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Baroness Neuberger: My Lords, it is a great honour to become a Member of this august House, whose work I have always admired for its expertise, its dedicated public service and its collegiality. I, like my noble friend Lord Roberts, am enormously grateful for all the kindness and help that I have received since I have been in this House for not quite two weeks. I am particularly grateful to all those on all sides of the House who have stretched out an arm and said, "Don't go there!" and those who have said, "Sit down now!" Like my noble friend Lord Roberts, I know that no offence was intended, and no doubt I shall make many more such errors.
I am also enormously grateful to the staff, who have been unfailingly kind and courteous and particularly goodfor someone without a sense of directionin getting me from A to B. In the day of my introduction to your Lordships' House, when I was unable to work out where the River Thames was, my daughter was much amused to see me walking straight into the
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cleaning cupboard from which a member of staff kindly rescued me. She rather hoped, but was not sure, that I would be better able to deal with some of the issues coming up before your Lordships' House than getting around your Lordships' House. One's family has a habit of cutting one down to size; mine has been remarkably effective.
I welcome the Bill and the intentions behind it. Like those who have already spoken, however, I believe that there are ways in which it could be improved. Some of those are controversial, and a maiden speech must not be controversialthough, for those who know me, I do not promise always to be tame and bland. There are, however, three issues to which I should like to draw the attention of your Lordships' House.
First, while I welcome the fact that the Bill is predicated on the issue of consent, it is important that consent is spelled out rather more precisely. In saying that, I am much influenced by what I saw when chairing a committee of inquiry for the Medical Research Council in the mid-1990s, looking at radiation in MRC-supported research in the 1950s and 1960s.
The inquiry was prompted by serious allegations of abuses of patients' rights, most of which were unfounded. But one study that we investigated was measuring the population exposure to strontium 90. This was, of course, long before the incidents at Alder Hey and Bristol. As a matter of course at that time, pathologists removed thigh bones during autopsies on babies and children and sent them for further study and analysis. While the parents had normally given their consent for an autopsy to be performed, they had no idea that that meant that bones would be removed in that way. When the matter was exposed on television 30 years or more later, it caused great and palpable distress to many parents whose babies had died so many years previously. One woman had been refused access to her daughter to dress her in her christening robe for burial, no doubt so that she would not be able to discover what had been done to her daughter's limbs.
The parents that we talked to felt cheated and abused. They had given consent in the belief that it would help to uncover the causes of their children's death. They did not realise that they were implicitly allowing the removal of significant body parts for reasons that were completely different. Like the right reverend Prelate the Bishop of Portsmouth, I believe that that raises huge pastoral issues with which we need to dealcertainly where precision around the question of consent might help.
If we require that consent be given to the extraction of tissues, it is important that we make it clear that it is fully informed consent. We must recognise that there is widespread ignorance about what an autopsy involves. I welcome the way that the Bill imposes a duty on the Human Tissue Authority to provide public information about this. However, I would prefer to see greater precision about the nature of that information and how it is to be delivered, particularly as we have now heard the Minister announce that there will be a merger with the
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Human Fertilisation and Embryology Authority. To reassure the noble Lord, Lord Winston, I was a very independent member of that authority in the old days. The issues with which those two bodies are concerned are rather different and I would like to know how the information will be delivered.
Information does not lessen the importance of the principle that where somebody gives consent, he should fully understand what he is consenting to. While many scientists and doctorsthe noble Lord, Lord Turnberg, argued for thisurge that consent often be generic and enduring, it is important that that should be only one option for people. People may want to know more precisely to what they are consenting with the gift that they are making of their own bodies and their tissue. If we do not uphold the principle of informed consent, we may well find ourselves back with the scandals of Alder Hey and Bristol.
