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Ms Winterton: It will be important to distinguish between removing a person's organs for transplantation purposes, where the screening issue is clearly vital, and consent in respect of a deceased person. In the latter circumstances, different considerations might have to be taken into account. As I have said, the Bill will simply adopt and make clear existing best practice. That should reassure the medical research community, and the proposals need give it no cause for anxiety.

The Bill also introduces a new element to the question of consent. It provides that an individual may nominate another person to take decisions about tissue and organ retention, storage and use after his or her death. Where a person has not made their own wishes known and has not nominated another person, such responsibility will then revert to the next of kin, who would be empowered to take those decisions. Their consent would be needed, in contrast with the rather unclear formulation in the current human tissue legislation.

There is one other aspect of consent and part 1 that I should deal with before I move on. Clause 7 deals with tissue that is already held—what the Bill refers to as "existing holdings". This is tissue and organs currently stored from a variety of sources and for various purposes. The Bill simply provides for this to be lawfully

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kept and used. A pragmatic approach to the treatment of currently held tissue is vital. There is immense value in current archives, and it is important that we allow research options to remain open; but at the same time, respectful and appropriate disposal should take place where necessary. We have therefore provided for the new Human Tissue Authority to give guidance on the use and disposal of such tissue. Careful guidance from the Department is already in place. It was subject to lengthy consultation with researchers, families and other groups. That can assist in providing for a sensible approach to the future use of current archives.

Members will doubtless realise that anything more than a cursory view of this issue will show how complex and sensitive it is. Part 2 therefore proposes a regulatory system to oversee the implementation of this overarching legislation.

Mr. David Wilshire (Spelthorne) (Con): I should point out that I hope to catch your eye, Madam Deputy Speaker, although not on this specific point. Before the Minister leaves the subject of consent, I draw her attention to clause 2, which deals with appropriate consent in respect of children. The Bill defines children as those under 18, and clause 2(4) states:

In other words, we are talking about not the parents' consent, but the child's "in writing". How will we handle the need for specimens from infants, who are not yet able to understand and cannot, therefore, give consent themselves?

Ms Winterton: We are talking about anatomy—the dissection of whole bodies—which is why we have said that specific prior consent is needed. But the Anatomical Society has made it very clear to us that it is not the practice for examinations such as those to which the hon. Gentleman refers to take place on small children. The children referred to under that clause will be linked to the "Gillick test", to see whether they are able to give that consent.

The new Human Tissue Authority will be given the task of ensuring that the use of whole bodies, tissue and organs is regulated, in keeping with the legal and ethical standards that we have come to expect.

Clause 13 sets out the licensing role of the authority. As I have said before, it will also be necessary to license the use of bodies for public displays such as the "Bodyworlds" exhibition. The authority will consist of members appointed by the Secretary of State and will issue codes of practice. It will have the power to vary, revoke or suspend licences where the necessary conditions have not been met. In establishing the new authority, we are streamlining the regulatory arrangements already in place. Regulation of tissue banks, which is likely to become mandatory under the proposed EU tissue directive, will be carried out by the new authority.

Dr. Iddon: I am grateful to the Minister for her continuing patience in giving way. My understanding is that the Bill licenses an individual who is the custodian

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of the tissue collection. How will an institution be able to continue if, for whatever reason, that person either dies or leaves the institution suddenly?

Ms Winterton: The licence will continue through the person to whom it is then transferred. The Human Tissue Authority will issue guidance on exactly how that process will be continued.

Clause 44 will contribute to expanding the scope for transplants by making it clear that steps may be taken to preserve organs while it is established whether there is consent to donation for transplantation. Clause 29 extends the current prohibition on commercial dealing in tissue under the Human Organ Transplants Act 1989. Clauses 46 and 47 make it an offence to have human material with intent to analyse its DNA without consent or for certain specified purposes. That provision responds to a recommendation of the Human Genetics Commission.

Finally, under clause 49, the Bill will allow certain national museums to de-accession human remains—that is, to move them out of their collections; for example, in response to claims from the descendants of indigenous people. The statutory constitution of those museums currently prevents them from de-accessioning such remains, even where they may want to do so. Removing that barrier will fulfil a commitment that the Prime Minister made jointly with John Howard, at a meeting in July 2000, that they would increase efforts to repatriate human remains to Australian indigenous communities.

