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Human Fertilisation and Embryology Bill [HL]

Volume 696: debated on Tuesday 4 December 2007

House again in Committee.

Clause 11 [Activities that may be licensed]:

25: Clause 11, page 8, line 27, after “research),” insert—


The noble Lord said: In the absence of my noble friend Lord Patel—I must confess that I did not expect to be invited to move this amendment—I ask the Minister whether the present structure of the Bill is sufficient to fulfil the objectives discussed when the new regulations amending the Human Fertilisation and Embryology Act 1990 were passed by this House in 2001. The purpose of those regulations was twofold. The original Act was established to improve the treatment of infertility and to assist in the prevention of genetically determined disease. The new regulations introduced in 2001 were introduced to make it possible for, for instance, material developed from embryos to be used in the treatment of human disease.

Amendment No. 26, tabled by my noble friend Lord Patel, states that licences under the schedule should authorise activities in the course of providing therapy. My question, therefore, is whether the present structure of the Bill is sufficient to fulfil that objective, or whether it is necessary to amend it. I beg to move.

I thank my noble friend for moving the amendment for me, and I apologise to the Committee for having been caught up.

The amendment is intended to increase the scope of licences to include creating stem cell lines for therapy. The current provision under Schedule 2 to the Act sets out the activities for which licences can be granted by the HFEA. There are three categories: treatment, storage and research. Schedule 2(1) lists the activities that may be authorised under a treatment licence. It states:

“A licence under this paragraph may authorise any of the following in the course of providing treatment services”.

Section 2(1) of the Act defines treatment services as,

“medical, surgical or obstetric services provided to the public or a section of the public for the purposes of assisting women to carry children”.

That provision remains the same in the Bill.

Paragraph 3(1) of Schedule 2 provides that a licence may authorise the creation and use of embryos for a project of research which has been held to include authorisation of the creation and use of embryos for the derivation of embryonic stem cell lines. Paragraph 3(2) then lists the purposes for which the research licence may be granted.

The Bill includes a new purpose:

“developing treatments for serious disease or other serious medical conditions”.

However, it is a condition of all research licences that embryos created for research purposes may be used only for the purpose of that project.

The problem with that is that there are no provisions in the 1990 Act or the Bill that provide for the creation or use of embryos for the derivation of embryonic stem cells, particularly for the purpose of treating conditions other than reproduction. At present, embryonic stem cell lines from embryos and nuclear transfer for the derivation of embryonic stem cell lines is carried out under a research licence. That will continue until the technology is optimised. However, it is anticipated that, within the next five to 10 years, it will be necessary to derive such ES cell lines specifically for treatment, rather than research. Our current embryonic stem cell lines are all created using rabbit sera as feeder lines.

It is assumed that these lines will not be useable for treatment. I say assumed because they will use such lines in the United States for the first-stage trial in the treatment of spinal injuries. Regenerative medicine treatments will require the ongoing provisions of therapeutic-grade embryonic stem cell lines. These may be derived from surplus embryos from IVF treatment or following nuclear transplant. In the latter case, they will be genetically similar to the patient and can be used for therapy without the need for anti-rejection drugs. Embryonic stem cell lines may also be derived by nuclear transplant using the nucleus of a patient with a specific disease. Such lines will be used to investigate the disease in the laboratory. This may lead to an improved understanding of the disease and the development of new treatments.

We now also have the UK Stem Cell Foundation, which is a government/privately funded enterprise to try to take stem cell therapy to treatment. There are problems with regulatory issues. There is, for example, a high probability that the first clinical trials using ES-derived cells may be approved by the FDA and commence in the US. Due to the differences between the United States and the EU in the regulations that govern standards and the compliance of good manufacturing practice, it will be necessary for any embryonic stem cell for clinical use in the UK to be derived under EU/UK regulations and standards; that is, the cells proposed for the US trial would not be acceptable for use according to the EU cells and tissue directive, which came into force in the United Kingdom in July this year. Many universities and hospital trusts are upgrading their laboratories, even those for in vitro fertilisation treatment, to comply with the current GMP regulations for cell therapy. Our own UK Stem Cell Bank has already been given accreditation for GMP standards by the MHRA and the regulatory authorities.

UK scientists and clinicians are discussing a co-ordinated approach for deriving clinical-grade embryonic stem cell lines for future therapeutic use. At this stage, we do not know how many lines we might require, but we are not talking about thousands. Discussions are going on somehow to identify how many lines of clinical-grade embryonic stem cell lines will be required to satisfy the need for research and treatment. Because of the characteristics of embryonic stem cell lines—some people refer to them as being immortal—they can, if kept in ideal conditions, survive and grow for a very long time.

I do not think that defining the potential therapeutic use of ES cells derived either from surplus embryos from IVF or through cell technology research is satisfactory, or that legislation keeps pace with scientific and medical developments, and I realise that the amendment goes further than allowing licences for research. I am told that some commercial institutions already have clinical-grade embryonic stem cell lines, but they are not produced in this country. Following the report on stem cells by the committee chaired by the noble and right reverend Lord, Lord Harries of Pentregarth, some noble Lords recommended that all embryonic stem cell lines created in the United Kingdom should be deposited in the UK Stem Cell Bank and be available to all scientists for research and developing therapy. That applies here too. My amendment would extend this licence to allow this under licence and under regulation: my proposed new Section 3ZA defines the kind of regulation that would be required, so that the HFEA controls the licences that are awarded.

As the noble Lord, Lord Patel, has informed us, the HFEA currently has the power to issue licences for four types of activities: for treatment, for non-medical fertility services, for storage and for research. The Bill does not change this. Amendments Nos. 25, 26 and 49, tabled by the noble Lord, Lord Patel, would however extend the remit of the HFEA. It would enable it to license the creation and use of embryos for therapy. For instance, it could, as the noble Lord described, be used to derive personalised stem cells from embryos created for that specific purpose. It is important to distinguish that from the use of embryos in a research project, for instance, that seeks to understand how stem cells work. That is rightly within the remit of the HFEA. However, to provide for embryos to be created specifically for treatment or therapy that is not connected in any way to infertility or is part of a research project would be a highly significant development in the use of embryos. It would require very careful consideration. It is a step that the Government are not convinced should be taken in the Bill.

The HFEA’s scope to issue treatment licences is restricted to treatment to help a woman to have a child. Most people would agree that that is a right and proper use of embryos. It recognises the special status of the embryo and acknowledges concerns that embryos should not be created for inappropriate purposes. The use of embryos in research—subject to the research being necessary or desirable for a specific purpose, and the use of embryos for the research being necessary—is also a well established principle within the 1990 Act. The scope could extend to embryos being created and used for therapy in limited circumstances under clinical trials as part of the research licences. However, the introduction of a new type of licence that would allow embryos to be routinely created for therapy if the use of embryos for the therapy was considered to be necessary is an issue of a different order of magnitude altogether.

The noble Lord, Lord Walton, asked whether the Bill fulfils the purpose of the 2001 research purposes regulations. Yes, the Bill incorporates and builds on the research purposes as amended by the 2001 regulations. The list of research purposes is found in Schedule 2(6).

I note the exciting advancement cited by the noble Lord, Lord Patel, and his strong belief that his amendment is necessary to help us remain at the forefront of research. However, it clearly raises fundamental questions about the limits that should be placed on the use of embryos. It raises questions about whether the approval of such use of embryos should still lie with the HFEA or whether, as a medicinal product, it would be more appropriate for, for example, the Medicines and Healthcare Products Regulatory Agency to oversee this. It raises questions about making detailed provision in the Bill for a major technological development that may yet be some time away.

The Government regard this as a highly important issue about the future use of embryos which requires full and informed debate. It may be appropriate to have that debate once the potential benefits of the therapeutic use of embryonic stem cells are closer to being realised. I therefore ask the noble Lord to reconsider his amendment.

The noble Baroness advocates that this debate should take place in the future. Can she tell us whether the Bill’s regulation-making power could be used to extend the HFEA’s ability to issue licences on the basis put forward by the noble Lord, Lord Patel—or would this require new primary legislation?

Perhaps I may return to the point that I raised at the beginning, before the noble Lord, Lord Patel, spoke. It was my clear understanding when the House approved the new regulations in 2001 that the 1990 Act was being amended not to restrict it to approving treatment and research that was meant to improve the treatment of infertility and the prevention of genetic disease; the regulations amended the Act to make it possible to use embryonic material for the ultimate treatment of disease. I apologise if I am mistaken, but my clear understanding was that the regulations intended to allow the use of stem cells derived from embryonic material in human treatment.

I shall have to seek further clarification on the noble Lord’s point. However, in response to the noble Lord, Lord Jenkin, as I understand it, such research licences would require further primary legislation. This issue would not be covered by the regulation-making powers in the Bill before us. If I am wrong on that I shall come back to the noble Lord. As I understand it, however, it will require further primary legislation, but I have further information coming to me at this very instant. Can embryonic stem cells be used for research into treatment? Yes. The Bill allows the use of embryonic material for research into treatment. We are talking about the use of embryonic material for research into treatments and the use of embryos that can be created for therapy. As I understand it, those are two different things, but I stand to be corrected.

As I understand it the Bill will allow applications under regulation for a licence to create embryonic stem cell lines for research purposes. These research purposes include research on treatment but do not include creating embryonic stem cell lines specifically for therapy. My plea was that this is required to make clinical-grade stem cell lines—lines of a sufficiently high quality to have been produced under GMP facilities—available for use in treatment.

The noble Lord is right that we are talking about two different things, and he has explained it far better than I could. What he is seeking with his amendment, however, goes beyond the research that is currently covered in the Bill, and it raises deeper questions, not least the question of whether the HFEA itself should be responsible for regulating such research or whether it should be the Medicines and Healthcare Products Regulatory Agency. There are bigger questions to be explored, and the Government are suggesting that that happen at a later date.

I see the noble Lord, Lord Jenkin, looking queryingly at me. I understand his queries; I have perhaps not clarified whether this needs to be primary or secondary legislation. As I said earlier, I believe it has to be primary legislation, but I will come back to noble Lords.

I was looking more with admiration at the way the Minister manages to cope with some of these extremely difficult issues that, as a non-scientist, I only half understand. That was the only expression on my face.

I hesitate to intervene as a definite non-scientist. I apologise to the Committee for not being here for the very good debate that I understand there was on the previous amendment, which I had my name to. That was due to one of those problems of transport with which we are so familiar.

My concern is the same as the one the noble Lord, Lord Jenkin, was raising: whether or not future regulation and the embracing of a wider concept of the sort of work referred to by the noble Lord, Lord Patel, can be dealt with in the context of this legislation, or whether—since we could be creating a situation where we are retrospectively working on something that is happening, which we have avoided in all the legislation and regulation so far—we could not preview some of the work at this stage, which the noble Lords, Lord Walton of Detchant and Lord Patel, are discussing, in a way that would enable it to be embraced under a broader regulatory umbrella. The latter possibility would not require potentially retrospective primary legislation.

