Human Fertilisation and Embryology Bill [HL]

– in the House of Lords at 3:57 pm on 4 February 2008.

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Votes in this debate

Proceedings after Third Reading resumed.

Clause 11 [Activities that may be licensed]:

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 4:06, 4 February 2008

moved Amendment No. 5:

Clause 11, page 8, line 21, after "research)" insert "—


Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, the amendments in this group were tabled by my noble friend Lord Patel, who unfortunately is unable to be here today as he is on a professional visit overseas. They were tabled on Report, but it is important to say a few words before deciding how to proceed.

Research into deriving embryonic stem cell lines for treatment purposes is proceeding, and UK-based researchers are widely regarded as among the leaders in the field. There have been recent reports, for instance, of embryonic stem cells having a great potential to treat acute macular degeneration, and researchers from Moorfields hospital in London and Sheffield University are now developing embryonic stem cells in a GMP-compliant facility—meaning good manufacturing practice—to take that work to the next stage of clinical testing. The Medical Research Council, with the Department of Health, has invested £1.2 million to create laboratory facilities in which embryonic stem cells can be developed to appropriate standards for clinical application in humans. The MRC plans further investment in the development of tissue-typed embryonic stem cell lines.

When we debated in this House in 2001 the regulations amending the Human Fertilisation and Embryology Act 1990, many of us, including myself, took the view that the purpose of those regulations was to amend the Act in order to allow stem cells to be used for the treatment of serious human disease. We were therefore surprised when, either in Committee or on Report, the noble Baroness, Lady Royall, suggested that the use of such cells in treatment was not allowed under the Act and that it might even require new primary legislation. However, I am grateful to the noble Lord, Lord Darzi, for the letter he sent to many of us last week in which it would appear that that interpretation may not have been entirely correct. The Government's position has clearly changed. There appears now to be common agreement between the Government, my noble friend Lord Patel and I that the therapeutic and research use of embryo-derived stem cells in clinical trials would be regulated by the MHRA in consultation with the Human Tissue Authority and will not—and should not—be regulated by the HFEA. Indeed, the framework of EU directives and the like for that regulation is already in place.

Neither I, nor the scientists, nor the Government are arguing that the HFEA will be involved in regulation beyond the use of the embryo to derive the cell lines. For those of us who wish to see the therapeutic use of this technology without the need for further legislation—that now appears to be the Government's view—the question is whether the terms of the original licence to create or use embryos, which can only be a research licence as the Bill stands, are adequate to enable us to say, with the certainty required by research scientists, their funders and investors, that therapeutic use will be permitted. That assurance requires more than an assertion of ministerial hope or parliamentary belief—it requires legal certainty.

I therefore ask the Minister to give a clear assurance that stem cell lines derived from embryos under a research licence can ultimately be used for treatment purposes once all stages of clinical research are completed. I ask also for a commitment that the translation of research into treatment will not be delayed by the need for further legislation and that a pathway for any such legislation has been agreed. I beg to move.

Photo of Baroness Tonge Baroness Tonge Spokesperson in the Lords, Health

My Lords, I support the noble Lord, Lord Walton. The idea that stem cells should eventually be used for treating diseases is a major selling point of this Bill for the general public. We must have some clarification on that. In Committee, I understood that primary legislation was needed to achieve that purpose. In the letter from the Department of Health I think we are now being told something different, but I confess to not really understanding the letter. Therefore, I hope the Minister will now clarify the position for the benefit of all of us.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, who would determine whether embryos would be used in therapies rather than just in research, as currently? What expertise exists within the Human Fertilisation and Embryology Authority to determine issues surrounding the kinds of diseases that the noble Lord, Lord Walton of Detchant, has mentioned? Furthermore, what assessment has been made of safety hazards and risks that there might be because, where foetal cells have been used in the United States for the treatment of sufferers of Parkinson's, those treatments had to be withdrawn owing to the irremediable damage that they did?

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, I am grateful to the noble Lord, Lord Walton, and the noble Lord, Lord Patel—who is not in his place, and I quite understand why—for the further discussions that we have had on this issue after previous debates.

The noble Lord referred to the letter from my noble friend Lord Darzi, which covered a number of the issues raised during the passage of the Bill, including a considerable contribution on this subject, and copies have been placed in the Library. I am happy to repeat the salient points for all noble Lords present.

The Government have consistently supported the use of cells derived from embryos for the treatment of human disease and medical conditions, and have therefore given the issue very serious consideration. On the basis of advice and discussions we have had following Report, the Government are of the view that the licensing framework which would be in place following the introduction of the Bill would allow the derivation of embryonic stem cells. Furthermore, it would allow the development of those cells into a therapeutic product without the need for further amendment. Any embryonic stem cell line intended for therapeutic use will need to be subjected to considerable research activity, including rigorous safety assessment, before entering into preclinical and clinical studies. As each cell used would be different, significant investigation would be required in each case prior to, and during, preclinical and clinical study.

Regulatory oversight by the HFEA finishes once a stem cell line is derived. This 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 therapy.

There are a number of ethical and safety issues regarding the use of stem cells in patients that go wider than the regulatory remit of the HFEA. They include the regulation of clinical trials using stem cells, of the widespread therapeutic use of stem cells and of the standards against which the use of such stem cells would be regulated.

These are questions which a working group of regulators comprising the HFEA, the Human Tissue Authority and the Medicines and Healthcare Products Regulatory Agency are considering. This work will inform the research community about the steps to be taken to enable cell-based therapies to be introduced into clinical practice. The issue will be informed by the work of the stem cell bank steering committee, chaired by the noble Lord, Lord Patel, and the Medical Research Council.

The Government remain committed to developing an enabling regulatory system as part of the 10-year UK stem cell initiative. We look forward to engaging with all relevant stakeholders to ensure that the overall regulatory framework is effective and proportionate at all stages of the research pathway from laboratory to clinic. We are of the firm belief that there is no legal impediment to current research being developed into clinical application. As such, I hope that the noble Lord will feel able to withdraw his amendment.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 4:15, 4 February 2008

My Lords, I was greatly reassured by the Minister's statement, because it covered the main points with which the scientists involved in this research are concerned. In consequence, I am happy to beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 6 not moved.]

Clause 14 [Conditions of licences for treatment]:

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

moved Amendment No. 7:

Clause 14, page 9, line 34, at end insert—

"(6BA) In the case of treatment services falling within paragraph 1 of Schedule 3ZA (use of gametes of a person not receiving those services) or paragraph 3 of that Schedule (use of embryo taken from a woman not receiving those services), the information provided by virtue of subsection (6) or (6A) must include such information as is proper about—

(a) the importance of informing any resulting child at an early age that the child results from the gametes of a person who is not a parent of the child, and(b) suitable methods of informing such a child of that fact."

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, much of our discussion about the Bill has related to the importance of donor-conceived people being made aware of that fact. It has been expressed by, among others, the noble Baronesses, Lady Warnock and Lady Finlay, that this should at least be provided for in the code of practice, but, more ideally, also in the Bill.

The Government recognise the importance of ensuring that prospective parents understand the importance of telling a child at an early age that they were donor-conceived. A child who grows up with this knowledge will be better informed and is likely to have a better family relationship. They would receive the information from their parents in the most sensitive, constructive and least distressing way.

It is the Government's view that this is best achieved by education rather than enforcement. The Donor Conception Network has a planned programme of work, supported by the Department of Health, to promote the importance of letting donor-conceived children know at an early age that they are donor-conceived. The work will include providing, for patients who are to have treatment with donated sperm, eggs or embryos, guidance on the process of donor conception, its implications and its particular responsibilities. The aim is to prepare them for being the parents of a donor-conceived child. The work will also involve a "telling and talking" project that aims to encourage parents who have donor-conceived children to tell them, from a young age, about their origins. The work will be piloted and evaluated to assess the best way of communicating with parents and prospective parents, and to give them an opportunity to feed back information.

Encouraging openness in this way is the best way forward. The 1990 Act requires counselling to be available, and for such relevant information as is proper to be provided by all licensed treatment clinics. It is a condition of all licences that a woman shall not be provided with treatment services unless she and any person who is to be treated together with her have been given a suitable opportunity to receive proper counselling and relevant information. We introduced an amendment on Report that went some way to address the issue of donor-conceived children finding out about their origins, but following further discussions and amendments tabled by the noble Earl, Lord Howe, and the noble Lord, Lord Jenkin, we agreed to come back with something more specific.

Amendment No. 7 addresses concerns expressed in relation to the importance of parents discussing with their donor-conceived children, from an early age, details of their conception. Amendments Nos. 8 and 16 have two effects. The first strengthens the Bill with respect to the provision of counselling and information, in addition to requiring that all patients be offered counselling and provided with information. It also requires that the HFEA produces, in its code of practice, guidance for the clinics about doing so. In addition, Amendment No. 16 introduces a provision which ensures that it is a condition of all licences that people being treated using donor gametes, or embryos taken from a woman who is not being treated, must be provided with information about the importance of telling their child that they were donor conceived, as well as information about the best way to do this. The combined effect of these amendments will mean that clinics are obliged to provide patients with information about the importance of talking to children about their donor conception, and that the code of practice should provide details of what information should be provided, as well as how the offer of counselling should be made. I beg to move.

Photo of Earl Howe Earl Howe Shadow Minister, Health

My Lords, I thank the Minister for listening so carefully to the concerns expressed at earlier stages of this Bill and for these amendments, which go a long way towards meeting those concerns. I am sure I speak for the noble Baroness, Lady Finlay of Llandaff, who is, unfortunately, unable to be present today, in expressing that gratitude.

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

My Lords, as the mover, at Report stage, of amendments both to make it a condition of the licence, and to see that it went into the guidance, I also express my gratitude to the Minister for having met us so fully on this. This is a valuable addition. To have this in the Bill as a licence condition is a very important step forward. Can we assume that there will be a comparable paragraph in the guidance?

Photo of Baroness Warnock Baroness Warnock Crossbench

My Lords, I add my thanks to the Minister and associate my noble friend Lady Finlay of Llandaff with these thanks. We really are extremely grateful.

Photo of The Bishop of Chester The Bishop of Chester Bishop

My Lords, I support the amendment, but would like to ask one question of the Minister. The amendment speaks of an early age, and the Minister used the expression "a young age." That could mean a range of ages. While I am entirely supportive of the amendment, I am one of those who share the anxiety that children are denied their childhood these days by sometimes being treated as adults when they are too young. There is a very delicate balance here in all sorts of areas of life. This is clearly one of them. Will the Minister indicate whether the guidance will say at what sort of age it is thought appropriate to raise this? I would be anxious that there was not always a downward pressure to raise these matters with children before they are emotionally able to cope with the information.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, I entirely agree that children must be allowed to have their childhood. That is where the important work of the Donor Conception Network must be taken into consideration. It is working with families now, undertaking a pilot. I do not want to specify an age today at the Dispatch Box but we will be informed by the important work that the Donor Conception Network is carrying out. I can assure the right reverend Prelate that we would not want to do anything that would adversely affect a child's childhood. In answer to the noble Lord, Lord Jenkin, yes, it will be included in the guidance.

Photo of Baroness Howarth of Breckland Baroness Howarth of Breckland Crossbench

My Lords, the noble Baroness stood up so quickly that I did not have chance to stand up. I should like to make two brief points. First, I say to the right reverend Prelate that I hope that children are brought up in an atmosphere where they know from a very early age. We know from all the work in adoption that children fare much better when they know about their situation when they are very young indeed. It does not then come as a shock later on. Children who suddenly discover, at quite a young age, that they are adopted, find that extremely difficult to deal with. I remember talking to a child of four, when I was on Childline, about what "adopted" meant because she had just found out and was in a slight state of shock. She was being helped by an older child to call Childline to talk about this.

I did not have the opportunity to make my second point, but having spoken to a number of donor families, the thing that really concerns them is not being ordinary families. I understand that and we want them to be ordinary families as much as they can in bringing up their children. We want to get to the most resistant families who do not want to engage in telling the children at all about their backgrounds. That is why I shall support the later amendment of the noble Lord, Lord Jenkin, on research into how this process has worked through.

