which his constituents have gone—the counselling and expert advice that they have received—places them in a stronger position than most people will ever be in for taking an informed decision?

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Photo of Tom Levitt Tom Levitt Labour, High Peak

My hon. Friend anticipates what I was just about to say about David's parents. They are both doctors and are very well informed about what they are asking of their future child. It is also interesting that they are both Catholics. They are concerned that if they go ahead with the technique, they will be stigmatised among some of their friends.

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Photo of Judy Mallaber Judy Mallaber PPS (Rt Hon Baroness Ashton of Upholland, President of the Council (Leader of the House of Lords)), Privy Council Office

Did my hon. Friend hear his constituent speaking on the news at lunch time? Anyone else in the Committee who heard him will have had no doubt about the rationality of his decision, his love for his existing child and the love that he would give a second child. The decisions were taken in a very rounded way and were reached in difficult ethical circumstances, given the personal beliefs with which the parents had to contest. My hon. Friend's constituent should be a welcome example for anybody in the House.

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Photo of Tom Levitt Tom Levitt Labour, High Peak

My hon. Friend is right. I knew that the interview was taking place, although I did not hear it. However, I have been in e-mail correspondence with my constituent about this issue in the past few days.

David's parents are desperate that their child and others with similar conditions should be able to live. They have asked me to beg the Committee to let David live, accept the proposals for savour siblings outlined in the Bill and ensure that when that choice is the right and only way forward, it is not ruled out for families such as David's.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

This excellent debate has gone far and wide, well beyond the issue of saviour siblings. In fact, I am surprised that the debate has ended somewhat earlier than planned. Nevertheless, I should like to offer the following comments to the Minister and the Committee about my amendments.

Amendments Nos. 24 to 30 question whether "abnormality" is the right term to use for the genetic characteristic to be tested in pre-implantation genetic diagnosis. I accept that, as the Minister said, my amendments go further than the provisions of the Bill. But I am concerned that the Bill may not go far enough to capture all the conditions that are not single-gene mutations, and therefore abnormalities, that one might legitimately want to test for with the same threshold of seriousness. The Minister says that we would need to provide examples in order to persuade her that the existing wording was not sufficient, and that is the challenge. If, for example, one could identify two normal variants—causing a life-threatening disease—that could not be called abnormalities, perhaps the Government would look at the matter again. I shall ask the clinical advisers whom I have been hearing from—including Professor Martin Bobrow, who chaired the Academy of Medical Sciences working group into another aspect of the Bill—whether they can provide some specific examples.

The second area is that of licences for therapy, which is dealt with by amendment No. 30 and associated amendments. I listened carefully to the Minister, who made it clear that the Bill allows embryos to be created and used for research, which in itself should be sufficient to cover any therapeutic use. She gave a second reason, which I accept, that the therapeutic use of cells will be covered by the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and not the Human Fertilisation and Embryology Authority.

Moreover, any embryos from which stem cells are derived will inevitably have research associated with them, and therefore could be covered by a research licence. But I question whether that is the case in every situation. Briefly, I want to mention four scenarios and see whether the Minister recognises that there might be a problem.

There might be an organisation that is a specialist in the derivation of embryonic stem-cell lines in other jurisdictions, which applies to the HFEA for a licence to use embryos to create stem-cell lines that it intends to pass on to another organisation to use for research or therapy. How would such an applicant be able to specify what research was done if it is not doing the research? The current Bill requires the people producing the embryos to be the people associated with the research licences, which may stifle innovation, investment and the production of stem cells.

Secondly, cell-based therapy might be so well established in the future that only quality assurance need be carried out, without a research protocol, prior to therapy. In such a scenario, the embryo would be created and then used for therapy without a research step. The same distinction between quality assurance and audit on the one hand, and research on the other, is already made in the Human Tissue Act 2004 for the use of tissue. The Minister's argument depends on there being no possible therapeutic use that did not require a form of clinical or pre-clinical research on those cells, and I am not convinced that that is certain.

The assumption that the therapeutic use of ES cells will always follow formal research during the lifetime of the legislation is dangerous because if phase 1 and phase 2 trials are successful, there will be clinical pressure to use ES cells as experimental treatment, albeit licensed by the MHRA, outside of the phase 3 research protocol. Alternatively, phase 3 trials might be successful, and it would be questionable whether one could identify a proper research application, beyond quality assurance, within the subsequent use of the newly derived ES cell lines created under research licence. The Minister may say that that is dealt with, and if she agrees to put a summary of the legal advice in the Library, I shall look at it.

Finally, if therapeutic cloning works, it might be possible to provide autologous stem-cell therapy for a patient using their own somatic cells. That would be experimental therapy, not research, if it were used, and such a situation might apply in the lifetime of the Bill. I am concerned that the Government are not adequately future-proofing the Bill by accepting the relevant amendment, and we shall have to examine that question in the weeks to come. It is not my intention, however, to press it to a Division now.

