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Lord Redesdale: My Lords, I rise to speak extremely briefly. I feel like an interloper in these debates. I have just worked out that the last time I spoke on a health debate was when the noble Baroness, Lady Cumberlege, was a Minister—which was one or two years ago. This debate is very broad and covers many emotive subjects. However, I have a very small point—given the tone of the debate, some might call it slightly insignificant—to raise. I say that especially as the debate has attracted three maiden speakers. We have already heard two excellent maiden speeches from these Benches.

I support the Bill and will do nothing to try and derail it at any point. I am not speaking from the archaeological perspective, as archaeologists who deal with human remains which are more than 100 years old are not really covered by the legislation. Sometimes I think that archaeologists should be covered. I have friends who have gone round on buses touting bones in plastic bags for analysis. However, that has more to do with the financial strictures applying to archaeology than it does with the morals of archaeologists.

The small point I wish to address appears in Clause 52 and regards museum de-accession. The Minister has slightly shot my fox—if I may jump to
 
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another piece of legislation—by answering some of the questions that I wished to raise. I thank him and his colleagues in the DCMS for the help they have given on this issue, and especially for the letter of 20 July from the noble Lord, Lord McIntosh.

Museum de-accession obviously affects museums in different ways. It is important for many reasons that museums are able to remove human remains. The Museum of London, for example, faces the cost of storing thousands of bones collected during its digs in the cemeteries of London. The issue needs to be resolved. There is also a very real need to meet some of the moral ambiguities created by ethnographical collections, some of which are not very old. It would be not only against agreements drawn up in 2000 between our Prime Minister and the Prime Minister of Australia but I think morally objectionable to fail to repatriate some of those remains which, in museum terms, have been presented surprisingly recently.

However, Clause 52 causes me some concern. The American example provides some guidance. The Minister said that judicial review proceedings brought by parties seeking the return of human remains is one of the issues we will examine. The clause could cover that issue, and I know that the DCMS is looking at addressing it. In his letter, the noble Lord, Lord McIntosh, says:

He goes on to say:

Although that seems to meet many of the concerns that I wished to express, the fact that it refers to "some protection" rather than "full protection" against judicial review, will leave museums in lingering doubt.

On that point I have one small question, which the Minister might not be able to answer now. Considering that the review is taking place in a few days, starting next week, I doubt that it will be able to come to a conclusion before the next stage of the Bill, which will leave some issues unresolved when we debate further aspects. If the Minister cannot give me an answer today, perhaps he could write to me on whether it would be appropriate for secondary legislation guidance to deal with these issues so that any threat of judicial review by parties or even governments seeking the return of, say, mummies or valuable artefacts that have human remains bound to them could be dealt with. That would avoid causing museums, whose financial reserves are limited, a degree of worry.

Lord Walton of Detchant: My Lords, rarely, if ever, are we privileged to hear three maiden speeches in a Second Reading debate. We have already heard two exceptional such contributions from the Liberal
 
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Democrat Benches and I look forward with keen anticipation to hearing the contribution from my noble friend Lady Murphy.

More than 50 years ago, when I was a junior doctor training in the field of neurology, one of the most difficult and sensitive tasks that I was ever asked to perform was to talk to bereaved relatives, seeking their permission to arrange a post-mortem examination on their deceased relative, whether an adult or a child. Such individuals very occasionally refused but most often agreed to that request in the knowledge that the findings at post-mortem would be of no value to the deceased individual but might be of very great relevance to future individuals suffering from similar illnesses because of what might be discovered on examination of the organs. I clearly recall making it absolutely clear to them that the organs had to be removed and studied after death.

What has not come out in much of the publicity surrounding the so-called Alder Hey and Bristol scandals is that, in neurology, if one is to examine a brain in order to determine the diagnosis and the cause of death, the brain must be removed and then fixed in formalin for a minimum of two weeks before it can be sliced, examined and its tissues looked at under a microscope. In those two weeks, of course, the body has been buried or cremated. As a junior doctor I used to tell bereaved families that when the results of a post-mortem were known—and that might take several months, because examination of the cut brain and also the slides derived from the tissues subsequently might take several weeks or months—the general practitioner would be informed. I cannot recall a single occasion in those early years where I or the pathologist involved was ever asked to return the organs that had been examined for that purpose.

Having said that, I am gravely concerned, as others have been, about the distress caused to the parents of children in the Alder Hey Hospital from whom it was found that organs had been removed and stored without consent. I regret to say that a convention appeared to develop over the succeeding years to the effect that giving permission for a post-mortem involved the removal and retention of organs, and that was something of which many people in the general community and many patients were not aware. I agree entirely that informed consent is a crucial issue in this field.

I am talking about neurology, but the same principles apply to many other organs; hearts, kidneys, lungs and so on. If we had not been able to retain brains for examination, we would never have discovered the site of the principal changes in the brain in a disease such as Parkinsonism. We would never have discovered the chemical basis of those changes, which ultimately led to the development of a precursor of dopamine, which was missing from those brains, as a form of treatment in l-dopa and its derivatives, which has transformed the management of that condition.

Brains too were removed from patients with Alzheimer's disease, who themselves at the time of death were incompetent and incapable of giving
 
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consent, with the permission of responsible relatives. Many years ago, in my city of Newcastle-upon-Tyne, the changes in those brains of patients with Alzheimer's disease were compared and contrasted with those found in the brains of non-mentally impaired elderly individuals who had undergone post-mortem for other reasons. It was those changes that led to the discovery of cells that were responsible for Alzheimer's disease and also for the biochemical changes that showed an absence of a substance called acetylcholine, which in turn led to the introduction of so-called cholinesterase drugs which, although not a cure, have had a beneficial effect in many such patients.