In the guidance, has the noble Baroness thought about the kind of materials that might be available to help the various authorities in knowing how to tell children, because that can be quite daunting? We have learnt from adoption that materials alongside counselling can be helpful because you have something in your hand that you can take away.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I should like the Minister to comment on the difference between ordinary cases of donor conception covered by the amendment and the placing on the register at birth of facts that inevitably point to donor conception, thus distinguishing children affected, for example, by what is now Clause 46 from all other children who are donor conceived.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, perhaps I may welcome these amendments and ask two questions. First, can she respond to a point raised at an earlier stage by the noble Earl, Lord Howe, about how our guidance and laws relate to those in other European Union countries? I am thinking especially of Spain where a number of people now go to receive fertility treatment. Are we thinking of ways of dovetailing our laws with theirs, because in Spain, for instance, anonymity pertains for donors, unlike in the United Kingdom?

As well as looking at overall compliance within the European Union, can the noble Baroness say a word about the long-term effects on donor-conceived children? That issue was raised by the noble Baroness, Lady Howarth of Breckland, a few moments ago and in our earlier debates. Do the Government intend to keep it under review as the years proceed? On Report, the noble Lord, Lord Jenkin of Roding, made an attempt for us regularly to return to this question. If that cannot be done in statute, can the Government at least provide an assurance that we will keep this under review?

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, the notion of the noble Baroness, Lady Howarth, on making materials available for families is very good. Of course adoption and donor conception are very different, but we can learn from what we have done in the sphere of adoption. We will certainly take that on board. I note the point made by the noble and learned Lord, Lord Mackay, but our intention is that all children have a right to know whether they were donor conceived. The difference between us is on the way that this is done, but it is our intention to ensure that all children are availed of that right.

On the question on other EU countries, it is important that we work to ensure that our systems in this country are as like those of other European Countries as is possible, so that people can travel freely and widely, and because there are so many couples. One partner may come from France and another from Greece; another partner might come from the UK and another from Denmark. So we have to take into consideration what is happening in other European Countries.

The long-term effects on donor-conceived children are of course of the utmost importance and we will certainly keep this issue under review.

On Question, amendment agreed to.

Clause 23 [Code of practice]:

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

moved Amendment No. 8:

Clause 23, page 19, line 3, at end insert—

"( ) After that subsection insert—

"(2A) The code shall also give guidance about—

(a) the giving of a suitable opportunity to receive proper counselling, and(b) the provision of such relevant information as is proper,in accordance with any condition that is by virtue of section 13(6) or (6A) a condition of a licence under paragraph 1 of Schedule 2.""

On Question, amendment agreed to.

Clause 24 [Register of information]:

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, I shall speak also to the other government amendments grouped with it. These amendments have become apparent only since Report stage and correct minor drafting points.

Amendments Nos. 9 to 11 amend the wording of subsection (3) of new Section 31ZA to make it consistent with the wording in Section 31(3) of the 1990 Act and with new Section 31ZB(3) in the Bill.

Amendments Nos. 12 to 15 correct some inconsistencies in the wording of subsection (4) of new Section 31ZA and new Section 31ZB(5). Amendment No. 18 corrects a further inconsistency in the wording of Clause 61(3) when compared with Clause 64(7). I beg to move.

Photo of Earl Howe Earl Howe Shadow Minister, Health 4:30, 4 February 2008

My Lords, can the noble Baroness explain what "saving" means in Amendment No. 18. I am not sure that I understand.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, that is an excellent question and unless I get speedy assistance from the Box, I shall have to reply to the noble Earl in writing. If I keep going long enough, perhaps I will get an answer. I take this opportunity to say that the Bill team have been excellent and I am very grateful for all the work that they have done. I am extremely sorry. I will have to respond to the noble Earl in writing and I will copy the information to all noble Lords present.

On Question, amendment agreed to.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

moved Amendments Nos. 10 to 15:

Clause 24, page 20, line 21, leave out "if"

Clause 24, page 20, line 23, leave out "if"

Clause 24, page 20, line 27, leave out "gave" and insert "gives"

Clause 24, page 20, line 28, leave out from "(1)," to "give" in line 29 and insert "regulations cannot require the Authority to"

Clause 24, page 20, line 42, leave out from "donor" to "or" in line 44

Clause 24, page 21, line 32, leave out "gave" and insert "gives"

On Question, amendments agreed to.

Clause 26 [Mitochondrial donation]:

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

moved Amendment No. 16:

Clause 26, page 30, line 31, at end insert—

"( ) section 13(6BA) (information whose provision to prospective parents is required by licence condition),"

On Question, amendment agreed to.

[Amendment No. 17 not moved.]

Clause 61 [Orders and regulations: general provisions]:

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

moved Amendment No. 18:

Clause 61, page 50, line 29, after "transitional," insert "saving,"

On Question, amendment agreed to.

Schedule 2 [Activities that may be licensed under the 1990 Act]:

[Amendments Nos. 19 and 20 not moved.]

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

moved Amendment No. 21:

Schedule 2, page 58, leave out lines 11 to 13 and insert—

"(6) No licence under this paragraph is to be granted unless the Authority is satisfied that—

(a) any proposed use of embryos or human admixed embryos is necessary for the purposes of the research;(b) there is cogent evidence, which must include published, peer-reviewed scientific data, that—(i) the research proposed on human or human admixed embryos is likely to achieve its specified purposes; and(ii) it is not reasonably practicable to achieve the specified purposes of the research without using human embryos or human admixed embryos."

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, the House will recall that on Report, I mentioned that I would bring back the so-called Hunt test amendment, having changed it in the light of comments made by the noble and learned Lord, Lord Mackay of Clashfern, concerning one subsection that we agreed was not appropriate. So I have brought it back without the subsection that dealt with animal testing. The amendment before the House is straightforward and clear.

I will be brief and begin by saying that the potential of adult stem cells is now widely recognised in the scientific field. I will mention three quick examples, all very recent. Professor Thomson of Wisconsin, a leading figure in the field, says of retroprogrammed adult stem cells:

"By any means we test them, they are the same as embryonic stem cells".

Rudolf Jaenisch, head of the Whitehead Institute for Biomedical Research in the United States, says:

"This demonstrates that IPS cells have the same potential for therapy as embryonic stem cells, without the ethical and practical issues raised in creating embryonic stem cells".

Sir Martin Evans says:

"This will be the long-term solution".

We have to ask why it is important that wherever possible adult stem cells should be chosen instead of embryonic stem cells. I underline the phrase "wherever possible" and will come back to it in a moment. One reason, mentioned in our debates by the noble Lord, Lord Winston, is the shortage of human eggs, which is now serious. Professor Wilmut says:

"Cloning is still too wasteful of precious human eggs, which are in great demand for fertility treatments, to consider for creating embryonic stem cells".

In short, embryonic stem cells, as far as possible, should not be used because they are much more important for other purposes. One significant thing about this that I mentioned at Report stage last week concerns the market. No market is permitted in the United Kingdom, but there is a clear market in the United States, and the price of human eggs for fertilisation purposes has gone up very sharply. There is a real danger in introducing the market into a field where people are ready to pay for something that they desperately desire and need. Therefore, as far as possible, steps that one can take to reduce the market pressure should certainly be taken.

Scientists increasingly argue that embryonic stem cell research may be needed as an assessment tool—as a reference point, if you like. That has been argued by a number of people, including Professor Wilmut and Professor Thomson, who have said that they believe very strongly that the medium and long-term solution lies in adult and not embryonic stem cells. However, I recognise that that may not be the case yet and that there may be a demand for embryonic stem cells to be used as a reference point or test of the usefulness of adult stem cells.

Members of the House may have read a very interesting article in our distinguished journal Science on 21 December 2007. It is becoming increasingly clear that there is a growing consensus among many scientists that we are now looking at a much more promising road along which to advance—that of retro-programming adult stem cells to the point where they become plenipotentiary than pursuing what may well be an expensive and, indeed, ethically objectionable route of embryonic stem cells. In that context, I again quote the spiky words of Professor Thomson:

"A decade from now this"— by which he means embryonic stem cell research—

"will be seen as a funny historical footnote".

I draw the House's attention to a very significant fact. Today, controls over the use of animal testing are much stricter in this country than controls over the use of embryonic stem cells, as distinct from adult stem cells, as a tool for research. The animal research, which has been largely relied on by the scientific establishment over recent years, is governed by the Animals (Scientific Procedures) Act 1986. Under that Act, the Home Office determines whether research on animals is allowed and the test is very straightforward: it is whether any alternative procedure would be equally or more successful than the use of animals. Over the years under this Act, the Home Office has rejected a number of, although not many, research proposals. Last year, about 3.5 per cent of research proposals involving animal testing were rejected by the Home Office on the grounds that there were alternatives which would be more than adequate for the purpose. In the case of embryonic stem cells, only on one occasion has the HFEA rejected a proposal for research, and subsequently that proposal was slightly amended and then accepted. That is the record of the HFEA: it does not appear to be too ready to reject proposals for research on the grounds that there are alternatives to embryonic stem cell research.

I made it clear that in my view the likelihood is that adult stem cell research will increasingly overtake embryonic stem cell research, partly because it is not as expensive and partly because the genetically similar cells created by the use of stem cells from the same adult who is being treated completely removes the danger of an immune reaction. Invariably, that is not true of embryonic stem cell research. I outline once again that far more therapies have been created as a result of the burgeoning field of adult stem cell research than have been created from the not very burgeoning field of embryonic stem cell research. With the latter, arguably there have been about two therapies where there truly has been hope for the future, whereas with adult stem cells there have been many such therapies, including a recent breakthrough in the use of neural cells to treat, among other things, Alzheimer's disease.

I emphasise that much of the rest of the scientific world is now moving ahead clearly and strongly in the field of adult stem cell research. When it discussed this matter earlier, the House did not have before it the astonishing commitment now being made by the Government and research councils of Japan. Not only have they now decided to set up a major research centre at the University of Kyoto where Professor Yamanaka works but, more staggering still, the Government of Japan and their medical research establishments have committed themselves to spending $10 billion on the advance of adult stem cell research. In other words, they now believe that this is clearly the best way forward. I fear that our attitude of on the whole giving preference over the years to embryonic stem cell research as the way forward could mean that in the United Kingdom we are not sufficiently responsive to and aware of the huge potential of adult stem cell research. We consequently concentrate on a field that we are used to but a field that recent breakthroughs suggest will not move anything like as fast as will the use of adult stem cells.

We are proposing in this amendment as close a match as one can get to the pledge made to the House in 2001 by one of the most respected Ministers in this House, the noble Lord, Lord Hunt of Kings Heath. Let me remind the House of what he said in the debate on the HFEA:

"The 1990 Act already provides the answer to the question of what happens if and when research into adult cells overtakes research using embryos: embryonic research would have to stop because the use of embryos would no longer be necessary for that research".—[Hansard, 22/1/01; col. 120.]

He also said that the HFEA,

""must satisfy itself that there is no other way of doing the research, avoiding embryo use".—[Hansard, Commons, 19/12/00; col. 214.]

The noble and right reverend Lord, Lord Harries of Pentregarth, said that in his view the HFEA already largely abides by that consideration and does not choose embryonic stem cell research if adult stem cell research would be at least as efficacious or more so. Putting this in the Bill would a be great reassurance to the many in our society who are concerned and troubled about the use of embryonic stem cell research and the many more who are waiting for fertility treatment because there are no human eggs available. If the United Kingdom wishes to be in the vanguard of this movement, making it clear that where it is feasible—or better—to use adult stem cells, the HFEA is committed to doing so, far from being a blockage to advanced research, would actually encourage it. That would do so because it would show that the United Kingdom was moving with the times, and the times are extremely exciting for adult stem cell research and should be built upon. Having this in the Bill would also, incidentally, fully bear out the pledge made by the noble Lord, Lord Hunt of Kings Heath, in 2001 before any of us knew the potential of adult stems cells. I beg to move.

