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I do not have a knee-jerk reaction every time someone comes forward with something that may be of use and advantage to mankind, but I believe, as Professor Yamanaka has said, that we have to ponder these things. We should not retrospectively give consent for something that is not of great urgency; it would not prevent the development of life-saving cures. There are alternatives that we should be using. I hope the Government, before accepting the amendment, will give it a lot more thought.
Lord Winston: My Lords, does the noble Lord accept that all the embryos that have been involved in research have been researched with informed consent, although not specific consent in the way that is required in the Bill?
Lord Alton of Liverpool: Yes, my Lords, I accept that. That is why I would like this to be given further consideration. Where specific consent has been given I can see that, even if someone disagrees with the views I have expressed in your Lordships’ House, given that this is where the law stands today, that would be legal. As the noble Lord has just said, however, consent was not given with a view to this specific line of inquiry, and people should have had the right to know that before they were asked to give consent; if not, this issue would be in danger of discrediting the whole idea of consent. Before we proceed in the wider debate about organ donation, we should weight these matters carefully and try to turn this into not an area of controversy but one around which we can find some agreement.
Lord Walton of Detchant: My Lords, it is difficult to overstate the crucial importance of this amendment for the future of medical research. I am a firm believer in the principle of valid informed consent in the field of medical research, wherever it is possible for such consent to be obtained. I can do no better than to quote a letter in this morning’s Times from the 28 scientists to whom my noble friend Lord Patel referred:
- “we, as stem cell scientists and supporters of biomedical research, are very concerned about the proposed ban on the generation of embryos in such research by the use of cells for which the donors did not, or could not, give specific consent. We fully agree that in the future such consent should be a requirement and that it would be wrong to use previously donated cells if there were good reason to believe that the donor would have specifically objected to their use in embryonic stem cell research. However, many existing cell and tissue samples and cell lines were donated, for any research purpose, by patients (now untraceable) with particular diseases, before this sort of research was even imagined. These cells have been well characterised over many years, or have unique properties and may therefore be the best samples to use for the derivation of embryonic stem cells. Such stem cell lines would be of great value in understanding how diseases develop, as well in the search for therapies”.
“We are alarmed that the Government has expressed opposition to this amendment, even though it mirrors a similar provision in the Human Tissue Act 2004, regarding anonymous, untraceable ‘existing holdings’”.
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“We urge the Government to accept this important improvement to the Bill, which will help to maintain the UK’s reputation as the place of choice for this exciting and world-leading medical research”.
I could not have expressed it better. These stem cell lines already in existence, derived from cells which were donated for research purposes, are an invaluable source which must not be allowed to degenerate.
Baroness O'Cathain: My Lords, I should like some clarification. Proposed subsection (2) states:
When the noble Lord quoted from the letter in today’s Times, he said that many of the cells were given for an unspecified purpose, just for research. What about the ones which were not? Are there records of those who said, “You can take any cell and do anything you like with it” and those who imposed conditions, like people do with organ donation, allowing, for example, the use of their eyes but not their lungs? Is there a significant difference between those who made the point that those cells could be used for anything and those who did not?
Lord Patel: My Lords, just for clarification, the noble Baroness is right. The seven conditions include no specific consent given. So if anybody says that their cells or tissue should not be used, they will not be used.
Lord Jenkin of Roding: My Lords, the noble Lord, Lord Walton of Detchant, in reading out the letter that many of us have read in this morning’s Times, has really made the most important point. We are dealing with a cell bank which has been built up over many years. I suspect that, in the vast majority of cases, the original donors gave consent for research into the disease and that they are currently untraceable. Many of them have been anonymised and in other cases the individuals may not be able to be traced at all.
We are not talking about cells being taken from new donors. I suspect that the noble Lord, Lord Alton, was addressing at least some of his remarks to that. For that, consent will always be required. The amendment refers to cells stored before the date on which this Act comes into force.
There has also been mention of the Human Tissue Act or, as I frequently call it, the Human Tissue Bill. Those of us who spent many rather difficult days in the Moses Room debating the Committee stage of that Bill will never forget it. I am very sorry that the Minister’s predecessor, the noble Lord, Lord Warner, is not in his place, because he had to defend the Government’s position on the Bill when it reached this House. It was stated then—I suspect by many of the same people who have written the letter to The Times—that that Bill would have made most medical research impossible because of the amount of consent that would have been required before any tissues could be used. I always regard the noble Baroness, Lady Finlay of Llandaff, as one of the heroines of that particular battle. By the end of that Committee stage, we had succeeded in putting into the Bill the
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I have a horrid feeling that the Government are making the same mistake that was made four years ago when that Bill came through. This started by thinking that we must have consent for everything and therefore that there must have been consent for whatever is going to be done—even to tissues that were taken before. We were able to establish that that was impossible and therefore unreasonable. After debate, the Government, very wisely, accepted that.