The Bill provides a comprehensive response to a range of issues that have caused grief and distress to individuals, families and communities, but that have also created uncertainty among our medical and research communities. There is no doubt that many people suffered when they discovered that the organs of their loved ones had been kept without their knowledge. That must not happen again, and the aim of the Bill is to ensure that it does not. At the same time, we must create a framework to support research and development in science and medicine. With this Bill we can restore confidence and move from a difficult past to a stable and progressive future, and I commend it to the House.

2.31 pm

Mr. Andrew Lansley (South Cambridgeshire) (Con): I am grateful to the Minister of State for taking so many interventions and for beginning the process of considering the Bill with some care. I am sure that the House is grateful for the care with which she went through some aspects of the measure.

It is more than four years since the then chairman of the Association of Community Health Councils first raised concerns about the unauthorised retention and use of human tissue. Of course, the CHCs are no longer with us to undertake that function. Shortly after that, as the Minister said, as evidence was being gathered for the inquiry into the tragic deaths of children at Bristol royal infirmary, it became clear that tissue and organ banks had been set up at many other places, in many cases without proper consent. Indeed, the Redfern report on Alder Hey set out the especially shocking extent, in that case, of the clandestine acquisition of human organs, especially children's organs.

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As the Minister said, the chief medical officer's report, in 2000–01, illustrated the wide extent of organ and tissue retention. It is proper to say that the vast majority of cases had nothing of the clandestine character of the acquisition and retention of tissue demonstrated at Alder Hey, but were pursued according to what was regarded as normal practice. That is why we must be so careful to get the structure of the legislation right; we must ensure that normal practice has changed, continues to change and is properly buttressed by law.

It was not due only to the events at Alder Hey and Bristol that the retention of organs gave rise to considerable distress. Many Members from all parts of the country will share my experience in my constituency and will have met families of those whose relatives' organs or tissues were retained without consent or, in some instances, directly contrary to their expressed wishes. One of my constituents told me of the loss of their son in a road accident in 1984. At the time, they did not wish any of his organs to be retained after the coroner's post-mortem and were assured by the undertaker that that was the case and that their son had been buried intact. Members will thus appreciate the family's distress when they made inquiries—at the time of the press reports on the Alder Hey findings—and found that Addenbrookes hospital, in my constituency, had in fact retained their son's appendix. After systematic collection and examination of the hospital records—as the chief medical officer required of hospitals—the family found that not only had their son's appendix been retained, but also his thymus. On successive occasions, many years later, they had to arrange further interment of their son's remains. Their concerns and suspicion about whether their son had been buried with his brain are unresolved, as there are no longer any records that would give them that information.

Addenbrookes is a major teaching hospital so there was a substantial number of such retained tissue and organs, and a support network was set up by the affected families. I met them in late 2001 and since then have tried to work on their behalf to have legislation introduced. My colleagues and I are thus very much in favour of the principles behind the Bill and the desirability of proceeding with it. What has impressed me about my constituents has been their willingness to go beyond the pain and distress caused by the fact that tissues were retained and organs had to be buried. They want to ensure that such things never happen again and are working with the Retained Organs Commission and in the consultations to which the Minister referred so that the structure is right for patients and for families in the future. There will be much debate on the measure and I shall refer later to the many questions that arise about the detail of the Bill, and I hope that the House will recognise that we would be committing a disservice to those families if we did not maintain our determination that, in future, the retention of organs should be undertaken only with fully informed consent.

As a constituency Member, I have represented not only the families of patients whose tissues and organs were retained but also the researchers, because much medical research is carried out in Cambridge. There was thus a difficult balance for me to strike when I discussed

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the case that I mentioned earlier, which was covered in the Isaacs report, with both the constituent and the pathologist in question. It was perfectly clear that, in the majority of cases, pathologists had no malign intent; they were working according to what they believed was, in effect, normal practice in many parts of the national health service—retaining organs on the basis that they would be of value for future research, which, in the case covered by the Isaacs report, was a brain bank for research into mental illness. The pathologists believed that the practice was desirable and, as they explained, they did not want to put families through the pain and distress of having to consent to the retention of organs. However, they put those families through much pain and distress, and I hope that many people who had no malign intent at the time accept that what happened was wholly wrong and must not happen in the future.