Photo of Lord Brabazon of Tara Lord Brabazon of Tara Chairman of Committees, House of Lords, Deputy Speaker (Lords)

Amendment proposed, page 58, leave out lines 11 to 13 and insert the words printed on the Marshalled List.

Photo of Baroness Hollis of Heigham Baroness Hollis of Heigham Labour

My Lords, I am not sure whether technically I can do this. I want to ask a question of the noble Baroness before she sits down, but maybe she has already sat down. My question is not about whether one should support one or the other. My own instinct is to support all avenues of research because you cannot predict which will be the most fruitful long term. It is simply about whether I share her understanding of the import of paragraph (b) of proposed new subsection (6) which states:

"There is cogent evidence, which must include published, peer-reviewed scientific data".

Can the noble Baroness help me? On my reading, that would mean that you could never do research for the first time.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I assume that it is in order for me to reply. The noble Baroness is reading into the amendment an extremely precise statement of it being related to a particular piece of research. It is not. When peer group and scientific studies show that a particular form of research is generally useful in the field in which it is being put forward, it would not fail on the basis of the proposed new subsection. It would simply require that more than assumptions are made about the prospects for adult stem cell research in that particular area. There is now such a rapid build-up of research material available that I do not believe that the objections of the noble Baroness stand.

Photo of Lord Harries of Pentregarth Lord Harries of Pentregarth Crossbench

My Lords, the noble Baroness mentioned the HFEA in general and my name in particular. She made a comparison between the number of applications turned down by the Home Office from researchers wanting to do research on animals, abiding by the Animal (Scientific Procedures) Bill, with the small number of applications turned down by the HFEA. It is important to bear in mind the fact that hundreds if not thousands of applications are made to the Home Office for work using animals. Obviously we have so far had very few applications to the HFEA for work using embryos.

Furthermore, there is an early filtering-out system, not only by the local research ethics committees in hospitals; the scientific community knows that it will get approval only if research cannot be done using any method other than embryos. The comparison made by the noble Baroness is not entirely fair. She rightly stresses the importance of therapies using adult stem cells, which are obviously much more useful for therapies, but the scientific community would say—I am sure the noble Lord, Lord Winston, will bear this out—that for fundamental research, work is needed using embryonic stem cells. Again it is slightly unfair to contrast the work being done for therapies using adult stem cells and the work that still needs to be done at a very basic level.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I believe this was a question for me before I sat down so I shall respond to it if the noble Lord does not mind.

Noble Lords:


Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, the noble and right reverend Lord, Lord Harries, has been allowed to ask a question, so it would be odd if I were not permitted to respond to it.

Photo of Lord Neill of Bladen Lord Neill of Bladen Crossbench

My Lords, the noble Lord on the Woolsack has not yet said that the debate is open for discussion.

Photo of Lord Brabazon of Tara Lord Brabazon of Tara Chairman of Committees, House of Lords, Deputy Speaker (Lords)

I have, my Lords. I said that we were dealing with:

"Page 58, leave out lines 11 to 13 and insert", the words printed on the Marshalled List.

Photo of Lord Neill of Bladen Lord Neill of Bladen Crossbench

My Lords, with that invitation, I shall speak to an amendment that has been brought back with the deletion of a particular paragraph about animals that aroused a great deal of hostility on a previous occasion. We now have an innocent and, I hope, pleasing amendment that your Lordships will think fit to accept.

There are two extra points going for us today. First, in an earlier amendment, the principle that some things are good to have in the Bill was recognised. The big argument underlying this amendment is to get it in the Bill to reassure the public how seriously we take the development of science and the care we in this House are giving to it.

Secondly, the Minister referred to the noble and learned Lord, Lord Mackay of Clashfern, as being a benign influence on the Bill and a figure who has been watching its progress carefully. We now have an amendment that has been recommended by him. We have brought it back with the deletion of the animal bit, which I mentioned earlier. Many of the words in Amendment No. 21 come from previous legislation. Proposed new subsection (6) would go into the licensing provisions in Schedule 2. Paragraph (a) says,

"any proposed use of embryos or human admixed embryos is necessary for the purposes of the research".

Subject to the addition of the words "human admixed embryos", that precisely tracks the 1990 Act in Schedule 2(3)(vi).

There is cogent evidence, which the noble Baroness, Lady Williams, addressed, to answer the question raised there. The noble Lord, Lord Darzi, spoke on 15 January in favour of the importance of having peer review research proposals which could then lead on to monetary grants and support. Paragraph (b) says,

"the research proposed on human or human admixed embryos is likely to achieve its specified purposes".

As I said on a previous occasion, this will have echoes of the Patents Act about an employee making an invention. No answer was ever made to that. It seemed a good point—one often thinks one's own points are good—that you could recognise an invention made by an employee and award it to him rather than the employer if the circumstances were such that the invention might reasonably be expected to result in the carrying out of his—the employee's—duties. Finally, heading (ii) says,

"it is not reasonably practicable to achieve the specified purposes of the research without using human embryos or human admixed embryos".

The only objection I believe has been made at all to these provisions is that the authority more or less does what is set out in paragraph (b)(i) and (ii) already. Yet that does not meet the point that this is designed to give reassurance to the public.

Photo of Lord Winston Lord Winston Labour

My Lords, I have always had huge respect for the noble Baroness, Lady Williams. I have admired her speeches for many years, from when she was in the House of Commons. Yet I am little surprised at the speech she has just made on this issue because there are a number of areas which are frankly misleading. Scientists will read her speech in Hansard open-mouthed with surprise at what she has said.

First, let me make it clear that it is far easier in the United Kingdom to do animal research rather than human embryo research. It is simply not true that it is more difficult. As has already been mentioned, a huge number of applications may be considered and go through local ethics committees in all sorts of embryo research, but they do not get to the HFEA first. With animal research, one applies directly to the Home Office for an animal licence to do the research, and it is quite a different kind of system. It takes much longer to get an application through, as I know to my own cost as somebody who has both a licence to do embryonic stem cell research and a licence to do animal research. They are both difficult to do, but the comparison she makes is unfair.

Secondly, the noble Baroness mentioned cloning. Cloning has nothing to do with this issue. Human in vitro fertilisation produces a number of fertilised eggs which cannot be used for the treatment of patients. That means that these eggs will be discarded or thrown down the sink. To many of us on this side of the argument, the moral imperative is that such material could be used to protect, maintain and improve research into human health and human diseases. That is what it is really about. Of course there is a shortage of eggs, but eggs do not apply in this situation. Nobody is suggesting that we necessarily clone for embryonic stem cells; that is an entirely different and completely separate issue.

As has already been said, original research in this situation would be impossible. One had to do original research based on the ideas that one has. We have already gone through the differences in various debates in this House, which I do not intend to repeat now, between the adult stem cell and the embryonic stem cell. They have different properties. That is a major puzzle, and why we still need to look at embryonic stem cells. You cannot replicate with adult stem cells first what you might see in the embryonic stem cell because of that difference. For example, there is their potential to grow into other tissue types.

I have to say that I think that the noble Baroness rather misquoted Professor Jaenisch and, to some extent, Martin Evans. I know that the quotation is of itself correct, but the wrong inferences are drawn. If we look at the letter from the scientists published last week in the Times, we can see that there is tremendous support for the research to continue. It is not fair to say that a wide body of scientific opinion believes that we should abandon embryonic stem cell research, or even downgrade it. That is simply not true. Most biologists believe that it is still a very important area of research.

I say that with utter truth. I have no wish to do something that people might find disreputable, but there is broad consensus among people with very strong ethics that this is the appropriate thing to be doing. It is nothing whatever to do with keeping the UK in the vanguard. If something is wrong, as a scientist, I would not want to keep the UK in the vanguard. This is a question of doing research that we fundamentally believe will open doors to important biological questions that we hope may ultimately help people. We must not confuse research on a cell to understand its properties with the issue of therapy, which is completely separate. Translational research is entirely different from basic research. We are here discussing not translational research but basic research.

To my mind, it would be catastrophic if we abandoned those embryos, which would be lost after in vitro fertilisation. The only solution would be to destroy them against the wishes of the patients who, in my experience, give them extremely freely and with the great belief that we might find something to help other people in future.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I strongly support the amendment laid before your Lordships today by the noble Baroness, Lady Williams of Crosby. She cogently and persuasively argued its merits. They are merits that we have discussed at earlier stages and, mindful of the injunction placed on us earlier, I will not be repetitive, but one or two new points need to be addressed.

The first is that the amendment clearly does not ban any of the things to which the noble Lord, Lord Winston, referred a moment ago. I think that he would accept that nothing in the amendment would prevent him or any other scientist laying an application before the Human Fertilisation and Embryology Authority to undertake research. It is simply that the noble Baroness has laid out the criteria that would be required before that research application is met.

Indeed, that is precisely what happens under the Animals (Scientific Procedures) Act 1986. I have experience of my local ethics committee, on which I served for my university, where applications for the use of animals are gone through thoroughly first before they are submitted to the Home Office. The Home Office has turned down 3.5 per cent of all applications. When the Minister comes to reply, I would be grateful if she could confirm that the Human Fertilisation and Embryology Authority has only ever once turned down an application. When that application came back before the HFEA, it was subsequently approved. Therefore, the argument that the noble Baroness placed before your Lordships' House absolutely stands.

The fact is that 2.2 million human embryos have been destroyed—as the noble Lord, Lord Winston, said, mainly through IVF cycles—or experimented on since 1990. It is not unreasonable to ask how many more will be needed before we see any therapies provided, even if one thought that it was licit to use them in the first place, which I do not. I accept that the amendment is an attempt to uphold the special respect and status adumbrated in the report of the noble Baroness, Lady Warnock, back in 1986, and which was incorporated in the 1990 legislation.

My other point is about public confidence—an issue to which the noble Baroness referred. The Human Fertilisation and Embryology Authority itself conducted a survey last summer run by ICM. It found that 48 per cent of UK residents disagreed with scientists creating an embryo that contains mostly human with a small amount of animal genetic material purely for research, compared with only 34 per cent who agreed. Many people, therefore, do not concur with some of the provision in this Bill. Overall, 47 per cent—nearly half—agreed that creating embryos for research with mostly human, and a small amount of animal genetic material, concerned them. They said that it was meddling with nature. Nearly half—49 per cent—agreed that creating embryos for research with mostly human and a small amount of animal genetic material, concerned them because of what scientists might want to do next in research. Just over two-fifths—some 41 per cent—agreed that creating embryos for research with mostly human and a small amount of animal genetic material concerned them because they thought that it might be put into a woman or an animal, even though that was against the law.

Those are the anxieties that the Human Fertilisation and Embryology Authority discovered in the population at large. Therefore, it is not unreasonable for this type of proposal to be incorporated in the Bill. It is an ethical minimum that, for many of us, would not go far enough. However, at the last stage of this Bill, the noble and learned Lord, Lord Mackay of Clashfern, said that,

"it would help in reassuring people if we decided to include this amendment in the Bill.—[Hansard, 15/1/08; col. 1231.]

At present, I am inclined to believe that the HFEA may be less stringent than the Home Office in evaluating research proposals. Current requirements do not require cogent evidence which must include published peer-reviewed scientific data. Sending licence applications to peer reviewers is by no means equivalent. For example, they might not be aware of all the relevant work relating, as the noble Baroness has said, to adult stem cells, reprogrammed adult cells or umbilical cord stem cells. It is important that there is specific peer-reviewed data which can be examined, rather than merely opinion or assumption.

Her Majesty's Government have clearly been persuaded to permit research with transgenic human embryos, true hybrids and various interspecies entities, for which there is no current scientific demand or scientific consensus as to their necessity. Therefore the clear safeguards, provided by the Hunt test, are essential to ensure that all such research has a sound scientific basis and can proceed only where it has been demonstrated that no alternatives exist. I hope that this amendment will be supported by noble Lords today.