I wonder whether it would be helpful in due course for the Minister to write to everyone who has taken part in order to clarify this issue. My understanding as a member of the HFEA is that if any of the stem cell lines eventually came to be used for therapeutic purposes, that would fall outside the remit of the HFEA. Would the responsibility fall to the medicines and healthcare agency, or to another body? I think that that needs to be clarified.

I shall certainly clarify the position in writing. I have been informed that should we wish to use embryos specifically for therapeutic research purposes, we would need further primary legislation. I note that the noble Baroness, Lady Jay, said that such legislation might be retrospective. I will consider this matter further and write, if I may, to noble Lords before Report.

The Minister used the words “therapeutic research purposes”. I believe that that is agreed under the present regulations: in other words, research leading to the development of therapy. The problem arises out of the prospect of creating embryos solely for treatment purposes, which is a different issue. I hope that that would not require primary legislation, but could subsequently be included under secondary legislation. This is a matter on which I hope that the Minister will write to us. If it is not possible to do that, the amendment of the noble Lord, Lord Patel, has great importance and strength.

I think that I am not alone in supposing that the extension of research into this field is agreed to and welcomed on the grounds that it will lead to therapeutic use. It seems odd, therefore, to suggest that an amendment which simply foresees it should be rejected. Whether there needs to be another regulatory body when it happens is a separate question which I hope could be settled through regulations. The idea of having to wait and go through new primary legislation, with all the endless discussion that that involves, when all that is being done is putting into practice something which we all hoped would happen all along and which was the purpose of the extension that was agreed in 2001, seems to be an unnecessary obstacle in the way of the use that we all hope that this research will have.

Before my noble friend responds to the other inquiries that have been made of him, perhaps I may ask him whether it is intended that, within the scope of the amendment, interspecies embryos also would be used in therapies. Is it open to that interpretation?

No, it is not. Perhaps I may say something that might help the Minister in preparing her answer to us all. When these stem cell lines are used for treatment, EU and UK regulations will require that they will have been produced in what is called a good manufacturing practice environment, which is very strict. If they are not produced in that kind of environment, they will be rejected for use in treatment. Any lines that are produced in other environments could perfectly well be used for therapeutic research, but they cannot be used for treatment. It will take us some time. The facilities required are extremely expensive, costing more than £3 million to set up. It would be daft for everybody to have such facilities; it would be far better for one or two centres to have them and to be given a licence specifically to produce clinical-grade embryonic stem cell lines, with trials, which will be stored in further appropriate, good-quality facilities—our own bank has such facilities. The lines would then be accessible both to research workers and for therapy. We do not have to produce other lines.

Industry recognises this. I know that it already holds several such lines, but it will never give them to research workers or other people for use in therapy; it will use them for its own purposes. They are not being produced in this country, so they are not in our bank. Industry recognises that it needs to prepare clinical-grade, ES cell lines that meet EU and UK regulations. If we can do that for adult stem cells, where we can do without licences, why can we not have clinical-grade stem cell lines from ES cells?

Once more for clarification: the use of embryos for research into potential treatments for disease is allowed. Primary legislation would be needed to be able to use embryos for treatments, when the research has been proven. I note the strong views expressed by noble Lords and am grateful for their forbearance. I shall come back to them in writing, but I am sure that we shall return to the issue on Report.

When the Minister comes back in writing, would she be kind enough to define what she means by “embryo”? Are we talking about something up to the primitive streak or 14 days, or something else? Could we possibly have a name which means that an entity is 14 days old or up to the primitive streak, whichever is earlier, other than “embryo”, which also embraces a much later stage?

I have listened to the debate and thank the Minister for taking the time and effort to write to us. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 26 not moved.]

Clause 11 agreed to.

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

27: Schedule 2, page 54, line 28, leave out “the testing of embryos” and insert “embryological techniques and embryo storage”

The noble Baroness said: At this stage of the afternoon when I was at school we were allowed to put our heads down on the desk for two minutes for thinking time, but I suspect that we are not allowed such luxury here. I rise to move this amendment in the name of my noble friend Lady Barker, who cannot be here today.

We are concerned that training in embryo testing is too restrictive and there is a problem for embryologists who learn new techniques in a licensed research setting needing to apply those techniques also in a clinical setting. Of course, we welcome the reference in the Bill to the training of persons in the testing of embryos. However, the scope of the clause is very limited, being restricted solely to the techniques of embryo biopsy, which will be needed as part of genetic testing. At present, only a handful of clinics in the country are licensed and very few more are likely to apply, since it is so specialised. Someone will, I am sure, correct me if I am wrong, but I believe that only seven clinics are licensed for this technique.

On the other hand, all clinics offer embryo freezing, for which improvements in methods are needed; storage methods are evolving to include a technique called vitrification, in which an embryo is placed in a special protective solution for a very short period and then plunged directly into liquid nitrogen. That is proving better than traditional slow freezing, as it seems to protect the embryo better and provide higher intact survival rates on thawing. However, it is more labour-intensive; it needs skill to handle single embryos, one at a time, and to introduce the vitrification solution into the embryo with such precise timing.

I go into such detail on this matter because it requires very good training before the technique can be applied to patients’ embryos needed in their therapy. It could be practised using individual cells from embryos that are not suitable for replacement into the patient or when there are not enough cells to allow the embryo to be frozen and thawed using traditional methods. Individual cells could be vitrified and stored overnight then thawed the next day to examine how well the techniques have been applied.

In addition, some settings offer techniques such as assisted hatching, whereby the shell of the embryo—or the zona pellucida, as I found out it was called when I did my embryology—has a hole made in it with a laser or acidified solution or is simply thinned to improve the chances of the blastocyst hatching on day five or six when replaced in the womb. So it is to overcome the difficulty of there being too thick a shell around the embryo. There are other techniques whereby fragments that detach from some cells in the embryo or when a whole cell is disintegrated can be removed from that embryo prior to implantation, because it is thought that sometimes those fragments prevent implantation in some harmful way.

I hope that the Government will consider this probing amendment to see whether we can find ways of broadening the range and availability of training in all these techniques that I have tried to explain.

I have considerable sympathy with the intention underlying the proposal set out in the amendment. My only concern is that this part of the Bill is particularly concerned with protecting the programme of pre-implantation diagnosis relating to genetic disease. For example, as I said at Second Reading, the most severe form of muscular dystrophy, the Duchenne type, is manifest in boys and is transmitted by clinically unaffected females or carriers. One can now identify the carrier by various genetic techniques. If one can obtain from that carrier woman an ovum, have that fertilised in vitro by the husband's sperm and allow the embryo to develop to the 16-cell or blastocyst stage, it is then possible to take out a single cell from the part of the embryo that will produce the membranes of the placenta, preferably, and identify whether the gene responsible for that fatal progressive disease is present. If it is, we can allow the embryo to degenerate, as many do in the course of normal human fertilisation. If the gene is not present, we can implant it, thus allowing these women to have normal, unaffected babies.

That is the programme of testing embryos. My concern about the use of the phrase “embryological techniques” is that it embraces a much wider field of embryology, which is concerned with the whole process of development of the embryo into ultimately a foetus and so forth. I wonder whether that broadening, by the use of that particular phrase, is too great in this context.

However, it is important for individuals to be trained in the testing of embryos for the purposes that I mentioned and in the techniques of storing embryos. That is important, but I thought that I should mention the personal reservation that I have about the use of the phrase “embryological techniques”.

Perhaps this is the time I might be allowed to say that the document produced by the department showing how the 1990 Act might be amended by this Bill is one of the most useful that I have seen for a long time. If you attach it as a schedule to a Bill it is called a Keeling schedule. This is a large and extremely helpful Keeling schedule and I thank the department for making it available.

Because of that document, I wonder whether, with the greatest diffidence, I could express my doubt about what the noble Lord, Lord Walton, just said. One can look at Schedule 2 in this document and realise how the Bill will amend the original Schedule 2. The first section is headed “Licences for treatment” and the next section, which is introduced by this Bill, is headed “Embryo testing”. I say this with huge diffidence, but I am not sure that complaining about the words that the noble Baroness’s amendment would insert is necessarily correct. We will come on to embryo testing and I think that this licence, which allows the use of,

“embryos for the purpose of training persons in the testing of embryos”,

is in fact probably right. That is what this is about. I have some sympathy with what the mover of the amendment said, but I am not necessarily convinced that she is right. I say that with some hesitation.

I do not believe that I am making myself clear. The next section is concerned with pre-implantation diagnosis. But before you can carry out pre-implantation diagnosis, you have to have people trained in the testing. That is why I preferred the word “testing” to embryological studies, as proposed in the amendment. That was all I was trying to say.

I wonder whether I might put in a very brief word as I think that my laboratory invented pre-implantation diagnosis. We screened the first patient for Duchenne muscular dystrophy and published that work some years ago. I wonder whether this amendment is necessary. I have had many quarrels with the Human Fertilisation and Embryology Authority over the years, as is well documented, but I have never felt that its ability and effectiveness in making sure that people were properly trained in the various techniques involved in embryology were anything less than adequate. History has shown that it has been very careful in making sure that laboratories around this country have performed up to standard as regards all the techniques involved with embryos. On that basis I am not sure that a further amendment is justified.

I raise a slightly different point but I agree with the remarks that have just been made. To change the emphasis, as this amendment would, from the testing of embryos to techniques and embryo storage puts it the wrong way round. It takes the emphasis away from the human embryo and puts it on techniques. I would be unhappy about such a change for that reason. However, the noble Baroness raised an important point about embryo storage. What is the department doing to monitor the effects of long-term storage? Is there any empirical evidence, as has been suggested by some outside this place, that that can lead in turn to impairment and disability later?

I believe that there may have been some misunderstanding, which has resulted in this amendment—the misunderstanding being exactly what my professional friend Lord Winston described. The training that is required for any clinician to become a competent in vitro fertilisation clinician is normal process. It would include how to store gametes and embryos properly, how to handle them properly, how to identify good-quality embryos and how to make poor-quality embryos good quality by removing the fragment that reduces the chances of implantation. Those are normal training practices. The misunderstanding arises from the belief that this is not allowed under this legislation. I believe that is wrong. It does allow it. It does not include this normal training. The only thing that we are concerned about—that will be dealt with in the next amendment—is pre-implantation diagnosis testing. That testing requires one to have the expertise to carry out the biopsy to which the noble Lord, Lord Walton, referred. That is a completely different issue from that which this amendment is trying to cover. I thought there was a clear understanding that the reason this amendment is not required is that all these training issues are allowable as normal, good clinical training.