We must strike that balance of which I was only too aware. We need to ensure that there is a supply of tissues and organs for transplantation and research, but without prejudicing the principle of fully informed consent. We need a new legal structure. As the Minister said, it must incorporate the previous structure relating to anatomy, anatomical examination and anatomists.

It is fair to say that we are not working on the basis of abuse by anatomists, but that we want to incorporate them in a consistent legislative structure, with an additional regulatory structure that provides the necessary assurances.

I want to repeat a point about which I intervened on the Minister earlier. I have pressed for legislation on this matter since 2002, and have asked Ministers about the progress being made. The Minister said that it was agreed that a fundamental review of the law was needed before legislative proposals were introduced, but it was always clear that the matter was urgent. The chief medical officer's first recommendation was that the Human Tissue Act 1961 needed urgent amendment, to enforce the requirement for consent. That did not happen because a legal framework was required, but the urgency noted by the CMO was not negated.

We have been asking for that legislation since 2002, and the Government accepted that the provisions should be introduced as soon as possible. Colleagues in all parties believe that these provisions would have been suitable for pre-legislative scrutiny, and I am disappointed that that has not happened. Pre-legislative scrutiny turns the principles and intended purposes of legislative proposals into draft form, so that all parties concerned with the practicalities of a piece of legislation, and its future interpretation, can determine whether a Bill will serve its purpose.

The draft version of this Bill should have been published in July, but was in fact published in December. Now, in mid-January, the royal colleges, the Council of Heads of Medical Schools, the Wellcome Trust and other bodies are saying that the draft proposals are too complicated and do not give the necessary assurances and clarity. Proper pre-legislative scrutiny would have put that right.

Perhaps we can solve those problems in Committee. This debate is not about the programme motion, but the Minister is asking the House to complete consideration of the Bill by three weeks from today. That means that we will have to get on with it, and there will not be much

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time for evidence to be taken. I am sure that the Minister will not chide me for reminding her that I asked before Christmas for a Special Standing Committee to be set up. I wanted not to delay the Bill, but to ensure that we could take evidence from some of the organisations involved. There are not many of them, but their evidence could have helped with the way in which the Bill was drafted. However, the Minister wanted to expedite the Bill's passage through the House, and felt that a Special Standing Committee would not be appropriate. I am sorry about that, as I think that that approach would have been better.

We must get the scrutiny of the Bill right, and we have only three weeks in which to do it. A number of organisations do not believe that the Bill is as clear as it should be. I have mentioned the Royal College of Pathologists, which was closely involved in the workshops and consultation that took place last year. It maintains that the Bill lacks clarity, and that it fails to establish a structure that ensures that appropriate consent is sought by health care professionals, on whom pathologists subsequently have to rely. That is an interesting point, and the consultation did not deal with it adequately. We must make sure that the necessary consents are taken, on behalf of pathologists, at the front line of the health care system. Pathologists will be at risk if the consents taken for the retention of tissues and organs do not serve the purposes of researchers. Front-line health care professionals must be given an appropriate structure for taking consents.

The RCP also questions the extent of the record-keeping and information-flow requirements that will be needed as a result of the consent process. The estimate is that 3 million solid-tissue samples, and ten times as many blood samples, will be involved. It is clear that, even with the information management and technology programme in the NHS, it will be intensely difficult to manage information flows on that scale. In the immediate future, consent for the use of many tissues and organs may take the form of a written note but, for data protection reasons, those records will not necessarily be available to researchers. We must ensure that the consents will be passed on to researchers in a way that makes sense.

The RCP makes constructive points in relation to about one third of the total number of clauses contained in the Bill. I hope that the Standing Committee can reflect the college's close interest in the matter, and its constructive approach.