Photo of Baroness O'Cathain Baroness O'Cathain Conservative 5:00, 4 February 2008

My Lords, I also support Amendment No. 21. On Report, I supported an entirely separate amendment, expressing my opposition, in principle, to what we now call human admixed embryos. The majority of noble Lords voted in favour of such embryos and I accept the decision of the House. However, given the highly controversial nature of these embryos, it is right and proper that this House places clear and reasonable limitations upon where they are used.

Amendment No. 21—which we call the Hunt test—would ensure that human embryos are not used wastefully or unnecessarily. Such research would be a last resort. It is surely not unreasonable that human embryos, which many consider to have unique moral status, should be used only where other avenues for that research are shown not to be viable.

On Report, the noble and right reverend Lord Harries of Pentregarth and the noble Lord, Lord Patel—as the noble Baroness, Lady Williams, has told us—indicated their belief that the HFEA already considers whether the use of embryos is necessary. If that is true, I simply do not understand why they oppose including a provision that would ensure that the HFEA continues to act in this manner in the future.

The noble Lord, Lord Darzi, suggests, in response to this amendment, that a rigid framework of the criteria set out in the legislation would seriously limit the research that the HFEA can license. Will the Minister clarify what kind of research the HFEA could permit which would fall outside the limits set by this amendment and how such research could be justified?

On numerous occasions, several noble Lords have referred to the deep public unease about this Bill. Even today, I have received another 20 or so e-mails, from people I do not know, bringing this point to my attention. We must not leave the rest of the population with the impression that a human embryo has no higher status than a fruit fly. That, I am afraid, is what we are in danger of doing with this Bill. Including the Hunt test in the Bill would give some assurance to the public that their concerns had been acknowledged. The amendment is an opportunity for this House to demonstrate that permission to use ethically contestable science and technology is not granted lightly. I hope that the Minister and many other noble Lords will endorse the very reasonable proposal advanced by Amendment No. 21.

Photo of Lord Turnberg Lord Turnberg Labour

My Lords, I do not want to get into the pros and cons of adult versus embryonic stem cells—there are cases for both—but I do want to return to the actual words in the amendment. My noble friend Lady Hollis has already mentioned the difficulty of requiring published, peer-reviewed scientific data when one starts research for the first time. If the amendment had said something to the effect that the research must be peer-reviewed, that would be reasonable, but it must be published, which makes it more difficult, perhaps impossible, to do research for the first time.

Proposed new sub-paragraph (6)(b)(i) in Amendment No. 21 says,

"the research proposed ... is likely to achieve its specified purposes", but that misunderstands the nature of research. When research is done for the first time, you cannot possible know the answer. Indeed, it would be ethically immoral to do the research if you knew the answer before you started. You hope that it will achieve its purpose, but unfortunately research often fails—that is the nature of it. We can never be sure when we start it, so who is to judge the likelihood of the research achieving its specified purpose? That is not achievable, so the amendment is not valid in its present form.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I spoke to the amendment when it was proposed on Report, and I remain of the view that I expressed then that it would be a useful addition to the Bill. As we were told on the last occasion, this is how the HFEA goes about the matter at present—the noble and right reverend Lord, Lord Harries of Pentregarth, told us that. It is therefore perfectly reasonable that the tests that are currently used should continue to be used.

The noble Baroness, Lady Hollis, talked about proposed new paragraph (b) in the amendment, and the noble Lord, Lord Turnberg, with his great scientific background, has expressed the same concern. Proposed new paragraph (b)(i) says in effect that the present state of published, peer-reviewed scientific data suggests that the research is likely to achieve its purpose. That does not necessarily mean that it will achieve what one would like it to achieve, but it may well clarify a situation, which may be its purpose. Research sometimes fails, as we know, but the idea is that it must have promise.

My impression is that when the Joint Committee considered the matter, we were given the guidelines that the Medical Research Council uses to support research. After all, research money is not all that easily obtained, and the council must ensure that the money that it is putting into research is well used. The idea is that the likely outcome of the research is advancement of the knowledge of how an embryo works or a disease may develop. The essence of the matter is the way in which the embryo has been treated hitherto in the legislation.

In 1990, Parliament introduced a control on human embryo research and the treatments that use human embryos. It made it absolutely clear that after the primitive streak develops at 14 days, the embryo should not be used for research at all. I should have thought that there is a good deal to be said for specifying that that is the point at which there is a potential for human life. Until that point the embryo has a potential, right enough, but not necessarily a potential to develop into a human being. In the period before the primitive streak develops, Parliament thought that it was important to recognise that the embryo has special qualities which require special treatment. One of those treatments, of course, is that research using embryos should, first, be licensed by the HFEA. Secondly, as has been pointed out, the research must necessarily involve the human embryo; and, thirdly, the whole procedure should be as laid down by Parliament.

In looking at this matter again, it is perfectly reasonable that the same general framework should apply. I certainly do not take proposed new paragraph (b)(i) as meaning that you cannot do new research. That is not at all the meaning of the phrase. It means that the evidence accumulated so far suggests that it is likely to be useful research. It may not produce the answer the researcher wants, and indeed it may result in an answer the researcher does not want, but that is equally important in the development of the subject matter. So I support the amendment because it is useful from the point of view of recognising the public concern, which undoubtedly there is, surrounding embryonic research. It shows that Parliament regards that as a very important and special area of research which requires careful and thorough safeguards.

Photo of The Bishop of Chester The Bishop of Chester Bishop

My Lords, I support the amendment and agree with every word just spoken by the noble and learned Lord. However, were the amendment to be accepted, it may be necessary to look at the precise phraseology. I was a chemist in a previous incarnation and as I moved from being an undergraduate chemist to a research chemist, I can remember entering a completely different world where the experiments did not work out. As the noble Lord, Lord Turnberg, has said, in research you often do not know what is going to happen because it is a very uncertain procedure. Given that, you cannot be certain that a particular piece of research is likely to achieve its specified purpose, so the phraseology may need to be honed. However, the broad principle of the amendment is to enshrine in the Bill a note of caution.

I have only been able to be present now and again during the passage of the Bill through the House, but I have read all the reports as they have come in. There has been an understandable pressure from those engaged in the research to avoid unnecessary regulation, and indeed to deregulate to a degree. That is the natural instinct of those engaged in the research, but against that has to be put the issues so clearly set out for us by the noble and learned Lord. It is right that there is a note of caution written into the Bill so that we do not get drawn into thinking that research on embryos is a normal, natural way of proceeding. It should be done by exception. If the amendment is accepted, it may need to be tidied up in another place, but fundamentally it seems to me to be morally right.

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative 5:15, 4 February 2008

My Lords, I find myself for the first time throughout the proceedings on this Bill, and indeed on the Joint Committee on which we both served, taking a different view from my noble and learned friend. Perhaps I may advert for a moment to the right reverend Prelate. He acknowledged that the amendment is infelicitously worded for the good reason explained by the noble Lord, Lord Turnberg, which is that you cannot know in advance whether research is likely to achieve its specified purposes. Given that, surely the right approach is to say, "We like the principle, but clearly the wording is wrong. The amendment needs to be taken back and looked at again". When you add to that the point made, but not wholly answered, by the noble Baroness, Lady Hollis, that if it must include published, peer-reviewed scientific data that would make it almost impossible to have any new research, I find those arguments quite strong. It would be perverse to then pass the amendment into law at this stage and hope that someone else will amend it later in another place. That does not seem a sensible way to proceed. Nevertheless it is an important debate and it is right and to the advantage of the community as a whole that it is being held.

I was struck by the leading article in the Times last Saturday on the use of tissue banks—we have still to come to an amendment on this issue—which stated:

"Stem cell researchers sit uncomfortably on the boundary between invaluable scientific endeavour and inviolable human ethics".

That is exactly right. But when one comes to the end of the article it states:

"Stem-cell researchers need to do little more than move a muscle to spark off a round of agonised soul-searching".

That is a perfectly proper reaction, if I may say so. The article continues:

"Difficult questions will continue to arise and must be scrutinised case to case. With equal measures of determination and sensitivity, policymakers must balance pragmatism and ethics. In some parts of the world, misplaced didacticism would take over and elevate scientific endeavour above personal or religious ethics. Elsewhere, ethics may gain primacy over science".

It concludes:

"It is to the credit of Britain's democratic process that scientists and ethicists compete to be heard".

Those are very wise words but the article implies somehow that scientists are not ethical. That is not my experience. There may be a few mad scientists somewhere in laboratories who simply dismiss the whole ethical argument, but the overwhelming majority of scientists who are engaged in these sensitive areas are acutely conscious of the ethical argument. Indeed, when the Bill first appeared as a draft, it was called the human tissues and embryos Bill and there was an immediate reaction to say that we were simply putting tissues and embryos together as though they were of the same equality. We were not; we have always recognised, from the report of the noble Baroness, Lady Warnock, to which reference has been made, onwards that the embryo plays a very special part and that therefore any research involving embryos has to have regard to the ethical arguments as well. I believe that, overwhelmingly, scientists do that.

I sympathise with and understand the purposes of the amendment of the noble Baroness, Lady Williams, but it would not be sensible to put it into the Bill when even those who support it recognise that it carries some flaws. Perhaps the message to the Government should be, "Is there not something we could write in here?". I say this because the Joint Select Committee was critical of the fact that this Bill did not include, as the 1990 Bill did, an underlying ethical argument and purpose. It is something that this Bill lacks and it is not to the credit of this House that we have not yet found a way of rectifying that.

I do not think that this is the way for the reasons explained by the noble Lord, Lord Turnberg, and others. However, there is a purpose here which somehow needs to be reflected in the Bill. I hope that the House will not pass the amendment. Perhaps the noble Baroness may be prepared to withdraw it on an undertaking from the Government—I do not know whether they are prepared to do this—that they will continue to look at this argument and see whether it is not possible to write into the Bill an underpinning ethical argument. The Joint Committee felt that that was lacking and it is something we ought to put in.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, my comments will be extremely brief because I fully appreciate the intentions underlying the amendment and the ethical considerations that have led many noble Lords to support it. I am concerned about one matter only: the suggestion that cogent evidence must include published and peer-reviewed scientific data would effectively prevent researchers in the United Kingdom taking ahead cutting-edge research at the frontiers of science. It would mean that they could be engaged only in research on human embryos and human admixed embryos, following up work that had been done and published elsewhere. That alone makes the amendment quite unacceptable and, despite the excellent speeches we have heard, it is for that reason that I cannot support it.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, this has been an important debate and I am glad we have had it. Amendment No. 21 seeks to limit the HFEA's ability to license embryo research by extending the criteria the HFEA must consider before granting a licence. That would require published and peer-reviewed evidence demonstrating both that the research is likely to achieve its specified purpose and that it is not possible to achieve the same end result without the use of embryos.

The Government have carefully considered this issue in the light of the safeguards that already exist in the legislation, and which have been applied in practice since 1990 by the HFEA. We believe strongly that the existing controls are clear and sufficient. The HFEA undertakes a peer review process for each research licence application. However, making it a requirement that published evidence is available could be said to go against the fundamental principles of research, which are designed to test theory and produce facts. Those cannot be known before the relevant research has been undertaken.

Many noble Lords have referred to the statement from my noble friend Lord Darzi, who spoke of the importance of peer review, but he was referring to peer review of the licence application. The amendment in question refers to peer review data that are published demonstrating that such a research project would succeed. As other noble Lords have said, those two things are very different.

Under the provisions of the 1990 Act, the HFEA may grant research licences only where it deems the research necessary or desirable for one of the statutory purposes set out in the Act. The embryo does indeed have special status and it will continue to do so. The HFEA must be satisfied that the creation of embryos specifically is necessary for that project of research to be undertaken. Again, that is already in the Act. Each project is scrutinised on its merits to ensure that those criteria are met.