In my next life I am going to be a scientist.

Paragraph 2(2) of Schedule 2 to the Bill amends paragraph 1(1) of Schedule 2 to the 1990 Act, which lists what a licence may authorise in the course of providing treatment services. The Bill introduces an additional purpose for which embryos can be used under a treatment licence; that is, in the training of embryologists. The Bill specifies that this use in training is limited to techniques associated with the testing of embryos.

When embryo testing is carried out, a single cell or two cells are removed from embryos at the eight-cell stage. These cells are then tested and the embryo continues to develop. It is, of course, essential that embryologists should be able to practise the micromanipulation technique used in this process.

Further provisions in the Bill also ensure that embryos can be used for this purpose only where proper consent has been obtained from the people whose gametes were used to create the embryo and where the proposed use of embryos is necessary for that purpose. In practice, it is unlikely that a large number of embryos will be used in this way because only those embryos that are not suitable for treatment or storage will be used for this purpose. However, it is important that people should be able, if they so wish, to donate to the training of embryologists in order to benefit future patients those embryos that they do not require for their own treatment.

We are aware of other embryological techniques for which embryologists may wish to use embryos to practise. For example, there is vitrification, which is a technique for storage that requires a very precise process, as explained by the noble Baroness. Additionally, new techniques may be developed in the future that it would be beneficial for embryologists to practise. Training is of the utmost importance. To ensure that embryologists may be trained in techniques other than those associated with embryo testing, and for the sake of future-proofing the legislation in the event of techniques of which we are not yet aware, we were minded to consider the amendment further. However, clearly in doing so we must take into account the concerns that have been passionately expressed today by my noble friend Lord Winston and the noble Lord, Lord Alton. We will consider the amendment further, taking into account the strong views that they have expressed.

In response to the noble Lord, Lord Alton, on long-term research, the HFEA has a scientific and clinical advances group that monitors research, including safety studies in storage. I trust that the noble Baroness will feel able to withdraw the amendment.

I will comment just a little further. I accept the dilemma about which part of the Bill the amendment should fit into. Frankly, only the Bill team can decide that; I do not have the expertise to insist that it should go in one part of the Bill or the other.

The noble Lords, Lord Winston and Lord Patel, spoke very confidently about the training being absolutely fine and everything being wonderful.

That is how it came over. I would have said that a little humility was needed, in that training is never 100 per cent. We can never have enough training. There are seven centres where this takes place, which is not very many. I assure noble Lords that the backing for the amendment has come from many professionals; it is not just from the Liberal Democrat Benches, obviously.

I thought that there were six centres, but there might be seven. That refers to the training related to biopsy for pre-implantation genetic diagnosis. That requires training and it is necessary. The other aspects of training that I think are routine, good, clinical practice training should be allowable without having to be put in the Bill.

I have been through the mill of medical training, and I am sure that it is not like this now, but in my day many consultants and professors thought that the training and education that they gave us were absolutely wonderful and beyond reproach, when actually the students and the junior doctors did not share their view and would have liked much better training. I plead with noble Lords to retain a bit of humility and to look at this in the spirit in which it was intended—to broaden and deepen the training that people can acquire in these techniques.

Having had the assurance from the Minister that the Bill team and the department will look at the amendment, I beg leave to withdraw it at this stage.

Amendment, by leave, withdrawn.

[Amendment No. 28 not moved.]

29: Schedule 2, page 55, line 16, leave out first “abnormality” and insert “characteristic”

The noble Baroness said: I hope that this is a much briefer subject. It is another probing amendment, and I do not speak in any sort of dogmatic way. In embryo testing and sex selection, we feel that “abnormality” in these clauses is too restrictive. My understanding—and I have no experience of this—is that the characteristics of some cells, including genetic features, would occur in an otherwise healthy individual. Such a characteristic might lead to a serious risk of physical and mental disability. The example that I was given was of the apoprotein, which, if carried, gives an individual or even a family a higher risk of dementia or Alzheimer’s disease.

The amendment is asking for information and for the Bill team to look at this carefully and ensure that, by using “abnormality”, we are not excluding characteristics that might lead to disease, even though things are not abnormal at the time. This is a difficult distinction and may be semantics to some people, but it is worth looking at and I would like the Minister and the team to comment on it. I beg to move.

I hope that we will think carefully before making this change. I am certain that it is not the intention of the noble Baroness or that of her noble friend who tabled the amendment to widen this debate to the area of characteristic selection, but I worry that if we change the words in the Bill, that is how it could be misrepresented outside your Lordships’ House. I am glad that the Bill unequivocally prohibits sex selection. We are absolutely right to do that. We have to guard against the mentality that can sometimes lead to wanting designer babies.

A very good new book, Everything Conceivable: How Assisted Reproduction is Changing Men, Women and the World, which the Librarian in your Lordships’ House made available to me, has just been published in America. Interestingly, it was written by a feminist, and I would not necessarily share all her conclusions; but she says that what she calls “yuppie eugenics” can lead to all sorts of pressures when people are tested. I fully accept that this is more likely to happen in the United States than here, but we should always guard against these things. In the book, she says, for instance, that one couple argue about what height their egg donor should be. Another provides a score list, based on looks, education, IQ and sporting interest. Clearly, those are not abnormalities but are characteristics. I hope that the Minister will tell us whether, if we were to change the words in the Bill, it might be open to that interpretation.

I am really concerned about this, because leaving out “abnormality” and inserting “characteristic” opens up a wide area. Characteristics of human beings include colour of the eyes, mental ability, physical ability, or whether they are tall, small, white or whatever. These are all characteristics. This amendment would create designer babies; nothing more, nothing less. We really have to avoid this. What are we doing? We are trying to play God once more. I hope that we are not going down that way.

My noble friend Lord Alton must be surprised to hear that on this occasion I agree with him, because he is right in saying that “characteristic” is too broad. The noble Baroness, Lady Tonge, can be reassured that a mutant gene that might predispose to the development of Alzheimer’s or any other disease could readily be called an abnormality. In that case, it is perfectly appropriate to leave the wording of the Bill as it is.

Embryo testing involves removing one or two cells of an embryo created in vitro at the eight-cell stage. The Bill introduces five principal purposes for which embryos can be tested. These are: to determine whether the embryo has a genetic, normally chromosomal, abnormality that would affect its ability to result in a pregnancy; to determine whether the embryo has inherited a gene or genes from one or both parents that will mean that any resulting child will have or develop a serious medical condition—this is pre-implantation genetic diagnosis, and is what the amendments tabled by the noble Baroness relate to—to determine the sex of the embryo where there is a particular risk that any resulting child will have or develop a gender-related serious medical condition; to determine the tissue type of the embryo where there is an older sibling with a serious medical condition that could be treated with umbilical cord blood, bone marrow or other tissue of the resulting child; and finally, in the event that there is uncertainty as to whose gametes were used to create the embryo.

The purpose to which the amendments in this group relate is in new paragraph 1ZA(1)(b). This allows embryo testing where there is an inherited condition in one or both parents that could be passed on to any resulting child. A further provision relates to this. New paragraph 1ZA(2) specifies the criteria that must be met in relation to the risk of the condition for which the embryo is being tested—for example, that it must be a significant risk that a person with the abnormality would have or develop a serious condition, disability or illness.

The Bill is drafted to describe the genetic alteration that would result in the medical condition as an “abnormality”. Amendments Nos. 29 to 31 and 36 to 38 change “abnormality” to “characteristic” every time it is mentioned. The effect would primarily be a drafting alteration. The same tests would have to be met, regardless of how the trait that causes any given condition is described. “Characteristic”, in the description of the purpose, would not necessarily indicate that there would be something medically wrong with anyone born with such a characteristic. It could be argued that “abnormality” might indicate that. However, new paragraph 1ZA(2) ensures that however the trait is described, embryo testing could be carried out only where the trait gives rise to a significant risk of a person having or developing a serious medical condition.

We appreciate that there may be concerns about the use of “abnormality” in this context—although I note also the concerns of other noble Lords in relation to “characteristic”. There are many different variations of genes and we all have slightly different versions. Some changes will have very little effect, whereas others will result in a serious medical condition. Because of the variation, it could be said to be difficult to say that there is one version of a gene and that this is normal. However, from a drafting point of view, “abnormality” was intended to be interpreted as being a change in the gene chromosome or mitochondria that would result in any particular medical condition being present.

The word proposed by the noble Baroness would not have the same issue associated with it as “abnormality”. It also still ensures that embryo testing for the purpose specified in new paragraph 1ZA(1)(b) could be carried out only where there was a significant risk that the genetic alteration—or characteristic—would result in a serious medical condition being present or developing in any child born as a result of treatment. Therefore, we will agree to consider further the amendments tabled.

Amendment No. 38A also relates to embryo testing where the embryo is at particular risk of inheriting a condition that could result in a medical condition—perhaps when the parents both have a faulty copy of the cystic fibrosis gene. The amendment relates to new paragraph 1ZA(1)(b) of Schedule 2 to the 1990 Act, and new paragraph 1ZA(2) specifies the criteria that must be met in relation to the risk of the condition for which the embryo is being tested—that there must be a significant risk of the child that results having or developing a serious condition, disability or illness. The amendment inserts “may” into this paragraph.

Some conditions that it might be desirable to test for are not fully penetrant. This means that if you inherit the abnormality or characteristic, you will not always develop the condition. Instead, you inherit an increased susceptibility to the condition. This is the case for some types of cancers that can be inherited—for example, some forms of breast and bowel cancer. The Bill would allow for conditions that are not fully penetrant to be tested for, subject to licence by the HFEA. To paraphrase, the Bill states that the inheritable abnormality must result in a significant risk that the condition which it causes is present or developing in the person born as a result of testing. Therefore, if the particular abnormality resulted in a serious condition in nine out of 10 people with that condition, this could be considered a significant risk. Amendment No. 38A would not necessarily open the scope for the authority to license more conditions, as there would still have to be a significant risk that the condition may develop. The amendment could add a level of uncertainty, which would not be desirable.

The noble Lord, Lord Alton, asked whether “characteristic” would include sporting ability. The answer is no—a characteristic would still need to satisfy the criteria leading to a serious medical condition. The noble Baroness, Lady Tonge, asked whether testing for apoprotein would be allowed. We note the comments on conditions caused by apoprotein and will look at this further in the context of the Bill.

I note the views expressed from all sides in this debate, specifically in relation to characteristics, and I am very glad that the amendment has brought together so many parts of the Committee. In view of that, I hope that the noble Baroness will feel able to withdraw the amendment—

It seemed that the line of the noble Baroness’s answer precisely did not draw together various corners of this Chamber. The more she spoke and the more she dealt with “may”, she increasingly edged away from the unity of view of the noble Lords, Lord Alton and Lord Walton, and towards the noble Baroness, Lady Tonge. I think that we need to know whether that is her position or whether she is as clear as the noble Lords, Lord Alton and Lord Walton, that this proposal is too permissive by three-quarters.