The Council of Heads of Medical Schools also questions the clarity of the Bill. It is concerned about the scope for the code of practice to be extended into statutory requirements that might give rise to penalties if the code is breached. That is, a breach of the code might amount to an offence that carries a criminal penalty. I know that the Minister has said that we must not worry, as the code of practice will be based on current best practice. However, we need to ensure that that best practice is adequately translated into the code of practice, and we must then consider the code alongside the Bill.

Codes of practice are often published with the Bills to which they refer, but the relevant code for this Bill is not available yet. In particular, we need that part of the code that deals with the retention of human tissues and organs. That is very important, but there is a substantial

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difference between what is current best practice and what actually happens. Under the Bill, people who fail to comply with the code of practice may expose themselves to prosecution for a criminal offence. I hope that, when he responds to the debate, the Under-Secretary of State for Health, the hon. Member for South Thanet (Dr. Ladyman), will assure the House that we will be able to see the draft code of practice as the Bill proceeds through the House. In that way, hon. Members can be reassured on this matter.

The heads of the medical schools also say that they do not consider the Bill to be in line with the practicalities of clinical medicine and pathology. We will want to test that proposition in Committee, as we must achieve congruence in that respect.

The Wellcome Trust has raised a number of concerns with hon. Members. One problem is the risk of criminalising currently legitimate research, especially in connection with the new offence of testing DNA. It is also concerned about the definition of DNA analysis in this context. I hope that, with the help of greater experts on this matter than me, we can make progress on that matter in Committee and determine how to deal with it.

The Wellcome Trust also wants assurances about the provision for consultation by the Human Tissue Authority, a point that relates to what I said about codes of practice. It is also keen for the House to be able to put under proper scrutiny what the authority proposes. As I understand it, the authority will be able, through its code of practice, to extend the definition of what constitutes a criminal offence. We need to be sure that the House understands what is intended to be a criminal offence, and what is not.

The Bioindustry Association has raised a concern for which I have some sympathy, although we must be careful in our response to it. The Bill retains the provision that makes trafficking in human material and body parts a criminal offence, but the association is worried that currently legitimate commercial activities could be criminalised. Those activities involve research using human tissues, or transferring those tissues between organisations. I want to be sure that the Bill recognises that there is a commercial element to research, and I think that the Under-Secretary of State was probably engaged in such commercial activity at one time. It must not be criminalised, as it makes a vital contribution to the development of new therapeutic methods and drugs. We must be sure that we are not trespassing on legitimate research.

It will be apparent that many of the concerns that have been raised are about maintaining the extent and quality of medical research, clinical investigation or education. We have to achieve a balance between the necessity of securing fully informed consent and the desirability of supporting medical research. However, I want the Minister to be aware that such concerns do not derive only from medical research organisations and those working in pathology. Conservative Members, too, want to examine some issues more carefully.

On the definition of consent, we need to be sure that we are clear about who gives consent and under what circumstances, and that consent is given for the specific purposes that are set out in schedule 1, which deals with purposes normally requiring consent. Sometimes specific purposes are consented to, while in some

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circumstances it is reasonable that generic consent could be given to the whole range of scheduled purposes to prevent people from stepping into criminal activity at a later stage.

We also need to be clear, as I suggested to the Minister in the Adjournment debate on 29 April, that, especially from the point of view of families of those who have died, the consent that is given relates to specific kinds of tissues or organs. In the past, people often gave their consent to the retention of tissues because it had been explained to them that that would be necessary for the purposes of the post-mortem analysis to establish the cause of death, and they understood that that might be necessary in relation to bodily fluids, for example, but they were not thinking of major organs.

This morning, Dr. Mark Wolpert of the Wellcome Trust made a similar point from the standpoint of medical research, saying that there was often a distinction in the minds of families between the retention of small amounts of tissue such as skin, blood or fluid samples and major organs. Indeed, from the point of view of researchers there is an order of magnitude of difference between the retention of tissue samples and of whole organs. In that context, if we require detailed consent, the maintenance of records, and returning to families tissue blocks and slides for small amounts of tissue, compliance will be highly burdensome.