The noble Baroness, Lady Williams, and others have spoken of the number of applications rejected. It may be helpful if I clarify that a project for which a research licence is sought will have to have received approval from a research ethics committee before a licence can be granted. Where a project would in principle be suitable to be licensed but insufficient information has been submitted to the licence committee, or the committee is of the view that an aspect of the project needs to be reconsidered, it is usual practice for the committee not to reject the application but to ask the applicant to submit further information or undertake changes to the specifications of the project for reconsideration at a later date. Hence there are no, or very few, rejections.

The noble Baroness, Lady O'Cathain, asked what research this amendment would stop. It is difficult to say. The amendment would make it difficult for the HFEA to license research generally unless there was evidence in the first instance that the research was likely to work. As the noble Lord, Lord Walton, said, it would prevent novel and cutting-edge research.

The Government believe that we should not proscribe or unnecessarily curtail any avenue of research, as we cannot know in advance where breakthroughs may occur. For nearly two decades the HFEA has licensed embryo research with the flexibility to form its own tests on whether the use of embryos is necessary for each project of research. That system has worked well and I do not believe there is any need for change. As such, I urge the noble Baroness not to press her amendment.

Photo of Baroness Williams of Crosby Baroness Williams of Crosby Liberal Democrat

My Lords, I am grateful to noble Lords on both sides of the House for their contributions to what has been a significant and fascinating debate. I shall not keep the House long but I want quickly to make a couple of points about the conclusions we are approaching.

First, the noble Lord, Lord Jenkin of Roding, said—and he is absolutely right—that there is a distinction in people's minds between embryonic stem cell research and other kinds of research. In that context, I quote Professor Thomson, who was the first person to produce the human embryonic stem cell. He said:

"If human embryonic stem cell research does not make you feel at least a little bit uncomfortable, you have not thought about it enough".

Those are the words of one of the premier scientists in the field. Although the noble Lord, Lord Jenkin of Roding, does not support my amendment, he indicated that there was a distinction that should be underlined about the nature of research into embryos and the fact that embryos are not the same as other kinds of genetic material. That is an important distinction to make and the noble and learned Lord, Lord Mackay, quite rightly indicated that there is considerable public concern about maintaining that distinction.

The noble Lord, Lord Winston, for whom I too have the greatest respect, seemed to say that the amendment would make it very difficult to pursue embryonic stem cell research. That is not the case. In proposed heading (b)(ii) in Amendment No. 21, the requirement reads that,

"it is not reasonably practicable to achieve the specified purposes of the research without using human embryos or human admixed embryos".

In other words, where it is clear that that is required, it is not forbidden by the amendment. It simply asks that there should be careful consideration of what alternatives exist.

A number of noble Lords, including the noble Lord, Lord Turnberg, and in particular the noble Lord, Lord Walton, indicated that they have difficulties with,

"published, peer-reviewed scientific data".

As the noble Lord, Lord Jenkin of Roding, made clear, if the problem arises from "published", those of us in favour of the amendment would be willing to reconsider that. The Bill has yet to go through another place so there is lots of time to reconsider "published".

"Peer-reviewed scientific data" fall into a different category. My knowledge and recollection are that when research councils consider proposals for research they ask for peer-reviewed scientific data in most cases to establish that the research has a real possibility of being, in effect, worth the money invested. I find it strange that people should object to those words. I repeat that I can see there is a problem with "published". Indeed, the noble Baroness, Lady Hollis, raised that point. I apologise that I was not able to reply to her. If it raises great difficulties, we can consider it again.

I repeat that the amendment does not rule out embryonic stem cell research. It allows it in cases where it is clearly the one way forward. I think that meets the point made by the noble Lord, Lord Winston. Concerning his objection to my providing some indications that in some cases animal research had been ruled out by the Home Office, and that there did not appear to be a case of the HFEA having ruled out in the end any of the research put before it, I deliberately chose to give proportions and not numbers for the reasons that the noble Lord, Lord Winston, gave. I recognise that there are thousands of applications for animal research and very few for embryonic stem cell research. That is why I gave proportions and never mentioned numbers, which I thought would be misleading. The proportions stand whatever the actual numbers may be.

Finally, I am sorry that the Minister, who has been extremely helpful throughout the debate, seemed unable to say that the Government would take the issue back and consider it before the matter goes to the other place. I wish she had felt able to do that because I believe that there is sufficient support in the House for the amendment for it to be taken seriously. Some noble Lords who have spoken to it are people whose views, not least on the real state of public opinion, should be taken seriously. So far, the Government have rejected virtually every amendment on these lines. Therefore, I must ask to test the opinion of the House.

On Question, Whether the said amendment (No. 21) shall be agreed to?

Their Lordships divided: Contents, 41; Not-Contents, 197.

Division number 1 Private Parking: Ports and Trading Estates — Human Fertilisation and Embryology Bill [HL]

Aye: 39 Members of the House of Lords

No: 195 Members of the House of Lords

No: A-Z by last name


Resolved in the negative, and amendment disagreed to accordingly.

[Amendments Nos. 22 to 24 not moved.]

Schedule 3 [Consent to use or storage of gametes, embryos or human admixed embryos etc.]:

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 5:43, 4 February 2008

moved Amendment No. 25:

Schedule 3, page 65, line 2, at end insert—

"Cases where consent not required for storage and use for research

10A (1) The human cells of a person ('the donor') may be used to bring about the creation of an embryo or a human admixed embryo in vitro; and any embryo or human admixed embryo so created may be used or stored for the purposes of any project of research without the donor's consent if the following conditions are met.

(2) Condition A is that the human cells are lawfully taken from or provided by the donor.

(3) Condition B is that the human cells were first stored or used prior to the day on which Schedule 3 to the Human Fertilisation and Embryology Act 2008 comes into force.

(4) Condition C is that the human cells, embryos or human admixed embryos are used in circumstances such that the person carrying out the research ("the researcher") is not in possession, and not likely to come into possession, of information from which the donor can be identified.

(5) Condition D is that it is not reasonably possible to contact the donor to obtain their consent.

(6) Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or human admixed embryos are stored or used has to be confined to, or relate only to, material in relation to which there is an effective consent.

(7) Condition F is that it does not appear to the researcher that the donor has indicated any objection to such use or storage (as applicable)."

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, this is another amendment that was tabled on Report by my noble friend Lord Patel. Its purpose is to allow existing holdings of anonymised cells and cell lines to be used in embryo research in circumstances where it is not possible to obtain specific consent. The principle of consent underpins this Bill. Consent must be obtained wherever it is reasonably possible to obtain it. The Bill, as drafted, rightly introduces a new legal requirement that consent must be obtained from donors of tissues and cells before such material is used in research involving somatic cell nuclear transfer, in which embryos, or human admixed embryos, are created to generate embryonic stem cells.

However, huge collections of cells and cell lines, pre-dating this Bill and scrupulously gathered over many years, have not been specifically consented for use in embryo research and cannot now be reconsented because the donors are untraceable or deceased, the samples were anonymous, or it was agreed with the donor that the individuals in question would not be contacted again. Many of these collections are very scientifically valuable and cannot be reproduced readily, either in a reasonable timescale, or at a reasonable cost. Indeed, they may not be reproducible at all, particularly where they relate to very rare diseases or are accompanied by a wealth of historic associated data, collected over long periods.

The use of these collections in embryo research may offer tremendous insights into the development and causes of the serious and rare diseases from which their donors suffered. In the future, of course, researchers will have to take into account the requirement to obtain specific consent in designing and building tissue collections that may be used in embryo research but, retrospectively, this is impossible. This amendment therefore provides a limited, but very important, transitional exception to the requirement for specific consent introduced by Schedule 3. The exception applies only in relation to existing holdings where it is not reasonably possible to go back to donors to obtain specific consent, where the cells or cell lines have been anonymised, and where it is not possible to use other materials for which specific consent has been obtained. The amendment also provides that the material must have been lawfully obtained in the first place and that there must be no indication of any objection from the donor.

I quote one major example, from Professor Chris Shaw at King's College London:

"Over the past 5-10 years we have established primary fibroblast cultures and transformed lymphoblast cultures from patients with motor neurone disease ... Because MND is rapidly fatal the vast majority of these patients have now passed away and we could not obtain consent from them. In some of these patients we have subsequently discovered unique genetic mutations.

It is precisely these cells that we would like to use in nuclear transfer experiments to create embryonic stem ... cells. The ES cells generated will carry a gene defect that is harmful to motor neurones. We can drive these embryonic cells to differentiate into motor neurones and hope to identify"— abnormal—

"biochemical events through studies of gene and protein expression and cellular behaviour. These cells may also be used to screen for therapeutic compounds".

There could never be any intention or, indeed, any possibility, that such embryos, created by nuclear transfer and derived from people with these diseases, could ever be implanted into humans or animals. The only purpose of this amendment, and the cell lines that are in existence, is to investigate the processes of diseases occurring in the individuals from whom these cells were obtained.

The Minister agreed at Report stage to take this matter away and to come back. I am very grateful for the letter from the noble Lord, Lord Darzi, which says that the Government take the view that such an exception, if accepted, must be proportionate and necessary, and that the terms of the exception will require,

"careful consideration and should be made subject to appropriate safeguards. It will be particularly important that the exception", if the principles underlying the amendment were accepted,

"should only apply where there would be a significant adverse impact on scientific research in the public interest, if existing cells could not be used. The exception could not be used to overcome mere administrative inconvenience, and to ensure it could not be relied upon inappropriately. External scrutiny will be needed of the operation of the exception and to ensure that the research is in the public interest".

He went on to say:

"The Government believes that a very compelling case has been made for an exception to the consent provisions in the Bill as drafted. We have given a clear commitment to take this issue away for further consideration in the other place".

I understand that that is exactly what the Government intend to do. If I can have an assurance on that issue, I would certainly not wish to pursue the amendment further. I beg to move.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, this issue was not debated by the scrutiny committee and we did not debate it at Committee stage. My noble friend Lord Walton of Detchant has reminded us that we discussed this issue on Report, and we now have the amendment before us. I have grave reservations about it, although I fully understand the motives of my noble friend in bringing it forward. He is right to tell us that if genetic materials were available, they could be turned into human admixed embryos or into human embryos, but they would not be implanted. But of course they could be used for research, they would be created and they would exist for 14 days before we destroyed them. Many of us who would have profound misgivings anyway about the creation of human embryos in the first place, or human admixed embryos, would therefore be opposed to doing this.

There is another issue that ought to unite Members of your Lordships' House, even if they do not accept the premise that we should not create such entitites in the first place. No one who had given those tissues perhaps 40, 30, 20 or 10 years ago could have possibly known at that time that we would be considering in 2008 the creation of human admixed embryos. So it would not have been possible to have given consent at that time for this proposal. We simply could not have known.

I can say that if I had given permission 10 years ago for any genetic material of one of my own children to be used—indeed, two of them had treatment at Liverpool's Alder Hey hospital—I would have had no problem at all in those materials being used for scientific research, but I would have a profound problem with that material being used to create a human admixed embryo or human embryo for experimental purposes. It would be crazy to trade a list of horrendous diseases. All of us want to see disease conquered and want to use legitimate means to do that, but we should not blind ourselves to the other considerations when we think about issues of this kind. I particularly emphasise this question of consent.

I want to take the House back for a few moments to the Alder Hey organ scandal. I have been a supporter and admirer of the wonderful work of that hospital, both as the father of children who were treated there and as a local Member of Parliament at that time. It grieved me to see that wonderful hospital mired in allegations of organ theft, body snatching, contemporary necromancy and the rest of it. It was a tragedy for that hospital which was wholly avoidable, if only some of those who were intent on pushing the boundaries in the way that they did had considered their actions at the time. Who in the House would disagree with the response to the Royal Liverpool Children's Inquiry of Ministers who said:

"The traditional paternalistic attitude of the NHS, that the benefits of science and research are somehow self-evident, was no longer acceptable"?

It is not just Ministers who have held that view. The General Medical Council's guidelines on consent for research state the following:

"Obtaining consent is a process involving open and helpful dialogue, and is essential in clarifying objectives and understanding between doctors and research participants".