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As I say, the Human Tissue Act is workable. It is hugely bureaucratic, covering far too wide a field, but that is a separate matter. Why must we make the same mistake again? As the noble Lord, Lord Walton, has said, we are dealing with the bank of tissues taken in the past. Therefore, virtually by definition, consent is impossible. The arguments for that, as set out in that letter and in the speech made by the noble Lord, Lord Patel, are absolutely unanswerable.
I hope that the Government will have learnt from their previous error. They had to climb down and realise that if they could do something—make sympathetic noises today—that would be helpful. The amendment might not be right but could be put right in another place. However, we cannot send this Bill away with this requirement for consent for the use of tissues—to which the donor has consented but who cannot be traced—but with the inability to use them without further consent. It seems absurd and I hope to goodness that the Government will listen to the arguments that have been advanced.
Baroness Jay of Paddington: I hesitate to intervene because several points have been raised this afternoon about procedure at Report and I do not want to transgress any rules of the House. However, I wonder if my noble friends on the Front Bench—particularly considering the points just made by the noble Lord, about the arguments from the example of the Human Tissue Act—could find some way of looking at this again before Third Reading.
As I say, I understand the problems involved with introducing new matters at Third Reading in this House. However, there is a great deal of concern in the House, about the nature and substance of issues raised in the very powerful introduction of this amendment by the noble Lord, Lord Patel—and indeed supported by the noble Lord, Lord Walton of Detchant—combined with concerns raised on the regulatory side, if I may put it that way, by the noble Lord, Lord Jenkin of Roding. Is there any opportunity for my noble friends to find some way forward on this?
The Lord Bishop of St Albans: I have enormous sympathy with the proposition of the noble Lord, Lord Patel. I had the privilege of serving with him and others on the pre-legislative scrutiny committee. Part of that privilege meant that we had time to try to be
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Lord Neill of Bladen: My Lords, if procedures allow it, I would like to ask the noble Lord, Lord Patel, to clarify what happens in the real world in relation to these cells. Proposed new subsection (2) states:
That is probably the wrong use of the verb. Are we not talking about an existing bank? We are looking back at a time that the cells were provided and taken. Am I right so far?
- “it does not appear to the researcher that the donor has indicated any objection to such use or storage”.
What would the situation typically be—that we have a bank but we do not know the identity of the donor now? Do we know whether he indicated anything in relation to the cells—whether they were to be used for research or research on a particular character? Had he been asked to provide cells for a particular research project? What do we know and what meaning can be given to subsection (7) in the real world?
Lord Patel: My Lords, am I allowed to answer that? The noble Lord is quite right. Subsection (2) states that they were “lawfully taken” with appropriate consent. Subsection (7) states that:
“Condition F is that it does not appear to the researcher that the donor has indicated any objection to such use or storage”,
of those cells or tissues for the purpose wanted by the researcher. I gave a similar answer to the noble Baroness, Lady O'Cathain. If any conditions were attached, the authority would not allow the researcher to use the tissues, cells or cell lines.
Lord Turnberg: My Lords, I rise to intervene very briefly and only because of my position as scientific adviser to the Association of Medical Research Charities, which wrote the letter to which my friend the noble Lord, Lord Patel, referred. I support his amendment very much indeed. I have one further point: if the suggestion of the noble Baroness, Lady Jay, is accepted, we should think very carefully about what the Human Tissue Act 2004 had to say about the position of consent for the use of tissues that were anonymised or from donors who were no longer traceable. We set up
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Baroness Hollis of Heigham: My Lords, I join my noble friend Lady Jay in urging my noble friends on the Front Bench that if they feel that they cannot accept this amendment outright today for reasons related to its technical drafting, for example, they should take the amendment in the spirit in which it is intended and return to it at Third Reading. All of us on the pre-legislative scrutiny committee—I support every word that the noble Lord, Lord Jenkin, said, and although we have not heard on this issue from the noble and learned Lord, Lord Mackay, he steered us through many a quagmire on that committee—sought to take forward the legislative and ethical content of the previous legislation to reflect the changing scientific world we now face. That changing scientific world and the development of research and so forth depend very heavily on the accrued knowledge locked into the tissue bank on which further research can occur.
Our efforts in that pre-legislative scrutiny process were to produce sufficient headspace in this Bill for those of us who could not see round the corner, while none the less maintaining an ethical platform throughout. To require retrospective consent from donors who may well be anonymous or untraceable is not consistent with either the general thrust of this legislation or the work of the pre-legislative scrutiny committee. I hope very much that my noble friends, having heard the debate today, will reflect and see whether they can help the House by either accepting this amendment today or returning to it at Third Reading.
Lord Slynn of Hadley: My Lords, I have one brief point also about subsection (7). It provides that,
If there is a challenge by someone to the researcher’s subjective opinion about that, is there any way in which that could be examined by an independent body or authority? I am rather anxious about a researcher, hotfoot and full of enthusiasm for his research, looking at this without anybody having the power to look into it and saying that they had had another look and the research was right, or that the research was quite wrong and there was some evidence of objection.
