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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
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Lord Jenkin of Roding: 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?
Lord Walton of Detchant: 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.
Baroness Royall of Blaisdon: 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.
5 pm
Lord Patel: 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.
Baroness Royall of Blaisdon: 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.
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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.
Lord Jenkin of Roding: 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.
Baroness Jay of Paddington: 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.
Lord Harries of Pentregarth: 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.
Baroness Royall of Blaisdon: 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.
Lord Walton of Detchant: 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.
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Baroness Warnock: 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.
Lord Alton of Liverpool: 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?
Lord Patel: 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?
Baroness Royall of Blaisdon: 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.
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Lord Elton: 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?
Baroness Royall of Blaisdon: I shall do my utmost.
Lord Patel: 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.
Schedule 2 [Activities that may be licensed under the 1990 Act]:
Baroness Tonge moved Amendment No. 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
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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.
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Lord Walton of Detchant: 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”.
Lord Jenkin of Roding: 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
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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,
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.
Lord Walton of Detchant: 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.
Lord Winston: 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.
Lord Alton of Liverpool: 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?
Lord Patel: 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.
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Baroness Royall of Blaisdon: 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.
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