The General Medical Council goes on to say that,

"one must not make assumptions about participants' views, but discuss matters with them", and it describes how participants should be presented with information that first includes,

"what the research aims to achieve", and,

"an outline of the research method".

Can one retrospectively presume that previous approval for supposedly any research should necessarily encompass that which was utterly inconceivable at the relevant time? Perhaps the Wellcome Trust provides the best answer in a document entitled Public Perspectives on Biomedical Research, in which the following is stated:

"Implied consent was not welcomed as a model of the consent process. Implied consent was equated to no consent".

When we discussed this issue on Report many of your Lordships raised the question of human rights and my noble friend Lord Patel who is absent today for understandable reasons said at the time that he did not really understand human rights questions. Sometimes we can become myopic in the individual disciplines in which we live. We can sometimes become particularly absorbed with the ideas that influence the work we undertake in the disciplines in which we are involved. I do not think we should avoid the question of consent. We should not try to impute retrospectively to people who have never had the chance to give authority for this work something with which they might not have agreed. Certainly if it is possible to trace those who were involved at the time in giving such tissues, it might be possible to make this into a workable proposition; but without that I really do not believe that the amendment should be supported.

Photo of Baroness Tonge Baroness Tonge Spokesperson in the Lords, Health

My Lords, I support the amendment in the names of the noble Lords, Lord Walton and Lord Patel, concerning existing cell lines donated by patients who may or may not have given their consent to embryo research. We are assuming that they did not give their consent. It seems to me that a lot of patients in that situation, as the noble Lord, Lord Alton, said, would not have conceived that this sort of thing could happen in the future, but many of them may have conceived that, yes, it might happen; and when such people donate their cells they are prepared to let medical scientists research in any way that they choose within the guidance of the Government of the day.

The Government seem to be most worried about Article 8 of the human rights convention. There is a very good response from the Government on the science side, but we have a problem as to whether this issue contravenes Article 8 which states that a person has a right to personal autonomy. The Government say that the use of a person's genetic material without their express consent to create embryos and their subsequent use and storage would interfere with a person's rights under Article 8 of the convention.

It is arguable as to whether using someone's cells to make embryo stem cells, which are then destroyed anyway after 14 days, contravenes their human rights, because a bundle of cells, be they human embryo cells—we heard this from the Ministers in Committee—have no human rights anyway. Are we not splitting hairs a little by saying that it would contravene Article 8 if this research went ahead without the express consent of the individual? I suggest that we are being too particular and thoughtful on this issue. We must always keep in our minds, as the noble Lord, Lord Walton, said, that this sort of research could lead to huge relief of suffering for individuals. He gave the example of motor neurone disease, but there are many others. Surely these advantages will outweigh the disadvantages and the problems that we are arguing about.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative 6:00, 4 February 2008

My Lords, when I read this amendment prior to the debate, I was absolutely horrified because I found it breathtaking in its arrogance. But the noble Lord, Lord Walton, in introducing the amendment, has not been in the least arrogant—he has been the voice of reason itself. So I turn again to the wording.

I beg noble Lords to remember that only a very short time ago, when it was suggested that you ought to be able to take organs from dead people whether they had agreed or not, there was an outcry from the public. It is an extremely sensitive thing to assume that, with no consent forthcoming, anything can be done with human cells. It is that part of this amendment that worried me so much. It does not say that all the conditions must be met—I wondered whether it was just some of the conditions, or one of the conditions, or any of the conditions. That bothered me.

New sub-paragraph (2) says:

"Condition A is that the human cells are lawfully taken".

I imagine, because of what the rest of the amendment says, that you do not have to consent for such cells to be lawfully taken. That worries me. Perhaps I am wrong in my reading of the amendment, but I was trying to see exactly what we were being asked to consider and pass here. It worries me if anything can be taken lawfully without the agreement of that person—or of the parents if it is a child.

New sub-paragraph (4) says:

"Condition C is that the human cells ... are used in circumstances such that the person carrying out the research ... is not in possession, and not likely to come into possession, of information from which the donor can be identified".

That suggests that there is no requirement even to try to find out whether consent can be given. That worried me very much. New sub-paragraph (5) says:

"Condition D is that is it not reasonably possible to contact the donor".

I warned the House on an earlier occasion about the danger of using the word "reasonably". It is true that legislation has not been made into statute because the Houses of Parliament found unacceptable the use of the word "reasonable", because it is so bland. What is reasonable to one person may not be reasonable to another. New sub-paragraph (5) says,

"it is not reasonably possible to contact the donor to obtain their consent".

My goodness, you could say, "It was not reasonably possible, because I was on holiday, time was running out and I could not reach the person"; or, "Their phone was out of order"; or, "Their number was unlisted"; or, "The post in Arundel is very bad and I could not contact them that way"; or, "My computer had gone down". So many easy excuses could be made for not contacting the donor to obtain consent because, to some people, it would not be reasonable to continue to try to find consent if even one of those circumstances arose.

Photo of Baroness Hollis of Heigham Baroness Hollis of Heigham Labour

My Lords, perhaps I may intervene.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative

My Lords, I am sorry; I do not think that that is possible.

The wording of new sub-paragraph (7) is very sloppy. It states:

"Condition F is that it does not appear to the researcher that the donor has indicated any objection".

Surely we cannot pass that, because the researcher is very keen to go ahead with the research. I do not doubt what has been said about a lot of the research being very important and instrumental in helping to find cures for diseases that we cannot treat at the moment. None the less, we cannot accept the provision that "it does not appear to the researcher that anyone has objected". We would not have that in any condition, because it is so sloppy.

Because we are debating Amendment No. 26 as well, in order that I can make just one speech, I would like to speak about children. What we are being asked to do is bypass the parents. New sub-paragraph (2) does not even say, "The children or their parents should be contacted". Instead, it says:

"Condition A is that the human cells are lawfully taken from or provided by the child before the child attains that age of 18 years".

Eighteen years? You can be married at 18, you can sign up as a soldier and, if a boy of 17 steals birds' eggs from a nest, he can be sent to prison. But he is apparently not capable of saying, "I agree" or, "I don't agree", because you do not have to bother to ask him, because he is not 18. I cannot accept that.

New sub-paragraph (4) says,

"the child does not appear to the person storing or using the human cells ... to have indicated any objection".

That is the same point that I touched on earlier. We cannot accept that any researcher anxious to carry out research can be allowed to say, "It did not appear to me that anyone was objecting". There must be something far clearer than we have in these amendments, if we are trying to do what the noble Lord, Lord Walton, said. I respect the noble Lord and I know that he is absolutely genuine. I am not attacking him, but I am saying that any part of a human being is theirs to do what they like with, not ours to do what we find convenient, and these points and others in the amendment worry me greatly. I do not like Big Brother. I do not like the fact that Big Brother looks at us a lot of the time and knows extraordinarily intimate details about every one of us. But he is not going to have the right to assume that we will give bits of our bodies to be used in research when we have never been asked.

Photo of Lord Winston Lord Winston Labour

My Lords, it may be helpful to the House if I raise something that I did not raise in the previous debate. Almost certainly I am the only Member of your Lordships' House who has regularly approached patients, asking for consent to use their embryos for the purposes of generating stem cells. The consent procedure is different from that in any other form of medical research with which I have been involved for many years. I hope that noble Lords will understand that I am speaking with complete probity. When we deal with any embryo research, we make sure that we give not just the routine information you might give somebody about other forms of research—patients attend seminars and talks about the value of stem cell biology and there is a great deal of information given to them that is well beyond what you might give about other tissues that might be taken, for example, during an operation.

There are not many centres doing embryonic research of this kind in Britain—I think that only a handful of licences have been given. I imagine that what has happened in my experience at Hammersmith Hospital must reflect what happens in other units. In practice, we make absolutely clear to patients that we hope to generate embryonic stem cells in order to produce stem cell lines for whatever purpose may be appropriate. It is very open-ended. In effect, the consent covers pretty well every procedure. It is true that some of our patients will not have heard of admixed embryos but that is perhaps the one exception. That apart, the patients to whom I have spoken and those to whom my colleagues have spoken give their embryos entirely freely for whatever stem cell research might be appropriate. So, in a sense, the consent has already been obtained, even though it has not been specified for a specific research project.

I do not think it is quite fair to say that it is like the post in Arundel, as the noble Baroness suggested. It is a little different because the one concern that these patients have is that some of their genetic material might become public. That has always been a slight problem. In practice, all these research projects are anonymised for that very reason. Therefore, if a stem cell line is produced, there will be no way of knowing later whether it relates to a specific patient. When the stem cell line goes to the Stem Cell Bank, which is run by the Medical Research Council and my colleagues, it is not known which patient has given those cells. The anonymity is maintained to ensure that there is no risk of the genetic material becoming public, and that is why the patient cannot be traced—not for any other reason in the process.

Photo of The Bishop of Chester The Bishop of Chester Bishop

My Lords, the issue in this amendment turns around the meaning, nature and understanding of the word "consent". We all admire the noble Lord, Lord Winston, for the work that he has done in this area but I wonder whether the patients with whom he deals in his clinic are not a self-selecting group who will naturally be open to this sort of research in the first place. I would at least want to question whether it is fair to extrapolate that.

There is also an issue of democracy here, and it is very appropriate that we should come to that as we reach the end of the passage of the Bill through this House, which in many ways has shown the House at its very best. In any democracy you have to balance the rights of the majority with those of the minority. Clearly, in our society the majority favour the continuation of embryo research. I should think that that was almost certainly the case, although earlier today we heard of significant minorities—perhaps they are majorities but I tend to think that they are minorities—who have varying degrees of resistance to this concept. They include some who think that it is a barrier that must not be crossed under any circumstances—particularly, but not only, in relation to human admixed embryos. We recently enshrined in law provisions for significant minorities in our society.

Those who have given tissue in the past under a general consent include people who, had they been asked the question at the time, would have been adamantly opposed to this form of research, although they would probably have been open to almost any use of their body tissue other than creating embryonic life. I think that we owe a duty to that minority who have gone before us because in our democracy not only do we have to deal with living minorities but we have to have a sense of the democracy of the dead as well. I take particular account of the rights and views that we can reasonably presume would have been held by previous generations. Therefore, I think that, as the noble Lord, Lord Walton, said, the principle of consent is at the heart of the Bill.

However, one can be torn. During my life as a priest, I have watched people die of motor neurone disease and other diseases which are horrible and which I would not wish on anyone. I wholeheartedly wish for a cure, but I also understand the views of the minority of people, living and dead, for whom this type of research is a bridge too far—something to which they fundamentally object. I understand those views, despite the pressure that we naturally feel to allow the sort of research that would be permitted here. I have more sympathy for Amendment No. 26 but I am talking specifically about Amendment No. 25. To advert to what the noble Baroness, Lady Tonge, said, we cannot be too thoughtful about this; we have to think about the rights of minorities and the rights of those who gave their tissue.

At this point on Report, the noble and learned Lord, Lord Mackay, said that consent meant consent and that we should presume that, if people gave consent, that was the case, whatever research might take place in the future. However, I think that we are dealing with something unique here in research terms because of the views of a certain minority. I am not wholeheartedly part of that minority myself. I do not believe that IVF treatment is necessarily wrong, and I have certain open views about the status of life at the very first moment, not least because so many embryos are lost in the early stages of the natural reproductive process and so on. However, I think that we owe it to the minorities—who, if they were able to make their voices heard, would be adamantly opposed to what we are describing—not to make a general consent for the use of tissue gained 20 or 30 years ago or whatever.

Photo of Lord Turnberg Lord Turnberg Labour 6:15, 4 February 2008

My Lords, I support the amendment. I appreciated the seven-page letter which the noble Lord, Lord Darzi, wrote to most people who spoke on this subject on Report and which outlined the pros and cons of this type of amendment—in particular, the balance that has to be struck between, on the one hand, the rights of an individual who may be long dead and who gave cells for research and, on the other, the future generations that may benefit from the use of those cells. The letter carefully outlines the thorough safeguards that would have to be introduced before that could occur.