We said that we would be prepared to look further at Amendments Nos. 29 to 31 and 36 to 38, but made it absolutely clear that Amendment No. 38A would add undesirable uncertainty. However, we have agreed to look at this matter further and will take into consideration the very strong views expressed in all parts of the Committee, so the right reverend Prelate should feel reassured that we will not do anything about which he would feel desperately uneasy.

When I was first asked to move this amendment, my reaction was exactly that of the noble Lords, Lord Walton and Lord Alton, and the noble Baroness, Lady O’Cathain. Nevertheless, I thought that the Minister gave an excellent response. She clearly accepted all our concerns about children being selected for sporting ability, blue eyes or whatever. Obviously, that would be absolutely horrific and we do not want to go down that road. However, there is a point to be made here: some conditions may not be included in “abnormality”. None the less, I am entirely satisfied with the Minister’s response—it shows that the department has given a great deal of thought to this matter. I am grateful for that and am therefore happy to beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 30 and 31 not moved.]

32: Schedule 2, page 55, leave out lines 27 to 34

The noble Lord said: There is a typographical error in Amendment No. 39. It says “Page 56, line 3” but should read “Page 56, line 30”.

The cumulative effect of Amendments Nos. 32, 32A, 33, 34, 39, 40 and 41 would be to block tissue typing for the purposes of selecting an embryo that is an immune match to an existing child, to prevent children being used for organ donation after tissue typing for any purpose, to prevent the law being extended to allow children to be created to be organ and tissue donors, to limit the circumstances in which the creation of children as organ donors can take place, and to make the creation of children as organ donors a procedure of last resort.

I was struck by the prescience and acuity of a comment in the 25 August edition of New Scientist. It is worth listening to an extract from the article in question:

“It is excellent news that parents in the UK will probably be allowed to have sibling saviours to save children with ‘serious’ rather than merely life-threatening diseases ... Perhaps legislators should now seize the opportunity not only to permit this far-sighted approach, but also to solve the donor organ crisis.

It should be possible to ensure that all children born to a couple are immunologically compatible so that, were one of the family to suffer a catastrophic organ failure, siblings would be on hand to provide another. Naturally, the elected saviour sibling would be required to provide the organ, although since the issue of consent does not arise with saviours at present, there is no need to suppose that this will be a problem in the future.

The scheme would, of course, work best for kidneys, as the saviours could rely on their spare to see them through; half a liver could also be donated without too much worry. A heart and/or lungs would be trickier, but it does not stretch the imagination to suppose that our brave scientists and legislators will be able to see a way around this inconvenience”.

Let us first dispose of the casuistry that saviour siblings are donors. There is clearly something of a contradiction in using the word “donor”, as a donor has to give consent, and that is manifestly impossible in what is proposed. Personal organ donation is often a generous and altruistic act, and many Members of your Lordships’ House will carry donor cards, but it is always an act freely entered into. It is an act of autonomy and personal choice but clearly a baby or a young child does not have any say in this momentous decision. Furthermore, reducing the present hurdle for permitting such an extraordinary presumption from “life-threatening” to “serious” conditions—which, as we know in another context, may mean a cleft palate or webbed fingers—should not be allowed to happen without deep and fundamental debate.

The Bill proposes that an embryo can be tested to see whether it is an immune match for an existing sibling if the existing child suffers from a serious medical condition which can be treated by,

“umbilical cord blood stem cells, bone marrow or other tissue of any resulting child”.

On 21 November, I asked the noble Lord, Lord Darzi, what the words “or other tissue” meant. He left the House in no doubt that it included organs, including organs from non-consenting children who are too young to give consent. He stated:

“The Bill does not limit which tissue can be used in the treatment of a sibling … and the Human Tissue Authority must approve any transplants involving organs from living donors and children who are too young to give consent”.—[Official Report, 21/11/07; col. 869.]

Therefore, if the embryo is found to be an immune match, it will be implanted deliberately to become a source of spare parts for an existing child—its sibling—even when it is too young to give consent.

My Amendment No. 32 goes to the heart of this matter. Many of your Lordships may not be too unhappy about permitting a child to be created to provide tissue from the umbilical cord, but the difficulty is that, once an embryo is tissue-typed and is known to be an immune match for an existing child, it will be available to provide any tissue or organ after birth, even if ostensibly it had been created only to provide umbilical cord blood. I shall say more about this later but I am proposing Amendment No. 32 in order to bring about a complete ban on tissue typing to produce a saviour sibling.

Amendment No. 32A deals with the issue of life-threatening conditions. The Bill proposes that a saviour sibling can be created to provide tissue and organs for diseases in an existing child that are not even life-threatening but merely serious. When the Minister was asked why the Government have changed the criterion from “life-threatening” to “serious”, he replied:

“The pre-legislative scrutiny committee recommended that the Bill should not be limited to life-threatening conditions but should also include serious conditions”.—[Official Report, 21/11/07; col. 869.]

As I said at Second Reading, autism has already been suggested by the chairman of the Joint Committee scrutinising the Bill as one of the disorders for which a saviour sibling could be treated to provide tissue. In an interview with the Daily Telegraph, he said that saviour siblings cannot currently be used to help children with autism but it was an example of the kind of serious condition that the committee believed should be tackled by the technique. It is hard to see what kind of tissue could help to overcome autism. However, if a child could be created to help with autism in an existing child, what else could be classified as serious? That is why I am proposing Amendment No. 32A.

In Amendments Nos. 33 and 34 I propose that saviour siblings may be created only to obtain umbilical cord blood and that the disease that these stem cells can be proposed to treat has to be capable of being treated effectively by umbilical cord blood. As the Bill stands, the term “treated by umbilical cord blood” is very open to interpretation. It would seem not to matter how effectively the cord blood, or indeed any tissue or organ, could help the existing sibling. As the Bill stands, even if there was only a small chance of success in treating the disease, the saviour sibling could be created. That also raises the issue that if a child is created ostensibly only for umbilical cord blood and if the umbilical cord blood was not effective in treating the disease, subsequently any tissue or organ could be used to treat the existing child to see whether that would be more effective. It would be known that the child was an immune match for the existing sibling, as it had undergone deliberate tissue typing as an embryo to ensure that it was an immune match. Therefore any tissue or organ would be compatible. Thus to those of your Lordships who are concerned about the use of any tissue other than umbilical cord blood, both limiting tissue typing of saviour siblings to obtain umbilical cord blood, and inserting the phrase “treated effectively”, should ensure that taking other tissues or organs after birth need not occur.

Amendment No. 40 would permit a saviour sibling to be made only if there is no alternative treatment available, including umbilical cord blood from other donors. Amendment No. 41 deals with offences relating to harming saviour siblings, or taking tissue from them. The first paragraph of Amendment No. 41 proposes that it would be a criminal offence to take organs or bone marrow from a saviour sibling, or to subject it to any intrusive medical procedure in order to treat the existing child. Sub-paragraph (5) in Amendment No. 41 proposes that it would be a criminal offence to take organs from a saviour sibling, while permitting the taking of bone marrow. Sub-paragraph (6) of Amendment No. 41 proposes that it would be a criminal offence to cause harm to a child through any intrusive medical intervention in order to treat the existing child.

Such amendments are necessary to avoid a saviour sibling being created ostensibly for umbilical cord blood, or for cord blood and bone marrow, but then used for organs or other tissues after birth. Using other organs would be possible if there are no safeguards in place, since it would have been implanted, following tissue typing, to be an immune match. I emphasise that this is not similar to using organs from a child created normally, or by IVF, without tissue typing. Saviour siblings are the result of deliberate intervention, involving an optional stage of tissue typing following IVF, to create a child to be a tissue or even organ donor for an existing child. The saviour sibling’s entire existence would be lived with the sentence of knowing that it had been created to be a tissue or organ donor.

As this Bill is currently drafted, we are being asked to legislate in favour of the creation of embryos whose tissue type is a match for a sick sibling. The intention is to carry such embryos through pregnancy in order to harvest the cord blood or bone marrow or other tissues—perhaps a liver or kidney; who knows?—later on in an attempt to cure the child already in existence.

Any parent who has had a sick child—most of us in this House will have been in that position at some time—and certainly any parent caring for a seriously ill child will understandably search desperately for cures, and nothing is more likely to evoke compassion in the hearts of the nation than a plea for help from such parents. We do have a duty as a caring society to offer the services of the very best medicine, and to continue the search for new and successful cures. Medicine, however, cannot function in a moral vacuum and many ethical considerations need to be taken on board, even when dealing with relatively simple issues, let alone a dilemma as complex as this one.

At first instance, this may well seem an heroic solution, an acceptable way to cure a seriously ill child. On the other hand, we may have a gut feeling that something is not right about this procedure. Gut feelings are absolutely valid and often represent the greatest wisdom. Our compassion for the welfare of existing sick children does not legitimise a trade-off with our legal responsibilities for the welfare of children, including those created by assisted reproduction. There is no reason why criminal law prohibitions on battery or abusive behaviour towards children should not apply as much to children created by IVF as to everybody else. In the current legal realm, how could any invasive medical intervention performed on a child not for its own benefit, when it could not possibly give consent, not be argued in law to be an assault against the bodily integrity and right to autonomy of that innocent child?

No child should be created specifically for the benefit of a third party, no matter how pressing the anguish of the parents. That is the absolute principle at stake here, but it must also be added that the therapeutic benefits of creating tissue-matching babies have been inaccurately portrayed to the public as an easy procedure with guaranteed success. It is also usually argued that this is the only, or ideal, therapeutic route. In reality, the chances of the matching baby being created successfully are limited. IVF has a low success rate. Pregnancies do not always go to term. There is no guarantee, even in the case simply of cord blood, that there will be sufficient blood harvested, or that any subsequent transplant will be successful.

The medical team awaiting the birth of a tissue-matching child to provide therapy is placed in an unenviable position, with a significant risk that best practice in pregnancy may be hijacked by the interests of the sick sibling. Worsening of the sick child could inspire thoughts of provoking a premature delivery. Such a response has already been recorded. What if the cord is around the neck of the new baby and needs to be sacrificed in the interests of good obstetric practice? Another reality is that, in order to create the matching baby, many unwanted embryos will be discarded in the process, including those diagnosed as carrying genetic disease and those who are disease-free. It is very much a hit or miss technology and it is criticised for some of the eugenics practices associated with embryo selection in the first place.