I turn to amendment No. 15, in the name of Mark Simmonds, which I did not address in my earlier comments. It proposes to change the definition of serious disease to a disease that causes a serious impairment of quality of life. He defended that on the basis that his definition was tighter and less open to interpretation. I questioned that in interventions. To be fair, he kindly accepted that he was not sure that it was tighter.

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Photo of Mark Simmonds Mark Simmonds Shadow Minister (Health) 9:45 pm, 19th May 2008

The hon. Gentleman will recall that the Minister confirmed that my interpretation was correct and his was incorrect.

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Photo of Evan Harris Evan Harris Shadow Minister, Innovation, Universities and Skills

I question whether the definition is tighter, but I do not believe that it should be because the decision should be left to doctors and patients, under the regulator's guidance. It is difficult for us to decide at the outset that something is not serious when the regulator, the doctor and the patient might consider it serious. When pre-natal diagnosis is done through amniocentesis, with an indication for termination of pregnancy, not at an embryonic but a foetal stage, weeks into the pregnancy, there are no criteria for seriousness. It is illogical to have a high threshold for embryonic steps to avoid illness when amniocentesis and pre-natal diagnosis in an established pregnancy require no such threshold. Doctors have written to me saying that they do not understand that distinction: why one can terminate a pregnancy without a seriousness threshold—the doctors and patients decide—when we set such a threshold for embryo testing, before a pregnancy is established.

Let me consider the important speech of Mr. Todd about the extent to which it is appropriate to conduct invasive procedures on a child to derive tissue for transplant to a sibling. I am a member of the BMA Medical Ethics Committee. The BMA wrote that it is not worried about that ethical problem because there is already provision for taking the child's best interests into account. In the case of disagreement by doctors and parents or between parents, a court must be involved. Paragraph 44 of the Human Tissue Authority code of practice states clearly, if briefly:

"Courts have identified certain important decisions which require court approval where one person with parental responsibility consents against the wishes of another. If there is any dispute between persons with parental responsibility or any doubt as to the child's best interest, the matter should be referred to court for approval."

Invasive procedure could be sanctioned only when there is no doubt that it is in the child's best interests. Of course, that is relevant to every sibling, not only the small minority of saviour siblings, who may be a match for an affected child. It is wrong to suggest, in the few cases that the Bill covers, that there is a problem with common law, medical ethics and the guidance to doctors about the best interests of a child for invasive procedures if we do not extend those provisions to the many more children in that position. The Bill strikes the right balance on saviour siblings and I urge hon. Members to bear that in mind.

I respect the commitment of Mr. Burrowes and the way in which he presented amendment No. 4, on which I am sure the Committee will divide. However, it is clear from advisers on cord blood banking that, however much one expands cord banks, it will not remove the need in a minority of cases for saviour siblings. I hope that he accepts that I can find no medical opinion, including from those who run the banks, to support the view that expansion would do away with the need for legislation on saviour siblings in a minority of cases.

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 11 ordered to stand part of the Bill.

Schedule 2

Activities that may be licensed under the 1990 Act

Amendment proposed: No. 15, page 55, leave out lines 24 to 28 and insert—

'(i) a gender-related physical or mental disability which is life-threatening or severely impairs their quality of life,

(ii) a gender-related serious illness which is life-threatening or severely impairs their quality of life, or

(iii) any other gender-related serious medical condition which is life-threatening or severely impairs their quality of life— [Mark Simmonds.]

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Question put, That the amendment be made:—

The Committee divided: Ayes 149, Noes 318.

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Question accordingly negatived.

Amendment proposed: No. 4, in page 55, leave out lines 30 to 37.— [Mr. Burrowes.]

Question put, That the amendment be made:—

The Committee divided: Ayes 163, Noes 342.

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Question accordingly negatived.

Amendment proposed: No. 18, in page 55, line 35, after 'other', insert 'regenerative'.— [Mark Simmonds.]

The House divided: Ayes 200, Noes 293.

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Question accordingly negatived.

Amendments made: No. 36, page 57, leave out lines 37 to 41 and insert—

'(a) bringing about the creation of human admixed embryos in vitro, and

(b) keeping or using human admixed embryos,'.

No. 37, page 58, leave out lines 3 to 10.

No. 38, page 58, leave out lines 17 to 19.

No. 39, page 58, line 21, leave out ', (3) or (5)' and insert 'or (3)'.— [Ms Diana R. Johnson.]

Schedule 2, as amended, agreed to.

To report progress and ask leave to sit again .—[Liz Blackman.]

Committee report progress; to sit again tomorrow.

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