I want to point to one particular element in the letter and to probe a little further. In paragraph 23, the noble Lord talks about the need for external scrutiny in the process by which permission is granted for the use of stem cells. That might well provide this whole issue with an important area of safety. I mentioned this briefly on Report, suggesting the use of the Patient Information Advisory GroupPIAG—which is used in the Human Tissue Act. That body seems to have worked reasonably well in allowing for research purposes the use of tissue from patients who are no longer available and in seeking further consent. Perhaps that sort of model would be applicable here.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, I draw the attention of the House to one point in Amendment No. 26. I listened with great interest to the noble Baroness, Lady Knight of Collingtree, as I always do. We very rarely agree on these matters but I always like to listen to the points that she makes because they are important. In her analysis of the amendment, she did not reach proposed new sub-paragraph (6), which states:

"Condition E is that there are reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project of research for which the human cells, embryos or human admixed embryos are stored or used has to be confined to, or relate only to, persons who have capacity to consent to it".

This is principally about research into childhood diseases which are so severe that the children never make it to adulthood. That is why this is such an important amendment. The noble Lord, Lord Walton, has spoken to us on previous occasions, giving examples. I want to make that point because I think that this afternoon we are in danger of giving the impression that only those on one side of the argument are approaching this matter with a concern for children in particular. That is not so; this is a set of circumstances where one would wish to take what I believe are now the main tenets of the Mental Capacity Act and apply them to this form of research.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I assume that the basis of this amendment is that the human cells in question are lawfully taken from or provided by the donor in relation to some definition of research. Some consent is implied. There is no question of this happening completely without the consent of the donor. I said before and I remain of the view that the term "research" includes research as it may develop. As we heard in connection with the previous amendment, you cannot tell when you start research where it may lead, although if you wish to get money for it you had better be able produce some good reason why you want to do it. New sub-paragraph (7) is intended to deal with that situation. At the moment it is restricted to the researcher. As my noble friend has said, the researcher is keen to get on with the research so he will not be looking very hard for reasons why he should not be able to get on with it. It may be that new sub-paragraph (7) needs to be opened out a bit to say that there does not appear to be any reason to suppose that the donor would object to the use or storage of the material for this particular purpose. What the right reverend Prelate referred to might well come under that. If you were to find out a little bit about the donor's background, you might conclude that they are in the minority that he speaks of who would not wish this research to be carried out. It may require some more elaborate provision than is here at the moment but I think that is the purpose of new sub-paragraph (7).

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench

My Lords, after consulting the Minister, it seems appropriate that I should now speak to Amendment No. 26 which is also tabled in my name. This amendment relates to consent by parents and guardians on behalf of children lacking capacity and seeks to ensure that research involving the tissue and cells of such children to create embryos and human admixed embryos can be undertaken in important but limited circumstances, subject to strict safeguards. The Bill does not currently make any provision for parents or guardians to consent on behalf of their children. This has the regrettable side effect that it will in future be impossible to carry out embryo research using cells from sufferers of serious or life-threatening diseases that exclusively affect and usually kill children, such as muscular dystrophy, Batten disease and many more. This removes a vital route to increasing our understanding of the development and causes of these terrible diseases. This amendment makes provision for those with parental responsibility to give consent for their children where they lack capacity to consent, provided each of the conditions set out in the amendment are met. The conditions include that it is not possible to undertake the research using tissue or cells from donors with capacity and that the tissue or cells were lawfully collected, deriving, for example, from blood, muscle or tumour tissue removed with parental consent for treatment or diagnostic purposes. There must also be no knowledge that the donor indicated any objection. This research would, of course, be subject to the scrutiny of the HFEA and an NHS research ethics committee to the requirements of the common law concerning the removal of the tissue and to the regulatory requirements of the Human Tissue Act.

This is a vital amendment. I gave an example in Committee. Much of my earlier research involved muscular dystrophy. The most severe form of muscular dystrophy is called the Duchenne type and occurs in young boys. It begins to cause difficulty in walking early in life. By the age of nine or 10 those boys are confined to a wheelchair and many do not survive beyond the age of 20 or thereabouts. It is now known that it is possible to diagnose that condition in the newborn infant by taking a blood sample and a small sample of muscle by needle biopsy. If a therapeutic opportunity arises, if a new treatment becomes available, it is clearly important that the treatment should begin immediately after birth in order to prevent the breakdown of the muscle which is so significant a feature of that disease. There are now five trials of treatment continuing in the UK and in other parts of the world using various forms of treatment for muscular dystrophy.

On Report the Minister suggested that, because an infant or child below the age of consent was incapable of giving valid consent, this would not be a possible form of research. If that argument were pursued to its logical conclusion, it would make the practice of paediatric medicine virtually impossible because, for diagnostic procedures and treatment to be given to young infants and children, parental approval is necessary. The General Medical Council and the BMA in its handbook, Medical Ethics Today, have made clear the carefully defined circumstances in which research involving children with explicit parental consent is feasible. For that reason it is crucial that this amendment or something very like it should go in the Bill to enable such diagnostic work on infants to be carried out. In the case of the muscular dystrophy patient, if you can diagnose the condition at birth, it would not be impossible to take a tiny sample of skin to create an admixed embryo and a stem cell development of muscle cells to treat the condition. This kind of research is at the cutting edge and must be pursued.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, the Bill sets out a framework where to use a person's gametes or other cells in the production of an embryo or a human admixed embryo there must be effective consent from that person in place. Consent, as noble Lords have said, is one of the cornerstones of the 1990 Act and only with the strongest of justifications would we be able to consider exceptions to this important rule. This is particularly true because of the human rights considerations. It is important to have regard to someone's personal autonomy when their cells would be unknowingly used for embryo and human admixed embryo research. It has been made very clear that there is concern that without any exceptions there could be a serious adverse impact on scientific research. The research affected could be important research aiming to better understand and treat serious medical conditions. On Report we gave a clear commitment to take away this issue for further consideration. We are grateful for the very helpful discussions on this issue that we have had with noble Lords. My noble friend Lord Darzi wrote a lengthy letter to set out the legal issues and to reiterate our intention to consider this issue further with a view to resolving it in another place. Copies of that letter have been placed in the Library. We are in the process of gathering specific information regarding the concerns raised and of re-examining our position in the light of our findings.

Regarding the use of cell lines, a compelling case has been made. We have outlined in writing to noble Lords that the Government take the view that it will be possible to make an exception to the requirement for express consent, provided that sufficiently stringent safeguards are in place. The details of those safeguards will require significant further consideration and discussion to ensure that research takes place only where to require consent would impose a substantial burden on scientific research, with such research being in the public interest. We will also need to develop a framework through which the safeguards will be introduced. My noble friend Lord Turnberg mentioned the importance of external scrutiny and I am sure that we will be looking at examples such as the patient advisory group that he mentioned.

Regarding the use of a child's tissue, we agreed that in some circumstances, particularly those where a child is suffering from a terminal illness at a very early age, the current consent requirements in the Bill are not appropriate and should be revised. We are currently examining this issue carefully and we have agreed to take it away for further consideration in the other place. There are good reasons for further consideration of this issue. In particular more detailed consideration is needed to address children who are not competent to consent, on grounds of both age and mental capacity. Further concerns are then raised about all persons, including adults incapacitated throughout their entire life. The changes to the consent system regarding these concerns will require considerable thought to ensure that not only children but all those who require exemption are provided for. Consideration will also need to be given to other pieces of legislation, such as the Mental Capacity Act 2005 and the common law governing children and consent.

I am happy to state clearly once again our commitment to find a way through each of these concerns. We shall take the issue away for further examination and revisit it in the other place. With that reassurance, I hope that the noble Lord will not feel it necessary to press his amendment.

Photo of Lord Walton of Detchant Lord Walton of Detchant Crossbench 6:30, 4 February 2008

My Lords, in the light of those assurances, I am happy to beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 26 to 28 not moved.]

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

moved Amendment No. 29:

Schedule 6, page 72, line 26, at end insert—

"The Secretary of State shall within four years of the coming into force of this Schedule, carry out a review of the law and practice concerning the inclusion in the birth certificates of donor conceived persons the fact of such conception."

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

My Lords, those of us who have followed the argument on whether a birth certificate should record the fact of a donor conception will recognise that this is yet another attempt to try to find a way forward, given that as everyone recognises there are deep divisions of opinion within what might be called the donor conception community—whether as parents or as donor-conceived children.

I have very much in mind the admonition of the noble Baroness, Lady Royall, at the beginning about not repeating the arguments that I advanced—at some length, I fear—on Report. Then I asked that the HFEA should keep the matter under review, and I added that if the HFEA recommended that there should be a change in the law relating to birth certificates in practice, the Government could then make the necessary changes by statutory instrument. Both conditions were criticised by the noble Baroness, who said that the HFEA was not best placed to carry out a review in that area. She said:

"Changes to the birth registration laws would involve amending a number of different Acts and I do not believe that a review of the law in this area would be within the remit of the HFEA".

She went on to say:

"It is also not clear that this provision is necessarily appropriate to be implemented by secondary legislation".—[Hansard, 28/1/08; col. 510.]

Anyone reading the amendment will recognise that I have met those two requirements. It will now be the Secretary of State who will carry out the review, and the suggestion that a change in the law might be made by order has been removed. That there needs to be a review from time to time is extremely clear. There is widespread feeling that birth certificates should not connive in a lie. That was considered at some length by the Joint Committee, and we did not like the idea one bit that there should be an element of deliberate deception, as it were, connived at by the authorities.

There are those who feel strongly that the birth certificate should record the facts. My noble friend Lord Ferrers was very eloquent on that subject. However, there is the great difficulty that a large number of the parents of donor-conceived children believe that to make it public at this stage would play to the prejudices of a great many people and harm their children's prospects in life. But they agreed that opinion might change as people become more and more aware of the capacity of the medical profession to allow parents to create children when it was not possible before and the idea of donor conception might become better understood and more tolerated. That is why it needs to be reviewed.

I am perfectly happy that the review should be carried out by the department. I am not happy that it should rest solely on what the noble Baroness said last time when she assured noble Lords,

"that we will continue to keep under review options about informing donor-conceived people about their conception".—[Hansard, 28/1/08; col. 511.]

I think by that she meant the birth certificate question.

As I said then, I have been around for long enough to know that departments can keep things under review for an astonishingly long time without actually doing anything. I want to see something in the Bill. I had been led to believe that this amendment might be accepted by the Government, but I have since been led to believe that that might be difficult. I think that the noble Baroness's heart is in the right place but she is contending with a departmental attitude that is very deeply ingrained. At this stage in her career she is not in a position to change that. I am perhaps anticipating what she will say, but we must have something in the Bill. That must be agreed either in this House or in another place. I beg to move.

Photo of Earl Howe Earl Howe Shadow Minister, Health

My Lords, whatever the Minister's reply to this amendment, the motives of which I strongly support, I take this opportunity to thank her and the noble Lord, Lord Darzi, for the constructive and helpful way in which they have handled the Bill during its passage through this House, and for willingly agreeing to consider in depth so many of the ideas and proposals put forward in our debates. My thanks extend also to the Bill team, who have devoted much time to advancing the discussions that have taken place outside as well as within the Chamber.

The Bill has been improved in substantive and important ways, and I believe that our debates and the Ministers' joint efforts have served to clarify a number of difficult questions that the other place will now take forward.

