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Baroness Warwick of Undercliffe: My Lords, I, too, compliment the noble Baroness, Lady Neuberger, on an exceptional maiden speech. Despite being uncharacteristically uncontroversial, she has set out the agenda for our future debates on this Bill. I congratulate her.
After what has been said by so many speakers already, I hardly need to remind the House that universities have a leading role in clinical teaching and research involving the use of human tissues and organs. I declare an interest as chief executive of Universities UK.
I fully support the Government's aim of introducing legislation that will prevent a recurrence of the distress caused by retention of tissue and organs without proper consent by providing robust safeguards. In bringing forward legislation to regulate the storage and use of human organs and tissues for purposes such as teaching, research, transplantation, public health monitoring and public display, the Government have rightly placed the primary emphasis on improving public confidence in the ethical and professional standards that underpin such uses.
I warmly welcome the amendments made to the Bill on Report in the Commons. They addressed the majority of concerns articulated by those working in universities and clinical settings regarding the unintended and unduly restrictive aspects of the legislation in relation to the conduct of medical research. Nevertheless, as so many others have said in the debate, further steps still need to be taken, to ensure both that the Bill is effective and that it achieves the clarity and public confidence that we all wish to see.
As other noble Lords have said, a number of concerns have been expressed by the key bodies with an interest in the future of clinical research, including the Academy of Medical Sciences, the Association of Medical Research Charities, Cancer Research UK, the MRC, the Wellcome Trust and the Royal Society. Those concerns range from the need to clarify that consent to use tissue for research is both generic and enduring, through to the need to clarify the roles, duties and liabilities of designated individuals named on licences from the Human Tissue Authority.
A concern of which I am mindful is the need for greater clarity regarding the process of ethical approval. It will be necessary to establish who is authorised to grant such approval. Without clearer guidance, research ethics committees are likely to err on the side of caution, with the consequence that research with direct patient benefit would be unnecessarily inhibited.
What unites those various concerns is the need to provide reassurance that the implications for clinical teaching and research have been thought through fully. Despite the improvements which have been made to the Bill, there are still too many issues where the consequences for teaching and research do not seem to have been adequately addressed. One issue of particular importance is the need for reassurance regarding the
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process by which secondary legislation will be conducted. It is imperative that there is appropriate consultation with the medical and scientific community in that regard. Various steps could be taken to address that need. I support the proposal made by the Royal Society that legislation should explicitly state that the membership of the Human Tissue Authority should include representatives of the scientific research community.
Given the critical importance, however, of the codes of practice in determining the detailed processes of authorisation and consent, and in light of the level of uncertainty which clearly still prevails, I urge my noble friend the Minister to take a further step. In order to provide the certainty required, the most appropriate way forward is for there to be parliamentary debate on how the codes of practice will work. I hope that my noble friend will feel able to accept that, or at least confirm that the essential secondary legislation and codes of practice will be in place before the substantive provisions of the Bill commence.
Lastly, there is a specific issue which may not have been fully appreciated. The legislation has significant implications for a wide range of staff, and there is a need to consider the role of those not directly involved in clinical research. Non-research clinicians are a vital link in the chain of medical research, due to the role which they play in securing consent to obtain human tissue for future research purposes. We therefore need to ensure that appropriate provision is made for advising such staff on all relevant aspects of the consent process.
Considerable progress has been made in achieving a balance between the rights of patients and their families, and the need for biomedical research for public and patient benefit. I urge the Minister to build on that achievement by providing the comprehensive reassurance and clarity required during the scrutiny of the Bill in this House.
Baroness Cumberlege: My Lords, I should like to start by declaring two interests: first, I chair St George's Hospital Medical School and, secondly, I am a trustee of Cancer Research UK. I should also like to join those of your Lordships who joined up to the lay brigade.
I seek some advice from the Minister. It used to be a House convention that to be allowed to contribute to other parts of a Bill one had to speak at the Second Reading. There were two purposes to that. First, the Minister found out who was interested in the legislation and, secondly, it let interest groups know who they could contact to express their concerns. I just wonder if that convention has withered, because if it has I would not be here this afternoon to speak. Like my noble friend Lord Newton, I would be here to listen and support. But although I would not have spoken I would have attended this afternoon because these issues are so important and crucial and we have had a debate that has been enriched by two maiden speeches of the highest quality. I am grateful for those and there is one to come from the noble Baroness, Lady Murphy.