And what happens if the donation is not successful or—a rare but real likelihood—if the donation itself causes the death of the recipient, or the recipient dies anyway? Sadly, even when the tissue matches come from uncontentious sources—cord blood banks, unrelated donors and so on—the recipient is not always cured. What burden will that place on the designed baby? It is often recorded that children feel an irrational responsibility for the death of their parents or siblings. The psychological burden put on a tissue-matching child must not be dismissed in a rose-coloured enthusiasm for the benefits that might accrue to a third party. When the Minister replies, perhaps she will say what research has been done on the psychological impact of being a saviour sibling.

Are there any other ways to provide the cures in question? Thankfully, yes, and there is a middle ground here, to which the Committee should give deep and serious consideration, especially between now and Report. The lottery of trying to design a saviour sibling is a lengthy and unreliable process at best, making it immensely impractical and never likely to be universally practised. Instead, we should explore less controversial routes to the desired cures and, in particular, we should support the collection of stem cells from cord blood and invest seriously in this non-controversial and exciting source of transplant material.

Colin McGuckin, the professor of regenerative medicine at Newcastle University, in evidence submitted to the Joint Committee on the Human Tissue and Embryos (Draft) Bill, said:

“Cord blood stem cells, which we specialise in, already treat 85 clinical diseases”.

But it was said in a meeting that I organised in the Moses Room of your Lordships’ House by Dr Peter Hollands, a senior scientist specialising in this area, that 98 per cent of cord blood produced in this country is routinely destroyed. There are, I understand—no doubt the Minister will correct me if I am wrong—only four NHS facilities in this country at the moment that do that collection. Contrast that with the situation in the United States. If we were to store the cord blood from every baby born in this country, we would have a bank of stem cells of infinite value, and if this was practised internationally on the largest possible scale, the therapeutic potential would be extraordinary.

I interrupt my noble friend for one moment to say that there is now a major project under way, funded by the Wellcome Trust and the Medical Research Council and others, to produce a cord blood bank in the United Kingdom, which I think will be immensely valuable.

I am very grateful for the intervention of my noble friend. I know that he has been personally involved in that project and I am delighted that it is under way. That is a very worthwhile step forward. Nevertheless, I think he would accept that at the moment, for us to destroy 98 per cent of cord blood, and to have only four NHS facilities routinely collecting it, is not a satisfactory situation.

It takes a speedy 24 hours to send cord blood stem cell transplant material from one country to another. That is the right way forward—not the unethical practice of designing babies as tissue donors. I beg to move.

I advise the Committee that if this amendment is agreed to, I am unable to call Amendments No. 32A to 35 inclusive, or Amendments Nos. 39 to 41.

The noble Lord, Lord Alton, has set out a range of concerns about these provisions. While I cannot support him on all of them, I join him in expressing a considerable degree of worry about the idea of using a saviour sibling as a source of organs for transplantation. That is the subject of Amendment No. 35.

The whole concept of a saviour sibling lies on the borders of ethical acceptability. The idea of creating a particular child as a means to someone else’s ends devalues that person as an individual. Nor should we ignore the psychological effect that this knowledge may have on the person in later life, something to which the noble Lord rightly drew our attention. Many of us are prepared to reconcile ourselves to the notion of the saviour sibling because of the benefit brought to the other sibling, who would otherwise suffer or die. We are also willing to accept the process because the donation of cord blood does no harm to the donor sibling. Some of us—I am one—are willing to go further and countenance the donation of regenerative tissue such as bone marrow on the ground that, although invasive to the donor, the procedure should not, in normal circumstances, result in lasting harm. However, the donation of an organ, which is what the phrase “or other tissue” implies, is of a different order altogether. Organ donation results in lasting harm. While I have no objection to an adult taking an informed and voluntary decision to sacrifice a kidney, for example, to save the life of a close relation, it does not seem to me that the state has any right to raid the body of a child for any part of him that will not naturally regenerate.

The state is centre-stage here. As I understand it, if there is ever a question of a child donating tissue, the Human Tissue Authority is legally charged with taking that decision under the 2006 regulations. Of course, it must do so on the basis of the common law test of “best interests”, but “best interests” is a concept capable of being interpreted quite broadly. During the passage of the Human Tissue Bill, the noble Baroness, Lady Andrews, said:

“The noble Lord made several points regarding best interests … We would argue that consent may well be in the best interests of a person lacking mental capacity if a carer or relative on whom they are dependent is in need of a transplant or other procedure requiring the use of their tissue, and without which the carer may be in danger of dying and, therefore, not in a position to take care of the person. That is not a far-fetched instance”.—[Official Report, 16/9/04; col. GC 469.]

Those words worried me at the time, and they still worry me. I should make it clear that the context of that debate was the power given to the Secretary of State over the storage and use of tissue taken from individuals who lacked mental capacity. It was not a debate about the powers given to the Human Tissue Authority to determine issues about the removal of tissue for transplant. Nevertheless, the point that I seek to emphasise is the broad way in which the expression “best interests” is capable of being interpreted.

I may be wrong, but I do not believe that, when the members of the Joint Committee considered saviour siblings and tissue typing, they had in their mind anything other than the donation of cord blood and bone marrow. I am not happy with the Bill as worded here. I would be much happier if the phrase “or other tissue” were qualified so as to make it clear that it was confined to regenerative tissue.

If this part of the Bill were to go through unamended, I would worry greatly that it would give the green light to the HFEA and clinicians to sanction the creation of saviour siblings for the explicit purpose of whole-organ transplantation. While such a decision in itself would not tie the hands of the Human Tissue Authority later on, it might well create a momentum and pressure that the HTA would find hard to resist. I hope very much that the Minister will agree to look again at the wording of this part of the schedule.

I intervene for the first time in these proceedings to support the amendments tabled by my noble friend Lord Alton. It is always important that any legislation should be as precise as is reasonably possible. That is especially so when one is dealing with a subject as sensitive as human embryology, on which reasonable people can, as we have learnt at Second Reading and again yesterday, take very different views.

“Life-threatening disease”—the language we heard—was something that we could all understand. I imagine that it would not be too difficult to make a list of life-threatening diseases on which doctors could agree. Why, then, are we changing from “life-threatening disease”? I am of course aware that the Joint Committee took the view that “life-threatening disease” was too narrow, too tight. I understand its reasons and largely sympathise with them, but I cannot accept that “serious medical condition” was the right substitute. We seem to have gone from one extreme—too narrow—to the other, which is far too vague and too wide. It could cover almost anything. I have serious concerns about “serious medical disease” being the right terminology.

However, I have much greater concerns—they were set out so clearly by the noble Earl—about the inclusion of the phrase “other tissue” in sub-paragraph 1(d). Umbilical cord stem cells are again something that we can all understand. The Joint Committee’s recommendation 17 did not suggest any change. It was the Government’s idea to include “bone marrow” and, certainly, “other tissue”, which presumably means any other tissue. That means that “umbilical cord” and “bone marrow” become otiose, but I shall put that lawyer’s point on one side.

As with “serious medical condition”, surely “other tissue” is much too vague? I have read a paper in which it is said that “other tissue” would certainly include organs such as the human kidney. I hope that that is not the Government’s intention, but if it is that raises serious questions. Following the noble Earl as well as my noble friend, I would have great doubts about the morality of creating a child for the specific purpose of donating a kidney to an elder sibling. I would have even greater concern for the effect on the child when he discovers that that is one of the reasons why he has been brought into the world. How, in those circumstances, could we ever be sure that he was donating the kidney truly voluntarily? This is the first time I have intervened in these debates, but we are on very dangerous ground.

I am grateful to the noble Lord and noble Earl for raising these issues. There is clearly widespread concern. The issue has vexed the HFEA now for a good number of years. Some years ago, we approved one application for a saviour sibling for a genetically inheritable disease. Then, we had another application for a disease in a sibling who was not genetic; we turned it down and then reconsidered it. It went backwards and forwards between the ethics and law committee and the HFEA. I say this to indicate to the noble Lord, Lord Alton, that the HFEA gives serious ethical consideration to these issues. However, I am glad that he and the noble Earl have raised the issue because I share a lot of their concerns.

We need greater clarity from the Minister about what is meant by “or other tissue”, as the noble and learned Lord, Lord Lloyd, emphasised. We also need much greater clarity about what is meant by “serious”, if we are not going to use the phrase “life-threatening”. As was said, the phrase “life-threatening” is reasonably clear.

The main point that I want to make is slightly to dispel the impression made by the noble Lord, Lord Alton. All Members of this Committee would agree with the Kantian principle that we should never treat any other human being simply as a means to an end. That is fundamental to any ethical view. However, a woman who is having a baby in this situation probably has a range of motives. She is very unlikely to want to have another child purely for the purpose of helping a sick sibling. Her motives are much more likely to be mixed: a bit of one and a bit of the other. Quite a significant part of her will want another child for its own sake.

The psychological effect on the baby who will be born has been mentioned. The noble Lord, Lord Alton, said that for the rest of its life it would be hanging over it that it had been brought into this world simply for another person. I suggest that the psychological effect could be the opposite: if as the result of the child’s bone marrow a child who was dying is alive, that would surely enhance the sense of the preciousness and value of that child and the gratitude for it within the family. If we suppose that the child had died and the parents had a new child because there was a gap in the family, what would the psychological effect of that be? The psychological effect—this is an unknown, and we are only speculating—is more ambiguous and could be much more positive than the noble Lord suggested.

Overall, I am glad that the noble Lord and the noble Earl raised the matter. There are questions about the Bill, and it will probably have to be amended.

I shall make two points, but as a preface to them I shall say that I strongly support the amendment tabled by the noble Lord, Lord Alton of Liverpool, and I was greatly taken by the arguments used by my noble friend Lord Howe in his lucid exposé of the dilemmas that face us when legislating in this area.

My first point is that this place should legislate only about those things that we can define. It is not that I distrust the courts of the future to help Parliament out or that I am fearful about what some future agency might do, helped on by regulation, to alter things. However, during yesterday’s Committee we had a good example of this. The noble Lord, Lord Darzi, who is in his place, explained that it is very difficult for some of the greatest figures in the medical world to agree a definition of an interspecies embryo. He read out a letter about that. That made me very uneasy because we were discussing legislating about something that the greatest medical brains in the country could not define. Today, the noble Lord, Lord Alton, has brought to the attention of the Committee saviour siblings and the misuse of the word “donor”. A saviour sibling cannot, by definition, be a donor so as presently drafted the Bill uses highly inexact language. I fear that we shall have to struggle with these fiendishly difficult matters of definition if we are to proceed usefully in this Committee and if great trouble is not to be caused on Report.