Photo of Baroness Howarth of Breckland Baroness Howarth of Breckland Crossbench

My Lords, I am assuming that the noble Baroness is unlikely to accept the amendment tabled by the noble Lord, Lord Jenkin, but I want to make two points about it. In some ways, I do not support this proposal being in the Bill, but it is crucial, as has been demonstrated throughout the debate, that before we move forward we must have some sort of framework in which to examine the issues and questions about these families. It is interesting that the science may have been debated on the Floor of this House, about which there have been some marginal differences, but the social science has been disagreed with seriously. All I ask is that it should be understood from the start that the review should be looked at in a social science framework, so that at the end some objective assessment can be made, rather than a whole load of opinion about what children and families require to develop appropriately, and what adults need in terms of understanding their genetic inheritance to ensure their health.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I am glad to find that I am again on the same side as my noble friend Lord Jenkin of Roding after a small deviation earlier. It is important that something of this kind should be in the Bill. Apart from anything else the government amendments proposed to the law, which have been incorporated in the Bill, will certainly require amendment of the form of the birth certificate. There can be no question about that. Some review of the structure of birth certificates will be necessary before the Bill can be implemented.

I have made the point, so I shall not weary the House by making it again, that there are some cases in which donor conception will become apparent on the birth certificate—not expressly but by implication. For a minority of children, the fact of their donor conception will be recorded on the birth certificate from the time that the Bill is fully implemented. Some degree of review is essential if the Bill is to work. I support the view that this important matter, to which we devoted a lot of attention in the Joint Committee, and for which there was strong feeling from different groups, must be kept under review. I cannot compete with my noble friend's experience and his knowledge of things lying around departments for a long time, but a little prod arising from the fact that the provision is in the Bill might be helpful.

Photo of Baroness Hollis of Heigham Baroness Hollis of Heigham Labour

My Lords, I also support the push of this amendment. Sitting on the pre-scrutiny committee, I found this one of the hardest issues. There were conflicting pulls and it was hard to know where the balance should lie. This was not about faith, beliefs or scientific background. It was a set of clashing considerations over, for example, whether the birth certificate should reflect the biological—that is, genetic—parentage or, as many same-sex couples might wish, the social parentage of a child.

Secondly, where do the child's wishes come into play as against, possibly, the social parents' wishes? That child may wish the certificate to reflect his or her social parents. That child may prefer, for whatever reason, the birth certificate to reflect his or her genetic parents. In some societies, where you need a full birth certificate for entry, there could be possible areas of discrimination or stigma that the child might find difficult to handle.

Thirdly, there is the issue of privacy. We all hope that parents will follow best practice and ensure that their children are aware of their origins, how much they have been wanted and so on. Yet some parents will not. I registered my own child at 10 days or whatever, but there was no subsequent evidence to back that up. The registrar took my word for it that I was the mother and that the person I said was the father was the father. That went on the birth certificate. How are you going to police it if a person should, wrongfully, seek to conceal the genetic origins? There is, effectively, a compulsory reporting system but, as far as I am aware, no way of monitoring the information put on that birth certificate—nor perhaps should there be.

Given all of these problems—I do not know what I think about most of them—I would welcome some sense that we can revisit this issue. Where the consensus lies on any of these issues may change over the next few years, as greater openness, frankness, transparency, scientific information and understanding of the ethical issues come to the fore. As a result, we may find that we can come to a view collectively, as a society and as a Parliament, which reflects a consensus that does not currently exist. If for that reason alone, I hope that if my noble friend cannot accept this amendment today, something similar will be introduced in the other place.

Photo of Lord Alton of Liverpool Lord Alton of Liverpool Crossbench

My Lords, I too support the amendment of the noble Lord, Lord Jenkin of Roding, not least for the sorts of reasons that the noble Baroness, Lady Hollis, has just advanced. It is true that sometimes birth certificates do not tell the truth. As the noble Lord said earlier, the concern of the Joint Committee—as I understand from reading its report—was the difference between an individual concealing truth and the state "colluding in a deception", to use the committee's phrase. The noble Baroness is right; there is a series of complex questions here, some of which we have been unable to resolve during our proceedings. They are questions we should return to. This is a sensible proposal which I hope will be agreed.

As the future unfolds, the changing attitudes that the noble Baroness has rightly identified might well tilt in favour of genetic, biological information truthfully being recorded on a birth certificate—I hope it will. We might also look at producing another document within whatever social arrangements obtain for bringing up a child. A social document can record other questions—perhaps the parents or those bringing up that child want to appear on that document. A social document alongside the birth certificate might be one way forward. I believe that we should not tamper with birth certificates and that they should be a true record of genealogy and lineage. Everyone is entitled to the best possible proof of their origins.

At the fag end of the Bill's consideration, I remain implacably opposed to many of its provisions. That will come as no surprise to your Lordships' House, but I too thank the noble Baroness, Lady Royall, and the noble Lord, Lord Darzi, for their unfailing courtesy and patience in dealing with many of the objections that I and others have raised.

Photo of Baroness Knight of Collingtree Baroness Knight of Collingtree Conservative 6:45, 4 February 2008

My Lords, the noble Baroness, Lady Hollis, is absolutely right when she says the word of the mother or father is taken automatically when they register a birth. I am sure that there will have been cases when wrong information has been put on a birth certificate because it was believed that the mother or father was telling the truth and that it was an accurate record of the parentage of the child being registered.

One can make a strong case that feelings can be hurt by what is on a birth certificate, but once you deviate from the principle that you must put down the truth, you are in all sorts of difficulty. Once we say, to be kind to people and not to hurt their feelings, that we will allow a lie, or, that as the truth is not always told, the truth is not important, then we are really in trouble. It is often hard to face the truth in many instances. But this is an official record, and I support the amendment. Once we deviate, we really are in trouble.

Photo of Earl Ferrers Earl Ferrers Conservative

My Lords, I was getting on famously with understanding this amendment until the noble Baroness, Lady Hollis, stood up. She said that, on birth certificates, you might have to consider the parents' interests and the child's interests. Surely the whole purpose of a birth certificate is to record the facts. I agree with my noble friend Lady Knight that you cannot get away from the facts. To use an extreme but hypothetical example, in some families things go from father to son to son. That is a biological thing. If a mother has a son who is not the son of the father, does that not cause a hitch? For the certificate to say that the son is the father's son because that is the social wish of the parents is wrong. I agree with the noble Lord, Lord Alton, that, if necessary, you would have to have two certificates, one creating and recording the biological facts and one creating and recording the social facts. That seems a funny birth certificate because it does not record the birth at all.

Photo of Baroness Barker Baroness Barker Spokesperson in the Lords, Health

My Lords, throughout the course of this Bill, I have undergone a remarkable educational experience. The education has been confined not solely to science, although I now have an understanding of scientific matters I never knew existed, but to the social sciences as well.

Like the noble Lord, Lord Jenkin, I have paid attention to these matters and listened as fully as I can to the different views of the different parties. I congratulate him on turning up with a slightly new amendment; I do not wish to go back over the debates we have already had. Yet we have moved no further forward than was the case in 1990, when the great brains of people like the noble Baroness, Lady Warnock, tried to find an answer to this question. We simply have not done so. While many people will welcome the amendment as a force behind the department which will make it consider the issue, it is important to remember that for some others it is something to fear, something they will not want to see.

I state again that, although many of us share very deep concern that people should know their genetic identity, we are yet to be convinced that mandatory inclusion of information on birth certificates is the most effective way to ensure that that information ends up with those children. My concern is that the amendment attempts to address the issue in one way only, when that may not be the most effective way. I hope that, if there is any review, it is a very expansive review about the need of children to know who they are and how they get to find out.

Finally, I, too, want to place on record our thanks from these Benches to the Ministers—the noble Lord, Lord Darzi, has got a tremendous first innings under his belt—to the Bill team, who have been exceptionally generous with their time, and to the scientific noble Lords for giving us all some splendid tutorials along the way. To those who disagreed with what I had to say, I found their contributions remarkably helpful at times.

Photo of Baroness Royall of Blaisdon Baroness Royall of Blaisdon Chief Whip (House of Lords), HM Household, Chief Whip (House of Lords)

My Lords, these are indeed complex issues. There has been considerable debate during the passage of the Bill on the issue of recording the fact of donor conception on birth certificates. As I said during Report, the Government fully recognise the importance of donor-conceived children being aware of their origins and we have a policy of openness in that area. We are taking a number of steps in this respect.

The Department of Health is working closely with the Donor Conception Network to support projects to encourage telling donor-conceived children about the details of their conception. We are funding the "Telling and Talking" project, which supports parents who have donor-conceived children to tell them about their conception. We are also funding a second project, which will be working with prospective parents hoping to conceive using donor gametes. The House earlier accepted an amendment that will require a licence condition to be placed on clinics to ensure that people being treated with donor gametes or embryos are provided with information about the importance of telling their child from an early age that they were donor conceived.

However, I fully recognise the point the noble Lord, Lord Jenkin, makes about the need to review the position on the birth certificates of donor-conceived people. It is clear that many noble Lords have given a lot of thought to the needs of donor-conceived people, the importance of knowledge about their genetic history, and the implications of annotating birth certificates in some way. We need to keep in mind the options and consider how people's views on those options may change. Assessing the impact of the Donor Conception Network's projects to educate patients and parents about the need to tell will play a part in that.

I can make a firm commitment that the Government will carry out a review of practices in informing donor-conceived children of the fact of their donor conception and whether there is a need for a change in the law to best ensure that donor-conceived children are informed of their donor conception. We will do this within the timeframe suggested by the amendment tabled by the noble Lord, Lord Jenkin.

The noble Baroness, Lady Howarth, is right to speak of the need for us to be clear about the aims and remit of the review. We must take care. We cannot accept the amendment as tabled, as it refers to the law and practice in this area, but there is no law in place to review in relation to the annotation of birth certificates. I can commit to a review. Placing the provision in the Bill still poses problems, but I understand the reasoning behind the amendment and the strength of feeling in your Lordships' House. I therefore invite the noble Lord to withdraw the amendment and accept the firm commitment I am making, and assure him that I will continue discussions with him and others as the Bill continues its passage in the other place.

Before I conclude, I also want to place on record my thanks to my noble friend Lord Darzi and to all Members of the House who have taken part in these extraordinary debates on such scientific and ethical issues. It has been the most amazing education and a huge privilege to have taken part in discussion on the Bill. I am also very grateful to the Bill team. The Bill has benefited greatly from the wisdom that your Lordships have imparted in debates in this House.

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

My Lords, I, too, begin by adding my thanks to the noble Baroness and to the noble Lord, Lord Darzi, for the way in which they have dealt with the Bill. The noble Lord, Lord Darzi, is familiar with many of the technicalities, but the way in which the noble Baroness, Lady Royall, has coped with some of the noble and scientific Lords has been remarkable. I congratulate them.

On the amendment, the noble Baroness went almost all the way. I am going to disclose one thing that she told me in her telephone conversation this afternoon: that she would work to get something into the Bill in another place. That was not repeated on the Floor of the House. If she could, just by nodding, give me her assurance that, as well as discussing it with us, as she has offered, she will discuss it with her noble friends in another place—

Photo of Earl Ferrers Earl Ferrers Conservative

They are not noble.



Submitted by Francis Barton

Photo of Lord Jenkin of Roding Lord Jenkin of Roding Conservative

No, my Lords. I meant the noble Baroness's right honourable and honourable friends—I am happy to stand corrected—in another place. She is nodding very vigorously; I shall make sure that Hansard records that. On that basis, I think that we have reached the end of the Bill and I beg leave to withdraw my amendment.

Amendment, by leave, withdrawn.

An amendment (privilege) made.

Photo of Lord Darzi of Denham Lord Darzi of Denham Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

My Lords, I beg to move that this Bill do now pass. I just want to say a few words of thanks to all noble Lords. This has been an amazing experience for me, I can tell you. I thank you all for your patience, your support, the scientific support, the legal support, the ethical support and the moral support. I have never been through an experience like this before and it has certainly been a pleasure. I also make a specific point of thanking my noble friend Lady Royall, who has been absolutely brilliant in taking me through this interesting journey. I never thought that I would take a Bill like this through but, more importantly, resuscitate a colleague through it. I am obviously delighted to see that the noble Lord, Lord Brennan, is doing very well. Thank you all for the privilege of this experience.

Moved, That the Bill do now pass.—(Lord Darzi of Denham.)

On Question, Bill passed, and sent to the Commons.