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I have the privilege to serve on the Select Committee examining the issues surrounding stem cell research and cloning along with the noble Baroness, Lady O'Neill, from whom I learned so much. As is usual practice with such committees we took evidence and in my naivety I expected enormous resistance from the scientific community to regulation. In fact, the contrary was the case. Time and again the researchers and the scientists who we interviewed said that they welcomed regulation because it enabled them to understand where they stood and how far they could go without contravening the law.
I visited Poland just after the introduction of democracy where, interestingly, there was great concern, particularly among obstetricians and gynaecologists, about the conflict between the Church and the state. It was a pincer movement because the Church banned abortions and the state encouraged them. The Polish people said how much they admired this country because we could debate these issueseveryone could have a shout and even if one did not agree with the outcome of the debate, at least one had had one's say and there was a chance for everyone to have their voices heard.
Today we are listening to the science community which has expressed a view that, again, it is not against regulation but it is against unnecessary bureaucracywhich is so damaging, which saps energy and which erodes the inquiring mind. No one today has disputed the intentions of the Bill and we all agree that a degree of regulation is possibly essential, but it is the degree which concerns us.
In his opening remarks the Minister outlined the history. Without a doubt what happened at the Royal Bristol Infirmary and at Alder Hey was off-limits. More than that it was actually illegal and it shook not only the scientific and medical worlds but society as a whole. The law was there. The problem was that it was not respected or upheld. I agree with the noble Baroness, Lady O'Neill, that we have to ensure that we are not taking on issues which are already partly resolved and that we are not simply gold-plating what is already there.
Looking back at what happened, it is interesting that the concern was centred on post-mortem practice, whereas much of the Bill is not about post-mortem practice but ante-mortem practice. I very much agree with my noble friend Lord Jenkin, who said that when the issue blew up the Government's response exacerbated the situation. However, the NHS is always diligent and is always trying to put things right. In this case, I know that at St George's every specimen was examined to ensure that it complied with the law and with good practice.
The noble Lord, Lord Winston, spoke of over-reaction. In my view, some other institutions did over-react. Medical studentsyoung peoplewere paid to telephone parents to inform them that the institution still had body parts belonging to a child. I know of a woman who, 20 years previously, lost a baby in the eighth month of pregnancy and was telephoned. I am sure that she was told as kindly and compassionately
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as possible but that call reopened a tragedy that she had managed to put behind her. Again, I think that that was an over-reaction. As legislators, do we not have to be careful not to over-react but to get the balance right?
I very much respect the Minister and the department's officials, who I know have been extremely diligent in talking with and meeting groups, and they have sought to achieve that balance. But, as a former health Minister, I also know how easy it is to over-react. When a problem arises, the pressure is enormous and there is a huge clamour for the Government to do something. The classic response is an inquiry, which we know takes evidence chiefly from those affected. It addresses specific issues, sometimes, I believe, without seeing the much wider implications of assessing the unintended consequences.
Among its recommendations, an inquiry will often call for legislation. Quite properly, that is for the Government to design and for Parliament to decide. The role of Parliament is to see the issues in the round and to identify the unintended consequences. I fear that there are several unintended consequences in this Bill, and we must try to put those right in the Committee stage.
The noble Lord, Lord Clement-Jones, rightly outlined the generosity of the public in donating organs. In whatever way we legislate, we must ensure that that generosity is not put at risk. The Minister mentioned retaining confidence. Of course, that is crucial. In order to do that, I think that three main areas need to be addressed in the Bill. The first is clarity; the second is proportionality; and the third is practicality. The Bill must work in practice.
With regard to clarity, as noble Lords have said, the Bill started life with a great deal of confusion. Much of that has been reduced by the amendments made in the Commons, but I think that some areas remain foggy. Several of your Lordships mentioned those. They are linked to anonymity, the breadth and duration of consent, and the distinctions between research and training and training for research. I also believe that the definitions of certain terms in the Bill need to be clarified.