My second concernmy noble friend Lord Clement-Jones has already drawn attention to thisis the way that coroners' post-mortems are at present excluded in the legislation by Clause 11. This would exclude 90 per cent of the post-mortems carried out in the UK. It is not as if these post-mortems have been free of public concern. In my pastoral experience, I found that they can cause considerable distress, particularly if they are much delayed. The exclusion leaves unresolved at least a part of the major issues that led to this legislationthe discovery that tissue, including whole organs, had been retained largely, although not only, as a result of coroners' post-mortems, such as at Bristol. The primary reasons for the post-mortems were to investigate the cause of death rather than research. But if coroners are not included in this legislation, and new coroners' rules do not appear at the same timeas the noble Lord, Lord Patel, suggestedwith the purposes and authority of coroners' rules and practices made clear and precise, parents and relatives will still not be able to rely on the law for assurance that they will be fully notified about retained material from coroners' post-mortems.
My third point is one that is of great concern to many of the scientific and medical bodies that have shown an interest in this legislation. I am particularly grateful to the Nuffield Council on Bioethics, the BMA and the Royal College of Pathologists for their guidance. While the Bill has been amended to ensure that identifiable residual tissue taken from living individuals can be used for medical education and research, there is still real confusion between activities that are categorised as public health monitoring, those that are clinical audit and those that are research. Since the first two can be undertaken without consent using identifiable tissue and the third may not, real problems may well occur.
One has only to sit in on research ethics committees, as I did for nearly two years in the early 1990s, to know that health professionals very often have real difficulty in deciding into precisely which category the studies that they wish to carry out fall. Unless clear and precise definition is provided, either on the face of the Bill or in codes of practice, some people may feel that they are inadvertently committing a criminal offence by categorising as public health monitoring something
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that ought properly to be categorised as research. Even more likely, and even more worrying, is that other people will be so worried that they might be breaking the law in one way or another that they are likely to discard remaining tissue that could have been extremely valuable for future research.
This is important legislation. No doubt it is capable of improvement to make it even more useful and reassuring to the public and to doctors and scientists alike. I am bound to avoid being controversial at this stage, so I shall end by once again expressing my delight at being able to participate in a debate on a subject of great importance for our society and its attitude to scientific research and informed consent.
Baroness O'Neill of Bengarve: My Lords, it is a great pleasure to follow the noble Baroness, Lady Neuberger, and her outstanding maiden speech. It was humane and wise and everything that those of us who have known the noble Baroness for many years, and known of her great contribution through the King's Fund and in other fora, would have expected. We look forward to future occasions where she can be her real and controversial self. The other maiden speech from the Liberal Democrat Benches was also a great pleasure to hear and an example of outstanding humanity in reflecting on these issues.
I have for some years been hoping to see legislation brought forward on the use of human tissues. Ten years ago I took part in drafting the Nuffield Council on Bioethics report, Human Tissue: Ethical and legal issues. That experience left me keenly aware of the patchiness of existing legislation, of areas that existing law leaves unclear and of the importance of consent. I have continued to take an interest in the topic and must declare an interesta non-financial interestas the lay chair of the Addenbrooke's tissue bank management committee.
When the Nuffield Council on Bioethics reported in 1995, the government were unfortunately not particularly interested in dealing with gaps in the legislation concerning the use of human tissues. Sadly, subsequent events brought a number of further issueslargely to do with tissues removed post mortemto wider and critical public attention. However, in my view the present Bill is still disappointing because it does not deal clearly enough with the issues identified well before the events at Alder Hey or Bristol or with the small minority of cases in which tissue is removed post mortem. We should remember the very great difference in the numbers of instances in which tissue is removed from living patients and when that is done post mortem. The difficulties that occurred at Alder Hey arose primarily as a result of lack of legal clarity about the subsequent use of tissues that had been lawfully removed under coroners' authority in order to determine the cause of death.
I ask the Minister why this Bill has been brought forward before legislation to revise the Coroners' Rules. I believe that such legislation is in preparation and has been in preparation for some time. It is hard to understand why the two pieces of legislation are being
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brought forward in this sequence. It appears to be the wrong order. Why was it thought more urgent to reorganise the vast range of uses of human tissues taken from patients for clinical reasons than to clarify and limit coroners' authority to determine subsequent use of tissue lawfully removed post mortem? If we are worried about the events of Alder Heyclearly we have reason to beour first move should surely be to address those issues rather than to write new laws for the entire range of pathology services for living patients within and beyond the NHS.