As my noble friend Lady O'Neill said, we would never have discovered the relationship between new variant CJD on the one hand, and bovine spongiform encephalopathy on the other, if it had not been for the fact that the brains were compared with those suffering from sporadic CJD. Nor would we have discovered the fact that a progressive and fatal form of encephalitis was due to the persistence in the brain of the measles virus over many years.

I could give innumerable other examples. It is clear that the development of new and sophisticated techniques of examination has made it absolutely vital that archival material, which has been stored in laboratories over many years, should be made available for research purposes. New techniques may reveal unexpected findings which were not apparent many years ago. Such stored material, including the gross specimens but also the histological slides for microscopic examination, is vital in the training of young pathologist and clinicians in order that they might relate the changes that are seen in sections of the brain on one hand to the clinical symptoms that the patients previously experienced on the other.

One of the best training aids for young neurologists that I have experienced in my professional career, and which I first saw when I worked in the United States in 1953, was the so-called brain cutting session, where the patient's clinical findings were described, the radiological and other investigative findings were described, and then those were compared with the changes that were discovered in the brain. That led to new light being cast on many well recognised diseases such as stroke, and also led to the recognition of conditions not previously known, which in turn had a profound effect on the management of patients subsequently presenting similar symptoms.

Of course, I favour the principle of informed consent. The days of doctor's orders are long past. The practice of medicine is a partnership in which it is up to doctors to recommend to patients what they regard as the most appropriate management of a condition; it is up to the patients to decide whether to accept that recommendation.

The same principle of informed consent must apply to the use of tissues and organs from individuals obtained at post-mortem whenever feasible—I repeat, whenever feasible. Of course, the same principles have been applied to the examination of tissue and fluids
 
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from living individuals—not only for the removal of growths, cancer, tonsils and other material, but also for the very common use of the biopsy method where biopsies of tissues of various kinds are taken in order to determine what disease is present.

In my experience while working many years ago on muscular dystrophy and other muscle diseases, we commonly took specimens of muscle and examined them under the microscope—muscle biopsy—with the full informed consent of the individual. That had a profound effect on our recognition of new and previously undiscovered diseases of muscle. I am glad that such biopsy specimens, blood samples and other tissue samples have now been subject to amendment of the Bill in another place so that they may be used for education and training without explicit consent.

However, the issue of research is much more crucial. The Bill requires that such tissues can be used for research only with the approval of an ethical committee, with which I heartily approve. But they must also be subject to anonymisation so that the individual patient cannot be identified. I regard that as totally impractical. If I were to go back to my old department, which I shall not do at my age, to look at biopsy specimens for research, using new techniques of examination for research purposes I would inevitably recognise the samples that had been taken from patients who were under my care.

Will any doctor who carries out research on tissue that has been removed—with their approval and that of the individual—be guilty of a criminal offence? That area must be considerably modified. The whole issue of obtaining informed consent for research in those situations could place an intolerable burden on researchers.

As my noble friend Lady O'Neill and others have said, coroners' post-mortems are very important. They can remove tissues without any consent. In the Bristol inquiry, 90 per cent of the hearts removed were for coroners' post-mortems. Under law, the coroner was entitled to retain those organs until he was satisfied that the necessary investigations had been completed. Once those investigations had been completed, if the organs were to be used for research, the whole question of explicit consent, ethical approval and so forth arose. How, after many months and sometimes years, could such permission readily be obtained? I am sure that the Coroners Rules need to be modified.

There are many provisions in the Bill that are welcome. The establishment of a human tissue authority has a great deal of merit, although I am much less sure about the proposed merger between the HTA and the HFEA. In 1989, when I first became a Member of this House, my baptism of fire was the Human Fertilisation and Embryology Bill. I believe that the responsibilities of the two authorities are likely to be very different.

It is crucial that the Human Tissue Authority should include within its membership not only a majority of lay people but also pathologists, scientists and others who may not have the same authority or expertise in relation to in vitro fertilisation, which is a very important issue.
 
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Turning to licensing, in a department of pathology at a university, presumably the head of department—a professor—will hold the licence and can delegate work under that licence to other members of his staff. In a regional hospital where consultants are of equal standing and no consultant as a rule supervises another, does every consultant have to have a licence? Is the licensing requirement also applicable to those working in clinical biochemistry, virology, microbiology, immunology and haematology? Must they all have licences from the authority?

Regarding tissue transplantation, I would like to have the Minister's confirmation, which I believe he gave, that stem cell lines, like other tissue lines, are excluded from consideration under the Bill. But what is the position with regard to bacteria? A swab is taken from a human orifice which is then plated on to an agar plate so that the bacteria can grow, as Sir Alexander Fleming did years ago in his laboratory in St Mary's Hospital. The plate was contaminated with penicillium notatum and resulted in the discovery of penicillin. Would every line of bacteria grown in that way need to have implicit consent? Moreover, would the same apply to viruses? Will we have to have a very important matter relating to the discovery of new diseases like SARS dealt with like this? Can the Minister clarify the point?

I believe that this Bill has come back from another place greatly improved, but it is still significantly defective in several respects. We need to know more about its relationship to the Mental Capacity Bill and about the proxy individuals who will be able to give consent on behalf of incompetent individuals. Anxieties remain which have been referred to by many noble Lords today.

I hope that the Minister will use the shining hours of the forthcoming Recess to study carefully the briefings we have received from the Royal College of Pathologists, the BMA, the Royal Society and from the BioIndustry Association. I say that because it could well be that the Government, in their wisdom, may bring forward even more sensible amendments by the time the Bill is considered in Grand Committee.


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