My second point is the noble Lord, Lord Alton, is right to say that medicine cannot and should not proceed in a moral vacuum. That point was also strongly made by my noble friend Lord Howe. He referred to the borderlands, the uneasy frontier land, between what is ethical and what is not. This cannot be a morality-free zone. For fear that noble Lords may think that I am speaking from a draft helpfully provided by the Roman curia, I have a number of friends who I would describe—one in particular—as high-church atheists. They strongly disbelieve in religion, but they also feel strongly about the moral impropriety of these steps and about going over the frontiers that my noble friend Lord Howe so accurately described.

I am grateful for the speeches we have heard, in particular, for those of the noble Lord, Lord Alton, and the noble Earl, Lord Howe. I want to go the whole way with the noble Lord, Lord Alton, in his amendments. I regret not being able to be present at Second Reading or yesterday, but that has given me the opportunity of reading the Second Reading debate, yesterday’s debate and the preparatory material all at one go. That prepared me to speak now.

I am not convinced by my friend the noble and right reverend Lord, Lord Harries, who turned the question about instrumentality upside down. That seemed not subtler than I could follow but subtler than is acceptable, but he and I have found ourselves in that position before and he will not be surprised at that reaction.

On asking the Government for clarity about “other tissue”, it seems to me that the phrase is precisely designed not to be clear but to be broadly inclusive. I should be surprised if the Minister is able to offer us any clarity about it.

The noble Lord, Lord Alton, spoke about gut feelings. I want to put those into words, as the noble Lord, Lord Alton, would have been able to do, but he had much else to say. Those gut feelings are very widely held. Noble Lords will, like me, have had a lot correspondence on this issue and will know that this is one of the points on which gut feelings have been widely expressed. The view held by the high-church atheists mentioned by the noble Lord, Lord Patten, is widely held whether by those of Christian or other faiths or none, but I shall put it in Christian terms.

At least from the implantation of a fertilised embryo we are a unique character for others, for society, for our maturing, enjoyment and fulfilment, and for God. We grow into the fullness of that unique character in the context of our parents, which is relevant to some of the later clauses in the Bill about fathers, and then under an ever-widening range of influences throughout our lives and, I should say, beyond. It is an archetypal human right that we are that unique character for those purposes. It is our responsibility first as parents to defend that right around our children and for them, then it is society’s responsibility to do so and society, in this context, includes Parliament and the medical professions. If that picture of what it is to be human and of humankind’s responsibility for human individuals is valid, the picture of saviour siblings as imagined in the aspects of the Bill that the noble Lord, Lord Alton, is seeking to remove, or to amend if removal fails, is fundamentally at odds with the picture I have painted.

Enabling the collusion of parents—whom I have suggested have major responsibilities to defend and succour the growth of the infant into maturity—in making this individual an instrument, making legal the engagement of the medical professions in such a creation of instrumentality and the lack of choice in being a donor but being an instrument, is a fundamentally serious thing to be doing, and, in my judgment, a wrong thing to be doing. I say that understanding, to the extent that outside the situation one can understand it, the urgent desire of parents with a desperately, chronically, perhaps even terminally sick child to find any means of approaching this situation, and the perfectly respectable and laudable wish of clinicians, if they may possibly, to assist them to do it. It still seems to me that Parliament would be wrong to allow that. For that reason I support the amendment of the noble Lord, Lord Alton.

Before the right reverend Prelate sits down, can he help me? I am now confused between the concept of instrumentality on the one hand and the issue of consent on the other. I gather from the right reverend Prelate that he is opposed to a second child being conceived through IVF in such a way through screening that that second infant is known to be compatible and therefore in a position to donate an organ or whatever. The right relevant Prelate has said that however much loved the child may be by its parent and however much that parent might have wanted a second child in any case, none the less, turning that child instrumentally into a means to an end is somehow degrading to human dignity.

There is a second issue of consent. What would be the right reverend Prelate’s advice to us were that first child to become ill after that second child was born and it so happened that there was a fortuitous tissue match and that that first child would survive only if the one year-old’s or the two year-old's kidney was removed without that small child being able to give consent to save the life of the first? Does the right reverend Prelate think that both those circumstances are identical? Does he think there is less instrumentality about the second because it is about chance?

The noble Baroness's second example is where the noble Lord’s later amendments come into play. It is entirely one thing for somebody as an adult and in a position to choose to offer some part of themselves for a sibling or a close relative, but quite another for an organ to be removed from a two year-old, which was the example she mentioned, for that purpose. A two year-old clearly is not in a position to give consent or to judge the risks involved. That would be the same whether or not there had been the intention to create this child so that it could do that.

I have already spoken about the intention to create and I have said that I am not convinced by the turning upside down by the noble and right reverend Lord, Lord Harries, of the argument of the noble Lord, Lord Alton, and, by implication, of my argument. The noble Baroness’s second point runs straight into the later set of amendments which would make such removal of organs from a child for another’s good a criminal offence.

No other field has been as extensively analysed by the lawyers as well as by the ethicists. The noble and learned Law Lords of this House gave a judgment in the case of the Hashmi family, who were the first family to be granted permission by the HFEA. Their little son Zain suffered from beta thalassemia major, which might be cured by umbilical cord blood. The HFEA gave permission and was roundly condemned. When it subsequently refused permission in the case of the Whitakers, where diamond blackfan anaemia was at issue, it was again roundly condemned.

The Law Lords gave judgment in the case of Hashmi and found that the procedure was legal and, I believe, ethical. The trouble lies in the Human Tissue Act. It has been said in many quarters that it is a pity that amendments are not being made to the Human Tissue Act on this occasion. Until very recently there would have been no question of a donation from a child who did not have the capacity to consent unless that child was made a ward of court. The judges would consider the case and most likely not give their permission. The fault lies, if there is one, in this new law that the HTA should be giving permission in these cases.

The Law Lords regarded it as legal for umbilical cord blood to be used, although in fact the Hashmis never succeeded in becoming pregnant. The lady in the case did have a child naturally, but that child was not a matching sibling. There is only a one in 16 chance of finding an embryo that is free of the disease and is capable of developing into a saviour sibling. In other words, the law is very narrow indeed. The fault lies, if I have it right, in the removal of the wardship jurisdiction which would protect a child who did not have the capacity of consenting to have an organ taken.

As to “means to an end”, I am sure that Members of the Committee will agree that no one should be used as a means to an end, but until the dawn of the age of contraception very recently there could be no question as to whether there was a good or a bad reason to have a child. People had babies because they came along, maybe to till the land, to inherit a title indeed, or for whatever reason, and there is no question but that parents are likely to love that saviour sibling very much indeed because they have gone to enormous lengths to have it. The Law Lords have been on the side of this procedure. The fault lies in the way that permission might be given in relation to any tissue other than the umbilical cord.

Before my noble friend sits down, perhaps I may ask her a question because of her knowledge in this area. She is quite right. Without the ability to amend the human tissue regulations, which was of course originally part of the purpose of this Bill when it was first presented, we are not able to lay a statutory duty in the context of things like the routine collection of cord blood. Rather more importantly, and on the point she has just made, will she clarify what are the best interest regulations inside the Human Tissue Authority’s code of practice and confirm that they extend way beyond the medical questions to psychological, social and emotional issues? If we incorporate those into these tests that will obviously be a wide area indeed on which to make these judgments.

I am sorry to say that I am not as familiar as I clearly should be with the definition there, but there are legal definitions of “best interests”. In my view, looking back at decisions made in the past, it is very unlikely that a court would give permission for a major organ to be removed from a small child. At least that was the case in the past; the Human Tissue Act is new.

In the discussion of a person being born as a means to an end or treating anyone as a means to an end, the most egregious example of that was the Diane Blood case where sperm was taken from a dying and then a dead man. There are provisions in this Bill which would continue to prevent any such thing, but that is the area to be careful of.

I rise to speak to Amendment No. 35A in the name of my noble friend Lady Barker. I wish I had done this earlier in the debate but I could not somehow get in. Before I do so, I should like to make some brief comments on the debate as it has evolved so far.

To complain that “serious” should not replace “life threatening” is quibbling because surely a serious condition is one which could become life threatening if not treated. Therefore, it would be better to treat it when it is serious rather than life threatening. I really do not understand that amendment. I take a similar view on the amendment about effective treatment. Who knows whether a treatment is going to be effective before it takes place? You hope that the patient will be treated effectively, but you cannot guarantee it.

None of us seems to have any qualms about the use of cord blood from saviour siblings—as we may call them. Having done many bone marrow punctures in my junior doctoring days, I do not have any qualms about bone marrow being used either, but I support the noble Earl, Lord Howe, and the noble Lord, Lord Alton, in their amendment to the phrase “other tissue”. That phrase is very worrying. The Minister needs to explain that. We have heard that it could be interpreted to mean that the organ—a kidney, say—of the saviour sibling could be removed. We have been assured by the noble Baroness, Lady Deech, that that could not occur under the Human Tissue Act. I suggest, moreover, that it could not occur because the mother who, once the baby is born, bonds with it, whatever was the reason for its birth, and loves her children equally, would have great difficulty in going one step further to save the first child.

May I make a small correction? I am not sure what would be the procedure under the Human Tissue Act. I do not believe that it is right for the Human Tissue Authority to be giving that permission. It would be better if we had the old system, whereby a child was made a ward of court and the judges gave permission. I do not know how the Human Tissue Authority would approach that.

I thank the noble Baroness for that intervention. It is something that all of us on all sides of the argument in these debates are clearly extremely concerned about, and it needs to be clarified by the Minister in her summing up.

Amendment No. 35A states:

“in a case where a person (the parent) who is one of the persons whose gametes are to be used to bring about the creation of an embryo suffers from a life threatening condition which could be treated by umbilical cord blood stem cells of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the person”.

In other words, this is a probing amendment to see whether it would be possible—whether the Committee thinks that it would be feasible—for cord blood stem cells to be used to save the life of the parent, perhaps, should they be compatible with the saviour sibling. We need to consider that. If we are doing it for children, why not do it also for the carer of those children?

As I said, it is a probing amendment. We need to hear the Minister's response to see whether the Government will consider it. I look forward to her comments.

I do not intend to make a lengthy speech on this very difficult issue, which bristles with scientific, medical, ethical and social problems, not all of them easy of solution. Speaking entirely personally, I have a great deal of sympathy with the view expressed by the noble Earl, Lord Howe. The idea of creating a so-called saviour sibling to produce an individual who could then be used as a source of human organs—such as a liver or kidneys—fills me with considerable concern.

Having said that, speaking now as an honorary fellow of the Royal College of Paediatrics and Child Health, I am fully aware that a number of serious, life-threatening disorders—I prefer the term “life-threatening” to “serious”, because it is crucial that something of this nature could be used only for the amelioration of conditions that are life threatening— which are genetically determined and occur in infants, are progressive and utterly devastating in their effects. One such is the X-linked disorder called adrenoleucodystrophy, which produces progressive paralysis, fits and a whole lot of other things in young infants. There is evidence to suggest that if that disease exists in a family and is diagnosed early, it is possible—in that condition and in some of the other metabolic and storage disorders of young infants, if we could obtain immunologically compatible bone marrow and transplant it—significantly to ameliorate the condition. In certain instances, there are other conditions in which that could produce a cure.