Nor, unfortunately, does the Bill as drafted achieve its central purpose of providing clarity about which action will be lawful and which unlawful. It has been widely said that the drafting of the Bill is rebarbative and that the problem, unfortunately, is not just stylistic but structural. The danger, I fear, is that many whose work will be regulated by the Bill will not be able to grasp what it requires because of that unfortunate structure.
Since the Bill proposes considerable criminal penalties, the result is likely to be an atmosphere of intimidation in which professionals and institutions responsible for the custodianship of human tissues used in clinical care and research are fearful of criminal penalties even for actions that they believe to be medically important. If the interests of patients and donors were genuinelysystematicallyopposed to those of the research community, it might be reasonable to regulate very tightly all research on tissues taken from the living and accept that very little research using human tissues would or should be done. However, that is not the situation. The study of human tissue benefits present and future patients and we should constantly ask ourselves, when considering the Bill at subsequent stages, whether the interests of patients and public health are secured or put at risk by the drafting.
It may be saidI believe that it has been saidthat the nature of the drafting does not really matter because the proposed Human Tissue Authority will clarify what is meant and provide acceptable guidelines for those responsible for the proper custody and use of human tissues. I do not believe that that is adequate reassurance when a Bill criminalises so many complex actions. If we are establishing criminal offences, it should be clear in the Bill which sorts of action will attract fines and prison sentences and which will not. I believe that it is not clear. The constant references to beliefs and intentions in defining offences throughout the Bill makes it particularly important that this legislation be comprehensible to clinicians, pathologists, tissue banks and others whose responsibilities it will shape and govern.
I believe that the structural difficulties reach very deep. They begin with the fact that the Bill is organised round an attempt to authorise and regulate only scheduled purposes while failing to prohibit or to regulate purposes outwith the schedule. There are some sorts of actionI do not wish to name them herewhere one has to ask whether action is permissible even if consent has been given with all
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careful process. I believe that the Bill says nothing about those sorts of action. If we are legislating in this area, it is of great importance that we do not begin by regulating what we think is legitimate and imposing heavy criminal penalties on those who put a foot wrong while failing to impose criminal penalties for things that many of us would find seriously disturbing.
There are other areas of difficulty, and many that need clarification. Despite the wholesale rewriting in another place, as other noble Lords have said, the list of scheduled purposesthat is the scheduled purposes in the two parts of Schedule 1remains confusing and, I think, incomplete. I offer two small examples of many but they are not small in practice.
First, the schedule tries to draw a very sharp line between education or training relating to research and other education or training relating to human health, the former requiring consent while the latter does not. However, I have yet to meet anyone knowledgeable who thinks that this distinction can be well drawn in all cases. Advanced clinical training is often done by involving students in clinical research. Secondly, the list of scheduled purposes allows for public health monitoring not requiring consent but it does not appear to allow for other research that is important for public health purposes. It does not, in particular, allow for the unconsented use of data and of tissues for secondary data analysis.
There are many well known examples but I give one that I think will mean something to all of us. When new variant CJD first appeared in the early nineties, it was not known whether it was or was not a clinically new disease. The only way in which it could be established that it was a clinically new disease was to look back at brain tissue from persons who had previously died in many European countries from genetic and sporadic CJD. It was, of course, discovered that it was a new clinical disease. It would not have been possible to seek consent from the very unfortunate people who died of the older forms of CJD in order to ensure that the study of these tissues was indeed the study of a different sort of tissue from that of those who had tragically contracted new variant CJD.
That sort of example must give us all pause in thinking about the interests of patients. That is why I am so glad that the medical research charities are speaking up about the importance of that. We must not forget patients. I fear that the list could go on. We are aware that the Bill has been modified in its passage in another place and greatly improved. None the less, I think that a great deal will have to be changed if we are to end up with workable, let alone satisfactory, legislation.
It has been said that this Bill constructs a sledgehammer to crack the proverbial nut, but that, unfortunately, it misses the nut. I do not think that we can reshape the hammer to ensure that it really hits the nut because for that we would also need to reform the Coroner's Rules, but I hope that with close attention we may be able to do a little to mitigate the damage potentially caused by hyper complex legislation.
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