Lord Patel: My Lords, I do not know if I should answer this in winding up, but I will answer now. As I said when I introduced the amendment, both the HFEA and the research ethics committee will have to be satisfied that the researcher applying for a licence has secured the appropriate consent. It is not the researcher who decides, but the research ethics committee.
Lord Slynn of Hadley: My Lords, if that is right, could not the ethics committee, or some other similar body, be brought in to intercede as a further protection? That would satisfy completely.
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Lord Mackay of Clashfern: My Lords, the letter in the Times suggests that the vast majority of the subject matter of this amendment—or, at least, a substantial amount of it—will have been the subject of general consent. If it had been the subject of general consent, it is difficult to see that that consent should be restricted or reduced retrospectively. That would be the result of not giving effect to it.
On the other hand, the letter suggests that that may not be true of all. It is not quite clear that this amendment differentiates in that way between material that is the subject of general consent and other material. I have difficulty knowing how the other material reached the bank. On what basis is it in the bank? As I understand this problem, the general consent provision should operate. If there is no general consent, but there have been some conditions under which the material has reached a bank, that must determine whether it is right to use the material in the way proposed. Therefore, there may be slight differences between the different types that are subject to this amendment. Generally speaking, the idea of using the material for a purpose covered by the general consent already given ought to be perfectly in order. I would think it wrong to try to obstruct that.
Baroness Royall of Blaisdon: My Lords, Amendments Nos. 75 and 107 seek to permit the use of cell lines, a tool commonly used in research, for the creation of embryos in the laboratory by means of therapeutic cloning, without specific consent to this activity being obtained from the cell donor. The amendment would apply in cases where the cell lines are already in existence, and the original donor cannot be contacted to obtain such consent.
Cell lines are immortalised cells kept in the laboratory for use in biological science experimentation. Once taken from the donor, they can be cultured indefinitely and without limit. Scientists gain permission to use these cells by obtaining a general consent from the donor for their use in scientific experimentation. Due to the nature of cell lines, these cells may be cultured for many years. Some in existence today originate from donations made decades ago. Schedule 3 to the Bill preserves the system of consent found in the 1990 Act for the creation, storage and use of embryos and gametes to create embryos, but makes changes to reflect the fact that human embryos can now be created in more ways than simply by mixing human gametes. Additional consent requirements are introduced to ensure that informed consent is obtained before any human material can be used to create an embryo, and for the subsequent use and storage of such embryos. Equivalent consent provisions are also introduced in relation to the creation, keeping and use of human admixed embryos.
In essence, the Bill sets out a framework which ensures that, if a person’s gametes or cells are used to create an embryo, effective consent is in place beforehand. In the case of cell lines, even though the original cells may have been taken from the donor with their consent to research in general, the use of their genetic material to create cloned embryos or human admixed embryos is exceptional, and requires its own express consent. To provide otherwise would
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Before concluding, I shall answer a couple of important questions. The noble Lord, Lord Jenkin, rightly pointed out the Government’s situation in relation to the Human Tissue Bill. The Government take the view that the use of tissue for purposes under the Human Tissue Act is distinct from the use of a person’s genetic material to create a human embryo or a human admixed embryo. The Bill’s provisions reflect the special status of the human embryo and are compatible with the European Convention on Human Rights. For that reason, the issue is different also to the considerations being undertaken by the Organ Donation Taskforce on presumed consent for organs.
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Although existing cell lines could be a useful resource for the creation of cloned embryos, there is scope for an alternative option of using other cells, for which proper consent is in place. This is critical in considering whether using existing cell lines would be compatible with the convention rights. The fact that there are other possible and effective routes for research means that it is not possible to argue that interference with the rights of persons to whom the cell line relates is justified on the basis of scientific need. However, I hear the very strong will of the House that we should take back this amendment and reflect further. Naturally, anything that the Government say or do at Third Reading must be compatible with the Human Rights Act, as noble Lords would wish; but I am very willing to take this back, reflect further and we will report to the House at Third Reading, and say where we can move from there.
Viscount Bledisloe: My Lords, researchers have embarked on programmes of research on the basis that they have this tissue available to them for their use. As I understand it, if the Bill is passed as it stands, all that research would suddenly have to stop at that moment. Is that correct and, if so, can the noble Baroness give me any idea of how much money will have been wasted on the research that has been done so far, but cannot be continued, because the researchers cannot go on using this material?
Baroness Royall of Blaisdon: My Lords, as I understand it, we are talking about the use of tissue whose donors have said it can be used for research; but what they have not explicitly said is that the tissue can be used for the creation of embryos. That is the crux of the problem.
Viscount Bledisloe: My Lords, so this is research that involves the creation of embryos.
Baroness Royall of Blaisdon: My Lords, I should point out that this is Report stage. Therefore, procedurally it is now for the noble Lord, Lord Patel, to respond.
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