For that reason, I certainly agree with the noble Earl, Lord Howe, that bone marrow must remain covered by the clause. I entirely understand why he wants to remove the words “other tissue”, but let me postulate something for the future. My personal interest is in research into muscle disease. A number of genetically determined muscular dystrophies exist that are the rare congenital dystrophies present from birth which are the result of abnormal genes. Muscle is a regenerative tissue; it has an enormous ability to regenerate. It is perhaps theoretically possible that one could remove with a needle a small amount of muscle from an individual, culture it and derive from it stem cells that could be used in treatment of the human disease. I am talking purely hypothetically, but I think that to have the term “other tissue” ruled out completely might in the ultimate be very restrictive. The noble Earl himself used the term “regenerative tissue”. That may be a satisfactory alternative.

I agree with the noble Earl and with my noble friend Lord Alton about the concern expressed around the Committee about the creation of a sibling as a source for organ donation.

I first echo support for my noble friend on the Front Bench and for the noble Lord, Lord Alton, in what he is trying to achieve. Secondly, we will clearly have amendments tabled to the Human Tissue Act at Report—

We cannot? In that case, I withdraw that sentence.

The principal concern is the legislation to allow tests of an embryo to take place before implantation to discover whether it will be compatible with a sibling or other person. The noble and right reverend Lord, Lord Harries, said that there would be mixed motives in the generation of such a child and that we should remember the emotions of a mother—the parents—who might want a child whether or not it was compatible.

If the child was compatible and the emotions— the motives—were mixed, the embryo would be implanted and might go to full term. If it was not compatible, the question then arises: what would happen to the embryo? If the mother and father wanted a child anyway, the child would again be implanted and would hopefully go to full term. What is exercising us, as much as the question of the use of a child as something from which to harvest organs—which is a repulsive idea—is the idea that if the child was not compatible, the embryo would be destroyed.

There are three courses, are there not? There is the compatible child, when all that is wanted is a compatible child, which goes to full term; there is the incompatible child that is not wanted for other purposes, which is destroyed; and there is the one for which there are two motives for generation, which also goes to full term. I merely wanted to draw to the Committee's attention the fact that the purpose of the part of the Bill that the noble Lord, Lord Alton, wants to remove is in part to identify embryos for destruction.

Very briefly, I wonder whether I might, without causing too many jitters on my Front Bench, throw a tiny embryological spanner into the works. Perhaps the noble Baroness, Lady Deech, will correct me if I am wrong, but so far, in practice, most of these diagnostic procedures, which are very rare—they have been done only a very few times—have usually been done in collaboration with other countries, for example in the United States where tissue-typing or a gene-specific diagnosis has been made by a pre-implantation diagnosis overseas. How would that be covered by British law under the Bill if it was passed? Should that be considered, because it seems to be quite relevant to our discussions?

As I have said before, we live in a world of freedom of mobility. There is nothing to stop anyone going abroad to have a procedure that is limited or prohibited here. Indeed, the HFEA refused the Whitakers permission to have such a procedure. I understand that they had the procedure in the United States and it was successful. We have no control in that sense, but we live in a world of globalisation so far as IVF and embryology go, as the noble Lord, Lord Winston, knows only too well. All we can do is to set standards in this country and do what we can to counsel people. If we get the law right, we can rely on the judges to uphold and protect it, but only of course within the boundaries of this country.

In the light of the debate, I have reread a bit of the Joint Committee’s report and the evidence on which we made our recommendation that we should substitute “serious” illness for “life-threatening” illness. The argument has been that “life-threatening” was very restrictive and that you could have an elder child—no doubt the noble Lord, Lord Walton, could give us many examples of this—who was bound to live an extremely restricted life as the result of disease but who would not actually die prematurely. We came to the conclusion that it really would be unduly restrictive to refuse permission for a saviour sibling to be used in those circumstances. We based this on the evidence of two distinguished academics, Professor Sheldon and Professor Wilkinson. If anyone wants to read it, it is in their memorandum at pages 454 and 455 of the evidence. Even in the light of this discussion, I would draw the same conclusion reached by the Joint Committee.

The report says, however, that,

“we do not understand why the practice is limited to ‘life-threatening’ conditions capable of treatment using umbilical cord blood stem cells”.

Our evidence was that the phrase,

“using umbilical cord blood stem cells”,

was intended to be restrictive and to create a limitation, so that you could not have a saviour sibling for the purpose of harvesting a kidney or anything else.

I listened to my noble friend Lord Howe speaking to the amendment in his name and that of the noble Lord, Lord Alton, and I do not think for one moment that the Joint Committee would have contemplated a saviour sibling being used for that purpose. I yield to the noble Lord, Lord Alton, who referred to the recommendation, but I do not think that that is what we meant or that I would have agreed to that if it were. I like the idea of regenerative tissue. Bone marrow is a very good case in point. Of course it is regenerative, and there may well be others, but that is what it should be limited to, and I very much hope that we may come back to this on Report and put it into the Bill. I wish to retain “serious” illness and not restrict this to “life-threatening” illness.

I have one other thought. There is a huge difference between the conduct of a joint pre-legislative committee, which we had, and the importance of a debate such as the one that we have had this afternoon. Both serve their purpose, but the pre-legislative committee can never be a substitute for debate in the House.

I am very grateful to the noble Lord, Lord Jenkin of Roding, for his interpretation of and personal feelings about this. I suspect that he will have seen the interview with Mr Phil Willis, the Chairman of the Joint Committee, and heard the quotation about autism which I cited from it. I am certain that that does not reflect his view, but he will see how, given that interview and its publication, there could certainly be concerns that “serious” can be interpreted very differently from the example that he has just given.

I expressed at Second Reading my admiration for the way in which Phil Willis chaired our committee, but I do not agree with everything that he said, which he recognises. No one could be happier than me if the position could be resolved by an amendment to the Human Tissue Act, because, as I explained in my Second Reading speech, I am advised by the House authorities that it is outwith the scope of the Bill and so cannot be done.

I, too, was a member of the scrutiny committee, and I was always unhappy about this definition and the difference between “serious” and “life-threatening”. I take a different view from that of the noble Lord, Lord Jenkin. The definition of a life-threatening disorder can be extremely wide. We face in this country the possible threat of a bird flu epidemic that might kill people. Influenza is a life-threatening disease that has killed many thousands of people in the United Kingdom in the past century. The definition of “life-threatening” is very broad and in many ways is preferable to “serious”, which is open to all sorts of interpretations and is much looser. “Life-threatening” is a better definition and would cover genetic diseases.

I see the noble Lord smiling, so let me give an example. One genetic disease that could be classed as serious but is certainly not life-threatening is colour blindness. I think most of your Lordships would agree that it would be rather unjustified under the purposes of the Bill to screen an embryo for colour blindness, but it might be a serious condition under this vague definition. It is certainly not life-threatening.

The noble Lord knows far more about this than I do, but, with the greatest respect, he has taken rather a strange example. I would not for one moment have regarded colour blindness as a serious illness. It may damage the person’s enjoyment of life in a number of ways, but it is not serious. I hear what he says and I will listen to any future argument on this, but I thought that we were justified in widening the definition. I think that we saw the definition of “life-threatening” illness as much narrower than the slightly broader definition of “serious” illness. That was the weight of the evidence from the two witnesses whose names I have mentioned.

It is always difficult to know exactly what one thought earlier in our consideration of these things. I felt, as I think the Committee as a whole did—probably including the noble Lord, Lord Winston, at the time—that “life-threatening” had in it the idea of a condition that would certainly be very apt to shorten the life of the child in question. This was not quite broad enough to cover a situation in which a disease might accompany a person throughout their life, having a very detrimental effect on it and restricting it without shortening it. We substituted “serious”, which the noble and learned Lord, Lord Lloyd of Berwick, criticises. I would be extremely glad to hear his suggestion of what should go in its place. No doubt I will have the opportunity to do that in due course. This is not an easy matter. I think that we in the Joint Committee were all of the view that this had to be pretty weighty. One does not do this kind of thing for trivial reasons. It has to be for some pretty important reason. For the reason I have explained, we felt that “life-threatening” fell short of the possibility of allowing the consideration of illnesses which might continue for the whole of life yet be extremely restrictive on that life.

If “or other tissue” means more than umbilical cord blood stem cells and bone marrow and is an additional phrase, the paragraph will, in effect, amend the Human Tissue Act by giving a power which, until the Bill comes along, will not exist in respect of a saviour sibling. If that is correct, the House authorities may want to reconsider whether the Human Tissue Act is brought into this Bill sufficiently to enable my noble friend Lord Jenkin of Roding and the Joint Committee as a whole to succeed in their wish to have that Act seriously amended, to deal with the difficulties that the Royal College of Pathologists has identified in its working. If that is right, this may be a way of handling it. This thought occurred to me in the course of the discussion.

We, or certainly I, felt that allowing a testing for the purpose of seeing whether an embryo might be beneficial to another member of the family—I suppose the purpose of such a test is to select an embryo—was something the authority should have the power to license.

The screening and selection of embryos for the purpose of providing stem cells to treat a seriously ill child—so-called saviour siblings—is one of the most emotive issues in this controversial field, as we have learnt today. At the outset I should say to the noble Lord, Lord Alton, that I was deeply disturbed, as I am sure were other noble Lords, to hear the views expressed in the New Scientist in relation to saviour siblings and organ donations.

The HFEA currently licenses on a case-by-case basis the screening of embryos where the intention is that the resulting baby’s umbilical cord stem cells or bone marrow stem cells will be used to treat an existing sibling who has a life-threatening or serious illness. The Bill clarifies the scope of the HFEA to make such decisions. As the noble and right reverend Lord, Lord Harries, and the noble Baroness, Lady Deech, informed us, these discussions are not made in a moral vacuum.

Amendment No. 32 specifically removes the tissue- typing purpose so that it would not be possible to license embryo testing to find out the tissue type of an embryo. When embryo testing was first introduced there were concerns that removing cells from the embryo for testing would have an effect on the health of any resulting children. Although children born as a result of embryo testing are not yet adults, from the thousands of children born following embryo testing there is no such evidence of harm.

In contrast, the benefits offered by tissue typing are considerable. The Bill allows potentially life-saving treatments to be offered for children who are affected by serious medical conditions. In practice, tissue typing is only ever considered when all other options are exhausted—in other words, when there are no match donors on the register or within the family. The HFEA has licensed tissue typing for three conditions. If we were to accept the amendment we would be taking a backward step. As the noble Earl said, we are not aware of any specific risk as a result of embryo biopsy, particularly when balanced against the benefit of treating serious medical conditions. For the sake of children where this treatment is their only hope, we do not think the amendment is appropriate.