Nobody, whether in the medical research world or in the families concerned, wants a system whereby to be sure that one has legal cover, front-line health care staff will have to ask for consent for the retention of relevant human material for all the purposes in schedule 1. The explanation that is given to families may not necessarily make it clear that whole, sometimes major, organs are going to be retained. We have to avoid reaching that position. We therefore need to think hard about whether we can build into the Bill or the code of practice a provision that distinguishes where major organs will be retained so that families understand that before any organs are taken from their loved ones. The "Human Bodies, Human Choices" consultation specifically addressed that. The Government have decided not to set off down that path, but I hope that they will reconsider, because the phrase "relevant human material" does not adequately convey the variety of organs and tissues that require specific consent.

In due course, wherever possible, consent should be given in an explicit fashion in relation to major organs and the process should normally be related to specific purposes. However, in order to relieve the burden on medical research, we might be able to contemplate generic consent for other tissues and samples in relation to the whole set of scheduled purposes.

The issue of nominated representatives needs to be dealt with, because it is not yet sufficiently clear. The spouse and partner question in the Bill is linked to other legislation that is forthcoming this year, and I hope that we can clarify the relationship between them. Grandparents are not currently reflected in the structure of qualifying relationships; that has been mentioned to me by at least one hospital.

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Then there is the question of arbitration. As the Bill stands, if those in a qualifying relationship and more than one person at the same rank in the qualifying relationship differ, the consent of one could be accepted even if it was contrary to the wishes of the other. We need to be certain that that is what we intend. Complicated family arrangements might surround a person who has died. In a dispute about qualifying relationships, not many people in the health service will want to be responsible for arbitrating who is in what qualifying relationship to an individual and how they should be ranked in all the circumstances that can apply. We should consider whether we can give those NHS staff an easy way in which to pass the problem on to some form of independent arbitration, perhaps even to the Human Tissue Authority, thereby absolving the health service of the responsibility. Failing that, the situation could seriously interfere with the relationship between the clinical team and the family of someone being treated.

This House should determine the possible extent of a criminal offence—it should not be left to the Human Tissue Authority—and I hope that we can do that in the course of our scrutiny of the Bill. I also hope, notwithstanding the desire to achieve a seriously enforced regulatory system, that we can minimise the burden imposed by the licensing requirement, which could otherwise be very substantial. We heard about some of the difficulties involved in the question of who a licensed designated individual is, how that is passed on to others, where the premises to which it applies are, and so on. The licensing process itself may be relatively straightforward, but the requirement to go back to the Human Tissue Authority to notify variations in the licensing may be so burdensome that it adds many thousands of pounds per year to the cost, because there will be somebody working more or less full time to tell the authority which individuals have entered or left a pathology department, which parts of a hospital are the appropriate premises for such purposes, which purposes are being acted on and what kinds of tissues are involved. The structure may become very complex if we do not try to ensure that it is minimised.

On consent, the code of practice should allow families and patients sometimes not to receive information. That was part of the consultation, and I know that the Government have it in mind, but it is not reflected in the Bill. There must be a way in which families can be offered the full information that ought to accompany consent, but are not required to have it, in order subsequently to protect those who have received tissues and organs that were so consented.

The Bill provides a necessary reform to which we can give our support. The system has to be clear and practical and has to be built on the principle of consent. I will not seek to direct my colleagues on how to think or vote about this issue when the time comes—they will be able to make those judgments for themselves.

On presumed consent, I share the Minister's view that the evidence from Spain, on which I have corresponded, does not necessarily point so much to a structure of presumed consent as to an efficient and effective structure of organisation in hospitals to provide information and to form a basis on which consent is freely given. Let us leave that to one side. My personal

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view is that in a Bill whose purpose is to make the giving of organs the subject of a positive decision based on fully informed consent, the concept of presumed consent does not count as consent at all. It is directly contrary to the underlying principle of the Bill. I would find it difficult to say to the public, "Under all normal circumstances, if you want to assist medical progress in the future, we have to explain in great detail to you what will happen and obtain your consent, but if you want to assist medical intervention now, we can just take the organs and presume that you have given consent." That is inconsistent.

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