Regarding proportionality, one of this nation's great successes has been our ability to invent and discover. We have a proud record of discovery. Twenty-five of the world's 100 top-selling medicines were discovered and developed in the United Kingdom. That is more than in any other country except the United States. Clearly, we want to cherish and enhance that.
I am concerned that a great deal of research is funded through research charities on five-year grants. When I have talked to researchers, they have said that on average it takes about two years to carry out the preliminary work in order to set up a research grant. That clearly leaves them only three years in which to do the work.
If the Bill is enacted unamended, I think that research will probably take longer and I fear that the scientists will think, "Is this really worth doing?
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Worse, I may infringe the regulations either through ignorance or through inadvertent mistakes. If I do that, there is a possibility that I could be prosecuted. There is even a possibility, albeit a remote one, that I could be sent to prison". Do we really want to criminalise our research community? I think that that is disproportionate. There are other disproportionate measures; for instance, as the noble Lord, Lord Turnberg, said, having to go to the High Court for permission. However, I am sure that more of that will be explored in Committee.
Finally, I want to talk about practicalities. I am not an academic. I am a Martha rather than a Mary. I like to see practical things happen. I want to cite four examples of where the practicalities, even at this moment, are difficult. First, the current Department of Health guidelines allow 24 hours for next of kin to give consent for removal of tissue. This means that certain types of tissuefor example, brainwill be of limited or no use to researchers as the delay affects their quality. Schizophrenia researchers in Oxford have been unable to acquire a single brain for research since 1999. Will the Bill, when enacted, ensure that such research can be safeguarded? From watching the "Panorama" programme the other night on Alzheimer's, we know how much brain research is essential for our future health as a nation.
The second example concerns a group of doctors in 2002. They were associates of the International Society of Nephrology and decided to set up an international study on a rare kidney condition; a very unpleasant disease which affects many children between the age of five and 15. Two items were required: first, access to the tissue, which was then archived, and secondly, anonymous linkage to the patients, so that clinical progress could be corrected with the tissue appearances.
An application was made to the ethics committee. Ethical permission was refused on two grounds: first, that consent from the patients or their relatives must be sought, which was considered impossible by the British investigating team, as many of the patients had died; and, secondly, that the information about their clinical course could not be released, albeit anonymously, without the patient being identified personally as that infringed the Data Protection Act. The British arm of the study was therefore abandoned and only carried out in other countries. In his opening remarks the Minister mentioned research projects which had been abandoned, and probably this was one of them. If the Bill is enacted with enormous clarity, will it safeguard future studies of this kind?
Thirdly, as part of the QUASAR multicentre study for colorectal cancer, a questionnaire was sent to GPs asking their attitudes to seeking consent from their patients for the research use of archival tissue samples. About 20 per cent of the GPs replied. Of those who did, they either refused to help or said that they would expect payment for the work. A typical fee expected was £50 per patient. A further questionnaire to patients indicated that they did not want to be asked and the study was allowed to proceed without consent. It is worth noting that in its present form the Bill would
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make most teaching of cervical cytology illegal without consent as a cytological opinion requires histological confirmation of the diagnosis, so the diagnostic process must be complete. Such consent would have to be requested by a GP. Can we be confident that we shall have the co-operation of GPs once the Bill is enacted so that future cytology studies will be able to be pursued?
Lastly, in Leeds a section was introduced into the surgical consent form where the patient was asked to indicate consent or objection to the subsequent use of any residual material for research or teaching. An audit showed that only 48 per cent of specimens received in the laboratory had traceable consent forms. Of those which were found, 40 per cent did not have the "tissue" section completed. This method did not address blood samples where explicit consent for taking the sample is not recorded.
Interestingly, in the Leeds study, of the completed forms, only 0.8 per cent of participants objected to research use. Bearing in mind the generosity and the willingness of the general population to recognise and value research, is it not possible to design some sort of mechanism, possibly using a swipe card so that we are not into mounds of paper, indicating a general consent?
My purpose in highlighting these examples is to question whether the new measures in the Bill will ease rather than exacerbate research. I very much look forward to the Minister's response, to the work the Government will do in Committeeand I, too, have heard the comment made by the noble Baroness, Lady O' Neill, that this Bill has been described as a sledgehammer that misses the nut. Perhaps a little more skill and a lighter touch would be of benefit to our population as a whole.
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