Amendment No. 32A was tabled by the noble Lord, Lord Alton. The Bill states that the sibling must suffer from a “serious” condition; the amendment seeks to change this to “life-threatening”. The result would be that, to license embryo testing to discover tissue type, the HFEA would have to be satisfied that the condition to be treated in the sibling was life-threatening. As we have heard, the pre-legislative scrutiny committee recommended that the Bill should not limit to “life-threatening” those conditions that could be licensed by the HFEA, but should also include “serious” conditions. This word was inserted in the Bill—and, indeed, replaced “life-threatening” in the draft Bill—at the recommendation of the pre-legislative scrutiny committee. I am grateful to the noble Lord, Lord Jenkin, for explaining why the committee made its recommendation, as did the noble and learned Lord, Lord Mackay.

I hear the views expressed by the noble and learned Lord, Lord Lloyd of Berwick, and the noble Lord, Lord Winston. This is clearly a matter that we should explore further—I do not know whether in discussions before Report or on Report.

Amendment No. 33, tabled by the noble Lord, Lord Alton, seeks to add “effectively” to the tissue-typing provision. The result would be that it would only be possible to carry out embryo testing for the purpose of creating an embryo from which cells could be used in the treatment of a sick sibling if the treatment were effective. From a legal perspective, inserting “effectively” introduces uncertainty. As with many medical treatments, there is no guarantee that it will work. Also, what would effective treatment mean? Would it only mean where the child would be permanently cured of the condition? What if the treatment could extend the life of a sick child for a year or two, or 10? We are content that the Bill does not allow the creation of embryos where there is no chance that a treatment could be offered to a sick sibling, and that this is sufficient.

Amendments Nos. 34 and 35 would limit the circumstances when embryo testing for tissue typing could be carried out—to allow it only when the older sibling could be treated with cord blood in Amendment No. 34, and with bone marrow or cord blood in Amendment No. 35. Clearly there is much more that we should do to store cord blood, and we welcome the new cord blood bank.

The Human Tissue Authority oversees transplants of bone marrow for children. Along with an independent assessor, it would have to be satisfied that the child’s best interests had been properly considered and that the its codes of practice had been properly implemented. The Government decided on balance that the creation of embryos where the intention was to collect bone marrow for the treatment of a sick sibling was appropriate, subject to these safeguards. Concerns have been expressed about the donation of organs such as kidneys by children born following treatment. Although strictly speaking it could be possible under the provision to test an embryo for this purpose, it is not in any way the intention behind including the words “or other tissue”. I shall return to this issue shortly.

The role of the HFEA in regulating tissue typing is limited to the creation and testing of an embryo. However, there are further regulatory controls imposed by the Human Tissue Authority, which must approve such transplants. The HTA’s code of practice advises that before the removal of a solid organ from a child it is good practice for court approval to be obtained, as the noble Baroness, Lady Deech, explained. In practice, since the HTA took on responsibility for approving organ donations from children in September 2006, it has yet to approve a single case.

The Bill has no impact on the Human Tissue Act or the powers of the Human Tissue Authority. It addresses the grounds on which embryos can be selected, not the subsequent controls on interventions on the child that result. I note what the noble and learned Lord, Lord Mackay, said earlier about the scope of the Bill. We are content that, for the moment, amendments relating to the Human Tissue Authority are outwith the Bill. However, he and others may wish to seek clarification from the House authorities. If we accepted these amendments, the HFEA would not be able to license embryo testing where the intention was to use cells of the umbilical cord or other non-invasively obtained tissue that could be used in the treatment of a sick child.

Amendment No. 35 seeks to introduce the possibility of tissue typing being carried out where the intention is to use this tissue to treat a parent. To date, the HFEA has undertaken a fine balancing act in making these assessments when deciding whether to license embryo screening and selection to create a saviour sibling. I am not convinced that enabling a parent to create a child for the purpose of providing the parent with treatment for a life-threatening condition maintains that delicate balance.

The Bill introduces a regulation-making power to amend the purposes for which embryo testing can be carried out. Amendment No. 39 would restrict that power so that it could not be used in relation to tissue typing except to restrict the circumstances for which it could be carried out. As the regulation-making power is subject to the affirmative procedure, both Houses of Parliament would have the opportunity to debate and approve any regulations that were passed. To ensure that the Bill is flexible, and in light of the parliamentary oversight afforded by affirmative regulations, we do not feel that the amendment is appropriate.

Amendment No. 40 inserts a new paragraph that requires the authority to be satisfied, before licensing tissue typing, that other sources of tissue or therapy available have been thoroughly considered and rejected on reasonable medical grounds. People would not choose to do this if there was another option, as the right reverend Prelate explained. The process involves IVF to create the embryos for testing. Assuming an embryo had the correct tissue type, there is still a significant chance that that embryo would not result in a pregnancy. Although people seeking to use IVF for the purpose of creating a saviour sibling would not necessarily be infertile, the chance of pregnancy is still only likely to be around the 30 per cent mark.

The HFEA produces guidance in the form of a code of practice. For tissue typing, it includes a list of factors to consider, including the availability of alternative sources of tissue or therapy, now and in the future. The authority already takes into account the factors proposed by the amendment. Because of the HFEA’s guidance and the fact that it is extremely unlikely that someone would choose to create a saviour sibling where there was any other option, we think that the provision provided by the amendment is unnecessary.

Amendment No. 41 would prohibit the use of bone marrow and organs from a saviour sibling and make an offence of removing organs from a child born following tissue typing. With the regulatory protection and the very remote chance of people creating embryos for the purpose of removing organs, and to allow flexibility for the future, we do not consider the amendment to be necessary. It would also prohibit the use of bone marrow, which would not be desirable because that would prevent children being able to be treated with bone marrow cells when their life could be saved by such treatment, which generally causes no lasting harm to the donors.

The noble Lord, Lord Alton, asked what assessment had been made of the psychological impact of being a tissue-type child. In its code of practice the HFEA requires consideration of the long-term emotional and psychological implications for any child who may be born. I will write further to the noble Lord.

I acknowledge and understand the concerns that have been raised about the use of embryo-testing technology for the purposes of creating saviour siblings. The Bill allows the treatment of sick children where there really are no alternatives. We think, on balance, that this is appropriate for the majority of the discussions we have had today about bone marrow. However, I have listened carefully to all the concerns raised about the potential for the removal of organs. I feel rather uneasy about that, and I am certainly prepared to take that specific issue back and consider it further. There are perhaps other ways of expressing these issues; for example, “regenerative” may be the way forward. I am not sure that is something we need to discuss, but the Government are prepared to look at the donation of organs from saviour siblings. With that, I trust that the noble Lord will feel able to withdraw his amendment.

I am grateful to the Minister for the offer she has made to reconsider that issue. If she is right that the Bill does not allow scope for the House to amend the Human Tissue Act or the functions of the Human Tissue Authority, why is there on page 101 an amendment to the Human Tissue Act where the remit of the authority is modified?

We have been advised by the House authorities that the Human Tissue Act is outwith the Bill. I will look into this further and come back to your Lordships with clarification from the House authorities.

The Minister has done real justice to this. Along with the noble Earl, I welcome her assurance that she will look again at the issue of organs and that she will be willing to discuss some of the other anxieties and concerns that Members from all parts of your Lordships’ House have raised in Committee today.

The noble Lord, Lord Jenkin of Roding, was right when he said that after scrutiny has taken place and the Joint Committees have had their deliberations, of course people in this House can change their mind on Report as they come to see in the full light of day precisely what we are being required to do. Those who sometimes talk about moving to a unicameral legislature, and would like to see the abolition of your Lordships’ House, ought to see the record of yesterday’s and today’s parliamentary debates to see the quality of the contributions from all sides of this argument. I welcome every contribution that has been made today. This debate more than justifies the existence of this House.

I reassure the Minister that the article from New Scientist was meant to be cryptic. It was actually pointed at the provisions we are allowing for in the Bill, rather than advocating them.

Two issues have been raised during the debate. The first is the question of “serious” rather than “life-threatening”. The noble and learned Lords, Lord Lloyd of Berwick and Lord Mackay of Clashfern, have two of the finest legal minds in the country and I hope that between now and Report they will have the chance to give further consideration to this. It may well be that provisions around the wardships of court, which have previously prevailed, should apply in all circumstances. Maybe that is the route we will have to go, rather than looking at whether we use “serious” or “life-threatening”. We should consider other options for dealing with these questions when they arise.

None of us wants this to become routine—that seemed to be a theme that united us. The right reverend Prelate the Bishop of Winchester said we should not go towards a society that becomes deliberately instrumentalised. I agree entirely.

The noble Baroness, Lady Tonge, raised the issue of “serious” and wondered what the problem was for people like me in the interpretation of that word. During my opening remarks I tried to allude to one instance that is a good parallel here. She will know the case of the Reverend Joanna Jepson, a young woman who challenged the Lords because, on reading the statistics for late abortions, she discovered that cleft palate, club foot, hare-lip, webbed fingers and webbed feet were being included in the “serious” category for abortion of a child. Clearly none of those by itself is a life-threatening disease. That is an issue my noble friend Lady Masham raised at Second Reading. It goes to the heart of how we interpret things. Therefore, we have to be careful before we change a phrase, such as from “life-threatening” to “serious”, that sends a signal, intentionally or not, that somehow we want to lower the threshold of the requirement.

The other issue that has been raised is whether other tissues should be included in the scope of the Bill. I refer to some comments by Dr Simon Fishel, a senior IVF expert and an inspector, peer reviewer and external adviser for the HFEA who has already created saviour siblings to obtain umbilical cord blood, and who is the managing director of CARE Fertility Group, the United Kingdom’s largest independent provider of assisted conceptions. He welcomed the new legislation and predicted, in an article entitled “Secret ruling on ‘designer babies’” by Mark Henderson in the Times, that saviour siblings would be used in future to provide organs such as kidneys to treat existing children.

“You might start looking at organs”,

he has said.

There are therefore IVF experts who would take into consideration the effect on the planned child, as specified in the seventh code of practice, and would consider it a good idea to create a child to be a kidney donor. I do not believe that is the intention of the Committee, and I hope we will be able to make progress between now and Report in dealing with that matter.

I am grateful to everyone who has contributed to the debate today. We have covered some very controversial, difficult and profoundly testing issues. In the spirit of the answer the Minister has given, I am more than content to withdraw the amendment at this stage and hope it will not be necessary to test the opinion of the House on Report. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 32A to 48 not moved.]

I beg to move that the House do now resume.

Moved accordingly, and, on Question, Motion agreed to.

House resumed.